1. health and fitness
2. disease
3. allergies

ISSUE
11
MARCH
2015
all things contact dermatitis
™
NEWS & NOTES
in thi s i ssue
Confronting Narrow Networks, Workplace Shortages, and Lengthy Wait Times P1
Hypoallergenic and Other Hyporeliable Marketing Terms P3
And the Winner is . . . Formaldehyde! P4
Confronting Narrow Networks, Workplace Shortages,
and Lengthy Wait Times for Appointments
S
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.
Kind Regards,
Dr. Curt Hamann
President & CEO, SmartPractice
ince 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 (Table 1) 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
Continued on next page
1
Confronting Narrow Networks, Workplace
Shortages, Lengthy Wait Times…continued
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.
the art and science of smart patch testing®
State-of-the-Art Patch Test Chambers
Economical, easy to use, provide excellent adhesion, consistent
performance and optimized for patient comfort
allergEAZE patch test chambers
on nonwoven polyester
•
allergEAZEclear on moistureresistant clear polyurethane
•
866.903.2671
smartpractice.com/dermatology
JOIN the CONVERSATION!
Are you a health care professional looking to develop
your skills in the area of patch testing?
Table 1.Estimates of Mean Appointment Wait Times in Selected States Across Time
State
a
Mean Wait Time (days)a
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
For 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.
Reference:
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
2
As a member of CDI you get access to:
Online Education: Exclusive access to education and resources to help
you develop your patch test clinic.
News Updates: Read the latest news in contact dermatitis, and find out
what you need to know to stay informed and connected.
CDI Community: Connect with peers year round on the CDI community
boards. Post your most interesting case reports, blogs and research!
contactdermatitisinstitute.com
Hypoallergenic and Other Hyporeliable Marketing Terms
P
atch 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 (Table 1) 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 (Table 1). 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!
Table 1. 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)
1.5
MI and MCI were tested together as a mix in the NACDG study.
a
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/sll882-0140444-6
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
3
And the Winner is . . . Formaldehyde!
A
new 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 (CH2O) 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
Standardize Your Patch Test Clinic with
TruVol Precision Allergen Dispenser
smartpracticecanada.com
4
Accurately delivers a standardized dose
(20 μl) with each use
800.878.3837 l truvol.com
81635-B_0315 © 2015 SmartPractice Canada • All rights reserved