# Presentation: 500833

## Using the Web to Educate Consumers about Drugs

- Carol S. Cavanaugh, MLS
- Sally Winthrop, MLS
- U. S. Food and Drug Administration
- Center for Drug Evaluation and Research
- Office of Training and Communications
- Division of Information Services
- June 2004

## Presentation Overview

- Agency mission changes
- Web site growth and shift
- Research and tools to improve customer satisfaction
- Example:  Drugs@FDA
- Existing consumer content
- Future CDER web plans
- Audience Q&As and feedback

## FDA’s History

- Adulterated food and drugs
- Safety alone
- Safety and efficacy
- Safety, efficacy, expanded access, and security
- Risk management
- Patient and consumer safety

- 1906 Original Food and Drugs Act
- 1938 Food, Drug & Cosmetic Act
- 1962 Kefauver-Harris Amendment
- 1983 Orphan Drug Act
- 1984 - Generics (Waxman-Hatch)
- 1980’s - Accelerated approvals
- 1990’s - Pediatric Initiatives
- 1992 - 2004 - Review timelines (PDUFA, FDAMA)
- 1999 - Managing the Risks from Medical Product Use
- 2003 - FDA Strategic Action Plan

## FDA’s Mission Statement

- 	The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

## FDA’ Strategic Initiatives

- Efficient risk management
- Improving health through better information
- Improving patient and consumer safety
- Protecting America from terrorism
- More effective regulation through a stronger workforce
- http://www.fda.gov/oc/mcclellan/strategic.html

## Evolution from “Gotcha” to Public Health Outcomes

- Strategic Objective 2
- 	Empowering Consumers:  Improving health through better information
**	****“*****Enable consumers to make smarter decisions by getting them better information to weigh the benefits and risks of FDA-regulated products.”***

## From Strategy to Implementation

- New Division Mission Statement
- 	*We advance the exchange of information and knowledge among our customers, ultimately improving public health and the quality of life.*
- Division Reinvention
- FDA Information & Research Services
- Information consultancy
- Vocabulary control
- CDER Internet and Intranet sites
- Medwatch Internet site

## CDER Web Site Profile

- Our users are from all walks of life--consumers, patients, health professionals, pharmaceutical industry, and other stakeholders
- 1.5 million visits to our CDER site each month, making 25 million hits
- We reach 25,000 CDER “What’s New” subscribers and 50,000 MedWatch update subscribers
- Site contains more than 75,000 documents and files, with content growing rapidly
- Site contains more than 360,000 hyperlinks
- Growing number of web applications

## Web Strategic Change Activities

- Changing from Agency-centric site to user-centric
- Working with expert consultants on bench marking and best practices
- Getting to know our **Users** better
- Designing and testing information seeking scenarios
- Why is a particular user seeking information?
- What does he want/need to find?
- How does she search for it?
- Measuring success, frustration, and failure rates.
- Developing Information Architectures that organize information for specific users around their “context” or information need

## Archetypal User Profiles:  Personas 

- Hypothetical archetypes, i.e., “stand-ins” for actual users.  Used to drive the decision making for web site **form** and **function**.
- Not real people, but representative of real people that web teams and sponsors refer to throughout a web design / redesign.  Our consumer profiles are created based on the PEW Internet survey reports.
- Discovered through a handful of 1-2 hour ethnographic interviews.  Defined with significant rigor and precision.  Names, photos, and brief bios are contrived to make them “come alive”.
- Personas are defined by their goals.  Interfaces (form) and features (functionality) are created by understanding the scenarios a persona undertakes to achieve its goals.

