Prilosec 1 Label Comprehension Studies 02255 and12179

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Prilosec 1 Label Comprehension Studies 02255
and12179

• Karen Lechter, J.D., Ph.D.
• FDA
• Division of Surveillance, Research, and
  Communication Support
• Office of Drug Safety

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Overview

• Purpose of label comprehension studies
• 2 Prilosec 1 label comprehension studies
• Study 02255--general pop./self-selection
• Study 12179--appropriate use by special
  populations
• Issues about which we have concerns
• Implications for label

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21 CFR 330.10 (a) (4) (v)

• OTC labels must be
• likely to be read and understood by the ordinary
  individual, including individuals of low
  comprehension, under customary conditions of
  purchase and use.

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Study 02255 Participants

• N684 43 male 57 female
• 1. General population (N297)
• Frequent HB sufferers
• 2. low literate (lt8th gr. reading level N162)
• 3. high literate (N155)
• 4. HB sufferers taking drugs listed on label as
  requiring MD advice (N96)
• 5. Pregnant or nursing HB sufferers (N42)

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Study 02255--Product Purpose

• Product Purpose (open-ended question)
• High
• Response Gen.pop. Lit. Low Lit.
• Prevent frequent HB 39 39 36

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Study 02255--Episodic Use

• 3 questions about acute episodic relief
• range 48-55 correct (general cohort)
• 2 questions about acute episodic prevention
• range 54-61 correct (general cohort)

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Study 02255--Self-Selection

• Subgroup Correct/Acceptable
• Had labeled symptoms (85) 41
• Used labeled meds (96) 50
• After brand names 82

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Study 02255--Self-Selection Those who should not
use or should consult MD

• Subgroup Correct/Acceptable
• Total should not use (659) 67
• Non HB (137) 80
  
• Infreq. HB (92) 76
  
• Allergic to product (7) 86
  
• HB preg./nursing (42) 91
• continued...

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Study 02255--Applying the Label to Self and Others

• Self-selection questions suggest problem applying
  label to self
• Scenario responses about use with listed
  medications or medical conditions suggest good
  understanding but may be artifact

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Conclusion--Study 02255

• The tested label failed to convey adequately that
  Prilosec is not for episodic use
• It is not for acute HB symptoms
• It is not for prevention of meal-induced HB

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Conclusion--Study 02255

• It is not clear if consumers can apply the label
  well to their own situation if they require
  physician consultation because
• They are using medicines listed on the
• label, or
• They have health conditions listed on the
• label

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More Data Needed

• Further testing would help determine if the
  proposed label works better.

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Study 12179 Purpose

• Do consumers with medical conditions requiring
  physician consultation
• Understand they must see a physician before use?
• Understand the indication?
• Apply label information correctly about
  consulting a doctor before use with certain
  medical conditions?

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Study 12179 Participants

• N145 41 male 59 female
• Had frequent heartburn
• Had at least 1 condition mentioned on label as
  requiring physician consultation
• Were not taking medications listed on label as
  needing physician consultation

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Study 12179 Label

• Label similar to final proposed label, but listed
  6 medications requiring physician consultation,
  rather than 3

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Study 12179 Agency Analysis of Self-Selection
Question

• Include only those who should see a physician
  before use
• Eliminate those 40
• Taking Prilosec
• With infrequent chest pain or infrequent wheezing
• Analyze results for the 105 remaining
• All should have said they should not use or would
  consult a physician

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Study 12179 Scoring Differences with Sponsor

• Sponsor scored anyone who had ever discussed
  their condition listed on label with health care
  professional as OK to use the product.
• Agency did not score these participants as OK to
  use

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Study 12179 Agency Analysis of Self-Selection
Results

• Responses N
• Incorrect--would use 56 53
• Correct/Acceptable 47 45
• Ask a doctor 27 26
• Would not use 20 19

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Study 12179 Product Purpose

• Response (N145)
• Prevent frequent HB 32

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Study 12179 Applying the Label to Other People

• Hypothetical question scores in 90s
• 3 conditions needing physician consultation
• Correct response was to consult doctor or not use
• 1/3 said person with headache should consult
  doctor or not use

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Label Changes after Label Comprehension Studies

• The label was not changed to improve
  communication of non-episodic use and prevention
  only messages.
• List of medications shortened in proposed label
  from 6 to 3.
• List of medical conditions in proposed label is
  shorter and more bulleted than in 02255 study,
  same as in 12179

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Conclusions Studies 02255 and 12179

• Participants understand
• Prilosec 1 is for frequent heartburn
• Do not use Prilosec 1 if you
• Do not have heartburn
• Have infrequent heartburn
• Are allergic
• Are pregnant or nursing

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Conclusions Studies 02255 and 12179

• Participants understand do not use if
• Trouble swallowing
• Chest pain with other symptoms
• Chronic cough
• Black tarry stools
• Unexplained weight loss
• Under age 18
• Heartburn worse with nausea and vomiting

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Conclusions

• Consumers believe Prilosec 1 can be used
  episodically to relieve acute HB symptoms or to
  prevent meal-induced HB
• Not clear if consumers with medical conditions
  listed on label or taking medications listed on
  label would seek medical advice before use or
  decline to use