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Pg. 4 Trademark Services:

SCREEN-ERR®

ERRS MODEL®

Pg. 1 About Med-ERRS

Pg. 2 The Med-ERRS Difference

Pg. 3 Our Services

© 2009, Med-ERRS, Inc. Med-ERRS®, SCREEN-ERR® and ERRS MODEL® are federally registered trademarks of Med-ERRS, Inc.

Pg. 6 Safety Consulting:

Focused FMEA

Advisory Groups

Technology Consults

Pg. 8 Package and Label:

Design

Safety Testing

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Our vision is to be

recognized and

respected as the leading

authority working with

pharmaceutical and other

healthcare industries to

prevent medication errors.

About Med-ERRS®

Med-ERRS was established in 1997 in response to a growing need within the pharmaceutical industry to develop trademarks, packaging and labels that minimize the potential for medication errors. Since then, we have worked with over 100 pharmaceutical companies to provide services that have helped our clients make safety-focused decisions regarding their products.

A wholly owned, for-profit subsidiary of the nonprofit Institute for Safe Medication Practices (ISMP), Med-ERRS is founded on a heritage of expertise in medication safety. Our relationship with our parent company gives us an industry advantage, enabling us to apply their breadth and depth of safety knowledge to the services we provide to our clients.

Our staff consists of healthcare professionals with extensive experience in clinical practice. We understand the real-life situations of the healthcare environment. More than that, we integrate our knowledge and experience with the input of practicing clinicians in the field.

There are many applications for our safety services. Depending on the stage of a product’s development, our capabilities have benefited clients in areas including:

Intellectual property and trademark development Trademark law Product management Regulatory affairs Drug safety Market research Marketing Communications

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Collaborative EffortsTo provide the widest

breadth of safety services, we often

collaborate with other companies. For more

information, please call 215.947.8306.

The Med-ERRS DifferenceFrom our proprietary work models to our strict standards of excellence, we continually strive to provide unique services that set us apart in the industry. More than that, our company is built from a strong foundation that makes us distinct:

We’re the only medication safety company “born” from a safety organization, the Institute for Safe Medication Practices (ISMP)

Our parent organization, ISMP, operates the Medication Errors Reporting Program (MERP). The Med-ERRS staff has gained extensive experience with medication error analysis through the regular review of ISMP error reports about the causes of medication errors and recommendations for their prevention

We are independent, and not affiliated with any other outside organizations to prevent conflict of interest; however, we do collaborate with other companies to offer a broader range of services to our clients. A collaborative effort example is Phyve, the Class 5 Consortium, an alliance of best-of-class providers of pharmaceutical and healthcare brand services whose goal is to offer the convenience and cohesiveness of both creative and validation services to pharmaceutical product teams

We have a relationship with international healthcare organizations and an extensive network of healthcare practitioners worldwide

Our unique expertise is

focused on making the

healthcare environment safer.

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FOCUSED FMEAADVISORY GROUPS ADVISORY GROUPS

TECHNOLOGY CONSULTS

PACKAGING & LABELDESIGN AND SAFETY TESTINGTECHNOLOGY CONSULTS

MARKET ASSESSMENTAND POSITIONING

TRADEMARKDEVELOPMENT

PACKAGE/LABELDEVELOPMENT

REGULATORYSUBMISSION

PRODUCTMARKETING

PRODUCTMONITORING/EVALUATION

LINEEXTENSION

PRODUCT DEVELOPMENT TIMELINE:

Our ServicesMed-ERRS is dedicated to serving the pharmaceutical industry around the world to ensure medication safety during the naming, packaging, label design and evaluation process. Throughout the United States, Europe, Canada, Asia and South America, we provide services that span a product’s life cycle, from pre-marketing assessments at an early phase of development through post-marketing evaluations and line extensions.

Using Failure Mode and Effects Analysis (FMEA), Med-ERRS helps companies determine the likelihood that a proposed product, trademark, package label, package design, or technology system would be vulnerable to user error.

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Our broad range

of services covers

every stage of a

product’s lifecycle.

