Effectiveness of FDA's new over-the-counter acetaminophen warning label in improving consumer risk perception of liver damage

Journal of Clinical Pharmacy and Therapeutics

Volumn 37, Issue 6, 2012, Pages 681-685

  Goyal, R K ^a,b   Rajan, S S ^a   Essien, E J ^a   Sansgiry, S S ^a  

^a UNIVERSITY OF HOUSTON   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

acetaminophen; behavioural intention; liver damage; OTC medication; risk perception; warning label

Indexed keywords

NON PRESCRIPTION DRUG; PARACETAMOL;

ADULT; ARTICLE; DRUG LABELING; EXPERIMENTAL STUDY; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; LIVER INJURY; MALE; PERCEPTION; PRODUCT SAFETY; QUESTIONNAIRE; RATING SCALE; VISUAL ANALOG SCALE;

ACETAMINOPHEN; ADULT; ANALGESICS, NON-NARCOTIC; CONSUMER HEALTH INFORMATION; DRUG LABELING; DRUG-INDUCED LIVER INJURY; FEMALE; HEALTH BEHAVIOR; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; MALE; MIDDLE AGED; NONPRESCRIPTION DRUGS; PERCEPTION; QUESTIONNAIRES; RISK; STATISTICS, NONPARAMETRIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84868353811     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/j.1365-2710.2012.01371.x     Document Type: Article

References (29)

1. Hermann F, Herxheimer A, Lionel ND,. Package inserts for prescribed medicines: what minimum information do patients need? Br Med J, 1978; 2: 1132.
2. Brass E, Weintraub M,. Label development and the label comprehension study for over-the-counter drugs. Clin Pharmacol Ther, 2003; 74: 406-412.
3. Morrell RW, Park DC, Poon LW,. Quality of instructions on prescription drug labels: effects on memory and comprehension in young and old adults. The Gerontologist, 1989; 29: 345-354.
4. Roumie CL, Griffin MR,. Over-the-counter analgesics in older adults: a call for improved labelling and consumer education. Drugs Aging, 2004; 21: 485-498.
5. Federal Register. Over-the-counter human drugs: labeling requirements. Food and Drug Administration, 13253-13303, 1999.
6. Federal Register. Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; Final Monograph. Food and Drug Administration, 19385-19409, 2009.
7. Kaufman DW, Kelly JP, Rosenberg L, Anderson TE, Mitchell AA,. Recent patterns of medication use in the ambulatory adult population of the United States: the Slone survey. JAMA, 2002; 287: 337-344.
8. Federal Register. Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling. Food and Drug Administration, 77314-77352, 2006.
9. Renner B, Herald S, Manja W, Freda-Marie H, Ralf S, Martina P,. Risk perception, risk cammunication and hea Ith behavior change. Zeitschrift für Gesundheitspsychologie, 2008; 16: 150-153.
10. McCool J, Ameratunga S, Moran K, Robinson E,. Taking a risk perception approach to improving beach swimming safety. Int J Behav Med, 2009; 16: 360-366.
11. Martin IM, Bender H, Raish C,. What motivates individuals to protect themselves from risks: the case of wildland fires. Risk Anal, 2007; 27: 887-900.
12. Sanz E, Gõmez-Lõpez T, Mart nez-Quintas MJ,. Perception of teratogenic risk of common medicines. Eur J Obstet Gynecol Reprod Biol, 2001; 95: 127-131.
13. Damase-Michel C, Pichereau J, Pathak A, Lacroix I, Montastruc JL,. Perception of teratogenic and foetotoxic risk by health professionals: a survey in Midi-Pyrenees area. Pharm Pract, 2008; 6: 15-19.
14. Taylor AH, May S,. Threat and coping appraisal as determinants of compliance with sports injury rehabilitation: an application of protection motivation theory. J Sports Sci, 1996; 14: 471-482.
15. Helmes AW,. Application of the protection motivation theory to genetic testing for breast cancer risk. Prev Med, 2002; 35: 453-462.
16. Wu Y, Stanton BF, Li X, Galbraith J, Cole ML,. Protection motivation theory and adolescent drug trafficking: relationship between health motivation and longitudinal risk involvement. J Pediatr Psychol, 2005; 30: 127-137.
17. De Vaus DA,. Surveys in social research. London: Routledge, 2002.
18. Babbie ER,. The practice of social research. Belmont, CA: Wadsworth Publication Company, 2009.
19. Bland J, Altman D,. Cronbach's alpha. Br Med J, 1997; 314: 572.
20. Clark D, Layton D, Shakir S,. Monitoring the safety of over the counter drugs. Br Med J, 2001; 323: 706-707.
21. Cham E, Hall L, Ernst AA, Weiss SJ,. Awareness and use of over-the-counter pain medications: a survey of emergency department patients. South Med J, 2002; 95: 529-535.
22. Neafsey PJ, Shellman J,. Misconceptions of older adults with hypertension concerning OTC medications and alcohol. Home Healthc Nurse, 2002; 20: 300-306.
23. Ajuoga E, Sansgiry SS, Ngo C, Yeh RF,. Use/misuse of over-the-counter medications and associated adverse drug events among HIV-infected patients. Res Soc Adm Pharm, 2008; 4: 292-301.
24. Harris Interactive. Uses and attitudes about taking over-the-counter medicines: findings of a 2003 National Opinion Survey. Bethesda, MD: National Council of Patient Information and Education, 2003. Available at: http://www.bemedwise.org/survey/summary-survey-findings.pdf. (accessed 21 March 2011).
25. Sansgiry SS, Nadkarni A, Doan T,. Misuse of over the counter medications among community dwelling older adults and associated adverse drug events. J Pharm Health Serv Res, 2010; 4: 175-179.
26. Wilcox CM, Cryer B, Triadafilopoulos G,. Patterns of use and public perception of over-the-counter pain relievers: focus on nonsteroidal anti-inflammatory drugs. J Rheumatol, 2005; 32: 2218-2224.
27. Peterson GM,. Selecting nonprescription analgesics. Am J Ther, 2005; 12: 67-69.
28. Sansgiry S, Cady P, Patil S,. Readability of over-the-counter medication labels. J Am Pharm Assoc, 1996; NS37: 522.
29. Lechuga Berné M, Riveros Rosas A, Sánchez-Sosa J,. Risk perception of the self-prescribed use of over the couter (OTC) cold/flu medications. Int J Clin Health Psychol, 2009; 9: 73-88.