EFFECT OF PLACEMENT OF WARNING INFORMATION ON OTC DRUG FACTS PANEL- IMPROVING EASE OF USE AND PURCHASE INTENTION

Author(s)

Bhansali AH*;Sangani DN;Mhatre S, Sansgiry SS University of Houston, Houston, TX, USA

OBJECTIVES: Order in which warning information is presented on the over-the-counter medication Drug Facts panel could enhance patient safety. This study assessed the effect of placement of warning information on OTC Drug Facts panel to provide guidance to the FDA in enhancing appropriate product use.  METHODS:   Two experimental labels (current and new) were developed from an existing marketed drug product by varying the sequence of information to- uses, directions, other information and warnings (new) vs uses, warnings, directions and other information (current). In this repeated measure experimental study, each participant evaluated labels on ease of use and purchase intention using an eleven point scale with appropriate scale anchors. The order in which participants viewed the label was randomized. Mean score for ease of use and purchase intention was contrasted between labels using match paired t-test. RESULTS: Of the 297 study participants (71% response rate), majority were males (60.4%) with a mean (±SD) age of 21.3 (±1.8) years. More than half (55%) indicating they often read labels, while 70% were currently not on any medications. The mean (±SD) scores were significantly (p<0.0001) higher for ease of use for the new (8.0 ± 1.2) as compared to the current label design (6.8 ± 1.2). Similarly the mean purchase intention were also significantly (p<0.0003) higher for the new label design (7.8 ± 1.4) compared to current label (7.4 ± 1.2). CONCLUSIONS: The prototype new label developed with congruent information where uses and directions were clustered and were followed by warnings was perceived better. This information can help guide the FDA to conduct more studies and develop policy changes as necessary to improve information comprehension from OTC Drug Facts panel.

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PHP107

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Health Care Research

Disease

Multiple Diseases

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