CENTER FOR DRUG EVALUATION AND RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`22511Orig1s000
`
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`
`

`

`
`
`Date:
`
`To:
`
`Through:
`
`From:
`
`Subject:
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`April 14, 2010
`
`Donna Griebel, MD, Director
`Division of Gastroenterology Products
`
`Denise P. Toyer, PharmD, Deputy Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Laura Pincock, Pharm.D., Acting Team Leader
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Proprietary Name Review
`
`Drug Name(s):
`
`Vimovo (Naproxen and Esomeprazole Magnesium) Tablets
`375 mg/20 mg and 500 mg/20 mg
`
`Application Type/Number: NDA 022511
`
`Applicant:
`
`OSE RCM #:
`
`
`
`Pozen, Inc.
`
`2009-1779
`
`
`
`
`
`*** This document contains proprietary and confidential information that should not be released
`to the public. ***
`
`
`
`
`
`
`
`
`
`
`

`

`CONTENTS
`INTRODUCTION................................................................................................................... 3
`1
`2 METHODS AND RESULTS.................................................................................................. 3
`3 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 3
`4 REFERENCES........................................................................................................................ 4
`
`
`
`
`
`2
`
`

`

` 1
`
`
`INTRODUCTION
`This re-assessment of the proposed proprietary name Vimovo is written in response to the anticipated approval
`of this NDA within 90 days from the date of this review. DMEPA found the proposed name, Vimovo,
`acceptable in OSE Review # 2009-1244 dated September 10, 2009. In addition, the Division of Drug
`Marketing, Advertising and Communications (DDMAC) found the name acceptable from a promotional
`perspective, and the Division of Gastroenterology Products did not have any concerns with the proposed
`proprietary name, Vimovo, during our initial review.
`
`2 METHODS AND RESULTS
`For the proposed proprietary name, DMEPA staff search a standard set of databases and information sources
`(see Section 4) to identify names with orthographic and/or phonetic similarity to the proposed name that have
`been approved since the previous proprietary name review. We used the same search criteria previously used in
`OSE Review #2009-1244. Because none of the proposed product characteristics were altered we did not re-
`evaluate previous names of concern. Additionally, DMEPA searched the United States Adopted Names
`(USAN) stem list to determine if the name contains any USAN stems that may have been added during any
`USAN updates that occur since the initial assessment of the proposed proprietary name. DMEPA bases the
`overall risk assessment on the findings of a failure mode and effects analysis (FMEA) of the proposed
`proprietary name, and focuses on the avoidance of medication errors.
`The searches of the databases referenced in Section 4 did not yield any new names thought to look or sound
`similar to Vimovo and represent a potential source of drug name confusion. Likewise, DMEPA staff did not
`identify any USAN stems in the proposed proprietary name Vimovo as of April 8, 2010. Accordingly,
`DMEPA finds the proposed proprietary name Vimovo acceptable for this product.
`
`3 CONCLUSIONS AND RECOMMENDATIONS
`The proprietary name risk assessment findings indicate that the proposed name Vimovo is not vulnerable to
`name confusion that could lead to medication errors nor is the name considered promotional. Thus, the
`Division of Medication Error Prevention and Analysis (DMEPA) has no objection to the proposed proprietary
`name Vimovo for this product at this time.
`DMEPA considers this a final proprietary name review. However, if approval of the NDA is delayed beyond
`90 days from the date of this review, DGP should notify DMEPA because the proposed proprietary name must
`be re-reviewed prior to the new approval date.
`
`
`
`***This document contains proprietary and confidential information that should not be released to the public.***
`
`
`
`
`
`3
`
`

