Investigating the efficacy of an interactive warning for use in labeling strategies used by U.S. pharmacies

Keywords: Prescription Drugs, Drug Packaging, Product Labeling, Health Literacy, Mental Recall, Attention, Pharmacies, Fixation, Ocular, Cross-Sectional Studies, United States

Abstract

Background: United States pharmacies repackage medications into multi-dose vials, enabling customized dosing for prescription drugs. Investment in infrastructure has made this the predominant approach to packaging for US prescriptions. Although recent changes to labeling now discourage the use of auxiliary labels (small stickers highlighting information germane to the safe and effective use), they are still allowed by USP<17>, provided their use comes from an evidence-based perspective.

Objectives: Evaluate how ‘interactive,’ placements of auxiliary labels (placement requiring physical manipulation of the warning to accomplish a task (e.g. opening)) garner attention as compared to those placed vertically or horizontally.

Methods: Ninety-six participants were eye tracked while opening three prescription vials (each with an auxiliary warning label with a different placement: vertical, horizontal and interactive). Recall and recognition were tested subsequently. Linear mixed models were used to analyze the continuous variables while the binary response variables were analyzed using generalized linear mixed models. The effect of auxiliary labels was fitted as a fixed effect and the subject-to-subject variation was considered as a random effect in the model. Participants’ age, health literacy and sex were added to the models if their effect was statistically significant at alpha=0.05.

Results: The placement of the warnings significantly impacted the time spent viewing the information they contained at alpha=0.05; people spent significantly longer on interactive placements (0.96; SD 0.13 seconds) than either, horizontal placements (0.27; SD 0.037 seconds) or those placed vertically (0.18 seconds; SD 0.035). Participants were equally as likely to see information presented in an interactive placement (90%; SD 3.8) or horizontal placement (78%; SD 05.5) but less likely to view warnings placed vertically (60%; SD 6.9). Free recall responses also supported the use of interactive placement (62%; SD 6.8 recall) as compared to horizontal placements which were 29%; SD 3.0 and 20%; SD 6.0 for vertical placements.

Conclusions: Data provides evidence which suggests that interactive and horizontal placements out-perform auxiliary labels placed vertically on prescription vials with regard to garnering patient attention.

Downloads

Download data is not yet available.

References

About Medication Errors. National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) 2018. Available at: http://www.nccmerp.org/about-medication-errors (accessed Feb 3, 2019).

Aspden P, Wolcott J, Bootman JL, Cronenwett LR, editors. Preventing medication errors: quality chasm series Washington, DC: The National Academies Press; 2007.

Shrank W, Avorn J, Rolon C, Shekelle P. Medication safety: Effect of content and format of prescription drug labels on readability, understanding, and medication use: A systematic review. Ann Pharmacother. 2007;41(5):783-801. https://doi.org/10.1345/aph.1H582

Kebodeaux CD, Peters GL, Kindermann HA, Hurd PD, Berry TM. Patient-perceived content and formatting expectations for prescription container labeling. J Am Pharm Assoc (2003). 2016;56(3):242-247. https://doi.org/10.1016/j.japh.2016.01.007

Locke MR, Shiyanbola OO, Gripentrog E. Improving prescription auxiliary labels to increase patient understanding. J Am Pharm Assoc (2003). 2014;54(3):267-274. https://doi.org/10.1331/JAPhA.2014.13163

Shiyanbola OO, Meyer BA, Locke MR, Wettergreen S. Perceptions of prescription warning labels within an underserved population. Pharm Pract (Granada). 2014;12(1):387. https://doi.org/10.4321/s1886-36552014000100008

Shiyanbola OO, Smith PD, Mansukhani SG, Huang YM. Refining prescription warning labels using patient feedback: a qualitative study. PLoS One. 2016;11(6):e0156881. https://doi.org/10.1371/journal.pone.0156881

Webb J, Davis TC, Bernadella P, Clayman ML, Parker RM, Adler D, Wolf MS. Patient-centered approach for improving prescription drug warning labels. Patient Educ Couns. 2008;72(3):443-449. https://doi.org/10.1016/j.pec.2008.05.019

Jones JH, Treiber LA, Jones MC. Intervening at the intersection of medication adherence and health literacy. J Nurse Pract. 2014;10(8):527-534. https://doi.org/10.1016/j.nurpra.2014.06.014

Gill RT, Barbera C, Precht T, editors. A comparative evaluation of warning label designs. Proceedings of the Human Factors Society 1987 Annual Meeting. Los Angeles, CA: SAGE; 1987.

