> **[DSRCS REVIEW]{.underline}**

**NDA#:** 21-045

**Drug:** Plan B (levonorgestrel) Tablets

**Sponsor:** Women\'s Capital Corporation

**Study:** Plan B Over-the-Counter Label Comprehension Study Final
Report. Study Number 9728

**Study Report Date:** November 5, 2001 (Submission Date April 2003)

**Reviewer:** Karen Lechter, J.D., Ph.D.

**Reviewing Div:** HFD-410

**Review Completed:** November 2, 2003

**Executive Summary**

In a label comprehension study of the labeling on the outside and inside
of the package, study participants demonstrated good understanding of
some concepts and low understanding of a few concepts. Results for other
concepts were inconclusive due to the wording of some of the questions
and the sponsor\'s scoring system for open-ended questions. Despite some
shortcomings in the questionnaire and some scores that were lower than
desirable, the Division of Surveillance, Research, and Communication
Support (DSRCS) believes that labeling changes are likely to result in
acceptable levels of comprehension. Results of the Actual Use Study
should weigh more heavily in evaluating the labeling.

Concepts that received relatively high comprehension scores are the
following:

-   Plan B is for contraception.

-   Plan B does not protect against STD\'s, including HIV/AIDS.

```{=html}
<!-- -->
```
-   Do not take the product while pregnant; Plan B cannot end a
    pregnancy.

-   Do not use Plan B if you are allergic to its ingredients.

-   Nausea and vomiting are side effects.

Concepts with moderate levels of understanding include the following:

-   Take the first tablet within 3 days of intercourse.

-   Get medical help if severe abdominal pain develops.

Concepts that may not be clearly understood or for which the data are
inconclusive are the following:

-   Plan B is not for regular use for contraception.

-   Take the first tablet as soon as possible after intercourse.

-   Take the second tablet 12 hours after the first one.

-   Do not use Plan B if you have unexplained vaginal bleeding

-   Use Plan B **after** intercourse.

-   Plan B can be used even if the woman has medical conditions not
    mentioned on the label. (Asthma was mentioned in the question.)

As a result of these findings, DSRCS believes that comprehension of the
critical messages is adequate or would be adequate after changes to the
labeling. Therefore, DSRCS has the following recommendations based on
the study:

-   Strengthen the following messages:

    -   Not for regular use (sponsor has bolded this)

    -   Timing of first dose

    -   Timing of second dose (sponsor has bolded this)

    -   If severe abdominal pain develops, seek immediate medical care

    -   Do no use if unexplained vaginal bleeding (if kept in the
        labeling)

-   State on the label if there is a window of time for the second
    tablet, rather than just the 12 hour time already given.

In addition, DSRCS has a recommendation to help women time the second
dose appropriately:

-   Have a place on the label for the woman to write the time she took
    the first pill and the time she should take the second pill.

Inclusion of a package insert might be helpful for consumers.

**REVIEW**

The purpose of this study was to evaluate comprehension of a prototype
OTC package label for Plan B emergency contraceptive pills.

# Communication Objectives

The study tested 11 Communication Objectives important for safe and
effective use of the product:

1.  Plan B is indicated for prevention of pregnancy after unprotected
    sex.

2.  Plan B is intended as a back up method and should not be used for
    regular contraception.

3.  Plan B does not prevent sexually transmitted diseases or HIV/AIDS.

4.  The first pill should be taken as soon as possible after
    intercourse.

5.  The first pill should be taken within 72 hours after intercourse.

6.  The second pill should be taken 12 hours after the first.

7.  Plan B should not be used by women who are already pregnant (because
    it will not be effective).

8.  Plan B should not be used by women with unexplained vaginal
    bleeding.

9.  Plan B should not be used by women with allergy to any ingredient in
    the product.

10. Side effects of Plan B include nausea and vomiting.

11. If severe abdominal pain develops, the user should seek medical care
    immediately.

**Methodology**

[Participants]{.underline}

Participants were 663 females, age 12-50 years old. Sample size was
based on using a 95% confidence interval of [+]{.underline}5 percentage
points, conservatively assuming the proportion of correct responses
would be 50%. Based on these requirements, a minimum sample size was
385. To ensure adequate demographic representation and a sufficient
number of low literacy women for subset analyses, the target sample was
increased to 575. In actuality, data for 656 participants were reported.

Distribution by age was as follows:

  ------------------------------------ ----------------------------------
  **Age Range**                        **%**

  12-16                                12

  17-25                                54

  26-50                                34
  ------------------------------------ ----------------------------------

Black and Hispanic women were overrepresented with respect to the
general population as follows:

  ---------------------- ------------------------ ------------------------
  **Race**               **Study population %**   **General population %**

  Black                  24                       12

  Hispanic               24                       13

  White                  49                       75
  ---------------------- ------------------------ ------------------------

More than ¾ of participants were sexually experienced. Most of them had
had unprotected intercourse despite a desire not to become pregnant.
More than half of participants who had used oral contraceptive pills
reported having missed taking pills, and 40% of those who had used
condoms had had a condom break. At least 82% of the sexually experienced
participants had had either a pregnancy scare or sex not adequately
protected by contraception. Only 32 of the sexually experienced
participants had ever used emergency contraceptive pills.

Literacy levels among those age 18 or older who had not completed
college were as follows:

  ------------------------------------ ----------------------------------
  **Literacy Level**                   **% (n=395)**

  3^rd^ grade or less                  \<1

  4th-6^th^ grade                      4

  7^th^-8^th^ grade                    31

  High school                          64

  Missing                              \<1
  ------------------------------------ ----------------------------------

The highest level of school completed was as follows:

  ------------------------------------ ----------------------------------
  **Highest grade completed**          **% (n=656)**

  6^th^ grade or less                  1

  7^th^ or 8^th^ grade                 4

  9^th^-11^th^ grade                   23

  High school or GED                   30

  Vocational/technical school          3

  Less than 4 years of college         18

  College                              16

  Graduate school                      6

  Refused/missing                      \<1
  ------------------------------------ ----------------------------------

[Procedure]{.underline}

Interviews were conducted in shopping malls and family planning clinics
in eight US cities. Minor participants recruited from clinics did not
require parental consent to participate.

Before the interviews began, participants who were age 18 or older who
had not completed college were tested for literacy level using the Rapid
Estimate of Adult Literacy in Medicine (REALM) test.

For the main questionnaire, participants were asked to look at the
outside of the Plan B package as if they were thinking about whether to
purchase the product. The interviewer then removed the package while the
participant answered the first question. The participant was permitted
to look at the outside of the package while answering five additional
questions. Participants were then told to open the package and review
the contents as if they were about to use the product. Participants
could refer to the package as well as the contents for the remaining
questions.

The only information on the front outside of the package was the name of
the product, the statement \"Emergency Contraception,\" and the number
and strength of the tablets. On the back was the Drug Facts format
containing the most important information about the indication,
warnings, directions, and ingredients. The back also included storage
and manufacturing information. Additional information that reinforced
the Drug Facts information was on the inside of the package.

At the end of the main questionnaire, participants were given a
questionnaire asking information about their sexual activities.