`

`4 REFERENCES
`1.
`OSE Review # 2009-1244 dated September 10, 2009. Proprietary Name Review of Vimovo
`(Naproxen and Esomeprazole Magnesium) Tablets. Raichell S. Brown, Safety Evaluator.
`
`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`2.
`Drugs@FDA contains most of the drug products approved since 1939. The majority of labels, approval letters,
`reviews, and other information are available for drug products approved from 1998 to the present.
`Drugs@FDA contains official information about FDA approved brand name, generic drugs, therapeutic
`biological products, prescription and over-the-counter human drugs and discontinued drugs and “Chemical
`Type 6” approvals.
`
`USAN Stems (http://www.ama-assn.org/ama1/pub/upload/mm/365/stem-list-cumulative.pdf)
`3.
`USAN Stems List contains all the recognized USAN stems.
`4.
`CDER Proposed Names List
`CDER Proposed Names List is a compiled list of proposed proprietary names submitted to the Division of
`Medication Error Prevention and Analysis (DMEPA) for review. The list is updated weekly and maintained by
`DMEPA.
`
`
`
`
`
`
`4
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22511
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`POZEN INC
`
`------------------------------------------
`PN 400
`NAPROXEN/ESOMEPRAZOLE
`MAGNESIUM
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LAURA L PINCOCK
`04/15/2010
`
`DENISE P TOYER
`04/15/2010
`
`

`

`
`
`Date:
`
`To:
`
`Through:
`
`From:
`
`Subject:
`
`Drug Name(s):
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`September 10, 2009
`
`Donna Griebel, MD, Director
`Division of Gastroenterology Products
`
`Laura Pincock Pharm.D., Acting Team Leader
`Kellie Taylor, Pharm.D., MPH, Team Leader
`Denise Toyer, Pharm.D., Deputy Director
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Raichell Brown, Pharm.D., J.D., Safety Evaluator
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Proprietary Name Review
`
`Vimovo (Naproxen and Esomeprazole Magnesium) Tablets
`375 mg/20 mg and 500 mg/20 mg
`
`Application Type/Number: NDA 22-511
`
`Applicant:
`
`OSE RCM #:
`
`Pozen Inc.
`
`2009-1244
`
`
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`

`

`
`
`
`
`CONTENTS
`EXECUTIVE SUMMARY............................................................................................................. 3
`1 BACKGROUND..................................................................................................................... 3
`1.1
`Introduction.................................................................................................................... 3
`1.2
`Regulatory History......................................................................................................... 3
`1.3
`Product Information....................................................................................................... 3
`2 METHODS AND MATERIALS ............................................................................................ 4
`2.1
`Search Criteria................................................................................................................ 4
`2.2
`FDA Prescription Analysis Studies................................................................................ 5
`2.3
`External Proprietary Name Risk Assessment ................................................................ 5
`3 RESULTS................................................................................................................................ 6
`3.1
`Database and Information Sources................................................................................. 6
`3.2
`Expert Panel Discussion................................................................................................. 6
`3.3
`FDA Prescription Analysis Studies................................................................................ 6
`3.4
`External Name Study ..................................................................................................... 6
`3.5
`Comments from the Division of Gastroenterology Products (DGP) ............................. 7
`3.6
`Safety Evaluator Risk Assessment................................................................................. 7
`4 DISCUSSION ......................................................................................................................... 7
`5 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 7
`5.1
`Comments to the Applicant............................................................................................ 8
`6 REFERENCES........................................................................................................................ 9
`APPENDICES............................................................................................................................... 10
`
`
`
`
`
`2
`
`

