Consumer understanding of prescription Drug information: An Illustration using an antidepressant medication;La comprensión por parte de los consumidores de la información sobre medicamentos de prescripción: Un ejemplo con un medicamento antidepresivo

Annals of Pharmacotherapy

Volumn 45, Issue 4, 2011, Pages 452-458

  Shiffman, Saul ^a   Gerlach, Karen K ^a   Sembower, Mark A ^a   Rohay, Jeffrey M ^a  

^a PINNEY ASSOCIATES   (United States)

Author keywords

Comprehension; Consumer medication information; Medication guide; Written prescription drug information

Indexed keywords

ANTIDEPRESSANT AGENT;

ARTICLE; CONSUMER HEALTH INFORMATION; DRUG INFORMATION; DRUG SAFETY; EDUCATIONAL STATUS; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERVIEW; MAJOR CLINICAL STUDY; MALE; PATIENT EDUCATION; PRESCRIPTION; PRIORITY JOURNAL; RISK FACTOR; SCORING SYSTEM; SUICIDE;

ANTIDEPRESSIVE AGENTS; DRUG LABELING; DRUG TOXICITY; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; MALE; MIDDLE AGED; NONPRESCRIPTION DRUGS; PATIENT EDUCATION AS TOPIC; PRESCRIPTION DRUGS; QUESTIONNAIRES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79955670658     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1P477     Document Type: Article

References (27)

1. US Food and Drug Administration. Reports received and reports entered into AERS by year. www. fda.gov/Drugs/GuidanceComplianceRegulatory Information/Surveillance/AdverseDrugEffects/ucm070434.htm (accessed 2010 Mar 30).
2. Silverstein FE, Faisch G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the class study: a randomized controlled trial. JAMA 2000;284:1247-55. DOI 10.1001/jama.284.10.1247
3. US Food and Drug Administration. FDA drug safety communication: possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors. www. fda.gov/Drugs/DrugSafety/PostmarketDrug SafetyInformationforPatientsandProviders/ucm213206.htm#Additional InformationforHealthcareProfessionals (accessed 2010 Mar 9).
4. US Food and Drug Administration. FDA drug safety communication: completed safety review of Xenical/Alli (orlistat) and severe liver injury. www. fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm213038.htm (accessed 2010 Mar 9).
5. US Food and Drug Administration. Does FDA approve the information given out by pharmacies when I pick up my medicine? www. fda.gov/ AboutFDA/Basics/ucm194982.htm (accessed 2010 Mar 9).
6. US Department of Health and Human Services, Food and Drug Administration. Prescription drug product labeling; medication guide requirements; final rule. Federal Register 1998;63(230):66377-400. http://frwebgate1.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=646466496 512+0+2+0&WAISaction=retrieve (2010 Mar 9).
7. US Department of Health and Human Services. Food and Drug Administration amendments act (fdaaa) of 2007 (hr 3580), federal food, drug and cosmetic act chapter 5 drugs and devices. SEC. 505-1. [21 USC §355-1] Risk evaluation and mitigation strategies (accessed 2007 Sept 27).
8. US Food and Drug Administration. Medication guides. www. fda.gov/ Drugs/DrugSafety/ucm085729.htm (accessed 2010 Mar 9).
9. US Department of Health and Human Services. Guidance-useful written consumer medication information. www. fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm080602.pdf (accessed 2010 Mar 30).
10. US Food and Drug Administration. Guidance for industry: label comprehension studies for nonprescription drug products. www. fda. gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM143834.pdf (accessed 2010 May 14).
11. Wolf MS, Davis TC, Shrank WH, Neuberger M, Parker RM. A critical review of FDA-approved medication guides. Patient Educ Couns 2006; 62:316-22. DOI 10.1016/j. pec.2006.06.010
12. Kimberlin CL, Winterstein AG. Expert and consumer evaluation of consumer medication information 2008 final report to the US Department of Health and Human Services and the Food and Drug Administration. www. fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ RiskCommunicationAdvisoryCommittee/UCM117149.pdf (accessed 2010 Mar 30).
13. Dickenson D, Raynor DK, Duman M. Patient leaflets for medicines: using consumer testing to determine the most effective design. Patient Educ Couns 2001;43:147-59. DOI 10.1016/S0738-3991(00)00156-7
14. Payne SA. Balancing information needs: dilemmas in producing patient information leaflets. Health Informatics J 2002;8:174-9. DOI 10.1177/146045820200800402
15. Wallace LS, Keenum AJ, Roskos SE, Blake GH, Colwell ST, Weiss BD. Suitability and readability of consumer medical information accompanying prescription medication samples. Patient Educ Couns 2008;70:420-5. DOI 10.1016/j. pec.2007.11.017
16. LaPointe NMA, Pappas P, Deverka P, Anstrom KJ. Patient receipt and understanding of written information provided with isotretinoin and estrogen prescriptions. J Gen Intern Med 2007;22:98-101. DOI 10.1007/s11606-007-0109-4
17. Miller MJ, Schmitt MR, Allison JJ, Cobaugh DJ, Ray MN, Saag KG. The role of health literacy and written medicine information in nonsteroidal antiinflammatory drug risk awareness. Ann Pharmacother 2010; 44:274-84. DOI 10.1345/aph.1M479
18. Brass EP, Weintraub M. Label development and the label comprehension study for over-the-counter drugs. Clin Pharmacol Ther 2003;74:406-12. DOI 10.1016/S0009-9236(03)00239-X
19. Davis TC, Long SW, Jackson RH, et al. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med 1993;25:391-5.
20. Baer J, Kutner M, Sabatini J. Basic reading skills and the literacy of America's least literate adults: results from the 2003 National Assessment of Adult Literacy (NAAL) Supplemental Studies (NCES 2009-481). Washington, DC: National Center for Education Statistics, Institute of Education Sciences, US Department of Education. http://nces.ed.gov/pubs2009/2009481.pdf (accessed 2010 May 26).
21. Institute of Medicine, National Academy of Science. Committee on Health Literacy, Board on Neuroscience and Behavioral Health. Nielsen-Bohlman L, Panzer AM, Kindig DA, eds. Health literacy: a prescription to end confusion. Washington, DC: The National Academies Press. http://books.nap.edu/openbook.php?record_id=10883&page=R1 (accessed 2010 Mar 9).
22. US Food and Drug Administration Drug Safety and Risk Management Advisory Committee meeting, July 17, 2002. www. fda.gov/ohrms/dockets/ ac/02/transcripts/3874T1.htm (accessed 2010 May 26).
23. US Food and Drug Administration. Minutes of the Risk Communication Advisory Committee February 26, and Friday, February 27, 2009. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMateria ls/RiskCommunicationAdvisoryCommittee/UCM152593.pdf (accessed 2010 Mar 30).
24. Over-the-counter human drugs; labeling requirements; final rule. Federal Register 1999. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1999_register &docid=99-6296-filed.pdf (accessed 2010 Mar 30).
25. Svarstad BL, Bultman DC, Mount JK, Tabak ER. Evaluation of written prescription information provided in community pharmacies: a study in eight states. J Am Pharm Assoc 2003;43:383-93. DOI 10.1331/154434503321831102
26. Blake SC, McMorris K, Jacobson KL, Gazmararian JA. A qualitative evaluation of a health literacy intervention to improve medication adherence for underserved pharmacy patients. J Health Care Poor Underserved 2010;21:559-67. DOI 10.1353/hpu.0.0283
27. Shin HB, R Bruno. Language use and English-speaking ability: 2000. October 2003: www. census.gov/prod/2003pubs/c2kbr-29.pdf (accessed 2011 Mar 17).