*Comments: The sponsor did not give the REALM literacy test to women who
had graduated college or to participants younger than 18 years. It would
have been better to test everyone, to make their study experience
similar and to test literacy at all education levels, as all of these
women represented potential product users. The sponsor noted that even
at the level of some college education, there were some who tested as
low literate.*

*In correspondence with the agency (Serial No. 110), the sponsor
explained its decision not to test the younger participants for two
reasons: (1) the REALM is designed for adults, and (2) the sponsor
assumed that women under the age of 18 would not be well-educated. The
college graduates were not tested because the sponsor assumed that
college graduates would have at least a 9^th^ grade literacy level. In
hindsight, the sponsor notes that this assumption may not have been
correct. The sponsor also pointed out that about 25% of the entire study
population was either poorly educated or tested in the lower literacy
group on the REALM. Twenty-eight aged 17 or younger had not gotten past
8^th^ grade in school, and 139 who were tested were in the lower
literate category.*

*As only the 393 women age 18 or older who had not graduated from
college were categorized by literacy level, we do not have results by
literacy level for the entire sample. We do not know what effect, if
any, this fact had on the results of the analyses by literacy groups.
However, because the results suggest a literacy effect for almost all of
the communication objectives, we should proceed as if literacy has an
effect on almost everything tested, and try to improve those aspects of
the label for which the lower literate group seemed to have particular
problems.*

[Questionnaires]{.underline}

Questions included multiple choice and open-ended questions. The latter
are questions for which choices are not provided by the questioner. Many
questions presented a hypothetical scenario and asked participants if
Plan B use would be correct to use in the situation.

*Comment: Scenario-type questions require more cognitive processing than
more direct questions about information on the labeling because scenario
questions require participants to apply the information.*

*[Main Questionnaire]{.underline}*

Question 7 was the first question asked about the product. It was asked
after only the outside of the package had been read and after the
package was removed. Therefore, this response was based on recall.
Questions 8-12 were asked with only the outer carton available for
reference. For the remaining questions, participants could open the
carton and inspect the contents before responding.

At the end of the questioning about the labeling, participants were
asked for demographic information and took a self-administered test
(\"Confidential Information Questionnaire\") about sexual and
contraceptive history.

*Comments: The scenario questions asked, in essence, if the hypothetical
person was using the product correctly or not. Many questions were of
the yes/no or correct/incorrect variety. Such questions have a 50%
chance of a correct response by chance. It would have been better to
follow all of these questions with a probe asking participants why they
answered as they did. We therefore do not know if participants answered
correctly by chance or because they knew the information.*

*Personal information questions about marital status and income did not
seem useful to ask for comprehension purposes.*

*[Confidential Information Questionnaire]{.underline}*

This questionnaire asked about the participants\' experience with sex
and birth control. Results were used to further analyze responses to the
main questionnaire by categorizing participants according to their
responses to these questions.

*Comment: The question \"Have you ever had sex?\" (Q. 1) would have
benefited from providing a definition for \"sex.\" Without such a
definition, we must assume participants knew it meant sexual
intercourse, but we cannot be sure. Q. 6 asked if the participant had
ever used birth control pills and had missed taking two or more from one
pack. The results were used to conclude that participants responding
affirmatively to this question might have experienced anxiety about the
possibility of being pregnant. Q. 10 asked if the woman had ever used
emergency contraceptive pills. It would have been best to exclude these
women from the study, as their experience, possibly with Plan B, might
have raised their scores artificially. However, the results showed that
there were only 32 in this group, and thus, they may have had little
influence on the overall results. An analysis by the sponsor showed no
effect of this prior experience on understanding the Communication
Objectives. However, the small size of this group may be responsible for
the lack of apparent effect. Thus, we cannot conclude that women with
prior experience with emergency contraception would not understand the
information better than others.*

**Results by Communication Objective**

Results for the total sample were provided for each question. In
addition, results for each Communication Objective were provided based
on the following characteristics: literacy level, age, race, ethnicity,
interview location, type of site (mall or clinic), income, education,
previous sexual experience, sexual experience in the past three months,
experience with pregnancy scare (condom break, missed pills, unprotected
intercourse, worry about unwanted pregnancy), and experience using
emergency contraceptive pills. Literacy level and location of the
interview had an effect on most responses. Literacy level affected nine
of the Communication Objectives. Location affected all of them. Other
characteristics had far fewer effects. Any significant findings based on
particular characteristics are mentioned in the appropriate sections
that follow. The sponsor did not make adjustments for multiple
confidence interval estimations.

The sponsor determined whether Communication Objectives had been met by
participants based on formulas that differed among the Communication
Objectives. For some objectives, correct responses to only half of the
questions under that Communication Objective were deemed sufficient to
indicate understanding of that Communication Objective. For others, 75%
or 100% of the questions needed to be correct to satisfy the sponsor\'s
criteria for successful understanding.

Based on the sponsor's scoring method for Communication Objectives, more
than 85% of participants understood seven of the 11 Communication
Objectives, if both acceptable and correct answers were counted.
Ninety-three percent (93%) understood that Plan B is indicated for
prevention of pregnancy after unprotected sex (Objective 1), 94%
understood it does not prevent HIV or AIDS (Objective 3), and almost all
(98%) understood that it should not be used by pregnant women (Objective
7). Less than 80% understood two objectives: 67% understood Objective 2
(Plan B is intended as a back up method and should not be used for
regular contraception), and 75% understood objective 8 (Plan B should
not be used by women with unexplained vaginal bleeding.). The results by
Communication Objective appear in Table 1.

Table 1. Results by Communication Objective.

  ----------------------------------- -----------------------------------
  **Communication Objective**         **% Understanding\*** (N=656)

  1\. Plan B is indicated for         90/93\*\*
  prevention of pregnancy after       
  unprotected sex                     

  2\. Plan B is intended as a back up 67
  method and should not be used for   
  regular contraception               

  3\. Plan B does not prevent         94
  sexually transmitted diseases or    
  HIV/AIDS                            

  4\. The first pill should be taken  85
  within 72 hours after intercourse   

  5\. The first pill should be taken  82
  as soon as possible after           
  intercourse                         

  4\. or 5. The first pill should be  97
  taken within 72 hours or as soon as 
  possible after intercourse.         

  6\. The second pill should be taken 69/85^†^
  12 hours after the first            

  7\. Plan B should not be used by    98
  women who are already pregnant      

  8\. Plan B should not be used by    75
  women with unexplained vaginal      
  bleeding                            

  9\. Plan B should not be used by    91
  women with allergy to any           
  ingredient in the product           

  10\. Side effects of Plan B include 89
  nausea and vomiting                 

  11\. If severe abdominal pain       81
  develops, the user should seek      
  medical care immediately            
  ----------------------------------- -----------------------------------

\*Based on sponsor\'s criteria of 50%-100% correct on questions relevant
to each Communication Objective.

\*\*First number based on correct responses for Q. 7 (Sponsor's
interpretation). Second number based on correct/acceptable responses for
Q. 7 (Sponsor's interpretation).

† First number based on correct responses for Q. 30. Second number based
on correct/acceptable responses for Q. 30. (Sponsor's interpretation.)

More than 80% of lower literate women were able to understand eight of
the 11 objectives. Women aged 16 years or younger were less likely than
older women to understand many of the objectives, but the differences
were not statistically significant in most cases, and more than 80% of
the younger women understood seven objectives.

*Comment: In correspondence with the Agency (facsimile dated 10/21/03),
the sponsor stated that it developed the criteria for each communication
objective prior to conducting the study. The sponsor said \"it would be
inappropriate to require subjects to answer all of the questions related
to a particular objective \'right\' (i.e., correctly or acceptably) for
several reasons.\" These reasons included the fact that the sponsor knew
that some questions and some answers, particularly responses to
open-ended questions, would be ambiguous. Other reasons included the
fact that \"people do not always answer questions correctly even when
they know the correct answer,\" and that some questions were asked
before participants saw the whole package.*

*In some instances, these criteria made it easier to reach the objective
by using correct responses for less than all of the questions in an
objective. Because there may be disagreement as to what criteria would
be appropriate for each Communication Objective, this review will
examine results of questions individually, as well as results by
Communication Objective.*

*DSRCS would not necessarily agree with the scoring of some of the
\"acceptable\" responses. Thus, scores for some Communication Objectives
may be lower under DSRCS\'s scoring.*

*Of the subgroups, DSRCS is most interested in results by literacy
level. As noted earlier, the sponsor did not include all participants in
the analyses of Communication Objectives based on literacy levels.
Instead, only participants age 18 or older who had not completed college
were included. Thus, because we do not have a complete comparison of the
entire sample of the lower literate (reading level 8^th^ grade or below)
with those of a higher reading level, any conclusions we draw from the
literacy analysis should be viewed with the understanding that the
sample had limitations. Presumably, many of those below age 18 (at least
12%) would test as lower literate, because they had not completed high
school. On the other hand, those who had graduated from college (22%)
were more likely to be in the higher literacy group. Thus, we cannot be
sure how well the literacy results reflect the range of potential
product users.*

**Communication Objective 1:** **Plan B is indicated for prevention of
pregnancy after unprotected sex.** (Q 7, 14, 16, 19) *\[Communication
Objective satisfied if at least two answered correctly\]*

The first question in this set (Q. 7) was open-ended (not multiple
choice). The other three were all of the yes/no variety, asking if the
hypothetical situation described was a correct use of the product.. For
these three questions, the correct response was that it was a correct
use.

