Factors Affecting Adherence to Governmental Health Warnings and the Case of Over-the- Counter Cough and Cold Medications (OTCCCM) in Children Under Two - Innovation and Marketing in the Pharmaceutical Industry - page 353

First, we propose ways to increase awareness for the warning. Drug packages,
especially in the case of OTC medication, are highly visible to the consumer. In
addition to direct-to-physician dissemination of the warning, if the FDA were to
mandate printing the warning on the packaging (similar to Sample Warning D), it
would reach every potential consumer prior to the decision to purchase and possibly
at home prior to the decision to administer the medication (if the medication is
stored in its original packaging). This may be more practical than depending on a
pediatrician, patients' most trusted source of information (Mechanic 2004 ; Brown
2009 ; Fig. 12.2 ), to convey the warning, especially in the context of over-the-counter
products not necessitating a doctor's visit prior to purchase. We (Miron-Shatz et al.
2010 ) found that approximately half (55 %) of parents trust warnings on packaging
at least somewhat, with experienced parents slightly more likely to trust the warn-
ings. (Average trust ratings of participants in the Miron-Shatz et al. ( 2010 ) study for
various sources of trust are shown in Fig. 12.2 , separately for experienced and inex-
perienced parents.) Packaging has been used effectively for warnings in other con-
texts, including smoking (Kees et al. 2006 ; see Sample Warning D). Similarly, to
warn smokers of the associated health risks, in 2003, the World Health Organization
(WHO) adopted the Framework Convention on Tobacco Control requiring that
health warning information cover at least 30 % of the principal display areas on
tobacco packaging (WHO 2003 , Article 11). Thus, warnings such as those of the
FDA and MHRA may be more effective if printed on the medication package rather
than by public announcement (but see Lokker et al. 2009 ).
Further, regarding awareness to the warning, the FDA warning was issued in
2008 and not repeated since (though the agency recently announced removal from
the market of many unapproved prescription drugs with the same ingredients as
OTC-CCM; FDA 2011c ). Similarly, the MHRA did not repeat its 2008 warning
(though the agency extended the warning to children under 6 in 2009; MHRA
2009 ). Parents who initially heard these warnings may have forgotten them, and
new parents may be completely unaware of the warnings. Incorporating agency
warnings into drug packaging may also serve to keep them prominent in consumers'
minds. In fact, MHRA has indicated that it is working with industry to incorporate
its warning into product labeling (MHRA 2009 ).
Second, in spite of Ratner et al.'s ( 2008 ) recommendation to minimize excessive
deliberation in processing health and other public welfare messages, the FDA rec-
ommendation mentioned both safety and effi cacy as reasons for discontinuing
OTC-CCM use. We examined the importance of various factors in parents' delibera-
tions regarding whether to administer OTC-CCM (for participants in the Miron-
Shatz et al. 2010 study). Side effects were deemed “very important” by 53.6 % of
the respondents. By comparison, a smaller proportion of respondents indicated that
the following attributes were “very important”: reduce child's fever, relieve child's
pain, and relieve child's cough (40.5 %, 27.7 %, and 26.7 %, respectively). The
greater parental emphasis on safety over effi ciency is consistent with a more preven-
tive regulatory focus and suggests that parents may have exhibited better adherence
to the FDA and MHRA warnings had they been phrased in a “loss” or prevention
frame appealing to response effi cacy (Keller 2006 ), particularly prevalence of side