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Improved Health Outcomes through Effective Communication: Importance of FDA-Approved Drug Labels

Learn how FDA-approved drug labels serve as a crucial tool in providing physicians with the necessary information to treat patients effectively. Explore the different forms of consumer information available and the role of integrated consumer education campaigns in promoting improved health outcomes. Discover the benefits of paperless labeling and the proposal for electronic access to up-to-date labeling information at all dispensing sites.

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Improved Health Outcomes through Effective Communication: Importance of FDA-Approved Drug Labels

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  1. Drug Information for Consumers and Healthcare Professionals Food and Drug Law Institute Annual Meeting Alan Goldhammer, PhD Associate VP Regulatory Affairs Pharmaceutical Research and Manufacturers of America

  2. Importance of Communication • An Educated Patient must be Goal #1 • Improved Health Outcomes from Maximizing the Benefit and Minimizing the Risk is the Desired Result

  3. Basis of all Communication FDA-Approved Drug Label is the synthesis of all the information acquired from the drug development program. It provides the important information that physicians need to treat their patients.

  4. Useful Consumer Information • Comes in Many Forms • Increases Patient Knowledge and Awareness about Disease States and Treatment Options • Leads to Improved Health Outcomes

  5. Role of Integrated Consumer Education Campaigns Awareness Mass-reach advertising (TV/Print/PR) Depth of Education Websites, toll-free numbers, patient education Physician / Patient discussions Physician visit / Write Rx Patient education on use of product Compliance Each media has different strengths and purpose in comprehensive communication campaign

  6. Information Available at Dispensing • Medication Guides • Patient Package Inserts • Consumer Medication Information

  7. Paperless Labeling Industry Initiative to Move Beyond Paper Prescribing Information to Deliver a Fully Implemented Electronic System at Every US Dispensing Site

  8. The Current Regulation • 21 CFR § 201.100 Prescription drugs for human use • A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met: • (c)(1) Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including . . .

  9. The Current Product • “Less than User-Friendly” • Current??? • Bizarre sizes • the scroll • the newspaper • the wallpaper • Mouse-size print • Not always retained in pharmacies • New FDA Rule to Require Longer Labels is Pending

  10. The Paperless LabelingTask Force Proposal • The current labeling for all marketed prescription products to be available electronically at no cost to all dispensing locations. • “PDF” versions, using free software, available for viewing or printing. • “Bar-coded” labels would allow direct access to product-specific labeling

  11. Advantages to Proposal • Pharmacists will have access to the most recent labeling • Public Health Benefit • Labeling would be readable on screen • Pharmacist can quickly scan to section of interest • No possible product misbranding due to package insert mix ups

  12. User Requirements • Readily Accessible • Timely – label updates will be provided daily • Comprehensive • User Friendly • Standardized • Printable • Rapid access codes (“bar-coded”)

  13. User Requirements (cont’d.) • Text cannot be changed • Virus protected • Cost-neutral to dispensing site • Available at all dispensing sites

  14. Status and Next Steps • Proof of Concept Test (summer ’03) • Large Scale Field Test ( Nov ’04-Feb ’05) • Work with FDA and other stakeholders on full scale implementation • Commercial Rollout in 2006????

  15. Priority Goals • Talk to your doctor, pharmacist, or other health care professionals. • Know your medicines. • Read the label and follow directions. • Avoid interactions. • Monitor the medicine’s effects.

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