CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`202155Orig1s000
`
`PROPRIETARY NAME REVIEW(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
`Office of Medication Error Prevention and Risk Management
`
`
`Proprietary Name Review--Final
`
`Date:
`
`
`
`October 22, 2012
`
` Morgan Walker, Pharm.D., M.B.A.
`Division of Medication Error Prevention and Analysis
`Irene Z. Chan, Pharm.D. BCPS
`Division of Medication Error Prevention and Analysis
`Eliquis (Apixaban) Tablets
`2.5 mg and 5 mg
`NDA 202155
`Bristol Myers Squibb
`2012-2339
`
`Reviewer:
`
`
`
`Team Leader:
`
`
`Drug Name and Strength(s):
`
`
`
`
`
`Application Type/Number:
`
`Applicant:
`
`OSE RCM #:
`
`
`
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`Reference ID: 3206321
`
`
`

`

`
`
`CONTENTS
`
`INTRODUCTION .......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION ................................................................................................................... 3
`3 CONCLUSIONS............................................................................................................................................. 3
`4 REFERENCES ............................................................................................................................................... 4
`
`Reference ID: 3206321
`
`
`2
`
`

`

`
`
`1
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Eliquis (Apixaban) Tablets, 2.5 mg and 5 mg, 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, Eliquis, acceptable in OSE Review #2011-3807, dated
`December 6, 2011.
`
`2 METHODS AND DISCUSSION
`For re-assessments of proposed proprietary names, DMEPA searches a standard set of databases and
`information sources (see section 4) to identify names with orthographic and phonetic similarity to the
`proposed name that have been approved since the previous OSE proprietary name review. For this
`review we used the same search criteria described in OSE Review #2011-3807. We note that none of
`the proposed product characteristics were altered. However, we evaluated the previously identified
`names of concern considering any lessons learned from recent post-marketing experience, which may
`have altered our previous conclusion regarding the acceptability of the proposed proprietary name.
`Our re-evaluation did not alter our conclusion for OSE Review # 2011-3807. The searches of the
`databases yielded one new name (
` thought to look or sound similar to Eliquis and
`represent a potential source of drug name confusion. Failure mode and effects analysis was applied to
`determine if the proposed proprietary name could potentially be confused with Eliquis and lead to
`medication errors. This analysis determined that the name similarity between Eliquis and the
`identified name was unlikely to result in medication error for the reasons presented in Appendix A.
`Additionally, DMEPA searched the USAN stem list to determine if the name contains any USAN
`stems as of the last USAN updates. The Safety Evaluator did not identify any United States Adopted
`Names (USAN) stems in the proposed proprietary name, as of October 18, 2012. The Office of
`Prescription Drug Promotion (OPDP) re-reviewed the proposed name on October 18, 2012 and had no
`concerns regarding the proposed name from a promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Eliquis, did not identify any vulnerabilities that
`would result in medication errors with the additional name noted in this review. Thus, DMEPA has no
`objection to the proprietary name, Eliquis, for this product at this time.
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days
`from the date of this review, the Division of Cardiovascular and Renal Products (DCRP) should notify
`DMEPA because the proprietary name must be re-reviewed prior to the new approval date.
`If you have further questions or need clarifications, please contact Cherye Milburn, OSE project
`manager, at 301-796-2084.
`
`
`
`
`Reference ID: 3206321
`
`
`3
`
`(b) (4)
`
`

`

`
`
`4 REFERENCES
`1.
`OSE Reviews: RCM #2011-3807.
`
`2.
`
`3.
`
`4.
`
`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`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/ama/pub/physician-resources/medical-science/united-states-
`adopted-names-council/naming-guidelines/approved-stems.page?)
`USAN Stems List contains all the recognized USAN stems.
`
`Division of Medication Error Prevention and Analysis Proprietary Name Consultation Request
`Compiled list of proposed proprietary names submitted to the Division of Medication Error Prevention
`and Analysis for review. The list is generated on a weekly basis from the Access database/tracking
`system.
`
`Reference ID: 3206321
`
`
`4
`
`

`

`Appendix A: Risk of medication errors due to product confusion minimized by dissimilarity of the
`names and/ or use in clinical practice for the reasons described.
`
`
`
`Reference ID: 3206321
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MORGAN A WALKER
`10/22/2012
`
`IRENE Z CHAN
`10/22/2012
`
`Reference ID: 3206321
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
`
`
`Proprietary Name Review--Final
`
`Date:
`
`
`
`April 4, 2012
`
` Morgan Walker, Pharm.D., M.B.A.
`Division of Medication Error Prevention and Analysis
`Chi-Ming (Alice) Tu, Pharm.D.
`Division of Medication Error Prevention and Analysis
`Carol Holquist, R.Ph.
`Division of Medication Error Prevention and Analysis
`Eliquis (Apixaban) Tablets
`2.5 mg, 5 mg
`NDA 202155
`Bristol-Myers Squibb
`2012-541-1
`
`Reviewer:
`
`
`
`Acting Team Leader
`
`
`
`Division Director
`
`
`Drug Name and Strength(s):
`
`
`
`
`
`Application Type/Number:
`
`Applicant/sponsor:
`
`OSE RCM #:
`
`
`
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`Reference ID: 3110509
`
`
`

