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Narrow Networks/Allergen Of The Year

Confronting Narrow Networks, Workplace Shortages, and Lengthy Wait Times
Hypoallergenic and Other Hyporeliable Marketing Terms
And the Winner is . . . Formaldehyde!
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Dear Reader,

Health care these days is a moving target. Despite the endless changes and challenges ahead, however, there is a sustained need for skilled patch testers, a need that promises to deepen as provider networks are narrowed. If, as discussed in our lead article, there is already a shortage of practitioners in medical dermatology, clinicians will have to find ways to conduct patch testing as efficiently and effectively as possible.

Because undeniably, patch testing is an important and necessary diagnostic. The socioeconomic burden, let alone the personal costs, of skin diseases and disorders is enormous. Identifying an allergen underlying a patient’s allergic contact dermatitis through patch testing is just one way to help control spiraling medical costs—and to change lives. Once patients have received their diagnosis, clinicians must help them develop an allergenavoidance strategy, which includes becoming aware of the vagaries involved in product labeling—what isn’t regulated just may surprise you. We also invite you to take a new look at an old allergen—formaldehyde, the 2015 Allergen of the Year.

In our own quest to serve as the best possible partner for you, we have launched the Contact Dermatitis Institute (CDI) through which we hope to foster research and education involving all things contact dermatitis. Please take a look at the website (contactdermatitisinstitute.com) to get acquainted, and check back often to see how this growing endeavor can support your patch testing efforts.

Sincerely,
Dr. Curt Hamann
President & CEO, SmartPractice

Confronting Narrow Networks, Workplace Shortages, and Lengthy Wait Times

Since implementation of the Affordable Care Act (ACA) has your practice become part of a “narrow network”—a limited provider network selected for inclusion on a Medicare Advantage (MA) or state exchange health care plan managed by an insurance payer with the expectation of offering consumers less costly, more value-based health care? Or, perhaps, you have experienced the flip side: removal from an MA plan without warning or explanation. Either way, the overall result is a reduction in the number of contracted physicians. What will the effect be on medical dermatology in particular?

The impact could be considerable, especially given that medical dermatology is perceived as suffering from a workforce shortage based on several analyses by Resneck and colleagues. As reported in 2004, almost half of the respondents to a survey distributed in 2002 by the American Academy of Dermatology Association (AADA) believed that their area needed more dermatologists, and about a third of the responding practices reported that they were actively searching for new associates, a percentage that was unchanged in a similar survey conducted in 2007. With the relatively static training capacity of residency programs in dermatology, practices increasingly turned to physician extenders. The percentage hiring a physician assistant increased from 15 to 23% while those hiring a nurse practitioner increased from 8 to 10%. The majority of practice time was reported as still devoted to medical dermatology. As of 2007, however, 29% of dermatologists already spent the majority of their working time on surgical and cosmetic dermatology. If that trend continues, the capacity to treat skin conditions will likely be reduced further.

Data on wait times for new patients, which is considered a reflection of demand for services, support this concern. In the 2002 AADA survey, the mean wait time for 33 states was 36 calendar days. In the 2007 survey, the overall mean wait had decreased slightly to 33 days. Recently, however, Resneck and colleagues analyzed wait times in 12 different metropolitan areas in the United States based on scripted phone calls to the offices of physicians listed in the largest MA plans for appointments for a fictitious new patient. A decade after Resneck and coworker’s initial analysis of the AADA data, the overall mean wait time was 45.5 days. The different methodologies used in the two analyses, both of which have many limitations, are not strictly comparable. Nonetheless, the 25% increase in wait time is large enough to suggest that clinician capacity remains inadequate and is likely shrinking in many areas. This trend is apparent in more than half of the states included in both analyses (below) while wait times were about the same in fewer than 20% of the states and had improved in about 27%.