Q. 7 asked what Plan B is used for. The response was based on recall, as
the carton was removed before the question was asked. Forty-five percent
(45%) responded that the product is for contraception after sex.
Thirty-nine percent (39%) stated only that it is for contraception. The
sponsor counted both of these as acceptable responses. Therefore, a
total of 84% provided correct or acceptable responses to this question
under the sponsor\'s scoring system. For this question, the lower
literate group scored 73%, compared with 87% for the higher literate
group.

For this Communication Objective, there was a statistically significant
difference between the adult (age 18 or older) lower literate (8^th^
grade or lower) and those with a higher reading level. As noted earlier,
participants under age 18 and college graduates were not included in
this analysis. The results show that 84% of the adult lower literate met
the sponsor\'s criterion for success on this objective, while 96% of the
adult higher literate were successful. Table 2 summarizes the most
common responses to Q.7.

Table 2. Responses to open-ended question about purpose of product (Q.7)

  ---------------------------------- ------------------------------------
  **Response**                       **% Responding** (N = 656)

  contraception after sex\*          45

  contraception\*\*                  39

  after sex, purpose unspecified     4

  STI/HIV                            1

  emergency (sex not mentioned)      1

  other                              4

  don\'t know/refused                6
  ---------------------------------- ------------------------------------

\*correct under sponsor's scoring

\*\* acceptable under sponsor\'s scoring

*Comment: For Q. 7, it is not clear that those who mentioned only that
the product was for contraception, and did not mention \"after sex,\"
truly understood the full nature of the indication. It would have been
better if this question had probed for more responses by asking if there
was anything else the participant wanted to add. Therefore, the total
figure of acceptable responses for that question of 84% may be
overstating the level of understanding of the participants on this
issue. On the other hand, it is likely that some, perhaps many, of those
who mentioned only contraception actually understood that the product is
used after sex, but failed to mention that detail. We should keep in
mind that Q. 7 was answered without participants being able to refer to
the carton. For that reason, the relatively low totally correct score
(contraception after sex) for this item should not be cause for concern,
particularly when viewed in conjunction with other questions about
specific uses for the product.*

Q. 14 was a scenario about a woman who wanted to use Plan B after a
condom broke. Participants were asked if this was an appropriate use
according to the package. Ninety-one percent (91%) responded correctly
that it was an appropriate use. Eighty-one percent (81%) of the lower
literate were correct, while 95% of the higher literate were correct.

Q. 16 stated that a woman with asthma had unprotected sex and took Plan
B the next day to prevent pregnancy. Participants were asked if this was
a correct use. Sixty-three percent (63%) responded correctly that it was
an appropriate use.

Q. 19 asks about using the product two days after unprotected sex.
Eighty-seven percent (87%) correctly stated that it was an appropriate
use. For this question, 78% of the lower literate and 90% of the higher
literate were correct.

Table 3 summarizes responses to the three scenario questions for these
Communication Objectives for the total sample.

Table 3. Correct responses to scenario questions about the indication

  ----------------------------------- -----------------------------------
  **Question**                        **% Correct** (N = 656)

  14\. condom broke                   91

  16\. asthma/unprotected sex         63

  19\. unprotected sex 2 days ago     87
  ----------------------------------- -----------------------------------

The sponsor stated that 90% of participants met the criterion for
understanding this Communication Objective. The criterion for success
was to answer at least two of the four questions correctly or
acceptably.

*Comment: The relatively low rate of correct responses for the question
about the woman with asthma suggests that there may be a tendency for
participants to be confused if other medical conditions are mentioned.
This may be due to an inclination to respond conservatively to the
questions, so that when in doubt, the participant would state that
product should not be used. In correspondence with the Agency (Serial
No. 110), the sponsor speculates that some women may not fully
understand the term \"asthma\" and some women may have been flustered by
this question. Further study would be necessary to determine what caused
so many incorrect responses for the question mentioning asthma. Asking
participants why they responded as they did might have clarified the
situation.*

*Overall, results for this Communication Objective suggest the
following:*

-   *About 90% understand some specific situations in which it is
    appropriate to use the product.*

-   *There is a tendency to state, incorrectly, that certain medical
    conditions might preclude use. However, incorrect responses may be
    an artifact of the testing situation. Moderately high proportions of
    participants were able to identify two situations under this
    Communication Objective in which the product would be appropriate.*

-   *Many participants did not clearly express the full indication for
    the product when asked from memory without further prompting.*

-   *The sponsor\'s criterion for success on this Communication
    Objective (two of the four responses correct or acceptable) seems
    rather low. With a higher criterion for success, fewer than 90%
    would have been considered to have answered correctly.*

**Communication Objective 2:** **Plan B is intended as a back-up method
and should not be used for regular contraception**. (Q. 9, 21, 22, 25)
\[*Communication Objective satisfied if at least three answered
correctly\]*

For this series of questions, the three scenarios all depict
inappropriate uses, and one question is direct. Q. 9 asks the direct
question whether Plan B should be used as regular birth control.
Eighty-five percent (85%) answered correctly. Only 71% of the lower
literate were correct, while 93% of the higher literate were correct.

Q. 21 presents a scenario in which a woman\'s husband complains about
using condoms and asks if it is correct to use Plan B in this situation.
The correct response is that it is not an appropriate use. Only 47%
correctly responded here. The sponsor suggests this may be due to the
fact that some of the questions used to define this objective "may have
required excessively strict or unrealistic interpretation of the concept
of 'emergency' contraception.\" The intent of Q. 21 was that the woman
should find another contraceptive method or refuse to have sex when her
husband refuses to use condoms. The sponsor stated that this choice
might be improbable in the minds of many women, who may have assumed
unprotected sex was inevitable and therefore using Plan B would be
appropriate. The sponsor will bold the label text "Plan B should not be
used in place of regular contraception" to emphasize this point. The
lower literate scored 37% for this question, while the higher literate
scored 53%.

Q. 22 is a scenario about someone who inappropriately uses Plan B daily
instead of usual birth control. Ninety-one percent (91%) were correct on
this question. The lower literate scored 76%; the higher literate scored
95%.

Q. 25 is about a couple that wants to use Plan B as the main
contraceptive method. Only 68% answered this one correctly. The lower
literate scored 50%; the higher literate scored 78%.

The sponsor concluded that the Communication Objective was met by a
participant if three of the four questions were answered correctly.
Sixty-seven percent (67%) of participants met this criterion. There was
a statistically significant difference between the lower and higher
literacy participants for this Communication Objective. Forty-six
percent (46%) of the adult lower literate met the criterion for success,
while 78% of the adult higher literate were successful. Table 4 presents
the results for these four questions for the total sample.