`

`
`
`CONTENTS
`
`INTRODUCTION .......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION ................................................................................................................... 3
`3 CONCLUSIONS............................................................................................................................................. 3
`4 REFERENCES ............................................................................................................................................... 4
`
`Reference ID: 3110509
`
`
`2
`
`

`

`
`
` 1
`
`
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Eliquis (Apixaban) Tablets, 2.5 mg and 5 mg, is
`written in response to the anticipated approval of this NDA 202155 within 90 days from the date of
`this review. DMEPA found the proposed name, Eliquis, acceptable in OSE Review 2011- 3807 dated
`December 6, 2011.
`
`2 METHODS AND DISCUSSION
`For re-assessments of proposed proprietary names, DMEPA searches a standard set of databases and
`information sources (see section 4) to identify names with orthographic and phonetic similarity to the
`proposed name that have been approved since the previous OSE proprietary name review. For this
`review we used the same search criteria described in OSE Review 2011- 3807. Since none of the
`proposed product characteristics were altered we did not re-evaluate previous names of concern. The
`searches of the databases yielded one new name (
` thought to look or sound similar to
`Eliquis and represent a potential source of drug name confusion. Failure mode and effects analysis
`
`was applied to determine if the proposed proprietary name could potentially be confused with
`and lead to medication errors. This analysis determined that the name similarity between Eliquis and
`the identified name was unlikely to result in medication error for the reasons presented in Appendix
`A.
`Additionally, DMEPA searched the USAN stem list to determine if the name contains any USAN
`stems as of the last USAN updates. The Safety Evaluator did not identify any United States Adopted
`Names (USAN) stems in the proposed proprietary name, as of March 26, 2012. The Office of
`Prescription Drug Promotion OPDP re-reviewed the proposed name on March 29, 2012 and had no
`concerns regarding the proposed name from a promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Eliquis, did not identify any vulnerabilities that
`would result in medication errors with any additional name noted in this review. Thus, DMEPA has
`no objection to the proprietary name, Eliquis, for this product at this time.
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days
`from the date of this review, the Division of Cardiovascular and Renal Products (DCRP) should notify
`DMEPA because the proprietary name must be re-reviewed prior to the new approval date.
`If you have further questions or need clarifications, please contact Phuong (Nina) Ton, OSE project
`manager, at 301-796-1648.
`
`
`Reference ID: 3110509
`
`
`3
`
`(b) (4)
`
`(b) (4)
`
`

`

`
`
`4 REFERENCES
`1.
`OSE Review 2011-3807, Proprietary Name Review for Eliquis
`
`2.
`
`3.
`
`4.
`
`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`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/ama/pub/physician-resources/medical-science/united-states-
`adopted-names-council/naming-guidelines/approved-stems.page?)
`USAN Stems List contains all the recognized USAN stems.
`
`Division of Medication Error Prevention and Analysis Proprietary Name Consultation Request
`Compiled list of proposed proprietary names submitted to the Division of Medication Error Prevention
`and Analysis for review. The list is generated on a weekly basis from the Access database/tracking
`system.
`
`Reference ID: 3110509
`
`
`4
`
`

`

`Annendix A: FMEA Table
`
`
`
`Reference ID: 3110509
`
`5
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MORGAN A WALKER
`04/04/2012
`
`CHI-MING TU
`04/04/2012
`
`Reference ID: 3110509
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
`
`Proprietary Name Review
`
`Date:
`
`December 6, 2011
`
`Morgan Walker, Pharm.D., M.B.A., Safety Evaluator
`Reviewer(s):
`Division of Medication Error Prevention and Analysis
`
`Irene Z. Chan, Pharm.D., BCPS, Team Leader
`Team Leader
`Division of Medication Error Prevention and Analysis
`
`Carol Holquist, RPh., Director
`Division Director
`Division of Medication Error Prevention and Analysis
`
`Eliquis (Apixaban) Tablets
`Drug Name(s):
`2.5 mg and 5 mg
`
`
`
`
`Application Type/Number: NDA 202155
`Applicant/sponsor:
`Bristol-Myers Squibb Company
`OSE RCM #:
`2011- 3807
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3054251
`
`