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SCREEN-ERR®

SCREEN-ERR is a service designed to help companies evaluate multiple pharmaceutical trademark candidates at an early phase of trademark development. Once preliminary legal screening has taken place, SCREEN-ERR can determine whether any regulatory or other concerns exist which may result in a name deemed unacceptable to regulatory health authorities. It can be performed using global information resources, but SCREEN-ERR can be tailored to specific territories of interest.

SCREEN-ERR looks for obvious and potential regulatory conflicts. It is not intended to replace or supercede the ERRS MODEL® of safety testing, which incorporates a different range of criteria such as handwritten or verbal confusability of trademarks. It does consider each trademark candidate, providing a “green-yellow-red” scale rating of acceptability.

For our clients, SCREEN-ERR offers an efficient way to identify unacceptable candidates, saving both time and money.

Trademark Services:SCREEN-ERR®

ERRS MODEL®

We believe that objective safety evaluations of pharmaceutical trademarks should be conducted independently from the trademark development process. Med-ERRS provides trademark services focused solely on reducing the risk of error to improve the safety of the client’s product.

To do so, Med-ERRS uses a unique service to test proposed trademarks and packaging. This exclusive service, called the ERRS MODEL®, enables us to help pharmaceutical companies determine the likelihood that a proposed trademark might be vulnerable to user error.

ERRS MODEL®

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ERRS MODEL®

The ERRS MODEL incorporates various techniques recommended by the FDA to evaluate the safety of trademarks, including Failure Mode and Effects Analysis (FMEA), which is used in conjunction with expert panel analysis. It also utilizes practitioner survey results as one source of hypothesis generation.

A pre-marketing approach, the ERRS MODEL allows us to proactively help prevent medication errors by testing for potential look-alike and sound-alike confusion with proposed trademarks. The ERRS MODEL also helps identify potential regulatory issues that may render a trademark “unapprovable.” Though used for single country or international reviews for proprietary trademarks, the methodology used in the ERRS MODEL can be applied to test proposed nonproprietary names as well.

We recognize that each client has specific requests, so the ERRS MODEL has been designed to adapt to these requests. This adaptability also allows us to meet emerging regulatory guidelines.

By minimizing

possible errors,

we can help

maximize the safety

of a trademark.

DISPENSIN

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TION

M

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DRUG USE PROCESSANALYSIS (FMEA)

WORLDWIDE REGULATORYAUTHORITIES

WORLDWIDE REGULATORYAUTHORITIES

AB

BREVIATIONS L ABORATORY T

ESTS

MED

IC

AL TERMS DRUG NAM

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LOOK-ALIKESOUND-ALIKE

TESTING

DISPENSING STORAGE PRESCRIBING ADMINISTRATION TRANSCRIPTION MONITORING

DRUG USE PROCEANALYSIS

DISPENSIN

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BREVIATION L ABORATOR

MED

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ERMNOLOGY DRU

LOOK-ALIKESOUND-ALIKE

TESTING

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WORLDWIDE REGULATORY A

TIES •

PRODUCT DEVELOPMENT LIFETIME:

ERRS MODEL®

testing for potential look-alike and sound-alike confusion

DISPENSING STORAGE PRESCRIBING ADMINISTRATION TRANSCRIPTION MONITORING

DISPENSING

EMEA

FDA

USAN

WHO

MONITORING

STORAGE TRANSCRIPTION

PRESCRIBING ADMINISTRATION

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Focused FMEAExclusive to Med-ERRS, our Focused FMEA looks at a unique aspect of a product, such as a dosage form, special packaging, or trademark. We employ Failure Mode and Effects Analysis (FMEA) to determine which path or choice to follow to minimize the risk of error and provide specific recommendations and error-reduction strategies.

We have also performed the Focused FMEA in response to specific FDA requests or to fulfill a Risk Evaluation and Mitigation Strategy (REMS).

The Focused FMEA might be used by pharmaceutical companies wishing to choose between the use of a dual trademark or the original trademark with a modifier (suffix) for a new product in their existing product line.

Safety Consulting:Focused FMEA

Advisory Groups

Technology Consults

Med-ERRS provides consultative services, either on a per-project basis or on retainer, on any issues that pertain to the safe use of a product, including, but not limited to:

Trademarks Packaging Evaluation of educational, advertising or promotional materials

Instructions for use Medication guides Nonproprietary names

When necessary, we use outside collaborators, such as market researchers and human factors engineers.