`

`EXECUTIVE SUMMARY
`Vimovo is the proposed proprietary name for the combination product of enteric coated
`Naproxen and Esomeprazole Magnesium Tablets. This proposed name was evaluated from a
`safety and promotional perspective based on the product characteristics provided by the
`Applicant. We sought input from pertinent disciplines involved with the review of this
`application and considered it accordingly. Our evaluation did not identify concerns that would
`render the name unacceptable based on the product characteristics and safety profile known at
`the time of this review. Thus, DMEPA finds the proposed proprietary name Vimovo acceptable
`for this product. The proposed proprietary name must be re-reviewed 90 days before approval of
`the NDA.
`Additionally, if any of the proposed product characteristics as stated in this review are altered,
`DMEPA rescinds this finding and the name must be resubmitted for review. The conclusions
`upon re-review are subject to change.
`
`1 BACKGROUND
`
`1.1
`INTRODUCTION
`This review is in response to a request from Pozen, Inc. dated June 30, 2009 for an assessment of
`the proposed proprietary name, Vimovo, regarding potential name confusion with other
`proprietary or established drug names in the usual practice settings. In addition, the Applicant
`submitted an external study in support of their proposed proprietary name.
`Pozen Inc. also submitted container labels and carton labeling for review. The labels and
`labeling will be reviewed separately under OSE Review #2009-1245.
`
`1.2 REGULATORY HISTORY
` for this
`DMEPA reviewed and had no objection to the proposed proprietary name
`product on December 5, 2008 (see OSE Review # 2007-2558 for IND# 76,301). However, the
`Applicant submitted a Request for Proprietary Name Review for Vimovo on June 30, 2009
`stating that the tradename
` cannot be used for this product “due to language issues in
`other parts of the world.”
`
`1.3 PRODUCT INFORMATION
`Vimovo (Naproxen/Esomeprazole Magnesium) Tablets are indicated for relief of signs and
`symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of
`developing NSAID-associated gastric ulcers.
`Vimovo will be available in two strengths, 375 mg/20 mg and 500 mg/20 mg. The
`recommended dose is one tablet taken orally twice daily. Vimovo should be taken 30 minutes
`before meals. The Naproxen component of Vimovo is enteric coated. The tablets should be
`swallowed whole and should not be split, chewed, or crushed.
`Dose reductions are recommended, with regard to the Naproxen component, in patients with
`mild to moderate hepatic impairment. Vimovo is not recommended for patients with severe liver
`impairment because these patients should not receive more than 20 mg of Esomeprazole per day.
`
`3
`
`(b) (4)
`
`(b) (4)
`
`

`

`Likewise, Vimovo is not recommended in patients with moderate to severe renal impairment (i.e.
`creatinine clearance less than 30 mL/minute) because of the Naproxen component.
`The tablets will be packaged in bottles containing 60 tablets and 500 tablets, as well as in boxes
`of unit dose blister packs containing 100 tablets. Vimovo tablets should be stored at room
`temperature.
`Vimovo has a Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDS).
`
`2 METHODS AND MATERIALS
`Appendix A describes the general methods and materials used by the Division of Medication
`Error Prevention and Analysis (DMEPA) when conducting a proprietary name risk assessment
`for all proprietary names. Sections 2.1, 2.2, and 2.3 identify specific information associated with
`the methodology for the proposed proprietary name, Vimovo.
`
`2.1 SEARCH CRITERIA
`For this review, particular consideration was given to drug names beginning with the letter ‘V’
`when searching to identify potentially similar drug names, as 75% of the confused drug names
`reported by the USP-ISMP Medication Error Reporting Program involve pairs beginning with
`the same letter.1,2
`To identify drug names that may look similar to Vimovo, the DMEPA staff also considers the
`orthographic appearance of the name on lined and unlined orders. Specific attributes taken into
`consideration include the length of the name (six letters), upstrokes (one, capital letter ‘V’),
`down strokes (none), cross strokes (none), and dotted letters (none). Additionally, some letters
`in Vimovo may be vulnerable to ambiguity when scripted (See Appendix B). As a result, the
`DMEPA staff also considers these alternate appearances when identifying drug names that may
`look similar to Vimovo.
`When searching to identify potential names that may sound similar to Vimovo, the DMEPA staff
`searches for names with similar number of syllables (three), stresses (VI-mo-vo, vi-MO-vo, or
`vi-mo-VO), and placement of vowel and consonant sounds. Additionally, the DMEPA staff
`considers that pronunciation of parts of the name can vary. For example, ‘Vi-' may sound like
`‘Ve-’, ‘Va-’, ‘Vo-’, ‘Bi-’, ‘Bye-’ or ‘Bee’. Likewise, ‘-movo’ may sound like ‘-mova’, ‘-muvo’,
`‘-novo’, or ‘-nova’. (Also see Appendix B).
`The Applicant did not supply the intended pronunciation for this name and thus it could not be
`considered. Nevertheless, names are often mispronounced and/or spoken with regional accents
`and dialects, so multiple potential pronunciations of the name are considered.
`
`
`1 Institute for Safe Medication Practices. Confused Drug name List (1996-2006). Available at
`http://www.ismp.org/Tools/confuseddrugnames.pdf
`2 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artificial Intelligence in
`Medicine (2005)
`
`4
`
`

