To measure consumers’ understanding of where to locate additional information included in the package.
The Orlistat
Label Comprehension Study
Study Design and Population
Inclusion/Exclusion Criteria
Male/Female of any race/ethnicity.
At least 18 years of age.
Expressed an interest (“somewhat” or “very interested”) in weight loss.
Gender Breakdown
General Population (GP) – 36% male and 64% female.
Low Literacy (LL) – 39% male and 61% female.
Two cohorts of individuals
General Population of 304 subjects, 18% of which qualified as Low Literate and were also counted in Cohort #2 (the low literacy group).
Low Literacy group of 160 subjects, 54 of which were from the General Population group and 106 of which were specifically recruited as low literate subjects.
The correct answer is contained in the section of the label sub-headed:
“When using this product” where it says:
“How much weight you lose will depend on how closely you follow the recommended diet and the Orlistat program.”
The Interviewing Script
All of the study participants were told that . . .
This was a test of the package labeling.
They would not be questioned about previous knowledge or commonsense but about what has been learned from reading the information in the package labeling.
They should respond according to the information
in the label.
They would be able to view and read all the package labeling throughout the test.
Over 20% of the respondents from each cohort (GP & LL) rationalized
that, since “Jane” in the scenario was over 18 and healthy, and since
there was no specific warning on the box stating that non-overweight
people should not take Orlistat, it would be okay for “Jane” to take Orlistat.
Is not contraindicated
Package / label does not mention
Don’t have to be overweight to use
Over 18 years old / old enough
Healthy / isn’t sick
Safe to use
Possible Use by Non-Overweight Adults
Another set of responses reflected the idea that Orlistat
would be good for maintaining desired weight. Here are
some examples:
“It could help her not to be overweight.”
“If she wants to maintain her weight. It’s fine to use.”
“If she uses it moderately, it will help her maintain her weight.”
“It could help her stay thin.”
“She just might want to keep her weight the way it is.”
“It’s only a fat reducer and it would keep her thin.”
“Helps block fat so you don’t gain weight.”
Possible Use by Non-Overweight Adults
A variety of other interesting verbatim responses referred to whether or not
25-year-old, non-overweight “Jane” in the scenario could take Orlistat:
“If she really wants to go for that [famous actress] look, she can. It doesn’t say specifically not to, and it probably won’t be any worse for her than if she just goes bulimic.”
“If she wants to, it could help to lose cellulite but she really doesn’t need it but she has no health problems to keep her from using the product.”
“Some people may want to lose weight no matter what they weigh. Nowhere on this box does it say for those that are overweight only.”
“She can see if it will cut down her appetite.”
“It just says a well-balanced diet and I don’t think it says you can’t use it unless you are overweight.”
“She doesn’t need to take it, but it doesn’t say not to take it if not overweight.”
Steve is overweight. He has been using Orlistat. Steve is going out
to dinner tonight but is not sure what would be best for him to order.
The accurate response is:
“Away from Home Guide” which clearly states that it covers “Dining Out” issues.
Some variations are acceptable:
Dining Out Guide.
In the little restaurant guide.
Calorie/fat counter/diet cards.
Where to Find Information in the Educational Materials
GP % LL %
Q48 Information on fast food restaurants
90
90
Q49 Information on setting realistic goals
90
86
Q51 Information on understanding personal eating habits
82
76
Q47 Information on snacking tips
77
69
Q50 Information on learning to navigate the grocery store
66
65
Q52 Information on the food and activity tracker
43
41
Q35 Information on fat and calories
42
26
Q26 Information on preparing meals
42
24
Q19 Information on what to order when dining out
37
23
Additional Information Included in the Package
“Ask a doctor/pharmacist” is not an acceptable answer, nor are a number of
other responses that were coded as “acceptable.” The following are so
general as to be no better than default answers:
In the booklet
In the packet
Inside the box
As many as 42 respondents gave completely inaccurate answers such as:
“Back of package / on back in drug facts; Directions on box / label;
Directions; On the label / box”
4 respondents said:
“From restaurant / ask the waiter / restaurant / consult the restaurant”
Other respondents said look in the “When using this product” section of
the Drug Facts label; or “In the inactive ingredients” section of the
label; or in the “Activity Tracker;” or simply at “The bottom of the label.”
Where to Find Information on What to Order When Dining Out
Summary and Observations
There was very high comprehension of the label Warnings.
Correct response rates concerning cyclosporine were in the 90th percentile for both the General Population and Low Literacy cohorts.
Almost all the label Directions were well understood by the General Population group and the Low Literacy group.
Only the directions concerning multivitamin use were not particularly well understood by either group.
This indicates that some modification of the Drug Facts label is needed to clarify and emphasize the instructions concerning taking multivitamins.
Summary and Observations
The lack of a warning on the Drug Facts label specifically telling consumers “Do not use if you are not overweight,” confused some participants and led them to think that use by non-overweight individuals would be acceptable.
After the completion of the label comprehension study, the Sponsor amended the Drug Facts label to include a specific Warning that states: “Do not use if you are not overweight.” This may help to alleviate the misunderstanding.
It may help consumers to make a more informed self-selection and purchase decision if there were some indication on the external packaging as to what constitutes being overweight. From the label comprehension study it seems that many people have a variety of subjective opinions about this.