Furthermore, this latest analysis from Resneck and coworkers found that the MA physician directories included a worrisome number of inaccuracies. Of 4,754 physician listings, 45.5% were duplicates (e.g., multiple offices for the same physician). Of the remainder, callers were unable to contact 17.9% (e.g., wrong or nonworking phone numbers); 8.5% represented physicians who had died, retired, or moved; and 8.5% were not accepting new patients. Still others did not even accept the plan in which they were listed. Fewer than half the physicians listed who were reached and who did accept the plan offered an appointment for the fictitious patient. The authors assumed that the maturity of the MA marketplace would translate into relatively stable physician listings, but their findings indicate that the number of available dermatologists was substantially overestimated. The results also heighten concerns about the accuracy of the information included in the directories of the much newer ACA exchange plans

Together, the above data indicate that the capacity to meet the demand for medical dermatology services will be further challenged if narrowing of networks continues. A reduction in capacity would be the case in many areas even if misallocation of dermatologists is the root cause rather than an actual shortage as some physicians believe. Regardless, the current practice environment is challenging; yet, challenges also bring opportunities. So what opportunities are available for patch test clinicians while regulatory frameworks are being developed to ensure the adequacy of networks?

We at SmartPractice are here to partner with you to find the unique solutions that will help build your patch test clinic. Our ready-to-use patch test products require no preparation time and are suitable for screening or for combining with standard series to reduce the number of petrolatum or liquid allergens that must be dispensed. Using TruVol™ to dispense petrolatum allergens will ensure that your patch testing is consistent and reliable over time. The SmartPractice Allergen Bank can customize panels when you need to patch test with rare allergens that may not be cost effective for your office to purchase. And we are excited to introduce our new Learning Modules devoted to patch testing, building your practice, and all things contact dermatitis. To explore this new opportunity to learn more about how to provide your patients the diagnosis that they deserve, visit contactdermatitisinstitute.com.

Estimates of Mean Appointment Wait Times (days)a in Selected States Across Time
State, 2004b, 2014c
Arizona, 41, 39
Arkansas, NA, 30
California, 28, 42
Florida, 33, 20
Indiana, 47, 25
Massachusetts, 37, 71
Michigan, 39, 15
New Jersey, 23, 22
New York, 23, 135
Ohio, 40, 51
South Carolina, 35, 40
Washington, 31, 52
aFor new patients. bBased on a survey of members of the American Academy of Dermatology Association. cBased on scripted phone calls to dermatologists listed in directories of the largest Medicare Advantage plans in 12 metropolitan areas in the United States.

References
Resneck JS, Jr, Quiggle A, Liu M, Brewster DW. The accuracy of dermatology network physician directories posted by Medicare Advantage Health Plans in an era of narrow networks. J Am Med Assoc Dermatol 150(12): 1290-1297, 2014

Hypoallergenic and Other Hyporeliable Marketing Terms

Patch testing in healthy, North American children has been shown to be safe, and diagnosing allergic contact dermatitis in children can improve their lives by sparing them both physical and psychological discomfort. Until recently, however, reports of patch testing in children have been relatively rare. In fact, the first multicenter pediatric trials in North America were not published until 2008. The findings showed that the sensitivity rates to allergens in children were similar to those found in adults and that there was considerable overlap in the most common allergens between the two populations. The 10 most common pediatric allergens were nickel, neomycin, cobalt, fragrance, Myroxylon pereirae (balsam of Peru), gold, formaldehyde, lanolin/ wool alcohols, thimerosal, and potassium chromate. Based on adult patch test data from the North American Contact Dermatitis Group, these allergens correspond to 60% of the top 10 allergens and to 80% of the top 20 allergens while they correspond to 70% of the top 10 and 80% of the top 20 allergens in the most recent series of adult patch testing data from the Mayo Clinic.

