1. Enhancing Written Information from the Pharmacy: An Update on MedGuides & Consumer Medicine Information (CMI) National Association of Chain Drug Stores 2006 Pharmacy & Technology Conference San Diego, CA July 28, 2006 William Ray Bullman Executive Vice President National Council on Patient Information and Education Bethesda, MD

2. Why so Much Emphasis on Written Prescription Information? FDA regulation High risk medications (e.g., Vioxx) New IOM report – Preventing Medication Errors CMI usefulness survey in 2007 Challenges with MedGuides Many types of written prescription information

3. FDA Regulation of Prescription Medicine information What the FDA regulates? –Professional labeling and promotional materials, including direct-to-consumer (DTC) advertising What the FDA does NOT regulate –Websites with medication information –Consumer books (excluding some references)

4. Types of Written Information in Pharmacies Package Insert (PI) Consumer Medicine Information (CMI) Medication Guides (MedGuides) Patient Information Sheets (PIS) Patient Package Insert (PPI)

5. Package Insert (PI) To gain marketing approval, manufacturers must have official labeling for its product approved by FDA. This includes both the label on container & package insert or PI which contains detailed information about indications, warnings, precautions, side effects, dosage, administration, and clinical pharmacology. PI also referred to as professional labeling because it is written primarily for physician & pharmacist. With only a few exceptions, PI does NOT have to be given to patients because it is highly technical & not expected to be understood by average consumer. However, consumers can easily obtain PI via the PDR or by asking pharmacist or manufacturer for a copy.

6. An Aside on PIs November 2005 -- FDA, in collaboration with National Library of Medicine (NLM) and NIH, launched DailyMed, an interagency online health information clearinghouse. DailyMed requires manufacturers to submit prescription drug label information to FDA in a new electronic format. This information can be accessed through the National Library of Medicine at http://dailymed.nlm.nih.govhttp://dailymed.nlm.nih.gov Currently includes 521 approved prescription drugs.

7. Medication Guides (MedGuides) FDA has authority to require that FDA-approved labeling also include specific information for the patient under circumstances where the drug is considered to have significant safety issues that puts patient or public health at risk. Under such a circumstance, FDA-approved written information for patients, called a Medication Guide, must be given to pt. when the drug is dispensed. For example, antidepressants & NSAIDs now require that an FDA-approved Medication Guide be dispensed with those prescription drugs. MedGuides primarily emphasize risks as opposed to benefits.

8. Consumer Medicine Information (CMI) Unlike Europe, where patient information leaflets are highly regulated, only a few Rx drugs dispensed in the U.S. require FDA-approved written information for patients (primarily aforementioned Medication Guides). Federal law (P.L. 104-180) in the U.S. requires that new Rxs be dispensed with written CMI). The law further requires that content & format of CMIs must be useful for patients, as defined by criteria developed by a multi- stakeholder committee – the Keystone Committee a decade ago.

9. Consumer Medicine Information (CMI) The content and format of each written consumer medication information sheet, i.e., a CMI leaflet, that is dispensed by a pharmacist with a prescription is usually developed by private companies. While these leaflets are based on FDA-approved labeling, their specific content and format are not subject to FDA approval. However, FDA has authority to evaluate these pharmacist-delivered CMIs for usefulness. If the private sector fails to meet the goals of the Keystone Committee by 2006, the FDA has the authority to regulate the content and format of all future written information dispensed to patients with prescription drugs.

10. Patient Information Sheets (PIS) FDA in 2005 proposed a new Web page called Drug Watch, on which it would post emerging safety alerts. As part of this now revised initiative, the FDA links new safety alerts to what is called a Patient Information Sheet (PIS). PIS are prepared by FDA and, like MedGuides, the focus of PIS is on risk information. For example of PIS for Gabitril see www.fda.gov/cder/drug/infopage/tiagabine/default.htm. www.fda.gov/cder/drug/infopage/tiagabine/default.htm

11. Patient Information Sheets (PIS) FDA has not disclosed plans for dissemination of its Patient Information Sheets. Currently, PIS exist solely on the FDAs Web site and, unlike private sector CMI leaflets, PIS are not disseminated through community pharmacies. Healthcare professionals are encouraged by FDA to download and provide PIS to consumers.

12. Patient Package Insert For some prescription medicines, FDA approves manufacturer-prepared patient materials to instruct patients about the safe use of the product. These materials may be given to patients by their health care provider or pharmacist. Considered part of FDA-regulated product labeling.

13. CMI – Where it Stands (August 2006) 1996 Keystone Action Plan set 10-yr. timeframe for meeting specific target goals for formulation / dissemination of Useful CMI. FDA empowered to evaluate progress made by private sector: –By end of 2000: 75% of new Rxs convey with CMI that meets Action Plan criteria for content & design/layout and readability –By end of 2006: 95% of new Rxs convey with CMI that meets Action Plan criteria for content & design/layout and readability

14. CMI – Where it Stands (August 2006) FDAs interim assessment (reported July 03) found: –CMI distribution @ 89% (> 75% target) –CMI content/quality @ 50% -55% (< 75% target) Considerable concern voiced about how FDA contractor performed initial assessment (particularly by ASHP) & how final (07) assessment will be conducted.

15. CMI – Where it Stands (August 2006) FDA released Final Guidance on Useful CMI July 17, 2006 FDAs Final Guidance silent on how Agency will conduct final (2007) assessment, although likely it will be conducted like initial assessment (hidden shoppers; 4 Rxs; CMI collected & evaluated by panels of pharmacy experts & consumers)

16. What We Know About the 2007 CMI Assessment FDA silent (but considering) expanding final assessment to include mail order CMI. Action Plan will remain basis for FDAs assessment; CMI Guidance will be used to elucidate. Although encouraged to publish details about assessment for public comment (after collection of CMI in the field), FDA not excited about this approach.