`

`
`
`2.2 FDA PRESCRIPTION ANALYSIS STUDIES
`In order to evaluate the potential for misinterpretation of the proposed proprietary name in
`handwriting and verbal communication of the name, the following inpatient medication order,
`outpatient and verbal prescription was communicated during the FDA prescription studies.
`
`Figure 1. Vimovo Study (conducted on July 27, 2009)
`
`
`HANDWRITTEN REQUISITION MEDICATION
`ORDER
`
`VERBAL PRESCRIPTION
`
`Inpatient Medication Order:
`
`Outpatient Prescription:
`
`
`Vimova 375 mg/20 mg
`Take 1 tablet by mouth twice
`daily
`Dispense # 60
`
`
`
`
`
`2.3 EXTERNAL PROPRIETARY NAME RISK ASSESSMENT
`
`For this product, the Applicant submitted an external evaluation of the proposed proprietary
`name conducted by
`, a subsidiary of
` The
`Division of Medication Error Prevention and Analysis conducts an independent analysis and
`evaluation of the data provided, and responds to the overall findings of the assessment. When
`the external proprietary name risk assessment identifies potentially confusing names that were
`not captured in DMEPA’s database searches or in the Expert Panel Discussion, these names are
`included in the Safety Evaluator’s Risk Assessment and analyzed independently by the Safety
`Evaluator to determine if the potentially confusing name could lead to medication errors in usual
`practice settings.
`
`After the Safety Evaluator has determined the overall risk associated with proposed name, the
`Safety Evaluator compares the findings of his/her overall risk assessment with the findings of the
`proprietary name risk assessment submitted by the Applicant. The Safety Evaluator then
`determines whether the Division’s risk assessment concurs or differs with the findings. When
`the proprietary name risk assessments differ, the Division of Medication Error Prevention and
`Analysis provides a detailed explanation of these differences.
`
`5
`
`(b) (4)
`
`(b) (4)
`
`