Diagnosing allergens in children can be tricky enough, but helping to establish avoidance strategies for them and their parents can be even more complicated—especially when marketing terms can further cloud the process. Caretakers want to recommend and parents want to ensure that their children are using “hypoallergenic” products. This label is often applied to personal-use products intended to contact the skin such as cosmetics, hair products, or cleansers. But what exactly does the term mean? What allergens are covered under the umbrella hypoallergenic? What about other commonly encountered advertising terms such as “paraben free,” or “dermatologist/doctor recommended”? What dermatologist, doctor, or group made the recommendation? What were their qualifications? Is “fragrance free” the same as “unscented”? Just how reliable are these phrases as an index of the sensitizing potential of a product?

Although companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure that their products are safe and properly labeled, use of the term, hypoallergenic, is not regulated by the U.S. Food and Drug Administration (FDA). It is a marketing term intended to indicate that it will cause fewer skin reactions than other comparable products. However, neither caregivers nor consumers can take it for granted that a sensitized or atopic individual will not react to one or more ingredient in a product bearing the label, hypoallergenic. A company can define the term as it wants—use of the claim does not require any substantiation to be submitted to the FDA or to any other regulatory agency.

Few people probably understand the difference between fragrancefree and unscented. To the typical reader of labels, both terms likely suggest that the ingredients of a product contain no compound(s) associated with an odor. Unscented, however, is applied to products to which the manufacturer may have added just enough fragrance to hide an unpleasant smell related to other ingredients, but does not confer a noticeable scent. In essence, the term unscented often means that a masking scent has been used. In contrast, fragrance-free implies that no odorant or scent has been added to a product. The lack of fragrance alone, however, does not ensure that the product contains no potential allergens.

A recent evaluation of cosmetics labeled as hypoallergenic and intended for pediatric use underscores the challenges associated with identifying products that can be used safely in sensitized or atopic children. Of the 187 products labeled as hypoallergenic, dermatologist recommended/test, fragrance free or paraben free, 167—89%— contained one or more contact allergens included on the standard screening tray of the North American Contact Dermatitis Group (NACDG). Altogether, 37 potential allergens were identified in the products. The mean number of allergens in each product was 2.4. When analyzed by the individual marketing terms, one or more contact allergen was contained in 80% of the products with the label of dermatologist/doctor recommended, in 81% of those labeled as fragrance free, and in 90% of those labeled paraben free. As many as 11% of all the products even contained 5 or more allergens!

The 10 most common allergens in the products (below) did not include any of the 10 most common pediatric allergens as discussed above. However, about a third of the 37 identified allergens have been suggested for inclusion in a proposed North American standard series for children. Of the 10 allergens, 9 are on the standard tray of the NACDG (below). Methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI) were the seventh and eighth most prevalent allergens in the products, respectively. Both compounds, which are frequently used as a chemical preservative in infant wet wipes, liquid soaps, shampoos, and protective creams, have been noted to be highly relevant allergens for pediatric patients. Furthermore, in the minds of many expert patch testers, the recent increase in sensitization to these compounds has reached epidemic proportions (see the September 2014 issue of this newsletter). Indeed, the American Contact Dermatitis Society selected MI as the 2014 Allergen of the Year, and its use in cosmetics is about to be banned in the European Union.

If used by the wrong (i.e., sensitized or atopic) patient, all of the products tested have the potential to elicit or exacerbate allergic contact dermatitis. Furthermore, the number of products tested was relatively small compared to what is available on the market—especially when global markets are considered. Regulatory clarification of how labels can be applied to products fairly may be needed, but none are forthcoming in the United States. For now helping patients understand the limitations of labeling and providing them continuing education on products free of their allergen of concern is the only viable option. Once patients have the diagnosis that they deserve, your practice can add value to their experience—to their lives—by serving as a conduit to the resources that they need. And SmartPractice is here to help you in this process!

