Biomedical Engineering Reference
In-Depth Information
12.2.3
Were the FDA and MHRA Warnings Effective?
Experimental Evidence
Shortly after the FDA warning become public, we (Hanoch et al. 2010 ) surveyed
US parents' awareness of the new guidelines about OTC cough and cold medication
use, their trust in the FDA, and their intention to stop or continue using the
medication. We were also interested in parents' general knowledge, perception, and
behavior with regard to OTC-CCM. Overall, 377 parents of children under 6
responded to our online survey, the majority of whom (280) were female.
Of all 330 respondents without missing data, our results showed, fi rst, that 93 (or
about 30 %) had not heard about the FDA warning. Next we examined whether
parents with children less than 2 years old were more likely to have heard of the
FDA warning compared to parents of children over 2 years of age. Among parents
of children under 2, 142 of 189 (about 75 %) had heard of the FDA warning. In
comparison, 95 of 141 (about 67 %) parents with children over the age of 2 had
heard of the FDA warning. Although, as part of the target audience, parents of chil-
dren under 2 were more likely to be aware of the new FDA guidelines, over 25 % of
them had not heard of the FDA warning.
Our results were consistent with those of a National Public Radio/Kaiser Family
Foundation/Harvard School of Public Health ( 2007 , henceforth “NPR”) study that
surveyed a representative sample of US parents by telephone. In the NPR study,
32 % of parents indicated that they had heard either nothing at all or not much about
the FDA warning. The NPR survey also inquired regarding whether parents under-
stood the warning. They found that over a third (37 %) of parents indicated confu-
sion about the warning. Thus not only was a substantial minority of parents unaware
of the new recommendations, but among those who had heard of the warning, a
similar percentage was unclear on how to interpret the recommendations.
Next, we examined parents' intentions regarding further use of OTC-CCM. Of
the parents who had heard the warning, about a third (46, 32.4 %) indicated that they
would continue using it and a similar number of parents (43, 30.3 %) were unsure
what they would do. The remaining parents (53, 37.3 %) indicated that they would
adhere to the warning.
Finally, we explored the relationship between parents' trust in the FDA and their
intention to continue administrating OTC-CCM to their children. In our sample,
close to 50 % of parents with children under 2 reported not trusting the FDA recom-
mendations or were unsure whether to trust them. In accordance with our prediction
and the literature cited above, we found that parents who expressed the least trust in
the FDA recommendations were also more likely to continue using OTC-CCM. It
should be noted that although the NPR ( 2007 ) study did not examine the relation-
ship between adherence to the FDA recommendations and trust, it did fi nd that as
many as 71 % of parents reported trusting their child's doctors while only 29 %
reported trusting the FDA.
Our results thus highlighted the need to effectively communicate health warnings
to the general public by ensuring that they actually reach their intended audience.
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