Table 4. Correct responses to scenario questions about Using Plan B for
regular contraception

  ----------------------------------- -----------------------------------
  **Question**                        **% Correct** (N = 656)

  9\. Direct question about use for   85
  regular birth control               

  21\. Husband complains about        47
  condoms                             

  22\. Use Plan B daily instead of    91
  usual birth control                 

  25\. Couple uses Plan B as main     68
  contraceptive method                
  ----------------------------------- -----------------------------------

*Comment: Results for these questions would have been easier to
interpret if each question had been followed by another question asking
why the woman responded as she did. We do not know if correct responses
were correct for the right reasons, or if the incorrect ones were
incorrect due to misunderstanding or for some other reason.*

*In response to the direct question about use for regular contraception,
a respectable proportion of participants (85%) answered correctly.
However, far fewer were correct about use if one\'s partner does not
want to use protection. The scenario for that question (Q.21) stated
that "This time she plans to use plan B." The implication could be that
this is a one-time event. Thus, it may not be unreasonable for the women
to believe that Plan B is appropriate. Therefore, the relatively low
results of this question (Q.21) should not be counted heavily.*

*However, there does not seem to be a clear rationale for the relatively
low scores (68%) for the scenario about using Plan B as the main
contraceptive method (Q.25), despite the fact that many more (85%) were
correct in saying the product should not be used for regular birth
control (Q.9), and a high proportion (92%) answered correctly for a
different scenario (Q. 22) that the product should not be used daily
instead of usual birth control. In correspondence with the Agency
(Serial No. 110), the sponsor suggests that Q. 25 required \"more
extended thought processes\" than the other questions, which may have
contributed to the lower correct response rate.*

*Even using the sponsor\'s criterion for achieving the Communication
Objective (3/4 correct), a relatively low number of participants (67%)
seemed to understand clearly and consistently that the product is not to
be used as the main form of contraception. Even fewer lower literate
participants seemed to understand this concept.*

*The conflicting results for questions under this Communication
Objective suggest that the message that this product is not for regular
use should be strengthened on the label.*

**Communication Objective 3:** **Plan B does not prevent sexually
transmitted diseases or HIV/AIDS.** (Q. 13 and 27) *\[Communication
Objective satisfied if both answered correctly.\]*

The two questions in this group include a scenario question and a direct
question. Responses to both of these questions should be that Plan B
does not protect against STD\'s. Q. 13 is a scenario about a woman using
Plan B to avoid STD\'s. Ninety-six percent (96%) answered correctly.
Among the lower literate, 88% were correct, while among the higher
literate, 99% were correct. Q. 27 is a direct question asking if Plan B
protects against HIV and other STD\'s. Ninety-eight percent (98%)
answered this correctly.

For this Communication Objective, there was a statistically significant
difference between the lower literate and higher literate. Eighty-four
percent (84%) of the adult lower literate met the sponsor\'s criterion
for success for this question, while 99% of the adult higher literate
were successful. Table 4. summarizes these results for the total sample.

Table 5. Correct responses to questions about use for STD\'s

  ----------------------------------- -----------------------------------
  **Question**                        **% Correct** (N = 656)

  13\. scenario about use to avoid    96
  STD\'s                              

  27\. direct question about          98
  protection against HIV and other    
  STD\'s                              
  ----------------------------------- -----------------------------------

*Comment: Participants understood at high rates that Plan B cannot
protect against STD\'s. Although the lower literate scored lower than
the higher literate, scores for the lower literate were not very low.*

**Communication Objective 4:** **The first pill should be taken within
72 hours after intercourse.** (Q. 10, 29, 19, 20) *\[Communication
Objective satisfied if at least two answered correctly: 10 (if response
mentions 72 hours or 3 days), 29, (19 and 20)\]*

Q. 10 asks what the best time is to take the first pill. If the
participant has not already said both \"within 3 days\" **and** \"as
soon as possible,\" Q. 10 also includes a second part that asks if the
label says anything more specific. The correct answer is \"as soon as
possible **and** within 72 hours or three days.\" Twenty-three percent
(23%) gave this response. Acceptable responses were the following:
\"within 72 hours or three days\" (31%), **or** \"as soon as possible\"
(26%). Thus, a total of 80% had correct or acceptable responses. An
additional 10% said \"72 hours or 3 days.\" These responses were not
scored as correct because they did not indicate that was the maximum
time.

Q. 29 asks how many days is the longest after sex that a woman should
wait before taking the first pill. Ninety-one percent (91%) correctly
responded 72 hours. Eighty-four percent (84%) of the lower literate and
95% of the higher literate were correct on this question.

Q. 19 applies also to the first Communication Objective, discussed
earlier. Eighty-seven percent (87%) correctly said it was correct to use
Plan B if the woman had unprotected sex two days earlier.

Q. 20 asks about use if unprotected sex was a week ago. Ninety-five
percent (95%) correctly stated that this was an incorrect use.

The sponsor scored this objective as having been met if participants
answered at least two of the four questions correctly. Eighty-five
percent (85%) met this criterion. There was a statistically significant
difference between the literacy groups in attaining the criterion for
success for this Communication Objective. Seventy-one percent (71%) of
the adult lower literate and 90% of the adult higher literate met the
criterion. Table 6 presents the results for this Communication Objective
for the full sample.

Table 6. Correct/acceptable responses to questions about taking the
tablet within 72 hours after intercourse

+-----------------------------------+-----------------------------------+
| **Question**                      | **% Correct/acceptable** (N =     |
|                                   | 656)                              |
+-----------------------------------+-----------------------------------+
| 10\. Best time to take first      | 80                                |
| tablet                            |                                   |
+-----------------------------------+-----------------------------------+
| 29. The longest one should wait   | 91                                |
|     before                        |                                   |
|                                   |                                   |
| first tablet                      |                                   |
+-----------------------------------+-----------------------------------+
| 19\. Use 2 days after unprotected | 87                                |
| sex                               |                                   |
+-----------------------------------+-----------------------------------+
| 20\. Use 1 week after unprotected | 95                                |
| sex                               |                                   |
+-----------------------------------+-----------------------------------+

*Comment: If we deem as acceptable for Q. 10 those 10% of responses that
mentioned 72 hours or three days, but did not indicate that was the
maximum time, then the correct/acceptable score for Q. 10 would be 90%.
It is likely that many in this 10% group had the correct understanding,
but were sloppy in expressing it. Overall, the results for this
Communication Objective suggest moderately high understanding of the
timing of the first tablet. However, to be sure that more lower literate
women understand this issue, the timing of the first tablet should be
emphasized if possible.*

**Communication Objective 5:** **The first pill should be taken as soon
as possible after intercourse.** (Q.10, 26) *\[Communication Objective
satisfied if either answered correctly, where response to Q. 10 mentions
as soon as possible\]*

As noted earlier, Q. 10 asked the best time to take the first tablet.
Twenty-three percent (23%) scored correctly (as soon as possible **and**
within 72 hours or 3 days). A total of 57% scored acceptably (either
within 72 hours or 3 days, **or** as soon as possible, without providing
a time frame). Acceptable responses included 26% who said as soon as
possible. Therefore, for Q. 10, 80% scored correctly or acceptably. Q.
26 asks if Plan B will be more effective if taken one day after
unprotected sex or two days after unprotected sex. Seventy-one percent
(71%) correctly said one day. Sixteen percent (16%) said both were the
same, and 12% incorrectly said two days. Among the lower literate, 64%
were correct, compared with 75% of the higher literate.

The sponsor counted people as responding correctly for this
Communication Objective if for Q. 10 they mentioned \"as soon as
possible\" or answered correctly to Q. 26. Eighty-two percent (82%) met
this criterion. For this Communication Objective, there were no
significant differences between the adult lower literate and higher
literate participants. Table 7 presents these results.

