1. Medication Guides Nancy M. Ostrove, Ph.D. Division of Drug Marketing, Advertising, and Communications

2. Patient Rx Drug Information: Independently Produced u Supplied to pharmacies by information providers not affiliated with drug sponsors –private sector program u Computer-generated at point of purchase u Fairly wide distribution u Quality of information variable –recent assessment showed improvement needed, especially in risk disclosure

3. Patient Rx Drug Information: Mandated by Specific Regulations u Sponsor drafts and FDA approves u Different regulations -- different format and content requirements u Required to be distributed to patients –questions remain about whether distribution requirement is being achieved u Oral Contraceptives u Estrogens

4. Patient Rx Drug Information: Voluntary Patient Labeling u Sponsor drafts and FDA approves u No uniformity in format or content u No clear agreement whether distribution is required u Anecdotal evidence indicates that actual distribution is spotty, especially when not packaged in unit-dose containers

5. A New Type of Patient Rx Labeling: Medication Guides u Sponsor drafts and FDA approves u Non product specific regulation –designed for outpatient products that pose a “serious and significant public health concern” –necessary for safe and effective use by patients u On average, 5-10 products annually u Requires distribution

6. Triggering Circumstances u Could help prevent serious adverse effects u When patient needs to know of serious risks, relative to benefits, that might affect decision to use or continue use u When drug is important to health, and patient adherence to directions is critical to effectiveness

7. Medication Guide Requirements u Written in nontechnical, understandable language u Not promotional in tone or content u Scientifically accurate u Based on and consistent with professional labeling –language need not be identical to professional labeling

8. Medication Guide Requirements u Specific and comprehensive u At least 10 point minimum type size u Legible and clearly presented –appropriate use of highlighting techniques (bolding, underlining, other) to emphasize specific portions of text

9. Medication Guide Headings u What is the most important information I should know about... ? –description of the public health concern that creates the Medication Guide need u What is... ? –can include discussion of disease and benefits of treating condition u Who should not take...? –contraindications and what to do if any apply

10. Medication Guide Headings u How should I take...? –instructions for proper use u What should I avoid while taking...? –specific, important instructions to ensure proper use (activities, substances to avoid; risks to mothers, fetuses, nursing infants, children, etc.) u What are the possible or reasonably likely side effects of...?

11. Distribution is Required u Manufacturer responsible for ensuring distribution by either –providing enough to dispensers to give one to each patient, or –providing “means to produce” enough u Distributors responsible for passing on u Notation on container label that Medication Guide needs to be given out u Authorized dispenser required to give out

12. Exemptions/Deferrals u FDA can exempt applicant from any requirement except consistency with labeling and title (Medication Guide) u Prescriber can direct dispenser to withhold –but, patient can override withhold request

13. Conclusions u Medication Guides are for products posing a serious and significant public health concern u Medication Guides provide a uniform format and content to facilitate finding information u Medication Guides are required to be distributed to patients