1

Patterns of Use of OTC Topical Hydrocortisone

Presented by Charles N. Ellis, MDProfessor of Dermatology

University of Michigan Medical School, andChief of Dermatology

Ann Arbor Veterans Affairs Medical CenterMarch 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 LabelUses: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 beConsistent with the HC Label

Note: Data based on an overall calculation including condition treated, frequency and duration of use, and age of child.

4%

21% 22%

73%

2%4%

72%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Adults Children

Perc

ent

Consistent

Use Not Consistent: 1Reason

Use Not Consistent: 2Reasons

Use Not Consistent: 3Reasons

Condition was most common reason for non-consistent use.

110%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Adults Children

Pe

rce

nt

Used on conditionsconsistent w/ label

Other (+ vague and nocondition reported)

Cracking skin

Cuts

Fungus, arthritis, acne,diaper rash

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?”

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Age of Youngest Child (Years)

Cum

ulat

ive

Per

cent

age

13

92% of Adults, 94% of ChildrenTreated 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?”

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6 7 8-14 15-30 30-90 >90

Duration of Use(Number of Consecutive Days of Use)

Cu

mu

lativ

e P

erce

nta

ge

Adults

Children

14

98% of Adults, 97% of Childrenhad 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?”

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6 7 8 9 10

Frequency of Use(Number of Applications per Day)

Cu

mu

lati

ve P

erce

nta

ge

Adults

Children

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.