Table 7. Correct/acceptable responses about timing of the first tablet

  ----------------------------------- -----------------------------------
  **Question**                        **% Correct/acceptable** (N = 656)

  10\. Best time to take first tablet 80

  26\. Better to take at 1 days or    71
  two?                                
  ----------------------------------- -----------------------------------

*Comment: The moderate overall correct response rate for Q. 10, and the
even lower rate among the lower literate, combined with the somewhat
lower overall correct response rate for Q. 26 make it advisable to
strengthen the labeling for this issue. Approximately 1/3 seem not to
have understood the message about using the product as soon as possible,
although there seems to be good understanding, based on other questions,
that it should be taken within three days of unprotected intercourse.*

**Communication Objective 6:** **The second pill should be taken 12
hours after the first** (Q. 30)

Q. 30 asks directly when a woman should take the second tablet.
Sixty-nine percent (69%) correctly said 12 hours after the first tablet.
The sponsor counted as acceptable those who mentioned 12 hours but said
something other than the full correct response. Seventeen percent (17%)
responded in this way. An additional person (\<1%) gave the response of
the next morning, which the sponsor counted as acceptable. Thus, 87%
answered correctly or acceptably under the sponsor\'s scoring system.
For this question, there was a statistically significant difference
among the literacy groups, with 82% of the adult lower literate and 93%
of the higher literate responding correctly or acceptably. Table 8
presents these results for the full sample.

Table 8. Responses about when to take the second tablet (Q. 30)

  ----------------------------------- -----------------------------------
  **Response**                        **% Responding** (N=656)

  12 hours after first tablet\*       69

  12 hours (but did not give full     17
  response)\*                         

  the next morning\*                  \<1

  other                               12
  ----------------------------------- -----------------------------------

\*Scored as correct or acceptable by sponsor

*Comment: It is not clear whether those mentioning 12 hours but not
saying "12 hours after the first tablet" truly understood the concept.
It is possible that some of them did not, but it is also likely that
many of them did. In correspondence with the Agency (facsimile of
10/21/03), the sponsor stated that \"...some participants had difficulty
communicating in standard English.\" The sponsor counted as acceptable
\"responses we suspected were probably correct but were slightly
ambiguous, so we could not be sure.\" They included answers such as
\"after 12 after the first one,\" \"before your 12 hours is up,\" \"up
to 12 hours after the first,\" \"within 12 hours.\" Thus, it is possible
that some responses scored as acceptable by the sponsor did not reflect
correct understanding. Also, although it is a minor point, DSRCS would
not have scored " the next morning" as an acceptable response. We do not
know when the first pill was taken in that case.*

*Based on only the completely correct responses, only 69% conveyed clear
understanding of when to take the second pill. Because it is possible a
number of those participants who were scored as acceptable for this
question did not truly understand, the timing of the second pill should
be emphasized in the materials. We recommend also that the label state
what to do if the dose is not taken at exactly 12 hours. If possible,
the label should indicate if there is a window of time in which the
second dose can be taken.*

***To assist women in determining exactly when to take the second
tablet, we suggest there be a space on the package for the woman to fill
in with the time when she took the first tablet and the time when she
should take the second tablet.***

Q. 23 was not specifically associated with this Communication Objective.
However, it is related to the timing of the second dose. Q. 23 asked if
it was correct for a woman to take both tablets at the same time.
Ninety-six percent (96%) answered correctly that it was not correct.

*Comment: A more detailed scenario providing the reasons why the woman
might have taken both at the same time would have been more realistic
and perhaps would have provided a better question to test this concept.*

**Communication Objective 7:** **Plan B should not be used by women who
are already pregnant (because it would not be effective).** (Q. 11 or Q.
17) *\[Communication objective met if either answered correctly.\]*

Q. 11 asks whether a woman who is two months pregnant should use Plan B.
Ninety-two percent (92%) correctly responded. Q. 17 asks if it was
correct for a pregnant woman to use Plan B because she didn\'t want to
become pregnant. Eighty-nine percent (89%) answered this question
correctly. Ninety-eight percent (98%) answered at least one of these
correctly, which was the sponsor\'s criterion for having understood the
concept. While scores for both literacy groups were high, there was a
statistically significant difference between them. The adult lower
literate scored 95% on this criterion for success, while the adult
higher literate scored 99%.

Q. 12 was not associated with a specific Communication Objective by the
sponsor. It is a follow-up to Q. 11, which asked if a woman who is two
months pregnant should use Plan B. Q. 12 asks for the reason behind the
response to Q. 11. Ninety-four percent (94%) responded correctly that
she was already pregnant, the product won\'t work, or it is too late to
use it. Table 9 presents the results for questions related to this
Communication Objective.

Table 9. Correct/acceptable responses about use by pregnant women

  -------------------------------------- --------------------------------
  **Question**                           **% Correct/Acceptable** (N=656)

  11\. Use by woman 2 months pregnant    92

  12\. Reason for response to Q. 11      94

  17\. Use if have positive pregnancy    89
  test                                   
  -------------------------------------- --------------------------------

*Comment:* *As stated in the protocol, one aspect of this Communication
Objective was that the product is not effective in pregnant women. This
issue was not specifically tested, but it did surface in responses to Q.
12. It appears that a relatively high proportion of participants
understood that the product is not appropriate during pregnancy.
Responses to Q. 12 suggest that the reasoning for responses to Q. 11 is
appropriate.*

**Communication Objective 8:** **Plan B should not be used by women with
unexplained vaginal bleeding.** (Q. 15)

Q. 15 is a scenario about a woman who had unusual vaginal bleeding
during the week and who took Plan B to prevent pregnancy after
unprotected sex. Participants were asked if this was a correct use of
Plan B. Seventy-six percent (76%) answered correctly. Again, there was a
statistically significant difference between the literacy groups. The
adult lower literate scored 69%, while the adult higher literate scored
82%.

*Comment: Clearly, this concept was not highly understood. If it is kept
in the labeling, it should be emphasized further, either by bolding or
by explaining its importance, or both.*

**Communication Objective 9:** **Plan B should not be used by women with
allergy to any ingredient in the product.** (Q. 18)

Q. 18 is a scenario about a woman allergic to an ingredient in Plan B
who used it because she noticed that her partner\'s condom broke during
sex. When asked if this was a correct use of Plan B, 91% answered
properly that it was an incorrect use. The differences between literacy
groups were statistically significant. The adult lower literate scored
82%, while the higher literate scored 96%.

**Communication Objective 10:** **Side effects of Plan B include nausea
and vomiting**. *(Q. 32-37) \[Communication Objective satisfied if
correct on Q. 32 and Q. 34, or nausea/vomiting mentioned in answer to Q.
37. Scored as not meeting Objective if she answered \"yes\" to all of Q.
32-36.\]*

Q. 32-35 ask if different symptoms can be side effects of Plan B
(32-nausea; 33-trouble breathing; 34-vomiting; 35-fever). Q. 36 asks if
there are any other possible side effects, and Q. 37 asks participants
to name one of the possible side effects.

The sponsor considered participants as having understood the
Communication Objective if they answered Q. 32 and Q. 34 correctly or if
nausea and vomiting were mentioned in answer to Q. 37, unless all of Q.
32-36 were answered \"yes.\" Based on these criteria, 89% understood
this Communication Objective. For this Communication Objective, there
were statistically significant literacy differences. The adult lower
literate scored 84%, while the adult higher literate scored 96%. For Q.
37, 81% of the lower literate were correct and 93% of the higher
literate were correct.

When those who said there were other possible side effects were asked to
name one additional side effect, 87% provided a correct response. Table
10 presents the results for this set of questions.

Table 10. Correct responses to side effects questions.

  ----------------------------------- -----------------------------------
  **Question**                        **% Correct** (N = 656)

  32\. nausea a side effect?          99

  33\. trouble breathing a side       83
  effect?                             

