Clinical Commentary Review
Are You Comfortable With Over-the-Counter Intranasal Steroids for Children? A Call to Action Gary Rachelefsky, MD, FAAPa, and Judith Rosen Farrar, PhD, FAAAAIb The early expression of allergic rhinitis in children is a potential red flag for lifelong problems and comorbid conditions. However, treating pediatric allergic rhinitis in the United States is trending toward a self-management or parental management model with little clinical supervision, which reflects changes in the delivery of health care. Of particular concern are the recent approval of an over-the-counter intranasal steroid to treat nasal allergy symptoms in adults and children as young as age 2 years and the push for a retail model of health care as exists in some other countries. For children with allergic rhinitis, treating nasal symptoms alone with over-the-counter products may further delay a diagnosis that is often already ignored due to its “annoyance factor” as opposed to being considered a serious health issue. How to ensure an appropriate diagnosis and management for these children remains a challenge, regardless of who is doing the treating. The call to action is for allergists and allergy medical organizations to drive the effort to ensure awareness of the why and how for appropriately diagnosing and treating allergic rhinitis in children. Starting points for the discussion are provided. Ó 2014 American Academy of Allergy, Asthma & Immunology (J Allergy Clin Immunol Pract 2014;2:271-4) Key words: Allergic rhinitis; Pediatric rhinitis; Childhood rhinitis; Intranasal steroids; Over-the-counter; Pharmacy; Pharmacist; Health care provider; Allergy specialist
Allergic rhinitis (AR) in childhood is common and can adversely affect quality of life for both the child and the family. Treatment almost always starts at home, and medical decision making usually is in the hands of a primary care specialist, a trend that is not likely to be reversed despite comparative data that suggest better outcomes when pediatric AR is managed by allergists.1-3 In their 2013 review of pediatric AR, Gentile et al1
a
Center for Asthma, Allergy, and Respiratory Diseases, Geffen School of Medicine at University of California Los Angeles, Los Angeles, Calif b Life Sciences Press, Canandaigua, NY No funding was received for this work. Conflicts of interest: The authors declare that they have no relevant conflicts of interest. Received for publication August 19, 2013; revised December 16, 2013; accepted for publication January 21, 2014. Available online March 29, 2014. Corresponding author: Gary Rachelefsky, MD, FAAP, Executive Care Center for Asthma, Allergy, and Respiratory Disease, Geffen School of Medicine at UCLA, 1131 Wilshire Blvd, Suite 202, Santa Monica, CA 90401. E-mail: gary@ rachelefsky.com. 2213-2198/$36.00 Ó 2014 American Academy of Allergy, Asthma & Immunology http://dx.doi.org/10.1016/j.jaip.2014.01.006
Los Angeles, Calif; and Canandaigua, NY
noted that the clinical management of these children is likely to “shift even more into the primary care arena” due to evolving reimbursement patterns by insurers and changes in prescription and/or over-the-counter (OTC) status of medications. Indeed, on October 11, 2013, it was announced that the US Food and Drug Administration (FDA) approved the intranasal steroid (INS) spray, triamcinolone acetonide (Nasacort Allergy 24HR; Sanofi US, Bridgewater, NJ) for OTC use to treat nasal allergy symptoms (nasal congestion, runny nose, sneezing, and itchy nose) in patients as young as 2 years of age.4 Other INS will undoubtedly follow.