`

` RESULTS
`
` 3
`
`3.1 DATABASE AND INFORMATION SOURCES
`The searches yielded a total of 18 names as having some similarity to the name Vimovo.
`Seventeen of the names were thought to look like Vimovo. These include: Innovar,
`Lunivia***, Nexavar,
`, Remeron, Vascana***, Vermox, Vimar, Vimax, Vimpat,
`, Viramune, Visacor, Vivarin,
`, and Vumon. One name, Renova, was
`thought to both look and sound like Vimovo.
`Additionally, DMEPA staff did not identify any United States Adopted Names (USAN) stems in
`the proposed proprietary name as of August 10, 2009.
`
`
`
`3.2 EXPERT PANEL DISCUSSION
`The Expert Panel reviewed the pool of names identified by DMEPA staff (See Section
`3.1 above) and no additional names thought to have orthographic or phonetic similarity to
`Vimovo.
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did
`not offer any additional comments relating to the proposed name.
`
`3.3 FDA PRESCRIPTION ANALYSIS STUDIES
`A total of twenty-four practitioners responded with none of the responses overlapping with an
`existing name. None of the participants interpreted the name correctly as “Vimovo.” In both
`inpatient and outpatients studies the ‘i’ in Vimovo was misinterpreted as ‘e’, the second ‘v’ was
`misinterpreted as ‘n’ or ‘r’, and the ‘o’ in both positions were misinterpreted as ‘a’. In the verbal
`studies, all responses were misspelled phonetic variations of the proposed name, Vimovo. See
`Appendix C for the complete listing of interpretations from the verbal and written prescription
`studies.
`
`3.4 EXTERNAL NAME STUDY
`
`In the proposed name risk assessment submitted by the Applicant,
`identified and evaluated a total of 22 names thought to have some potential for confusion with
`the name Vimovo. The names are Bismuth, Darvon, Feosol, Nimotop, Quetiapine, Renova,
`Rimso, Timolol, Valproate, Vanadom, Vantin, Velosef, Vermox, Viagra, Vigamox, Vimpat,
` 5 were
`Vioxx, Vivotif, Vumon, Zymar, Zymine, and Zyvox. Of the 22 names identified by
`also identified by DMEPA during the database searches: Renova, Rimso, Vermox, Vimpat, and
`Vumon. The remaining 17 names were evaluated as part of the Safety Evaluator Risk
`Assessment.
`
`*** This document contains proprietary and confidential information that should not be released to the
`public.***
`
`6
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`
`
`3.5 COMMENTS FROM THE DIVISION OF GASTROENTEROLOGY PRODUCTS (DGP)
`
`DMEPA notified the Division of Gastroenterology Products via e-mail that we had no objections
`to the proposed proprietary name, Vimovo, on August 5, 2009. Per e-mail correspondence, the
`Division of Gastroenterology Products on August 7, 2009 indicated that they concur with our
`assessment of the proposed proprietary name, Vimovo.
`
`3.6 SAFETY EVALUATOR RISK ASSESSMENT
`Independent searches by the primary Safety Evaluator resulted in one additional name which was
`thought to look or sound similar to Vimovo and represent a potential source of drug name
`confusion. The name identified to have look-alike and sound-alike similarities was Rimso-50.
`Accordingly, we evaluated a total of 36 names: 18 identified in Database and Information
`Sources (Section 3.1), 17 identified in the External Study (Section 3.4), and 1 identified in this
`section by the primary Safety Evaluator.
`
`4 DISCUSSION
`DDMAC and the Review Division had no concerns with the proposed proprietary name ,
`Vimovo. DMEPA did not identify and safety issues with the proposed product except for
`potential orthographic and/or phonetic similarity with other drug names.
`DMEPA identified and evaluated 36 names for their potential similarity to the proposed name,
`Vimovo. Twenty-nine lacked orthographic and/or phonetic similarity and were not evaluated
`further (see Appendix D).
`Failure mode and effect analysis (FMEA) was then applied to determine if the proposed
`proprietary name could potentially be confused with the remaining 7 names and lead to
`medication errors. This analysis determined that the name similarity between Vimovo was
`unlikely to result in medication errors with any of the 7 products for the reasons presented in
`Appendices E through G. This finding was consistent with and supported by an independent risk
`assessment of the proprietary name submitted by the Applicant.
`
`5 CONCLUSIONS AND RECOMMENDATIONS
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Vimovo, is not
`vulnerable to name confusion that could lead to medication errors nor is it promotional. Our
`assessment supports the findings of the External Study submitted by the Applicant. Thus the
`Division of Medication Error Prevention and Analysis (DMEPA) has no objection to the
`proprietary name, Vimovo for this product at this time.
`However, if any of the proposed product characteristics as stated in this review are altered prior
`to approval of the product, DMEPA rescinds this Risk Assessment finding and the name must be
`resubmitted for review. In the event that our Risk Assessment finding is rescinded, the
`evaluation of the name on resubmission is independent of the previous Risk Assessment, and as
`such, the conclusions on re-review of the name are subject to change. If the approval of this
`application is delayed beyond 90 days from the signature date of this review, the proposed name
`must be resubmitted for evaluation.
`
`7
`
`

`

`If you have further questions or need clarifications, please contact Nina Ton, Regulatory Project
`Manager, at 301-796-1648.
`
`5.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Vimovo, and have
`concluded that it is acceptable.
`Vimovo will be re-reviewed 90 days prior to the approval of the NDA. If we find the name
`unacceptable following the re-review, we will notify you.
`
`8
`
`