  34\. vomiting a side effect?        96

  35\. fever a side effect?           80

  36\. other possible side effects?   94

  37\. name one other side effect     87
  ----------------------------------- -----------------------------------

*Comment: These results show that participants generally understand the
side effects of vomiting and nausea. However, there is a slight tendency
to say that everything is a side effect, as evidenced by incorrect
scores of about 15-20% for the questions about symptoms that are not
real side effects. Such a tendency may have slightly elevated the scores
for the nausea and vomiting items. The question asking for another side
effect does not seem to contribute much to our understanding of
participants\' knowledge of the full range of side effects. However,
there were no Communication Objectives addressing specific side effects
other than nausea and vomiting*

**Communication Objective 11: If severe abdominal pain develops, the
user should seek medical care immediately.** (Q. 31)

The question for this Communication Objective presented a scenario
asking what a woman should do if she gets severe stomach pain after
using Plan B. Seventy percent (70%) said to see or call a doctor, with
no time frame mentioned. Eleven percent (11%) said to see or call a
doctor immediately. Four percent (4%) said to see a doctor, but not
immediately, and 10% said to stop using the product. The sponsor scored
as correct responses to see or call a doctor immediately or to see a
doctor with the time not mentioned. On that basis, 81% responded
acceptably. There were no differences between literacy groups. Table 11
presents the results.

Table. 11. Responses about what to do for severe abdominal pain (Q. 31)

  ----------------------------------- -----------------------------------
  **Response**                        **% Responding** (N=656)

  See/call a doctor (time not         70
  specified)\*                        

  See/call a doctor immediately\*     11

  See/call a doctor, not immediately  4

  Stop using                          10

  Other                               1

  call number on box                  \<1
  ----------------------------------- -----------------------------------

\*Scored as correct or acceptable.

*Comment: Based on these results, it is not clear that participants
understand that they should get immediate medical help for severe
abdominal pain. However, as the sponsor suggests, perhaps in real life,
it is likely that women who experience this pain would seek medical help
quickly. The sponsor should consider emphasizing this message.*

**Additional Results**

Some questions were not associated by the sponsor with particular
Communication Objectives. Q. 8 asks if Plan B is the same or different
from ordinary birth control pills. Eighty two percent (82%) answered
correctly. For this question, 73% of the lower literate and 87% of the
higher literate answered correctly.

*Comment: Unfortunately, the questionnaire did not ask how this product
is different, to enable us to further understand the responses.*

Q. 24 was eliminated by the sponsor. It asked \"A woman stopped taking
her birth control pills a week ago and then she had sex with no other
birth control method. She then used Plan B to prevent pregnancy. Was
this a correct use of Plan B?\" The sponsor said the question was
\"excluded from the analysis because it was recognized to have been
ambiguous after the survey was concluded.\" No additional explanation
was provided.

*Comment: We do not know why the sponsor dropped this question, yet
retained Q. 21, which also may have been ambiguous. A better explanation
of the criteria used to drop a question would have been helpful here.*

Q. 28 was a multiple choice question that asked when a woman should
expect her next period after taking Plan B. The correct response, at
about the normal time, was given by 79% of participants. The sponsor
considered the response of one week later as acceptable because the
label said **\"...your next period should come at the normal time, or a
few days early or late. If your period is more than one week late, you
may be pregnant.\"** An additional 10% gave the acceptable response,
making a total of 89% correct or acceptable. Five percent (5%) said she
should expect her period immediately, and about 1% said she never should
expect it. Table 12 shows these results.

Table 12. Responses to when to expect the next period (Q. 28)

  ----------------------------------- -----------------------------------
  **Response**                        **% Responding** (N = 656)

  About normal time\*                 79

  1 week late\*                       10

  immediately                         5

  refused                             5

  never                               1
  ----------------------------------- -----------------------------------

\*Correct or acceptable

*Comment: These results suggest a fairly good understanding of the
effect of the medication on women\'s menstruation. The choice of
\"never\" seemed unlikely to be correct on its face, and should have
been replaced with another choice.*

[Results by demographic characteristics]{.underline}

**Age**. Using the sponsor's criteria for demonstrating comprehension of
each Communication Objective, age made a statistically significant
(p[\<]{.underline}.05) difference for four of the objectives. Table 13
presents those differences.

Table 13. Statistically significant differences for Communication
Objectives by age

+--------------+-------------+-------------+------------+------------+
| **C          | **Age 12-15 | **Age 17-25 | **Age      | **Total    |
| ommunication | Correct/**  | Correct/**  | 26-50      | Correct/** |
| Objective**  |             |             | Correct/** |            |
|              | *           | *           |            | **         |
|              | *acceptable | *acceptable | **         | acceptable |
|              | (%)**       | (%)**       | acceptable | (%)**      |
|              |             |             | (%)**      |            |
|              | **(n=76)**  | **(n=355)** |            | *          |
|              |             |             | *          | *(n=656)** |
|              |             |             | *(n=255)** |            |
+--------------+-------------+-------------+------------+------------+
| 1\. Plan B   | 86          | 93          | 95         | 93         |
| indicated    |             |             |            |            |
| for          |             |             |            |            |
| prevention   |             |             |            |            |
| of pregnancy |             |             |            |            |
| after        |             |             |            |            |
| unprotected  |             |             |            |            |
| sex\*        |             |             |            |            |
+--------------+-------------+-------------+------------+------------+
| 3\. Plan B   | 93          | 96          | 92         | 94         |
| does not     |             |             |            |            |
| prevent      |             |             |            |            |
| sexually     |             |             |            |            |
| transmitted  |             |             |            |            |
| diseases or  |             |             |            |            |
| HIV/AIDS     |             |             |            |            |
+--------------+-------------+-------------+------------+------------+
| 6\. Second   | 77          | 90          | 82         | 86         |
| pill should  |             |             |            |            |
| be taken 12  |             |             |            |            |
| hours after  |             |             |            |            |
| the          |             |             |            |            |
| first\*\*    |             |             |            |            |
+--------------+-------------+-------------+------------+------------+
| 10\. Side    | 90          | 93          | 84         | 89         |
| effects      |             |             |            |            |
| include      |             |             |            |            |
| nausea and   |             |             |            |            |
| vomiting     |             |             |            |            |
+--------------+-------------+-------------+------------+------------+

\*includes correct and acceptable responses for Q. 7

\*\*includes correct and acceptable responses for Q. 30

*Comment: We should keep in mind that there were no adjustments for
multiple comparisons. Therefore, some of these apparently statistically
significant differences might have occurred by chance. For 3/4 of these
Communication Objectives, the youngest age group scored lowest. For 3/4
of the objectives, the oldest age group scored lower than the middle
group. Thus, there is no clear linear effect of age on increasing or
decreasing comprehension. It is possible that there is a quadratic
relationship, with the youngest and oldest understanding less than those
in the mid-range. It is likely that because of the varying age ranges
for the three age categories, particularly the very wide (26-50) range
for the oldest group, some age-related differences were not detected.
Even with these differences, the youngest group (Age 12-15) did not
score extremely low.*

**Race**. For three of the Communication Objectives, race made a
statistically significant difference. Table 14 presents these results.
There was not a consistent trend for any particular racial group to do
better than others. In two of the thee objectives, whites did better
than blacks. However, in another, blacks did better than whites and the
\"other\" group.

Table 14. Statistically significant differences for Communication
Objectives by race

+--------------------------+----------+---------+---------+----------+
| **Communication          | **White  | **Black | **Other | **Total  |
| Objective**              | %        | %       | %       | %        |
|                          | Co       | Cor     | Cor     | Co       |
|                          | rrect/** | rect/** | rect/** | rrect/** |
|                          |          |         |         |          |
|                          | **Acce   | **Accep | **Accep | **Acce   |
|                          | ptable** | table** | table** | ptable** |
+--------------------------+----------+---------+---------+----------+
| 2\. Plan B is intended   | 75       | 57      | 61      | 67       |
| as a back up method and  |          |         |         |          |
| should not be used for   |          |         |         |          |
| regular contraception    |          |         |         |          |
+--------------------------+----------+---------+---------+----------+
| 8\. Plan B should not be | 77       | 68      | 79      | 75       |
| used by women with       |          |         |         |          |
| unexplained vaginal      |          |         |         |          |
| bleeding                 |          |         |         |          |
+--------------------------+----------+---------+---------+----------+
| 11\. If severe abdominal | 79       | 88      | 81      | 81       |
| pain develops, the user  |          |         |         |          |
| should seek medical care |          |         |         |          |
| immediately              |          |         |         |          |
+--------------------------+----------+---------+---------+----------+

**Literacy**. Literacy level had a statistically significant effect on
nine of the 11 Communication Objectives. Table 15 presents the
Communication Objectives that showed these differences.

