Acknowledgements: I want to thank the following faculty members from University of Pittsburgh: Randy Juhl, PhD, Laurie Knepper,

MD, Josif Stakic, MD, Raquel Buranosky, MD, MPH, and Christine Ruby-Scelsi, PharmD, BCPS, and friends from Pfizer Consumer

Healthcare: William Bailey, PharmD, Michael Zielinski, PharmD, and Unicel-Anne Flores, PharmD for their guidance throughout the

duration of the project. The views expressed on this poster do not necessarily represent the views of the University of Pittsburgh,

Pfizer Inc., or any individuals listed above.

Rx-to-OTC Switch of an Antimigraine Drug: A Label Comprehension Pilot Study Justin A. Saver, PharmD Candidate Class of 2018; Randall B. Smith, PhD

University of Pittsburgh School of Pharmacy, Pittsburgh, PA

RX-TO-OTC SWITCH BACKGROUND

• Test consumer comprehension of OTC label

• What proportion of subjects demonstrate understanding of 18 pre-

defined communication objectives?

• Do >90% of subjects understand the 4 primary communication

objectives?

• Identify aspects of label that are potentially misleading, confusing, or

poorly worded and thus pose a risk to consumer health

• Identify the feasibility of migraine self-diagnosis based on ICHD-3

LABEL COMPREHENSION PILOT STUDY OBJECTIVES

COMMUNICATION OBJECTIVES

COMMUNICATION OBJECTIVES (cont.)

COMMENTS

Use 1. Imitrex® (sumatriptan) OTC is indicated to relieve pain and other symptoms of

migraine headaches. - PRIMARY

• does not treat any other types of headaches, prevent, or decrease

Directions4. The second tablet should be taken at least 2 hours after the first, if headache comes

back, does not improve, or if more relief is needed.

5. Do not take a second tablet if your migraine headache worsens.

• Do not take more than 4 tablets in 24 hours, for more than 2 days per week, or for

more than 10 days per month (whichever occurs first) .

Warnings 8. You should not use if you had or have a personal history of CAD, heart attack,

or arrhythmias. – PRIMARY

Warnings (cont.)9. You should not use if you have a history of stroke. – PRIMARY

• Ask a doctor before use if you have peripheral vascular disease, are being treated for

high blood pressure, or have risk factors for heart disease (smoking, diabetes, family

history, and hyperlipidemia).

• Ask a doctor or pharmacist before use if you take any medication for depression,

psychiatric, emotional conditions, Parkinson’s disease, or any other triptan

medications.

• You should not use if you have uncontrolled high blood pressure, your headache

began abruptly or suddenly .

• You should stop use and ask a doctor if you have symptoms of a heart attack.

18.You should stop use and ask a doctor if your migraine worsens. – PRIMARY

* Developed via analysis of Rx safety and efficacy data as well as clinician consult

METHODS1. Subjects were recruited using standardized recruitment script at The

Birmingham Free Clinic of Pittsburgh

2. Subjects passed initial demographic screening

• 18 or older, not a healthcare professional and never have worked in a

medical office, read English over a 4th grade level

3. Subjects given REALM-R assessment to test health literacy

4. Label comprehension study questionnaire instructions read to subjects

5. Subjects allotted unlimited time to review label

6. Label comprehension questionnaire administered

7. Migraine self-diagnosis questionnaire instructions read to subjects

8. Subjects allotted unlimited time to review side panel (patient friendly

diagnostic criteria)

9. Self-Diagnosis questionnaire administered*Surveys administered via Qualtrics™

*This study was approved as exempt by the University of Pittsburgh Institutional Review Board

RESULTS (cont.)

RESULTS (cont.)

Demographic Characteristics Number %

Age (years)

18-34 6/12 50

35-49 3/12 25

50 + 3/12 25

Sex

Male 8/12 67

Female 4/12 33

Race

White 7/12 58

African American 3/12 25

Hispanic/Latino 1/12 8

Other 1/12 8

Asian 0/12 0

Native Hawaiian or other Pacific

Islander0/12 0

American Indian or Alaskan Native 0/12 0

I don’t know/Refused 0/12 0

Demographic

CharacteristicsNumber %

Education

Less than high

school0/12 0

High School 4/12 33

Associates Degree 1/12 8

Bachelor’s Degree 5/12 42

Master’s Degree 2/12 17

Doctorate Degree 0/12 0

Health Literacy

• Mean REALM-R Score: 6.75 (1-8),

var. = 4.39, σ = 2.09

• 92% of subjects read at or above a

7th-8th grade level (REALM-R >4)

Previous Migraine Experience

• Migraine diagnosis = 33%

• OTC analgesic in last 6 months =

58%

• Migraine in last 5 years = 33%

• Any medication for migraines = 33%

Figure 1: Rx-to-OTC Process

Table 1: Enrolled Subject Demographics

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Obj. #1

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Obj. #18

Figure 2: Comprehension rate of communication objectives(% of enrolled subjects)

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REFERENCES1. Food and Drug Administration. Guidance for industry: label comprehension studies for nonprescription drug products. Silver Spring M.D.:

U.S. Department of Health and Human Services, 2010.

2. Food and Drug Administration. Guidance for industry: self-selection studies for nonprescription drug products. Silver Spring M.D.: U.S.

Department of Health and Human Services, 2013.

Label Comprehension Pilot Study• Approximately 42% of subjects did not fully understand the indication of Imitrex®

(sumatriptan) OTC – objective #1

• Question #1: “Can you tell me what Imitrex® (sumatriptan) OTC is used for?”

• Many subjects responded “migraines” → not considered a “correct” or “acceptable”

response

• Strategy: Re-phrase question #1/expand “acceptable” responses

• Approximately 83% of subjects did not understand communication objective #18

• Question #19: “Suppose you woke up you noticed that you had a migraine. You took

one tablet of Imitrex® (sumatriptan) OTC at 7 a.m. At around 10:30 a.m. your

headache started to get worse. You then took a second tablet of Imitrex®

(sumatriptan) OTC. Was this correct use of Imitrex® (sumatriptan) OTC?”

• Answering “no/incorrect” demonstrated comprehension of objective #18

• Answering “yes/correct” demonstrated comprehension of objective #4

• Objective #5 very similar to objective #18

• Objective #5/Question #6: Suppose you had a migraine headache, you took one

tablet of Imitrex® (sumatriptan) OTC, and your headache got worse. What should

you do?

• Strategy: highlight label element corresponding to objective #18

• Study setting may have been potentially distracting and sample was not truly “random”

• Noisy medical clinic type setting

• Many subjects observed not referencing label during study

• Strategy: add “According to the label,…” to questions

• Subjects considered medically “underserved” and/or uninsured → varying prior OTC

use experience

• Gray area with regards to exclusion of health professionals and those working in a

medical office Migraine Self-Diagnosis• Subjects able to correctly self-diagnose approximately 44% of the time

• No “behind-the-counter” class in US

• Strategy: FDA NSURE Initiative may aid in self-diagnosis