`

` REFERENCES
`
`
`
` 6
`
`Micromedex Integrated Index (http://csi.micromedex.com)
`1.
`Micromedex contains a variety of databases covering pharmacology, therapeutics, toxicology and
`diagnostics.
`
`Phonetic and Orthographic Computer Analysis (POCA)
`2.
`POCA is a database which was created for the Division of Medication Error Prevention and Analysis,
`FDA. As part of the name similarity assessment, proposed names are evaluated via a
`phonetic/orthographic algorithm. The proposed proprietary name is converted into its phonemic
`representation before it runs through the phonetic algorithm. Likewise, an orthographic algorithm exists
`which operates in a similar fashion.
`
`Drug Facts and Comparisons, online version, St. Louis, MO (http://factsandcomparisons.com)
`3.
`Drug Facts and Comparisons is a compendium organized by therapeutic course; it contains monographs
`on prescription and OTC drugs, with charts comparing similar products.
`
`AMF Decision Support System [DSS]
`4.
`DSS is a government database used to track individual submissions and assignments in review divisions.
`
`Division of Medication Errors Prevention and Analysis proprietary name consultation requests
`5.
`This is a list of proposed and pending names that is generated by the Division of Medication Error
`Prevention and Analysis from the Access database/tracking system.
`
`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`6.
`Drugs@FDA contains most of the drug products approved since 1939. The majority of labels, approval
`letters, reviews, and other information are available for drug products approved from 1998 to the present.
`Drugs@FDA contains official information about FDA approved brand name, generic drugs, therapeutic
`biological products, prescription and over-the-counter human drugs and discontinued drugs and
`“Chemical Type 6” approvals.
`
`Electronic online version of the FDA Orange Book (http://www.fda.gov/cder/ob/default.htm)
`7.
`The FDA Orange Book provides a compilation of approved drug products with therapeutic equivalence
`evaluations.
`
`U.S. Patent and Trademark Office (http://www.uspto.gov)
`8.
`USPTO provides information regarding patent and trademarks.
`
`Clinical Pharmacology Online (www.clinicalpharmacology-ip.com)
`9.
`Clinical Pharmacology contains full monographs for the most common drugs in clinical use, plus mini
`monographs covering investigational, less common, combination, nutraceutical and nutritional products.
`It also provides a keyword search engine.
`
`9
`
`

`

`10.
`
`Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available at
`(www.thomson-thomson.com)
`The Pharma In-Use Search database contains over 400,000 unique pharmaceutical trademarks and trade
`names that are used in about 50 countries worldwide. The data is provided under license by IMS
`HEALTH.
`
`Natural Medicines Comprehensive Databases (www.naturaldatabase.com)
`11.
`Natural Medicines contains up-to-date clinical data on the natural medicines, herbal medicines, and
`dietary supplements used in the western world.
`
`Stat!Ref (www.statref.com)
`12.
`Stat!Ref contains full-text information from approximately 30 texts; it includes tables and references.
`Among the database titles are: Handbook of Adverse Drug Interactions, Rudolphs Pediatrics, Basic
`Clinical Pharmacology, and Dictionary of Medical Acronyms Abbreviations.
`
`USAN Stems (http://www.ama-assn.org/ama/pub/category/4782.html)
`13.
`USAN Stems List contains all the recognized USAN stems.
`
`Red Book Pharmacy’s Fundamental Reference
`14.
`Red Book contains prices and product information for prescription, over-the-counter drugs, medical
`devices, and accessories.
`
`Lexi-Comp (www.lexi.com)
`15.
`Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
`
`16. Medical Abbreviations Book
`Medical Abbreviations Book contains commonly used medical abbreviations and their definitions.
`
`APPENDICES
`Appendix A:
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name and the proprietary and established names of drug products existing in the marketplace and
`those pending IND, NDA, BLA, and ANDA products currently under review by the Center. DMEPA defines a
`medication error as any preventable event that may cause or lead to inappropriate medication use or patient
`harm while the medication is in the control of the health care professional, patient, or consumer. 3
`For the proposed proprietary name, DMEPA staff conducts searches of a standard set of databases and
`information sources to identify names with orthographic and phonetic similarity and hold a Center for Drug
`Evaluation and Research (CDER) Expert Panel discussion to gather professional opinions on the safety of the
`proposed proprietary name. DMEPA staff also conducts internal CDER prescription analysis studies. When
`provided, DMEPA considers external prescription analysis study results and incorporate into the overall risk
`assessment.
`
`
`3 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerp.org/aboutMedErrors.html. Last accessed 10/11/2007.
`
`10
`
`