Table 15. Statistically significant differences for Communication
Objectives by literacy level.

+-----------------+-----------------+-----------------+-----------------+
| **Communication | **Lower         | **Higher        | **Total**       |
| Objective**     | Literate** %    | Literate** %    |                 |
|                 | Cor             | Cor             | (N=393)         |
|                 | rect/Acceptable | rect/Acceptable |                 |
|                 | (N=139)         | (N=254)         |                 |
+-----------------+-----------------+-----------------+-----------------+
| 1\. Plan B is   | 84              | 96              | 92              |
| indicated for   |                 |                 |                 |
| prevention of   |                 |                 |                 |
| pregnancy after |                 |                 |                 |
| unprotected     |                 |                 |                 |
| sex\*           |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| 2\. Plan B is   | 46              | 78              | 67              |
| intended as a   |                 |                 |                 |
| back up method  |                 |                 |                 |
| and should not  |                 |                 |                 |
| be used for     |                 |                 |                 |
| regular         |                 |                 |                 |
| contraception   |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| 3\. Plan B does | 84              | 99              | 93              |
| not prevent     |                 |                 |                 |
| sexually        |                 |                 |                 |
| transmitted     |                 |                 |                 |
| diseases or     |                 |                 |                 |
| HIV/AIDS        |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| 4\. The first   | 71              | 90              | 83              |
| pill should be  |                 |                 |                 |
| taken within 72 |                 |                 |                 |
| hours after     |                 |                 |                 |
| intercourse     |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| 6\. The second  | 82              | 92              | 89              |
| pill should be  |                 |                 |                 |
| taken 12 hours  |                 |                 |                 |
| after the       |                 |                 |                 |
| first\*\*       |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| 7\. Plan B      | 95              | 99              | 98              |
| should not be   |                 |                 |                 |
| used by women   |                 |                 |                 |
| who are already |                 |                 |                 |
| pregnant        |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| 8\. Plan B      | 69              | 81              | 77              |
| should not be   |                 |                 |                 |
| used by women   |                 |                 |                 |
| with            |                 |                 |                 |
| unexplained     |                 |                 |                 |
| vaginal         |                 |                 |                 |
| bleeding        |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| 9\. Plan B      | 82              | 95              | 90              |
| should not be   |                 |                 |                 |
| used by women   |                 |                 |                 |
| with allergy to |                 |                 |                 |
| any ingredient  |                 |                 |                 |
| in the product  |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| 10\. Side       | 84              | 96              | 92              |
| effects of Plan |                 |                 |                 |
| B include       |                 |                 |                 |
| nausea and      |                 |                 |                 |
| vomiting        |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+

\*Includes correct and acceptable responses for Q. 7.

\*\*Includes correct and acceptable responses for Q. 30.

In addition to literacy differences by Communication Objective, there
were many instances of differences between the literacy groups for the
individual questions. Differences between the groups for correct and
acceptable responses varied from 1 percentage point to 28 percentage
points, with a mean of 11 points. In all cases, the lower literate group
scored lower than the higher literate group. The sponsor did not report
which of these differences may have been statistically significant.
Responses for the two literacy groups are reported in Table 16.

Table 16. Correct/acceptable results for questions by literacy groups.

+----------------------------------+-----------------+-----------------+
| **Question**                     | **Lower         | **Higher        |
|                                  | Literate %      | Literate %      |
|                                  | Corre           | Corre           |
|                                  | ct/Acceptable** | ct/Acceptable** |
|                                  |                 |                 |
|                                  | (N=139)         | (N=254)         |
+----------------------------------+-----------------+-----------------+
| 7\. Tell what Plan B is used for | 73              | 87              |
+----------------------------------+-----------------+-----------------+
| 8\. Different from ordinary      | 73              | 87              |
| birth control?                   |                 |                 |
+----------------------------------+-----------------+-----------------+
| 9\. Should Plan B be used as     | 71              | 93              |
| regular birth control?           |                 |                 |
+----------------------------------+-----------------+-----------------+
| 10\. Best time to take 1^st^     | 21/75\*         | 26/83\*         |
| tablet                           |                 |                 |
+----------------------------------+-----------------+-----------------+
| 11\. Use if 2 months pregnant    | 88              | 93              |
+----------------------------------+-----------------+-----------------+
| 13\. Correct to use to avoid     | 88              | 99              |
| STD\'s?                          |                 |                 |
+----------------------------------+-----------------+-----------------+
| 14\. Use after condom broke      | 81              | 95              |
+----------------------------------+-----------------+-----------------+
| 15\. Use if unusual vaginal      | 69              | 82              |
| bleeding                         |                 |                 |
+----------------------------------+-----------------+-----------------+
| 16\. Use if have asthma          | 61              | 66              |
+----------------------------------+-----------------+-----------------+
| 17\. Use if positive pregnancy   | 84              | 92              |
| test                             |                 |                 |
+----------------------------------+-----------------+-----------------+
| 18\. Use if allergic and condom  | 82              | 96              |
| broke                            |                 |                 |
+----------------------------------+-----------------+-----------------+
| 19\. Use 2 days after sex        | 78              | 90              |
+----------------------------------+-----------------+-----------------+
| 20\. Use after 1 week            | 88              | 96              |
+----------------------------------+-----------------+-----------------+
| 21\. Husband complains about     | 37              | 54              |
| condoms; woman wants to use Plan |                 |                 |
| B                                |                 |                 |
+----------------------------------+-----------------+-----------------+
| 22\. Use Plan B every day        | 76              | 95              |
| instead of usual birth control   |                 |                 |
| pills                            |                 |                 |
+----------------------------------+-----------------+-----------------+
| 23\. Take both tablets together  | 89              | 98              |
+----------------------------------+-----------------+-----------------+
| 25\. Couple wants to use Plan B  | 50              | 78              |
| as main contraceptive method     |                 |                 |
+----------------------------------+-----------------+-----------------+
| 26\. Is plan B more effective 1  | 64              | 75              |
| day or 2 days after sex?         |                 |                 |
+----------------------------------+-----------------+-----------------+
| 27\. Protection against STD\'s   | 94              | 100             |
+----------------------------------+-----------------+-----------------+
| 28\. When expect next period     | 65/84\*         | 85/91\*         |
+----------------------------------+-----------------+-----------------+
| 29\. What is longest woman can   | 84              | 95              |
| wait to take first tablet?       |                 |                 |
+----------------------------------+-----------------+-----------------+
| 30\. When take second tablet?    | 64/82\*         | 77/93\*         |
+----------------------------------+-----------------+-----------------+
| 31\. What do if severe stomach   | 7               | 10              |
| pain?                            |                 |                 |
+----------------------------------+-----------------+-----------------+
| 32\. Nausea a side effect?       | 96              | 100             |
+----------------------------------+-----------------+-----------------+
| 33\. Trouble breathing a side    | 78              | 88              |
| effect?                          |                 |                 |
+----------------------------------+-----------------+-----------------+
| 34\. Vomiting a side effect?     | 97              | 98              |
+----------------------------------+-----------------+-----------------+
| 35\. Fever a side effect?        | 77              | 82              |
+----------------------------------+-----------------+-----------------+
| 36\. Other side effects not      | 91              | 95              |
| mentioned?                       |                 |                 |
+----------------------------------+-----------------+-----------------+
| 37\. Name other side effects not | 81              | 93              |
| mentioned in previous questions  |                 |                 |
+----------------------------------+-----------------+-----------------+

