# Petition To Speak At The Health and Human Services / FDA Meeting On 7/31/03

**Current Status of Useful Written Prescription Drug Information For
Consumers:**

[Spokes Person:]{.underline} Newt Gingrich (Former Speaker of the House
of Representatives)

[Subject:]{.underline} Consumer Medication Safety and Education

[Issues Specifically Addressed]{.underline}:

1.  What steps is the private sector taking to improve the usefulness of
    the written information patients receive with prescription drugs and
    to meeting the Year 2006 goal?

> For approximately 2 ½ years a team of dedicated healthcare
> professionals have been working on development of solutions to address
> many of the consumer medication safety and education issues that exist
> in the world of pharmacy. This is a very difficult and complex issue
> that may require novel, innovative approaches to meaningfully address.
>
> In addition to highlighting briefly the most common reasons for
> medication errors, dosing mishaps, drug interaction issues, among
> other medication safety concerns, Newt wishes to ensure that the FDA
> and the pharmacy community is aware of our team's efforts as well as
> the efforts of other groups that may be labeled perhaps as
> out-of-the-box thinkers working on the issues outlined by the FDA for
> public discussion in the July 31 meeting. Newt's role in the process
> has been one of strategist and policy advisor. His goal at this
> meeting is to ensure that the FDA and pharmacy community is
> considering multiple solutions to the current problem (inclusive
> though not restricted to patient leaflet information provided by
> pharmacies). The overriding objectives behind our efforts have been
> maximum efficacy at minimum cost and simple to implement. One such
> fruit of our labor is depicted in an attachment to this document. Newt
> wishes to introduce this innovation at the upcoming meeting, a timely
> and well-fitted forum to introduce this intervention into the public
> debate and the FDA war chest of options.

2.  What other initiatives should FDA consider for providing patients
    with useful written information about prescription drugs as endorsed
    by Public Law 104-108. Such initiatives could include the
    possibility of FDA requiring manufacturers to provide authorized
    dispensers with the means to distribute useful written information
    approved by FDA.

> The attached graphic suggests several ways that through the
> prescription label itself; much important information can be conveyed
> to consumers using a forum that remains with their medication for the
> life of the prescription. The content of the label remains in the
> hands of the pharmacy utilizing the label format. Existing pharmacy
> software, printers, label suppliers, and content providers need not
> change either; only minor software add-ons are required to reconfigure
> the location and content that is printed. If desirable, there is
> sufficient space for the FDA to control a portion of the label if
> appropriate for printing of it's own messaging information if
> desirable. The novel label format depicted provides up to 5 ½ inches
> of incremental printable space directly on prescription labels
> generated on-demand at the point of dispensing. Several large and
> small pharmacy chains are currently in varying stages of action,
> moving toward adoption of the ScriptChek label design. Most have
> described the new label concept as perhaps the most important
> innovation in the world of prescription labeling in over 20 years.
>
> Among the most common medication errors / mishaps reported by
> pharmacies (Source: Drug Topics May 21, 2001) that have been addressed
> through the ScriptChek label design (other than physician hand-writing
> issues or prescribing errors) are:

-   Wrong dosage dispensed

-   Wrong drug given

-   Wrong route of administration

-   Failure to catch interactions

-   Failure to catch contraindications

-   Failure to warn patients of potential hazards

> The most commonly sited factors contributing to the above occurrences
> in decreasing order of reported frequency are:

-   Work overload

-   Inadequate staffing

-   Look-alike / sound-alike drugs

-   Failure to catch a technician's errors

-   Similarity in packaging

-   Illegible prescriptions

-   Insufficient prescription information

-   Confusing/unclear labels

-   Lack of system-wide control policies or procedures

Together with Newt Gingrich, at least one representative from the team
responsible for the ScriptChek label design and development will be
available at the meeting to address any questions that may arise or to
participate in any discussion during or after the meeting as warranted.

[Other Project Collaborators:]{.underline}

National Council For Patient Information and Education (NCPIE)

Convergent Label Technologies (approximately 1 Billion prescription
labels supplied to pharmacies annually)

NDCHealth (largest pharmacy connectivity and service provider in the
U.S.)

Catalina Marketing (largest distributor of patient leaflet information
through pharmacy systems)

Pharmaceutical manufacturers (several interested in helping to
underwrite any costs associated with pharmacy implementation)

Submitting Entities:

Stacy Kaufman

ScriptChek Visual Verification Systems, Inc.

959 Shotgun Road

Sunrise, FL 33326

954-423-4161

and

Kathy G. Lubbers

The Gingrich Group

Address and Phone contact provided on request