Ray Bullman, Executive Vice President National Council on Patient Information and Education

1. Ray Bullman, Executive Vice President National Council on Patient Information and Education USP Label Standards Update & FDA Patient Medication Information (PMI) Update

2. Medication misuse results in over 1 million ADE/yr (IOM 2007) The patient’s best source (and often only source) of information is the Rx container label. While written information and oral consultations may sometimes be available, the Rx container label must be able to fulfill the professional obligations of physicians and pharmacists to give the patient all the information needed to understand how to safely use the medication. USP Label Update

3. USP Label Update Determine optimal prescription label content and format to promote safe medication use by critically reviewing factors that promote or distract from patient understanding of prescription medication instructions Create universal prescription label standards for format/appearance and content/language Co-chairs: Gerald McEvoy, Pharm D; ASHP, Joanne Schwartzberg, MD, AMA

4. Recommendations for Universal Standards Advisory panel with 4 subcommittees studied the issues. Recommendations for prescription container labeling approved and posted on the USP website in November, 2009. Proposed General Chapter <17> Prescription Container Labeling drafted and published in USP Pharmacopeial Forum 37(1) January-February 2010

5. Universal standards - Principles Organizing the prescription label in a patient-centered manner Patient-directed information must be organized in a way that best reflects how most patients seek out and understand medication instructions. Prescription container labeling should feature only the most important patient information needed for safe and effective understanding and use

6. Universal standards: Format/Readability Patient-directed instructions Should be at the top of the label; the patient’s name, drug name and directions for use (i.e., specific dosage/usage/administration instructions) should be displayed with greatest prominence. Other less critical but important content (e.g., pharmacy name and phone number, prescriber name, fill date, refill information, expiration date, prescription number, drug quantity, product description, and evidence-based auxiliary information) should not supersede critical patient information.

7. Universal standards: Format/Readability Improving readability Critical information for patients must appear on the prescription label in an uncondensed, simple, familiar, minimum 12-point font that is in sentence case. Use numeric rather than alphabetical characters Use horizontal text Minimize need to turn container

8. Universal Standards: Format/Readability Optimize typography: Use high contrast print (black print on white background), Use simple, familiar fonts with sufficient space within letters and between letters, use effective fonts such as serif (e.g., Times Roman) or san serif (e.g., Arial), Use large print 12-14 point font for critical information and do not use smaller than 10 point font for important information). Bolding, highlighting with light color only, reserve for critical information.

9. Universal Standards: Format/Readability Optimize white space Use adequate space between lines of text (25-30%); Use white space to distinguish sections on the label such as directions for use vs. pharmacy information)

10. Universal Standards: Language/Content Simplifying language Language on the label should be clear, simplified, concise, familiar and used in a standardized manner. Only common terms and sentences should be used. Use of unfamiliar words (including Latin terms) and unclarified medical jargon should be avoided. Whenever available and appropriate to the patient context, standardized patient-centered translations of common prescribing directions to patients (SIG) should be used.

11. Universal Standards: Language/Content Use explicit text to describe dosage/interval instructions Instructions for use must clearly separate the dose from the dosage interval, so as to explicitly convey the number of dosage units to be taken and the timing of such. Instructions for use should contain numeric rather than alphabetic characters for numbers (For example, “ Take 2 tablets in the morning and 2 tablets in the evening” rather than “Take two tablets twice daily”).

12. Universal Standards: Language/Content Chapter also addresses: Limited English Proficiency Prescription container labeling should be provided in an individual’s preferred language, if a high-quality translation process has been used. Including the purpose for use Patient preferences in sharing such information on the label must be paramount consideration. Confidentiality and FDA approval for intended use (e.g., labeled vs. off-label use) will limit inclusion of indications on Rx container labels. Current evidence supports inclusion of purpose-for-use language in clear, simple terms (e.g. for high blood pressure versus hypertension).

13. Universal Standards: Language/Content Chapter also addresses: Auxiliary information Auxiliary information on the prescription container label should be minimized and should be limited to evidence-based critical information regarding safe use.

14. More than 150 comments from various organizations & individuals received at USP during 90 day comment period. All comments received are being reviewed and will be considered by the Prescription Container Labeling Expert Panel for possible revision of the Chapter. Recent acetaminophen issues (e.g., NCPDP recommendations) sent to the Panel and will be considered for inclusion in the prescription container labeling standard during this revision. Public Comments Received – Next Steps

15. Part II – PMI Update FDA Patient Medicine Information (PMI)

16. Relevant Chronology 1996 – 2006 – 10-Year Keystone Action Plan by private sector Dec. 2008 - FDA final assessment of PMI Feb. 2009 – FDA Risk Communications AC Meeting (single doc. sol) Sept. 2009 – FDA public workshop (elements of useful PMI; prototypes introduced) May 2010 – FDA releases plan for consumer testing of PMI prototypes (Fed. Register) July 2010 – 1st of 3 Brookings Institution/FDA) Meetings (Workshop on prototype design, assessment and distribution) Sept. 2010 (FDA Public Hearing – design / distribution of PMI) Oct. 2010 -2nd of 3 BI/FDA Meetings (ensuring access to PMI) Feb. 2011 – Final BI/FDA Meeting (prototype testing) Sept. 2011 – FDA receives OMP clearance to proceed with consumer prototype testing FDA hopes to have data available – ???