WHO CHOOSES INTRANASAL STEROIDS FOR PEDIATRIC ALLERGIC RHINITIS: AN EVOLVING PARADIGM All guidance documents recommend INS for patients who have moderate-to-severe AR,5-8 and the body of evidence strongly supports the superiority of INS over all other classes of medications for these patients: adults and children.1,9-11 It is especially important to treat early symptoms of AR in children. AR can have serious lifelong consequences, and treating children early with INS may improve disease control, which reduces the risk of developing comorbid conditions.11 In a theoretical sense, the role of INS in AR treatment is not disputed by any health profession involved in treatment choice, including allergy specialists, primary care practitioners, and pharmacists.12-14 However, globally, the use of INS in primary care has lagged behind recommendations, a trend that has been attributed to concerns about the potential adverse effects of the drugs on the hypothalamic pituitary adrenal axis; on eyes; and, in children, on growth.15,16 Early concerns about the effect of INS on growth were largely based on 1 study that showed reduced growth rates associated with beclomethasone dipropionate nasal spray;17 separate studies of mometasone, fluticasone furoate (FF), and budesonide were negative.18-20 However, subsequent studies designed to meet stricter requirements from the FDA revealed growth inhibition with the INS, FF, and TAA.21,22 It is not clear whether catch-up growth occurs so that final adult height is reached. However, for asthma, a long-term study of school-age children treated for 4 to 6 years with low doses of inhaled corticosteroids showed little or no catch-up growth,23 which raises the concern that INS also might affect final adult height. In addition, children who use inhaled corticosteroids along with INS may be at increased risk of growth effects due to the combined corticosteroid load, although there currently are no data. The FDA will continue to require INS to have labeling about potential adverse effects on growth, but the playing field has changed. Now that parents can choose to give their child an OTC INS without clinical supervision, how to monitor growth in relation to INS usage becomes an important consideration. The OTC label for TAA will 271
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Abbreviations used AR- Allergic rhinitis FDA- US Food and Drug Administration FF- Fluticasone furoate INS- Intranasal steroid OTC- Over-the-counter TAA- Triamcinolone acetonide
include information about the potential slowing of growth for some children as well as a recommendation that the nasal spray not be used for more than 2 months a year without seeing a physician.4 Ultimately, it will be up to the parents or caregivers to be mindful of these recommendations. So, regardless of the continued debate about using INS OTC, the reality is in play. Other INS, particularly those with higher therapeutic ratios and less patent life, will undoubtedly appear on the pharmacy shelves in the next few years, where, as with TAA, parents will be able to use them for their children’s nasal allergy symptoms, and,
J ALLERGY CLIN IMMUNOL PRACT MAY/JUNE 2014
without the supervision of a trusted clinician, that is really all a parent or caregiver can do, treat the symptom, not the disease. Selecting an OTC medicine for a child with a runny or stuffy nose is already a choice complicated by the number of medicines on the shelves. There are no data on how parents “try medicines” to help their child with “common ailments,” such as allergies, hay fever, or the common cold, but results of surveys have shown that parents often rely on information from multiple sources, including family members, friends, other parents, and product information on the box.24 For many OTC products, how information appears on the box, or on the label, is problematic. Analysis of data has shown that consumers often have difficulty understanding what is presented regardless of their level of education, but estimates that show that up to 25% of US parents have limited health literacy are especially troubling when it comes to choosing the right OTC medicine for a child.25,26 Making the scenario more complicated is the fact that parents may not understand or may not know about changes in regulations or recommendations regarding how a medicine should be used. This
TABLE I. The call to action: some discussion points for moving forward Keep information about AR simple, easy to use, and consistent for all For health professionals, distill the key points from current guidance audiences: health professionals as well as parents, caregivers, and documents* and provide straightforward tools to help with the diagnosis, children. choosing treatment, and when to refer to the allergy specialist. For parents, answering the following questions is important: (1) when is it AR, (2) when is an INS the appropriate choice, (3) how do I give a nasal spray to my child, (4) what do we need to know about adverse effects, and (5) why and when should I bring my child to a physician? The importance of “nontypical” symptoms for identifying AR in children Convey the message that AR in children goes beyond nasal allergy symptoms, and that early diagnosis is important to reduce a lifelong (eg, “persistent colds,” chronic cough, recurrent otitis media, mouth breathing, snoring, daytime tiredness or lack of energy, irritability and impact of the disease, including comorbidities, such as asthma, otitis behavioral changes, problems in school or daycare)† should be included media, and sinusitis. in messaging to health professionals and parents. Parents should be advised, through media and pharmacy interactions, to have their child evaluated by a physician. Simplify the presentation of drug information on packaging and on the label Format with words and pictures.z For OTC INS, this includes how to so that it is easily understood by parents and older children. administer a nasal spray and clear information about dosing and local adverse effects as well as information on possible growth inhibition (without being scary). There also should be a way to notify parents about label and use changes, including actions for the parents to take in such situations. Electronic databases will be useful for follow-up. Consider requiring parents and/or caregivers to talk to a health professional This could be done by keeping OTC-approved INS on the other side of the before purchasing an INS for their child. counter, with the prescriptions, rather than on the shelves, so that the pharmacy could monitor use. Either the parent would have a prescription, with an assumption of education on use at the clinic or the parent would require counseling in the pharmacy before purchase. At the least, there should be discussion at the point of sale. Use all media available to reach parents, caregivers, and children. The medium is the message, especially for today’s parents. It is important to have information about AR as well as tools to help parents understand how to treat their child available through multiple media, particularly, online, which reflects how today’s parents (and caregivers) access information. Involve all members of the health care community in data acquisition. More studies are needed to both further assess how early diagnosis and appropriate treatment of AR in children reduce the risk of disease progression and expression of comorbid conditions as well as to understand how to optimize outcomes in the evolving OTC culture. The availability and use of expanding electronic databases should help with this effort. *From Refs 5-8. †From Refs 1-3, 11. zFrom Ref 24.
