Advertisement

The Patient Labeling Program at Bristol-Myers Squibb

  • Cathleen A. O’Connell
  • Rebecca Skinner
Article

Abstract

Among the goals of the Department of Health and Human Services and the Food and Drug Administration (FDA) is to improve written communication to patients about their prescription medicines. Bristol-Myers Squibb Company recognizes the need for patients to receive high-quality information regarding their therapeutic options. The company has initiated a program to prepare patient-oriented labeling for certain prescription products for which such material is appropriate, using the FDA’s proposed Medication Guide as a basis for content and format.

Key Words

Food and Drug Administration Patient labeling Consumer labeling Patient package insert Medication Guide Healthy People 2000 Action Plan for the Provision of Useful Prescription Medicine Information 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Federal Register. 1968;33:8812 (21 CFR 201.305).Google Scholar
  2. 2.
    Federal Register. 1970;35:9O01 (21 CFR 310.501).Google Scholar
  3. 3.
    Federal Register. 1977;42:37636 (21 CFR 310.515).Google Scholar
  4. 4.
    Federal Register. 1978;43:47198 (21 CFR 310.516).Google Scholar
  5. 5.
    Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information. Action Plan for the Provision of Useful Prescription Medicine Information. December 1996: 11.Google Scholar
  6. 6.
    Federal Register. 1979;44:40016.Google Scholar
  7. 7.
    Federal Register. 1980;45:60754.Google Scholar
  8. 8.
    Federal Register. 1981;46:13193.Google Scholar
  9. 9.
    Federal Register. 1981;46:23739.Google Scholar
  10. 10.
    Federal Register. 1982;47:39147.Google Scholar
  11. 11.
    Federal Register. 1995;60:44182.Google Scholar
  12. 12.
    HR 104-180.Google Scholar
  13. 13.
    Federal Register. 1995;60:44199.Google Scholar
  14. 14.
    Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information. Action Plan for the Provision of Useful Prescription Medicine Information. December 1996: 3.Google Scholar
  15. 15.
    Federal Register. 1998;63:66378-66400.Google Scholar
  16. 16.
    Jones S, et al. Patient information leaflets for HIV positive patients. Pharmaceut J. Sep 8, 1990;245: 308–309.Google Scholar
  17. 17.
    Fleckenstein L, et al. Oral contraceptive patient information-a questionnaire study of attitudes, knowledge, and preferred information sources. JAMA. 1976; 235(13):1331–1336.CrossRefGoogle Scholar
  18. 18.
    Smith D. Compliance packaging: a patient education tool. Am Pharmacy. Feb 2, 1989;NS29(2):126–137.Google Scholar
  19. 19.
    Kuperberg JR, et al. All in one: the user-friendly rx product. Pharmaceut Exec. April 1990:74–78.Google Scholar
  20. 20.
    Gibbs S, et al. The benefits of prescription information leaflets (1). Br J Clin Pharmacol. 1989;27:723–739.CrossRefGoogle Scholar
  21. 21.
    George CF, et al. Prescription information leaflets: a pilot study in general practice. Brit Med J 1983; 287:1193–1196.CrossRefGoogle Scholar
  22. 22.
    Glazier R, et al. Written patient information about triple-market screening: a randomized, controlled trial. Obstet Gynecol. November 1997;90(5):769–774.CrossRefGoogle Scholar
  23. 23.
    National Institute of Health. Minimizing Medical Product Errors, A Systems Approach, Bethesda, MD; Jan. 8, 1998.Google Scholar
  24. 24.
    Sless D, Wiseman R. Writing about Medicines for People-Usability Guidelines for Consumer Medicine Information. 2nd ed. Communication Research Institute of Australia. Dickson, Australia. Ch 6, 73-96, Appendices 3, 4, 5, 121-157.Google Scholar

Copyright information

© Drug Information Association, Inc 1999

Authors and Affiliations

  • Cathleen A. O’Connell
    • 1
  • Rebecca Skinner
    • 2
  1. 1.U.S. and Export LabelingBristol-Myers Squibb CompanyPrincetonUSA
  2. 2.Bristol-Myers Squibb CompanyWallingfordUSA

Personalised recommendations