1 Patterns of Use of OTC Topical Hydrocortisone Presented by Charles N. Ellis, MD Professor of Dermatology University of Michigan Medical School, and Chief of Dermatology Ann Arbor Veterans Affairs Medical Center March 24, 2005

2 Disclosure Research sponsored by GlaxoSmithKline. GlaxoSmithKline is compensating me for my time and expenses; I am on a vacation day from the VA. I have served as a regular or occasional consultant to companies that sell topical corticosteroids: Connetics, Ferndale, Fujisawa, Galderma, GlaxoSmithKline, and Pfizer. I have no relevant stock, equity, etc.

3 J Am Acad Dermatol (in press) * “Consumers appropriately self-treat based on labeling for over-the-counter hydrocortisone” * Today’s public presentation approved by Editor, Jeffrey Bernhard, MD

4 What Our Research Has Shown About Use of Topical Hydrocortisone Reported use is largely consistent with the OTC monograph label. The percentage of use in accordance with the label is similar for both adults and children. OTC HC is used primarily for brief periods for treatment of apparently minor conditions.

5 Background Hydrocortisone 0.5% available OTC since 1979, 1% since 1990 OTC monograph label is designed for safe use Compliance with the label = low risk of AEs We found no published data on how OTC hydrocortisone is being used in the population

6 Research Objective Research on real-world user behavior Performed by Synovate through one of their regular national telephone surveys Evaluate patterns of use of OTC hydrocortisone As reported by users  Included adults’ reports of use in children  Reason for using, frequency, and duration of use Evaluated for consistency with the labeling

7 Methods and Numbers Random digit-dialing to 64,235 households in US  2,000 adult respondents completed the survey 396 adults reported using OTC HC in the last 6 months 168 households reported treating a child with OTC HC in the last 6 months

8 Analysis Data weighted to represent US demographics of the 2002 National Health Interview Survey (NHIS) Limitation Self-reports Strengths Open-ended questioning, without reference to the label, to avoid biasing respondents Asked about the youngest child at home who used OTC HC (who may be most at risk for AEs)

9 OTC HC Label Uses: eczema; psoriasis; poison ivy, oak, sumac; insect bites; detergents; jewelry; cosmetics; soaps; seborrheic dermatitis; external anal and genital itching Age (2 and over) Frequency (max 3-4 times daily) External use only Not diaper rash Avoid contact with the eyes Duration (up to 7 consecutive days)

10 Reported Use Tended to be Consistent with the HC Label Note: Data based on an overall calculation including condition treated, frequency and duration of use, and age of child. Condition was most common reason for non-consistent use.

11 Conditions Treated by 83% of Adults and for 86% of Children Were Consistent with the Label “The last time you used an over-the-counter hydrocortisone product...what were you using that product to treat?” 83%86%

12 In 93% of Reported Uses on Youngest Child, Age of Child Was 2 Years or Older Note: Dash line indicates non-compliant use “Think about your youngest child who has used over-the-counter hydrocortisone in the last 6 months. How old is that child?”

13 92% of Adults, 94% of Children Treated for 7 or Fewer Days Note: Dash line indicates non-compliant use; X axis not to scale “The last time you used an over-the-counter hydrocortisone product, how many days in a row did you use the hydrocortisone?”

14 98% of Adults, 97% of Children had 4 or Fewer Applications per Day Note: Dash line indicates non-compliant use “And how many times per day did you use the hydrocortisone product?”

15 Conclusion Reported use of an OTC topical corticosteroid is largely consistent with the label for conditions treated and for frequency and duration of use.