J ALLERGY CLIN IMMUNOL PRACT VOLUME 2, NUMBER 3
was illustrated by parents’ general lack of awareness about the 2007 FDA public health advisory that OTC cough and cold medicines not be used in children younger that 2 years old.27 Improving label formats has been recommended by a number of health organizations to reduce confusion and unintentional misuse of OTC medicines but with no commitment to do so at this time.27 There is an opportunity for TAA, as the first OTC INS, to provide a new, user-friendly label with clear pictures and easy-to-read text that depicts how to administer the nasal spray as well what to expect in terms of benefits and adverse effects; whether the manufacturer will do so is not known.
A RETAIL MODEL FOR HEALTH CARE DELIVERY Aside from the obvious issues of appropriate use and lack of clinical supervision, the approval of TAA OTC (and other prescription products in similar manner) supports observations that suggest that our health care system may be moving beyond a primary care model to a pharmacy or retail clinic model such as is found in other countries.14,28,29 We need to pay attention to ongoing efforts to increase the use of the retail pharmacy in the delivery of patient care. For example, a recent editorial in the American Journal of Pharmacy Benefits states that “pharmacists should replace other health care providers (ie, physicians),”29 not as sole providers of health care, but as part of a team effort, which would allow physicians to focus more on “complex patients and complex problems.”29 Whether pharmacists and retail clinics meet training requirements for patient care remains in question, but lower costs and increased access are already garnering support for this option. In the context of pediatric AR, what are the implications for children? Would pharmacists be able to identify AR in these children? By assuming so, would they then be able to recommend who should use an INS and oversee their treatment, or will they be required to work with other clinicians through a team approach? A CALL TO ACTION FOR ALLERGISTS Managing AR in children goes beyond controlling nasal symptoms with OTC medicines, and most pharmacists along with primary care health professionals undoubtedly recognize this fact. However, the onset of AR symptoms in early childhood is a red flag for potentially serious lifelong impact,11 and that message, and appropriate early diagnosis of the child, could be overlooked in the evolving health care paradigm. On the one hand, increasing reliance on OTC medicines to treat nasal allergy symptoms in children is likely to delay diagnosis and appropriate management of the disease. On the other hand, the OTC culture is not going away. How to prepare parents, pharmacists, and primary care health professionals to appropriately use OTC INS for children with AR is a challenge, the response to which would best be driven by allergy specialists. How to do so is a discussion that is beyond the scope of this article, although some recommendations are provided as a starting point (Table I). It is imperative that we start this discussion now and that the leadership for this effort comes from the professional allergy societies. REFERENCES 1. Gentile D, Bartholow BS, Valovirta E, Scadding G, Skoner D. Current and future directions in pediatric allergic rhinitis. J Allergy Clin Immunol Pract 2013;1:214-26.