\*First number correct; second number correct plus acceptable by
sponsor\'s scoring

*Comment: Literacy level had a definite effect on the results of the
study. For most Communication Objectives and for most questions, there
were substantial differences in scores between the two literacy groups.
Comprehension among the lower literate was particularly low for
Communication Objective 2, concerning use of Plan B as a back up method
and not for regular contraception. These results suggest that any
strengthening of the messages in the labeling might increase
comprehension among the lower literate, but particular attention should
be paid to messages about not using the product for regular
contraception and not using it if there is unexplained vaginal bleeding,
as the lower literate scores were the worst for these two concepts.*

*We should keep in mind that the only participants included in the
literacy analyses were those who were age 18 or older who had not
graduated from college. Therefore, all college graduates were
eliminated, as were teen-agers. Twenty-two percent (22%) of the full
sample had graduated college, and more than 12% were under age 18. (The
sponsor reported age ranges of 12-16, 17-25, and 26-50. Therefore, we do
not know exactly how many were below age 18.) As a result of this
analysis of fewer than the full sample, the literacy results may be
atypical, as only adults who had not graduated from college were
included. Because college graduates were excluded, it is possible that
the higher literacy group had lower literacy than a typical higher
literate group taken from the population as a whole, and differences
between the literacy groups may therefore be minimized. However,
balancing that possibility is the possibility that participants under
age 18 would lower the literacy level of the lower literate group, again
widening the differences between the groups.*

*It would have been better to include all participants in the literacy
analyses to get a better picture of how literacy would affect the full
range of potential product users. Nevertheless, the results do show that
literacy had an effect on almost every Communication Objective, making
it apparent that lower literate women may have more trouble in
understanding the labeling than higher literate women.*

**Previous sexual experience.** There were no statistically significant
differences based on whether or not the participants had had sexual
experience.

**Experience using emergency contraceptive pills**. There were not
statistically significant differences based on pervious use of emergency
contraception.

*Comment: As there were only 32 in this group, we should not conclude
that they would not answer differently than other women if there had
been a larger sample.*

**Location of interview.** There were statistically significant
differences based on geographic interview location for all of the
Communication Objectives.

*Comment: This result is not surprising, as locations are chosen to add
variety to the socioeconomic and demographic characteristics of
participants.*

**Other demographic and location effects.** Race had an effect on three
Communication Objectives, and ethnicity on two. Income affected three
Communication Objectives and education affected four. Previous sexual
experience had no effect, and experience with a pregnancy scare and sex
within the past three months affected only one Communication Objective,
as did site (mall vs. clinic).

*Comment: These differences were too few to lead to conclusions that
there were systematic effects of these participant characteristics.*

**Discussion and Conclusions**

Based on the sponsor's assessment, two Communication Objectives were
understood by less than 80% of the sample. One was that Plan B is
intended as a back up method and should not be used for regular
contraception. The sponsor attributes this as possibly due to the
wording of the questions. However, to help communicate this message, the
sponsor will bold the text "Plan B should not be used in place of
regular contraception." The other Communication Objective that was
understood by less than 80% stated that the product should not be used
by women with unexplained vaginal bleeding. The sponsor does not believe
this contraindication is appropriate and has stated that it will seek to
remove it from the label.

Based on the sponsor\'s analyses of Communication Objectives, two
objectives were understood by 80% and 85% of participants. One was that
the first pill should be taken as soon as possible after intercourse and
the other one was about what to do if severe abdominal pain develops.
The sponsor states that the timing of the first pill should not be
viewed in isolation, as the product is still highly effective if use is
delayed up to 72 hours. Almost all (97%) understood the product should
be used within 72 hours, or as soon as possible after sex. The sponsor
believes that failing to demonstrate understanding of what to do if
there is severe abdominal pain is not of "extreme clinical concern,"
because women "do not need written instructions to know that they should
see a doctor if severe pain develops." The sponsor plans to bold "as
soon as possible" and "a serious medical problem (describing ectopic
pregnancy) in the next version of the labeling.

*Comment: DSRCS does not agree with the sponsor\'s scoring of some
responses as acceptable. Further, some of the Communication Objectives
could be satisfied if fewer than 100% of the questions in the objective
were answered correctly. Thus, the sponsor\'s overall conclusions about
the level of comprehension based on Communication Objectives are
probably higher than those of DSRCS.*

*However, DSRCS believes that comprehension of critical messages was
generally adequate or could be improved by label changes.
Misunderstandings about regular use would be affected by the cost of the
product and would not present public health issues.*

The following summarizes DSRCS\'s findings for each Communication
Objective:

1\. Participants tended to understand that the product is for
contraception. However, it was not clear if it was on the top of their
mind that the product is for use **after** sex. As the question asked
for information from memory and participants who gave partial responses
were not probed for further information, it is possible that many
participants may have known that the product was for use after sex but
did not express that fact.

> Participants understood a variety of situations in which to use the
> product, but there was a tendency to say that it should not be used if
> one has other medical conditions. This tendency may have been an
> artifact of the questioning situation.

2.  There were inconsistent responses about use for regular
    contraception. These conflicting results may be due to weaknesses in
    the questionnaire rather than to lack of comprehension.

3.  There is a high level of understanding that Plan B does not protect
    against STD\'s, including HIV/AIDS.

4.  There is moderate to high understanding of when to take the first
    tablet. About 90% understood that users should wait no more than 3
    days.

5.  The fact that the first pill should be taken as soon as possible
    after intercourse was not understood at high levels. Of the two
    questions in this Communication Objective, one scored 80% and the
    other 71%.

6.  The fact that the second tablet should be taken 12 hours after the
    first was not highly understood, or the results are ambiguous.

7.  A fairly high majority understood not to take the product while
    pregnant and that the product could not end a pregnancy.

8.  There was relatively low understanding (76%) not to use the product
    if there is unexplained vaginal bleeding. The sponsor stated that it
    plans to request that this information be removed from the label.

9.  There is fairly high understanding not to use the product by persons
    allergic to its ingredients.

10. There is high understanding of nausea and vomiting as side effects.

11. There is moderate (81%) understanding that one must get medical help
    if severe abdominal pain develops. The sponsor states that women "do
    not need written instructions to know they should see a doctor if
    severe pain develops."

This study suggests that there may be some lack of clarity about some
issues. Failure to attain high scores for some questions may be due to
actual knowledge deficits or to shortcomings of the questionnaire. As we
cannot be sure of the source of the lower scores, we recommend stressing
the messages that did not score in the high ranges. Messages in the
labeling that may not have been communicated at the highest levels
include the following:

-   Do not use for regular contraception

-   Use after intercourse

-   Timing of doses

-   Do not use if experiencing unexplained vaginal bleeding

-   Get medical help for severe abdominal pain

Based on the results of this study, the sponsor has recognized some of
the shortcomings of the label and stated that it planned to bold certain
information in the label in an effort to communicate that information
more effectively.

Results of this study and the ensuing changes to the label to emphasize
information that had not been understood at very high levels should be
viewed in conjunction with the Actual Use Study. That study provides
insight as to whether the revised labeling was sufficient to enable
women in the use trial to use the product appropriately.

**Recommendations**

Based on these results, DSRCS has the following recommendations for
changes to the label that had been used in this study:

-   Strengthen the following messages:

    -   Not for regular use (sponsor has bolded this)

    -   Timing of first dose

    -   Timing of second dose (sponsor has bolded this)

    -   If severe abdominal pain develops, seek immediate medical care

    -   Do no use if unexplained vaginal bleeding (if kept in the
        labeling)

-   State if there is a window of time for the second tablet, rather
    than just the 12 hour time.

In addition, DSRCS has a recommendation to help women time the second
dose appropriately:

-   Have a place on the label for the woman to write the time she took
    the first pill and the time she should take the second pill.