`

`The Safety Evaluator assigned to the Proprietary Name Risk Assessment is responsible for considering the
`collective findings, and provides an overall risk assessment of the proposed proprietary name. DMEPA bases
`the overall risk assessment on the findings of a Failure Mode and Effects Analysis (FMEA) of the proprietary
`name and focuses on the avoidance of medication errors.
`FMEA is a systematic tool for evaluating a process and identifying where and how it might fail. 4 DMEPA
`uses FMEA to analyze whether the drug names identified with orthographic or phonetic similarity to the
`proposed proprietary name could cause confusion that subsequently leads to medication errors in the clinical
`setting. DMEPA uses the clinical expertise of its staff to anticipate the conditions of the clinical setting where
`the product is likely to be used based on the characteristics of the proposed product.
`In addition, the product characteristics provide the context for the verbal and written communication of the
`drug names and can interact with the orthographic and phonetic attributes of the names to increase the risk of
`confusion when there is overlap or, in some instances, decrease the risk of confusion by helping to differentiate
`the products through dissimilarity. Accordingly, the DMEPA staff considers the product characteristics
`associated with the proposed drug throughout the risk assessment because the product characteristics of the
`proposed may provide a context for communication of the drug name and ultimately determine the use of the
`product in the usual clinical practice setting.
`Typical product characteristics considered when identifying drug names that could potentially be confused with
`the proposed proprietary name include, but are not limited to: established name of the proposed product,
`proposed indication of use, dosage form, route of administration, strength, unit of measure, dosage units,
`recommended dose, typical quantity or volume, frequency of administration, product packaging, storage
`conditions, patient population, and prescriber population. Because drug name confusion can occur at any point
`in the medication use process, DMEPA staff considers the potential for confusion throughout the entire U.S.
`medication use process, including drug procurement, prescribing and ordering, dispensing, administration, and
`monitoring the impact of the medication.5 DMEPA provides the product characteristics considered for this
`review in Section 1.
`The Division of Medication Error Prevention and Analysis considers the spelling of the name, pronunciation of the
`name when spoken, and appearance of the name when scripted. DMEPA also compares the spelling of the
`proposed proprietary name with the proprietary and established name of existing and proposed drug products
`because similarly in spelled names may have greater likelihood to sound similar to one another when spoken or look
`similar to one another when scripted. DMEPA staff also examines the orthographic appearance of the proposed
`name using a number of different handwriting samples. Handwritten communication of drug names has a long-
`standing association with drug name confusion. Handwriting can cause similarly, and even dissimilarly, spelled
`drug name pairs to appear very similar to one another. The similar appearance of drug names when scripted has led
`to medication errors. The DMEPA staff applies expertise gained from root-cause analysis of such medication errors
`to identify sources of ambiguity within the name that could be introduced when scripting (e.g., “T” may look like
`“F,” lower case ‘a’ looks like a lower case ‘u,’ etc). Additionally, other orthographic attributes that determine the
`overall appearance of the drug name when scripted are in Table 1 below. In addition, the DMEPA staff compares
`the pronunciation of the proposed proprietary name with the pronunciation of other drug names because verbal
`communication of medication names is common in clinical settings.