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2. Meltzer EO, Blaiss MS, Derebery J, Mahr TA, Gordon BR, Sheth KK, et al. Burden of allergic rhinitis: results from the Pediatric Allergies in America Review. J Allergy Clin Immunol 2009;124(Suppl):S43-70. 3. Rachelefsky GS. National guidelines needed to manage rhinitis and prevent complications. Ann Allergy Asthma Immunol 1999;82:296-305. 4. Brooks M. FDA OKs OTC Triamcinolone. Medscape, October 11, 2013. Medscape [serial online]. Available at http://www.medscape.com/viewarticle/ 812522. Accessed October 21, 2013. 5. Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, et al. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol 2008;122(Suppl):S1-84. 6. Scadding GK, Durham SR, Mirakian R, Jones NS, Leech SC, Faroque S, et al. BSACI guidelines for the management of allergic and non-allergic rhinitis. Clin Exp Allergy 2008;38:19-42. 7. Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica CW, Casale TB, et al. Allergic rhinitis and its impact on asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol 2010;126:466-76. 8. Roberts G, Xatzipsalti M, Borrego LM, Custovic A, Halken S, Hellings PW, et al. Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology. Allergy 2013;68:1102-16. 9. Benninger M, Farrar J, Blaiss M, Chipps B, Ferguson B, Krouse J, et al. Evaluating approved medications to treat allergic rhinitis in the United States: an evidence-based review of efficacy for nasal symptoms by class. Ann Allergy Asthma Immunol 2010;104:13-29. 10. Lohia S, Schlosser RJ, Soler ZM. Impact of intranasal corticosteroids on asthma outcomes in allergic rhinitis: a meta-analysis. Allergy 2013;68:S69-79. 11. Rachelefsky G, Farrar JR. A control model to evaluate pharmacotherapy for allergic rhinitis in children. JAMA Pediatr 2013;167:380-6. 12. Stoloff SW, Hadley JA, Meltzer EO. Closing thoughts: implications of the findings from the National Allergy Survey Assessing Limitations for the Management of Allergic Rhinitis in America. J Fam Pract 2012;61(Suppl 1): S23-8. 13. Laine C, Goldmann D. In the clinic: allergic rhinitis. Laine C, Goldmann D, eds. Ann Intern Med 2007;146:ITC4-1-16. 14. Members of the workshops, Allergy. Bousquet J, van Cauwenberge P, Khaltaev N, eds. ARIA in the pharmacy: management of allergic rhinitis symptoms in the pharmacy. Allergy 2004;59:373e387. 15. Fokkens WJ. Nasal corticosteroids, first choice in moderate to severe allergic rhinitis. What prevents general practitioners from using them? Allergy 2003;58: 724-6. 16. Bousquet J, Lund VJ, van Cauwenberge P, Bremard-Oury C, Mounedji N, Stevens MT, et al. Implementation of guidelines for seasonal allergic rhinitis: a randomized controlled trial. Allergy 2003;58:733-41. 17. Skoner DP, Rachelefsky GS, Meltzer EO, Chervinsky P, Morris RM, Seltzer JM, et al. Detection of growth suppression in children during treatment with intranasal beclomethasone dipropionate. Pediatrics 2000; 105:e23. 18. Schenkel EJ, Skoner DP, Bronsky EA, Miller SD, Pearlman DS, Rooklin A, et al. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray. Pediatrics 2000;105:e22. 19. Allen DB, Meltzer EO, Lemanske RF Jr, Philpot EE, Faris MA, Kral KM, et al. No growth suppression in children treated with the maximum recommended dose of fluticasone propionate aqueous nasal spray for one year. Allergy Asthma Proc 2002;23:407-13. 20. Murphy K, Uryniak T, Simpson B, O’Dowd L. Growth velocity in children with perennial allergic rhinitis treated with budesonide aqueous nasal spray. Ann Allergy Asthma Immunol 2006;96:723-30. 21. Phase 4 fluticasone furoate nasal spray (VERAMYST) long-term pediatric growth study. Clinical Trial NCT00570492 (GlaxoSmithKline). Available at: http://clinicaltrials.gov/ct2/show/results/NCT00570492? term¼allergicþrhinitis&intr¼fluticasone&rank¼24§¼X36015. Accessed October 16, 2013. 22. Study of triamcinolone acetonide on the growth velocity of children, ages 3 to 9, with perennial allergic rhinitis (PAR). Clinical Trial NCT00449072. Available at: http://www.clinicaltrials.gov/ct2/show/results/NCT00449072? term¼triamcinolone&age¼0&safe¼Y&rank¼1§¼X601. Accessed October 16, 2013. 23. Kelly HW, Sternberg AL, Lescher R, Fuhlbrigge AL, Williams P, Zeiger RS, et al. Effect of inhaled glucocorticoids in childhood on adult height. N Engl J Med 2012;367:904-12. 24. Gray NJ, Boardman HF, Symonds BS. Information sources used by parents buying non-prescription medicines in pharmacies for preschool children. Int J Pharm 2011;33:842-8.