17. Patient Medication Information (PMI) Update FDA plan: develop, consumer test & require a single- Document, manufacturer-prepared prescription medicine information (PMI) sheet developed under FDA guidance for all Rxs New document intended to replace current Consumer Medicine Information (CMI) & Medication Guides Two prototypes for consumer testing FDA’s pilot testing plan okayed by OMB this month

18. Patient Medication Information Needs Consumers need to receive clear, actionable patient medication information in order to use prescription medication safely and effectively. The information provided needs to be accurate, balanced and delivered in a consistent and easily understood format. The information needs to be available when the patient receives a prescription.

19. Current System Patient Package Inserts (PPI) Developed by manufacturers, approved by FDA, and dispensed with specific products (e.g., oral contraceptives, estrogen-containing products) Manufacturers can voluntarily submit other PPI to FDA for approval but distribution not mandated by regulation Medication Guides (MG) For medications that “pose a serious and significant public health concern” Developed by manufacturers, approved by FDA, and mandated distribution to patients each time medication is dispensed Consumer Medication Information (CMI) Developed by organizations other than a drug manufacturer Voluntarily distributed to consumers by pharmacies

20. FDA’s Concern: Why do we need PMI? Under the current system, patients receive several types of information developed by different sources that may be duplicative, incomplete, or difficult to read and understand. Patients may not be receiving federally mandated Medication Guides from the pharmacy. 2008 Evaluation of Consumer Medication Information (CMI): 94% consumers received information with new prescriptions 75% met the criteria for usefulness Demonstrating the PMI need is not being met Based on above issues, recommendations from FDA’s Risk Communication Advisory Committee, and additional stakeholder input, FDA sees merit in adopting use of a single document standardized with respect to content and format, surveillance and submission, and enforcement.

21. A New Paradigm: The Single-Document Solution Clear actionable information that allows a patient to use their Rx medication safely & effectively. Single document solution that provides Rx medication risk and benefit information in an accurate and balanced form delivered in a consistent and easily understood format. Provided when a patient receives an Rx medication with the intent that the information be used to take medications properly once the patient has gone home. Purpose is to aid patients who have already received a prescription. PMI is not a replacement for patient counseling.

22. The Future of Patient Medicine Information FDA is considering new regulation to: Require all prescription drugs have a single PMI document Sources of information in PMI – FDA approved professional labeling Set standards for the content and format Define evaluation criteria Require manufacturers to consumer-test Manufacturers must submit PMI to an electronic central repository

23. Recent PMI Activities Part 15 Public Hearing on Sept. 2010 for input on a new framework for development & distribution of PMI. Stakeholders provided recommendations on content, format & strategies for creating, distributing & evaluating PMI effectiveness. On Oct. 12, 2010, Brookings Institute hosted public forum to discuss strategies for ensuring that patients have access to effective PMI. On Feb. 23, 2011, Brookings Institute hosted small expert PMI workshop that summarized challenges expressed in above Brookings meetings & considered how best to design pilot studies for the distribution of PMI. The Future of Patient Medicine Information

24. FDA Next steps: Future meetings with stakeholders Consumer testing of single-document PMI prototypes Identify and assess mechanisms to ensure PMI distribution through pilots. Standardization of content and format Evaluation and testing to ensure PMI meets standards Identify and assess mechanisms to ensure PMI distribution The Future of Patient Medicine Information

25. FDA Proposed Consumer Testing to Evaluate Prototypes Design includes three parts: Live pretest: small sample of in-person testing (n = 180) Internet with hard copy prototype: patients receive one of the prototypes in the mail and answer questions via the Internet (n = 900) Internet with electronic prototype: patients have an electronic copy of the prototype and answer questions via the Internet (n = 200)

26. Critical Process Issues Key process areas that need to be defined: How to enforce pharmacy distribution? A central repository needs to be selected before data standards can be determined. FDA study needs to be completed before content and format can be established. Distribution pilots need to be performed before distribution can be established. All of the aforementioned activities need to be addressed prior to the creation of new regulations for PMI.

27. Future PMI Considerations Although there is no evidence on optimal page length, FDA firmly stated that PMI must stay within the single-sided one-page limit. Decision based on concern of non-adherence to page limits from past experience, such as with MedGuides, where manufacturers exceeded specified page limits. There are, however, several variable elements that might influence success of PMI, such as: order in which information presented, font choice, and font size -- all of which must be tested with patients to determine the best mix of elements.

28. Future PMI Considerations(BI/FDA #1 – July 2010) Paper-based PMI remains necessary and is not likely to disappear in the foreseeable future. However, several offered long-term visions for integrating technology with PMI distribution (e.g., patient portals and smart phones) E-mailing PMI to patients seems to be the most realistic next step in the integration of PMI and technology. Anticipated this distribution method having minimal effect on format & content of paper-based PMI Note: e-mail distribution presents additional considerations, such as an opt-in requirement, concerns about security of information, & patient privacy

29. Bubble Drug Facts Style Prototype Examples (2)

32. FDA Contact Information If you have any questions for the FDA’s Office of Medical Policy regarding PMI, email PMI@fda.hhs.gov. FDA OMP Contacts: Bryon Pearsall: bryon.pearsall@fda.hhs.gov Denise Hinton: denise.hinton@fda.hhs.gov Richardae Araojo: richardae.araojo@fda.hhs.gov

33. NCPIE Contact Information Ray Bullman National Council on Patient Information and Education (NCPIE) 200-A Monroe Street, Suite 212 Rockville, MD 20850 bullman@ncpie.info (301) 340-3940 – telephone