Ten most prevalent allergens identified in 187 pediatric products
Allergen, Present in number (%) of products, Frequency of Positive Patch Test Reactions (NACDG data) in adults
Cocamidopropyl betaine, 45(24.1), 1.4
Beeswax/propolis, 35(18.7), 2.1
Phenoxyethanol, 33(17.6), 1.5
Tocopherol/Vitamin E, 25(13.4), 1.0
DMDM Hydantoin, 24(12.8), 1
Lavandula angustifolia (lavender) extract, 24(12.8), 0.2
Methylisothiazolinone, 21(11.2), 2.5a
Methylchloroisothiazolinone, 20(10.7), 2.5a
Propylparaben, 20(10.7), Not tested
Decyl glucoside, 19(10.2), 1.5aMI and MCI were tested together as a mix in the NACDG study

References
Hamann CR, Bernand S, Hamann D, et al. Is there a risk using hypoallergenic cosmetic pediatric products in the United States? (letter to editor). J Allergy Clin Immunol, Nov 2014. Accessed January 12, 2015. DOI:10.1016/j.jaci.2014.07.066
Jacob SE, Admani S, Herro EM. Invited Commentary: Recommendation for a North American Pediatric Patch Test Series. Curr Allergy Astham Rep 14:444, 2014. DOI:10.1007/sll882-014- 0444-6
Admani S, Jacob SE. Allergic contact dermatitis in children: Review of the past decade. Curr Allergy Asthma Rep 14:421, 2014. DOI: 10.1007/s11882-014-0421-0
Wentworth AB, Yiannis JA, Keeling JH, et al. Trends in patch-test results and allergen changes in the standard series: A Mayo Clinic 5-year retrospective review (January 1, 2006, to December 31, 2010). J Am Acad Dermatol 70: 269-275, 2014
Warshaw EM, Belsito DV, Taylor JS, et al. North American Contact Dermatitis Group Patch Test Results: 2009-2010. Dermatitis 24(2): 50-59, 2013

And the Winner is . . . Formaldehyde!

Anew year brings us a new Allergen of the Year from the American Contact Dermatitis Society. Why was this year’s choice formaldehyde? This simplest of aldehydes (CH2 O) has much to recommend it for being singled out for our attention. First, it is nearly ubiquitous in our environment and has been recognized as a top allergen for 75 years. Formaldehyde was associated with positive reactions in 5.8% of 4305 individuals patch tested by North American Contact Dermatitis Group and ranked as the seventh most prevalent allergen. Based on testing at the Mayo Clinic reported in 2014, 7.8% of 3093 individuals had positive reactions to formaldehyde. In that study, it ranked as the tenth most common allergen. Furthermore, formaldehyde is one of only five substances (along with para-phenylenediamine; epoxy resins with ethylenediamine, diethyldiamine, and diglycidyl ethers; powdered orris root; and oil of bergamot) considered as strong sensitizers by the United States Consumer Product Safety Commission.

Formaldehyde has a colorful history. It was discovered in 1859 by a Russian chemist, Butlerov, during the incomplete combustion of carbon. It was quickly adopted for embalming, which was practiced during the American Civil War (1861-1865). About 20 years later Robert Koch found that the cholera bacteria, Vibrio cholera, could be transmitted via food and water. His discovery launched a call for government-regulated sanitation for the food industry and the need for an antimicrobial additive, a purpose for which formaldehyde appeared to be well suited. During an outbreak of bubonic plague among the Chinese population of San Francisco in 1912, Chinatown was dusted with a mixture of lime and formaldehyde to control the outbreak. And in the early 1950s, formaldehyde was important in the development of the polio vaccine when Dr. Jonas Salk used it to kill the polio virus. The use of formaldehyde also helped propel the plastics industry into a $500 billion industry.

Because formaldehyde forms a gas at room temperature, perhaps today many first think of or first come in contact with this colorless liquid when it is used as a tissue fixative—anyone who has ever taken a biology class remembers its pungent, characteristic odor. The biocidal properties of formaldehyde, coupled with the ability to produce it relatively inexpensively, made formaldehyde popular as a preservative. It helps prevent spoilage, bacterial and fungal contamination, and biological degradation.