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25. Yin HS, Parker RM, Wolf MS, Mendelsohn AL, Sanders LM, Vivar KL, et al. Health literacy assessment of labeling of pediatric nonprescription medications: examination of characteristics that may impair parent understanding. Acad Pediatr 2012;12:288-96. 26. Yin HS, Johnson M, Mendelsohn AL, Abrams MA, Sanders LM, Dreyer BP. The health literacy of parents in the United States: a nationally representative study. Pediatrics 2009;124(Suppl 3):S289-98.
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27. Varney SM, Berbata VS, Pitotti RL, Vargas TE. Survey in the emergency department of parents’ understanding of cough and cold medication use in children younger than 2 years. Ped Emerg Care 2012;28:883-5. 28. Ryan D, Levy M, Morris A, Sheikh A, Walker S. Management of allergic problems in primary care: time for a rethink? Primary Care Respir J 2005;14:195-203. 29. Berger JE. Solving the obstacles to retail pharmacy as part of the healthcare solution. Am J Pharmacy Benefits. September/October 2013:182.
Are You Comfortable With Over-the-Counter Intranasal Steroids for Children? A Call to Action Gary Rachelefsky, MD, FAAPa, and Judith Rosen Farrar, PhD, FAAAAIb The early expression of allergic rhinitis in children is a potential red flag for lifelong problems and comorbid conditions. However, treating pediatric allergic rhinitis in the United States is trending toward a self-management or parental management model with little clinical supervision, which reflects changes in the delivery of health care. Of particular concern are the recent approval of an over-the-counter intranasal steroid to treat nasal allergy symptoms in adults and children as young as age 2 years and the push for a retail model of health care as exists in some other countries. For children with allergic rhinitis, treating nasal symptoms alone with over-the-counter products may further delay a diagnosis that is often already ignored due to its “annoyance factor” as opposed to being considered a serious health issue. How to ensure an appropriate diagnosis and management for these children remains a challenge, regardless of who is doing the treating. The call to action is for allergists and allergy medical organizations to drive the effort to ensure awareness of the why and how for appropriately diagnosing and treating allergic rhinitis in children. Starting points for the discussion are provided. Ó 2014 American Academy of Allergy, Asthma & Immunology (J Allergy Clin Immunol Pract 2014;2:271-4) Key words: Allergic rhinitis; Pediatric rhinitis; Childhood rhinitis; Intranasal steroids; Over-the-counter; Pharmacy; Pharmacist; Health care provider; Allergy specialist
Allergic rhinitis (AR) in childhood is common and can adversely affect quality of life for both the child and the family. Treatment almost always starts at home, and medical decision making usually is in the hands of a primary care specialist, a trend that is not likely to be reversed despite comparative data that suggest better outcomes when pediatric AR is managed by allergists.1-3 In their 2013 review of pediatric AR, Gentile et al1
a
Center for Asthma, Allergy, and Respiratory Diseases, Geffen School of Medicine at University of California Los Angeles, Los Angeles, Calif b Life Sciences Press, Canandaigua, NY No funding was received for this work. Conflicts of interest: The authors declare that they have no relevant conflicts of interest. Received for publication August 19, 2013; revised December 16, 2013; accepted for publication January 21, 2014. Available online March 29, 2014. Corresponding author: Gary Rachelefsky, MD, FAAP, Executive Care Center for Asthma, Allergy, and Respiratory Disease, Geffen School of Medicine at UCLA, 1131 Wilshire Blvd, Suite 202, Santa Monica, CA 90401. E-mail: gary@ rachelefsky.com. 2213-2198/$36.00 Ó 2014 American Academy of Allergy, Asthma & Immunology http://dx.doi.org/10.1016/j.jaip.2014.01.006
Los Angeles, Calif; and Canandaigua, NY
noted that the clinical management of these children is likely to “shift even more into the primary care arena” due to evolving reimbursement patterns by insurers and changes in prescription and/or over-the-counter (OTC) status of medications. Indeed, on October 11, 2013, it was announced that the US Food and Drug Administration (FDA) approved the intranasal steroid (INS) spray, triamcinolone acetonide (Nasacort Allergy 24HR; Sanofi US, Bridgewater, NJ) for OTC use to treat nasal allergy symptoms (nasal congestion, runny nose, sneezing, and itchy nose) in patients as young as 2 years of age.4 Other INS will undoubtedly follow.