## Slide 11

## Persona Design:  Why Do It?

- To identify and formalize an understanding of key segments of FDA’s audience.
- To gain a granular understanding of the audience’s requirements and expectations for information and services, offered through the web and other channels
- To focus and prioritize agency efforts to clearly and effectively communicate with its audiences by regularly measuring and evaluating progress.
- With citizens
- With industry
- With other governments
- With internal staff (through Intranet portal initiatives)

## Slide 13

## Draft “provisional Agency personas”
Summarize these persona, identifying centers and business units which share persona 
Pilot the persona framework to develop lessons learned and best practices
Evolve the provisional persona to actual persona, using interviews with audience segments
Begin a scenario design program to identify the “in context” needs a persona has for information, services and productivity tools (as they perform their jobs or take responsibility for their home life)

- Draft “provisional Agency personas”
- Summarize these persona, identifying centers and business units which share persona
- Pilot the persona framework to develop lessons learned and best practices
- Evolve the provisional persona to _actual_ persona, using interviews with audience segments
- Begin a scenario design program to identify the “in context” needs a persona has for information, services and productivity tools (as they perform their jobs or take responsibility for their home life)

## Evolving Actual fda.gov Persona

**Evolve**
**Actual Persona**

**Begin**
**scenario **
**design**

**Begin usability testing / develop success metrics**

**Integrate**
**Information Architecture**

**Evolve Editorial**
**Guidelines**

**Begin web CM pre-implementation  planning**

**Launch & sustain multiple**
**specific audience information products**

**Insure**
**technology infrastructure**
**is secure, robust ...**

**Ethnographic**
**interviews with**
**real users**

**Information Architecture embedded in interface**

**Interaction **
**Design **
**embedded in interface**

**Time**

## A sample scenario, test questions and draft wireframes for:

- Cecilia Vallin, “Vigilant Proxy”
- An FDA
- Provisional Persona

## Slide 17

## Skeletal Scenario

**Step #1**: Finds and uses the web site to locate the disease name supplied by Grace’s oncologist
**Step #2**:  Reviews approved drugs and details
**Step #3**: Toggles back and forth between patient information and heath care provider information – for complete picture
**Step #4**:  Notices “clinical trials and volunteering”, responding to opportunity to be informed of volunteers needed.

## Task-based Test Questions

- How would you “find out and determine what drugs are currently being used to treat xxxxxx”?
- How would you develop a strategy to conduct comprehensive research on the disease xxxxx?
- How would sign up to be notified of clinical trial opportunities for drugs used to treat xxxxx ?

## User goes to cancer site entry page

**User goes to cancer site entry page**

## Step 1:  User begins search

**Step 1:  User begins search**

## Step 2:  User selects type of cancer

**Step 2:  User selects type of cancer**

## User finds list of drugs approved for this disease

**User finds list of drugs approved for this disease**

## A Site-specific Enhancement

- A method to proactively alert
- Consumers about new information.

## How This Might Look

**How This Might Look**

## Drugs@FDADevelopment, Testing, and Redesign for Greater Customer Satisfaction

- U. S. Food and Drug Administration
- Center for Drug Evaluation and Research
- Office of Training and Communications
- Division of and Information Services
- June 2004

## Drugs@FDAComprehensive web site for:

- The latest drug approval information
- Therapeutically equivalent drugs for prescription medicines, and alternative OTC drugs with the same active ingredient
- Generic equivalents for brand name drugs
- Consumer information, including Medication Guides and Drug Information Sheets

## Regulatory Information

- New and supplemental approval letters, labels, and reviews
- Comprehensive approval history with all  supplement approval dates and types
- Updated on a real-time basis, within 10 minutes of posting

## Consumer Use

- To find out if generics or other therapeutic equivalents are available for a brand name drug
- To find out what OTC drugs have the same active ingredient
- To find out if a drug is Rx, OTC, or discontinued
- To find up-to-date consumer information
- Medication guide
- Drug Information Sheets

## Design Challenge

- How to show _accurate_ drug approval info that can be used by consumers, health professionals, and industry, and others
- How to use acronyms and phrases like NDA, RLD, and therapeutic equivalents
- How to use information based on applications numbers

**Notes:**
Developed glossary of every term used in Drugs@FDA, reviewed by OGD, OTC and general councel.
In the Instructions, we linked all of the terms to the glossary for easy reference

## Development

- Two years in development before the prototype was launched in Spring, 2003
- Extensive redesign of the Results screen based on user feedback and analysis reports
- Worked closely with OGD and OTC staff to create accurate search and results screens