Davis TC, Wolf MS, Bass PF, Middlebrooks M, Kennen E, Baker DW, Bennett CL, Durazo-Arvizu R, Bocchini A, Savory S. Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med. 2006;21(8):847-851. https://doi.org/10.1111/j.1525-1497.2006.00529.x

Davis TC, Wolf MS, Bass PF, Thompson JA, Tilson HH, Neuberger M, Parker RM. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006;145(12):887-894. https://doi.org/10.7326/0003-4819-145-12-200612190-00144

Wolf MS, Davis TC, Bass PF, Curtis LM, Lindquist LA, Webb JA, Bocchini MV, Bailey SC, Parker RM. Improving prescription drug warnings to promote patient comprehension. Arch Intern Med. 2010;170(1):50-56. https://doi.org/10.1001/archinternmed.2009.454

Mullen RJ, Duhig J, Russell A, Scarazzini L, Lievano F, Wolf MS. Best-practices for the design and development of prescription medication information: A systematic review. Patient Educ Couns. 2018;101(8):1351-1367. https://doi.org/10.1016/j.pec.2018.03.012

Bailey SC, Navaratnam P, Black H, Russell AL, Wolf MS. Advancing best practices for prescription drug labeling. Ann Pharmacother. 2015;49(11):1222-1236. https://doi.org/10.1177/1060028015602272

Wali H, Hudani Z, Wali S, Mercer K, Grindrod K. A systematic review of interventions to improve medication information for low health literate populations. Res Social Adm Pharm. 2016;12(6):830-864. https://doi.org/10.1016/j.sapharm.2015.12.001

McEvoy G. Creating a Standard for Medication Prescription Labels. Health Literacy Past, Present and Future. Washington, DC: IOM; 2014.

National Association of Boards of Pharmacy. USP prescription container Labeling chapter is now the official standard: the USP 36–NF 31. Mount Prospect, IL: NABP; 2012.

DeJoy DM, editor A revised model of the warnings process derived from value-expectancy theory. Proceedings of the Human Factors Society 1991 Annual Meeting; Los Angeles, CA: SAGE; 1991.

de la Fuente J, Bix L. A tool for designing and evaluating packaging for healthcare products. J Patient Compl. 2011;1:48-52.

Wogalter MS, Desaulniers DR, Brelsford Jr JW, editors. Perceptions of consumer products: Hazardousness and warning expectations. Proceedings of the Human Factors Society 1986 Annual Meeting. Los Angeles, CA: SAGE; 1986.

Wolf MS, Davis TC, Shrank W, Rapp DN, Bass PF, Connor UM, Clayman M, Parker RM. To err is human: patient misinterpretations of prescription drug label instructions. Patient Educ Couns. 2007;67(3):293-300. https://doi.org/10.1016/j.pec.2007.03.024

Laughery KR, Stanush JA, editors. Effects of warning explicitness on product perceptions. Proceedings of the Human Factors Society 1989 Annual Meeting. Los Angeles, CA: SAGE; 1989.

Hunn BP, Dingus TA. Interactivity, information, and compliance cost in a consumer product warning scenario. Accid Anal Prev. 1992;24(5):497-505.

Duffy RR, Kalsher MJ, Wogalter MS. Increased effectiveness of an interactive warning in a realistic incidental product-use situation. Int J Indust Ergon. 1995;15(3):159-166.

Sundar RP, Becker MW, Bello NM, Bix L. Quantifying age-related differences in information processing behaviors when viewing prescription drug labels. PLoS One. 2012;7(6):e38819. https://doi.org/10.1371/journal.pone.0038819

Bass PF 3rd, Wilson JF, Griffith CH. A shortened instrument for literacy screening. J Gen Intern Med. 2003;18(12):1036-1038. https://doi.org/10.1111/j.1525-1497.2003.10651.x

Flesch R. A new readability yardstick. J Appl Psychol. 1948;32(3):221-233.

The Flesch Reading Ease Readability Formula. Available at: http://www.readabilityformulas.com/flesch-reading-ease-readability-formula.php (accessed Feb 3, 2019).

Published
2019-06-14
How to Cite
1.
Lee J, Ladoni M, Richardson J, Sundar RP, Bix L. Investigating the efficacy of an interactive warning for use in labeling strategies used by U.S. pharmacies. Pharm Pract (Granada) [Internet]. 2019Jun.14 [cited 2019Sep.18];17(2):1463. Available from: https://pharmacypractice.org/journal/index.php/pp/article/view/1463
Section
Original Research