Hence, formaldehyde or a related compound has been used in many cosmetics such as mascara, blush, foundation, shampoos (including baby shampoo), body washes, soaps, baby wipes, lotions and creams, nail polish, nail hardeners, and medical creams such as topical wart removers. The chemical also may be found in other consumer products such as cleaning agents; fabric softeners; permanently pressed clothing; and paper products such as facial tissue, table napkins, and roll towels. In 2006 its use in hair straightening, antifrizzing products was introduced. As recently as 2011, the Food and Drug Administration (FDA) issued a warning that the products used for Brazilian blowout hair treatments contained dangerous levels of formaldehyde, but hair-smoothing products are exempt from labeling laws. Formaldehyde can be found in cigarette smoke and can be a break-down product of aspartame, which is used as an artificial sweetener. It occurs naturally in coffee, caviar, smoked ham, and cod. Avoidance of dietary intake of formaldehyde has been reported to ameliorate dermatitis.

Formaldehyde can also be encountered in many industrial products. It is used to make construction materials such as plywood; asphalt shingles; waterproof glues; and automobile parts such as gears, bearings, transmissions, electrical systems, engine blocks, door panels, axles, and brake shoes. It is also an important component of the plastics industry.

However, formaldehyde is highly toxic and considered a known carcinogen by many experts. Consequently it has been banned from use in cosmetics and toiletries in Japan and Sweden. In the European Union, its use in personal care products is restricted, and labeling is required. In Canada the concentration of formaldehyde that can be used is restricted. In the United States, the Occupational Safety and Health Administration requires an occupational hazard alert if the level of formaldehyde exceeds 0.1%.

Avoiding formaldehyde is complicated because formaldehyde itself may not be added to many personal products, but it is released by other ingredients used as a preservative. Use of such formaldehydereleasing preservatives (FRPs) was instituted under the assumption that they would release too little formaldehyde to be of concern. FRPs, which contain a small, detachable moiety of formaldehyde, include, from most to least formaldehyde releasing, quaternium-15, diazolidinyl urea, dimethyloldimethyl hydantoin, imidazolidinyl urea, and 2-bromo-2-nitropropane-1,3-diol (bromopol). As a result of the use of FRPs, formaldehyde may not always be included on product labels. According to the FDA database known as the Voluntary Cosmetic Registration Program, about 20% of personal hygiene products contain an FRP. Whether FRPs represent a risk to formaldehydesensitive patients is debated, but most release more than 200 ppm, which is sufficient to induce allergic contact dermatitis.

At-risk occupations for sensitization to formaldehyde include beauticians, textile workers, painters, printers, paper processors, individuals who work with disinfectants, embalmers, pathologists, machinists, food preparation workers, and health care workers (even dermatologists)! Distribution of the allergic reaction can help determine the underlying source of exposure. Being aware of product ingredients is always a challenging part of allergen avoidance. Other terms considered essentially synonymous with formaldehyde are methylene glycol, formalin, methylene oxide, paraform, formic aldehyde, methanol, oxomethane, oxymethylene, timonacic acid, and thiazolidinecarboxylic acid. Educating patients to look for FRPs, and not just formaldehyde and its synonyms, when they read labels is a crucial part of the allergen-avoidance strategy.

References
Pontén A, Bruze M. Formaldehyde. Dermatitis 2015; 26(1): 3-6
Vazirnia A, Jacob SE. Review ACDS’ Allergen of the Year 2000-2015. The Dermatologist 22(11), 2014. Accessed January 12, 2015. http://www.the-dermatologist. com/content/review-acds%E2%80%99-allergen-odyear-2000-2015
Jacob SE, Steel T, Rodriguez G. Focus on T.R.U.E. Test Allergens #21, 13, and 18: Formaldehyde and formaldehyde-releasing preservatives. The Dermatologist 13(12), 2005. Accessed January 12, 2015. http://www.the-dermatologist.com/article/5158
Yim E, Baquerizo Nole KL, Tosti A. Contact dermatitis caused by preservatives. Contact Dermatitis 25(5):215-231, 2014

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