## Internal Feedback

- Received numerous comments from  CDER staff
-  Formal survey with results dumped to a database for analysis
- General comments about the search and display features
- Reviewed design ideas and help screen information with OGD and general counsel staff

## Slide 33

## External Feedback

- Usability Review Report prepared by Communication Technologies Branch, NCI
- Analysis of Drugs@FDA report prepared by a web site design consultant
- Both reports written with the general consumer in mind
- Comments sent to us from users

## Slide 35

**Notes:**
Example of NCI recommendations

## Slide 36

**Notes:**
Example of Howard’s recommendations

## Help for Consumers and Others

- FAQs, Instructions, Glossary, and Contact Us links from every page
- We use your feedback!
- Interactive tutorial for basic searching in development

**Notes:**
Browsable alpha list
Links to Drugs@FDA records from the What’s New email – suggestion for a user
Preformatted reports

## Slide 38

## Slide 39

## Slide 40

## Plans for More Testing

- Develop personas and use them to design more Drugs@FDA features
- Select real people based on the personas to test the existing site and new design elements
- Consumers
- Healthcare providers
- Industry

**Notes:**
Other groups:
Lawyers
Insurance companies
Information and media professionals
Investors/economists
Students in  pharmacy, health policy, public health

## Drugs@FDA Demo

- Basic search showing results and how to see the drug details on
- 		therapeutic equivalents
- 		approval history
- 		label information
- 		consumer information

## Slide 43

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## Slide 47

## Slide 48

## Slide 49

## Consumer Information Web Page Redesign

- Originally designed to host Public Service Announcements (posters and brochures)
- Redesign of the web page reflects greater usability for consumers by emphasizing easy-to-access text
- The new design has been user tested by
- Consumers
- Health providers
- Media

## Slide 51

## Redesigned Web Page

## Redesigned Web Page with Consumer Emphasis

## “All Graphic and Other Media”

## We Are Recruiting Testers for Drugs@FDA

- For more information on volunteering to test Drugs@FDA, please send email to
- Sally Winthrop
- _[winthrops@cder.fda.gov](mailto:winthrops@cder.fda.gov)_
- www.fda.gov/cder

## Future Plans

- Analyze user information needs
- Continue persona development and testing
- Determine content gaps
- Apply best practices and current research
- Coordinate information development across CDER and the Agency
- Establishing working relationships outside the Agency to develop and provide new content
- Expand Drugs@FDA
- Expand usability testing

## Leveraging Activities

- FDA controlled vocabularies
- FDA -- Intranet Enterprise Portal development
- Look and feel
- Content management
- Governance
- FDA -- intra-agency content development by disease condition, botanicals, etc.
- NIH -- consumer and patient e-health tools
- CMS -- Medicare Prescription Drug Labeling
- NLM -- e-health content development
- International

## Expanding Drugs@FDA

**Content, user interface and help additions 2004**
- Inclusion of all biologic therapeutics
- Links to advisory committee meetings
- Safety alerts from MedWatch
- Drug shortage announcements
- Interactive tutorial
- Sort search results by column
- New search options--Boolean, left-right truncation
- Conversion of COMIS/Orange Book data from upper to  mixed case
- Add generic names to “Browse” selection list

## Administrative Changes for Drugs@FDA

- Importing COMIS data for first-time approvals
- Comparing application supplement histories with COMIS
- Comparing Orange Book updates with Drugs@FDA data
- Setting expiration/review dates for drug shortage announcements
- Revision of database structure to link documents by applications, groups of applications, or by product

## Possible Enhancements for Drugs@FDA2004 to 2006

- More patient package inserts
- Patents and exclusivity information
- Priority review status and chemical type
- Preformatted reports on new approvals by time period
- NDC codes
- Inactive ingredients
- Imprints
- Other

## Contact Information

- Carol Cavanaugh 	carol.cavanaugh@fda.hhs.gov
- Sally Winthrop	sally.winthrop@fda.hhs.gov
- Presentation materials on web site at
- http://www.fda.gov/cder/present/index.htm