WHO CHOOSES INTRANASAL STEROIDS FOR PEDIATRIC ALLERGIC RHINITIS: AN EVOLVING PARADIGM All guidance documents recommend INS for patients who have moderate-to-severe AR,5-8 and the body of evidence strongly supports the superiority of INS over all other classes of medications for these patients: adults and children.1,9-11 It is especially important to treat early symptoms of AR in children. AR can have serious lifelong consequences, and treating children early with INS may improve disease control, which reduces the risk of developing comorbid conditions.11 In a theoretical sense, the role of INS in AR treatment is not disputed by any health profession involved in treatment choice, including allergy specialists, primary care practitioners, and pharmacists.12-14 However, globally, the use of INS in primary care has lagged behind recommendations, a trend that has been attributed to concerns about the potential adverse effects of the drugs on the hypothalamic pituitary adrenal axis; on eyes; and, in children, on growth.15,16 Early concerns about the effect of INS on growth were largely based on 1 study that showed reduced growth rates associated with beclomethasone dipropionate nasal spray;17 separate studies of mometasone, fluticasone furoate (FF), and budesonide were negative.18-20 However, subsequent studies designed to meet stricter requirements from the FDA revealed growth inhibition with the INS, FF, and TAA.21,22 It is not clear whether catch-up growth occurs so that final adult height is reached. However, for asthma, a long-term study of school-age children treated for 4 to 6 years with low doses of inhaled corticosteroids showed little or no catch-up growth,23 which raises the concern that INS also might affect final adult height. In addition, children who use inhaled corticosteroids along with INS may be at increased risk of growth effects due to the combined corticosteroid load, although there currently are no data. The FDA will continue to require INS to have labeling about potential adverse effects on growth, but the playing field has changed. Now that parents can choose to give their child an OTC INS without clinical supervision, how to monitor growth in relation to INS usage becomes an important consideration. The OTC label for TAA will 271
272
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Abbreviations used AR- Allergic rhinitis FDA- US Food and Drug Administration FF- Fluticasone furoate INS- Intranasal steroid OTC- Over-the-counter TAA- Triamcinolone acetonide
include information about the potential slowing of growth for some children as well as a recommendation that the nasal spray not be used for more than 2 months a year without seeing a physician.4 Ultimately, it will be up to the parents or caregivers to be mindful of these recommendations. So, regardless of the continued debate about using INS OTC, the reality is in play. Other INS, particularly those with higher therapeutic ratios and less patent life, will undoubtedly appear on the pharmacy shelves in the next few years, where, as with TAA, parents will be able to use them for their children’s nasal allergy symptoms, and,
J ALLERGY CLIN IMMUNOL PRACT MAY/JUNE 2014
without the supervision of a trusted clinician, that is really all a parent or caregiver can do, treat the symptom, not the disease. Selecting an OTC medicine for a child with a runny or stuffy nose is already a choice complicated by the number of medicines on the shelves. There are no data on how parents “try medicines” to help their child with “common ailments,” such as allergies, hay fever, or the common cold, but results of surveys have shown that parents often rely on information from multiple sources, including family members, friends, other parents, and product information on the box.24 For many OTC products, how information appears on the box, or on the label, is problematic. Analysis of data has shown that consumers often have difficulty understanding what is presented regardless of their level of education, but estimates that show that up to 25% of US parents have limited health literacy are especially troubling when it comes to choosing the right OTC medicine for a child.25,26 Making the scenario more complicated is the fact that parents may not understand or may not know about changes in regulations or recommendations regarding how a medicine should be used. This
TABLE I. The call to action: some discussion points for moving forward Keep information about AR simple, easy to use, and consistent for all For health professionals, distill the key points from current guidance audiences: health professionals as well as parents, caregivers, and documents* and provide straightforward tools to help with the diagnosis, children. choosing treatment, and when to refer to the allergy specialist. For parents, answering the following questions is important: (1) when is it AR, (2) when is an INS the appropriate choice, (3) how do I give a nasal spray to my child, (4) what do we need to know about adverse effects, and (5) why and when should I bring my child to a physician? The importance of “nontypical” symptoms for identifying AR in children Convey the message that AR in children goes beyond nasal allergy symptoms, and that early diagnosis is important to reduce a lifelong (eg, “persistent colds,” chronic cough, recurrent otitis media, mouth breathing, snoring, daytime tiredness or lack of energy, irritability and impact of the disease, including comorbidities, such as asthma, otitis behavioral changes, problems in school or daycare)† should