Med-ERRS can also review and analyze any post-marketing error reports to determine what risk-mitigation strategies need to be taken. Other issues related to post-marketing error reports are handled by our parent company, ISMP, which now has PSO (patient safety organization) status.

What is Failure Mode and Effects Analysis (FMEA)? FMEA is a risk assessment method based on the simultaneous analysis of failure modes, their consequences, and their associated risk factors. Since the 1960s, FMEA has been used most extensively in areas characterized by high risk, such as nuclear power plant operations, or by high cost, such as the weapons and aerospace industries.

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Advisory GroupsAs new safety issues emerge and existing ones are challenged or reconsidered, it is often necessary to reach out to experts in the field for their valued opinions. Med-ERRS arranges advisory groups in which we gather key thought leaders from all over the world to introduce, discuss and consider solutions for difficult safety concerns.

Some of the topics covered by these advisory groups include:

The design of medication safety-related educational materials

Package label redesign

Safety challenges experienced by practitioners in the field

Product-specific safety issues

Technology ConsultsMed-ERRS provides consultations to assist companies who specialize in medication-related technology, whether it is a specific device, medication use system or product such as infusion pumps, barcoding devices or automated dispensing cabinets. Our expertise offers insight that helps improve the functionality and safety of these technologies. Using an interdisciplinary team, we pay particular attention to the ability of a typical practitioner to use the device safely under normal practice conditions.

As part of the evaluation, we conduct a site visit to analyze the functionality and efficiency of the product, device or system. The onsite visit allows us to consider the impact of the technology on other systems. Med-ERRS will meet with the research and development team as well as key professional staff where the product or device is being utilized and then provide recommendations to the manufacturer or developer as needed.

For all your

safety concerns,

we can offer

guidance and

solutions.

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DesignThe design of packages and labels has to be multifunctional. Not only pleasing to the eye, they must clearly provide information essential to the proper use of the medication described. Med-ERRS has the capabilities to create new labels or provide input on redesigns, paying particular attention to the placement of information and product differentiation.

We begin the process by collaborating with clients to obtain background information about the product and to discuss the proposed packaging and label. Included in our review is a consideration of the clinical environment in which the product will be used. We consider such factors as:

Overall appearance of the label

Readability and placement of the product name and information

Presence of confusing terminology, abbreviations, and other extraneous information

Visibility and positioning of important information

Package and Label:Design

Safety Testing

Med-ERRS uses the experience we’ve gained through interactions with other companies, as well as our knowledge of medication error causality, to perform expert reviews of drug product packaging and labels. Our findings help clients create packaging and labels for use around the world that are easy to understand and consistent with the most current FDA or international governing body regulations.

We can provide our services for a single label or across an entire line of products. Whether the product is oral, injectable, or topical, our goal is to reduce the risk of error in whatever clinical setting the product is used.

PRODUCT DEVELOPMENT LIFETIME:

APPEARANCE READABILITY

VISIBILITY

PLACEMENT

ABBREVIATIONS

TERMINOLOGY

POSITIONING

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Safety TestingMed-ERRS provides safety testing for packaging and labels produced for US and international use. These evaluations may be performed in response to specific regulatory requirements or to support sponsor-generated requests for label changes.

To do so, we apply various tools and techniques, including elements of Failure Mode and Effects Analysis (FMEA), to “error-proof” the written and associated graphic information on items including, but not limited to:

Medication bottles and cartons

Ampuls

Vials

Syringes

Dosing cards

Titration kits

Along with using FMEA, Med-ERRS also collaborates with human factors engineers to further ensure the safety of packaging and labels. By creating simulation studies, we can conduct tests in settings that mirror the actual locations where these products might be found.

We help ensure

that your package

labels are clear…

and clearly safe.

215.947.8306www.med-errs.com

200 Lakeside Drive, Suite 200

Horsham, PA 19044

Fax. 215.914.1492

This brochure has been printed entirely on Forest Stewardship Council certified paper. FSC Certification ensures that the paper used contains fiber from well-managed and responsibly harvested forests that meet strict environmental and socioeconomic standards. Med-ERRS is proud to be able to make this significant move to help our environment.

Cert no. XXX-XXX-000