be included media, and sinusitis. in messaging to health professionals and parents. Parents should be advised, through media and pharmacy interactions, to have their child evaluated by a physician. Simplify the presentation of drug information on packaging and on the label Format with words and pictures.z For OTC INS, this includes how to so that it is easily understood by parents and older children. administer a nasal spray and clear information about dosing and local adverse effects as well as information on possible growth inhibition (without being scary). There also should be a way to notify parents about label and use changes, including actions for the parents to take in such situations. Electronic databases will be useful for follow-up. Consider requiring parents and/or caregivers to talk to a health professional This could be done by keeping OTC-approved INS on the other side of the before purchasing an INS for their child. counter, with the prescriptions, rather than on the shelves, so that the pharmacy could monitor use. Either the parent would have a prescription, with an assumption of education on use at the clinic or the parent would require counseling in the pharmacy before purchase. At the least, there should be discussion at the point of sale. Use all media available to reach parents, caregivers, and children. The medium is the message, especially for today’s parents. It is important to have information about AR as well as tools to help parents understand how to treat their child available through multiple media, particularly, online, which reflects how today’s parents (and caregivers) access information. Involve all members of the health care community in data acquisition. More studies are needed to both further assess how early diagnosis and appropriate treatment of AR in children reduce the risk of disease progression and expression of comorbid conditions as well as to understand how to optimize outcomes in the evolving OTC culture. The availability and use of expanding electronic databases should help with this effort. *From Refs 5-8. †From Refs 1-3, 11. zFrom Ref 24.
J ALLERGY CLIN IMMUNOL PRACT VOLUME 2, NUMBER 3
was illustrated by parents’ general lack of awareness about the 2007 FDA public health advisory that OTC cough and cold medicines not be used in children younger that 2 years old.27 Improving label formats has been recommended by a number of health organizations to reduce confusion and unintentional misuse of OTC medicines but with no commitment to do so at this time.27 There is an opportunity for TAA, as the first OTC INS, to provide a new, user-friendly label with clear pictures and easy-to-read text that depicts how to administer the nasal spray as well what to expect in terms of benefits and adverse effects; whether the manufacturer will do so is not known.
A RETAIL MODEL FOR HEALTH CARE DELIVERY Aside from the obvious issues of appropriate use and lack of clinical supervision, the approval of TAA OTC (and other prescription products in similar manner) supports observations that suggest that our health care system may be moving beyond a primary care model to a pharmacy or retail clinic model such as is found in other countries.14,28,29 We need to pay attention to ongoing efforts to increase the use of the retail pharmacy in the delivery of patient care. For example, a recent editorial in the American Journal of Pharmacy Benefits states that “pharmacists should replace other health care providers (ie, physicians),”29 not as sole providers of health care, but as part of a team effort, which would allow physicians to focus more on “complex patients and complex problems.”29 Whether pharmacists and retail clinics meet training requirements for patient care remains in question, but lower costs and increased access are already garnering support for this option. In the context of pediatric AR, what are the implications for children? Would pharmacists be able to identify AR in these children? By assuming so, would they then be able to recommend who should use an INS and oversee their treatment, or will they be required to work with other clinicians through a team approach? A CALL TO ACTION FOR ALLERGISTS Managing AR in children goes beyond controlling nasal symptoms with OTC medicines, and most pharmacists along with primary care health professionals undoubtedly recognize this fact. However, the onset of AR symptoms in early childhood is a red flag for potentially serious lifelong impact,11 and that message, and appropriate early diagnosis of the child, could be overlooked in the evolving health care paradigm. On the one hand, increasing reliance on OTC medicines to treat nasal allergy symptoms in children is likely to delay diagnosis and appropriate management of the disease. On the other hand, the OTC culture is not going away. How to prepare parents, pharmacists, and primary care health professionals to appropriately use OTC INS for children with AR is a challenge, the response to which would best be driven by allergy specialists. How to do so is a discussion that is beyond the scope of this article, although some recommendations are provided as a starting point (Table I). It is imperative that we start this discussion now and that the leadership for this effort comes from the professional allergy societies. REFERENCES 1. Gentile D, Bartholow BS, Valovirta E, Scadding G, Skoner D. Current and future directions in pediatric allergic rhinitis. J Allergy Clin Immunol Pract 2013;1:214-26.
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