`

`
`
`CONTENTS
`
`1
`
`INTRODUCTION .................................................................................................................... 1
`1.1 Regulatory History............................................................................................................. 1
`2 RESULTS ................................................................................................................................. 1
`2.1 Promotional Assessment .................................................................................................... 1
`2.2 Safety Assessment.............................................................................................................. 1
`3 CONCLUSIONS....................................................................................................................... 4
`3.1 Comments to the Applicant................................................................................................ 4
`4 REFERENCES.......................................................................................................................... 5
`APPENDICES................................................................................................................................. 8
`
`
`
`
`
`
`Reference ID: 3054251
`
`

`

`
`
`1
`INTRODUCTION
`This review evaluates the proposed proprietary name, Eliquis, from a safety and
`promotional perspective. The sources and methods used to evaluate the proposed name
`are outlined in the reference section and Appendix A respectively.
`
`1.1
`REGULATORY HISTORY
`DMEPA previously completed a proprietary name review for the proposed proprietary
`name, Eliquis, during the IND phase (OSE RCM # 2010-654) dated September 9, 2010.
`The name was found acceptable at that time. Since our previous review, the product
`characteristics have changed to include a 5 mg dose and strength.
`
`1.2
`PRODUCT INFORMATION
`The Applicant/Sponsor provided the following product information for Eliquis as part of
`their October 4, 2011 submission.
`• Established Name: Apixaban
`•
`Indication of Use: Prevention of stroke and systemic embolism in patients with
`atrial fibrillation
`• Route of administration: Oral
`• Dosage form: Tablets
`• Dose: The recommended dose is 5 mg twice daily, or 2.5 mg twice daily in
`patients with at least 2 of the following: age ≥ 80 years, body weight ≤ 60 kg, or
`serum creatinine ≥ 1.5 mg/dL
`• How Supplied: Bottles of 60 and 180; unit dose blister cards of
`
`; and professional samples (5 mg tablet blister cards of 14
`
`tablets per card)
`• Storage: Store at 20°C to 25°C; excursions permitted between 15°C to 30°C
`
`2 RESULTS
`The following sections provide the information obtained and considered in the evaluation
`of the proposed proprietary name.
`
`2.1
`PROMOTIONAL ASSESSMENT
`OPDP determined the proposed name is acceptable from a promotional perspective.
`DMEPA and the Division of Cardiovascular and Renal Products (DCRP) concurred with
`the findings of OPDP’s promotional assessment of the proposed name.
`
`2.2
`SAFETY ASSESSMENT
`The following aspects of the name were considered in the overall evaluation.
`
`Reference ID: 3054251
`
`
`1
`
`(b) (4)
`
`

`

`2.2.1 United States Adopted Names (USAN) SEARCH
`
`The October 7, 2011 United States Adopted Name (USAN) stem search, identified that a
`USAN stem is not present in the proposed proprietary name.
`
`2.2.2 Components ofthe Proposed Proprietary Name
`
`This proprietary name is comprised of a single word, and does not contain any
`components (i.e. a modifier, route of administration, dosage form, etc) that can contribute
`to medication error or render the name unacceptable.
`
`2.2.4 FDA Name Simulation Studies
`
`Thirty-one practitioners participated in DMEPA’s prescription studies. Four outpatient
`respondents ended the name Eliquis with an ‘r’ instead of an ‘s’. One outpatient
`respondent ended the name with a ‘2’ instead of an ‘3’. See Appendix C for the complete
`listing of interpretations from the verbal and written prescription studies.
`
`2.2.5 Comments from Other Review Disciplines
`
`In response to the OSE, October 13, 2011 e—mail, the Division of Cardiovascular and
`Renal Products (DCRP) did not forward any comments or concerns relating to the
`proposed name at the initial phase of the name review.
`
`2.2. 6 Failure Mode and Effects Analysis ofSimilar Names
`
`Appendix B lists possible orthographic and phonetic misinterpretations of the letters
`appearing in the proposed name, Eliquis. Table 1 lists the names with orthographic,
`phonetic, or spelling similarity to the proposed proprietary name, Eliquis identified by the
`primary reviewer, the Expert Panel Discussion (EPD), and other review disciplines.
`Table 1 also included the names identified from the FDA Prescription Simulation or by
`(Ina) that were not previously identified by DMEPA and require
`
`further evaluation.
`
`Table 1: Collective List of Potentially Similar Names (DNIEPA, EPD, Other
`Disciplines, and External Name Study if applicable)
`
`Look Similar
`
`Name
`
`Source
`
`Name
`
`Source
`
`Name
`
`Source
`
`Adagen
`
`FDA
`
`Eliphos
`
`FDA
`
`Aloprim
`
`Atripla
`
`Atryn
`
`Clorpres
`
`Diquinol
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`Elixicon
`
`Elixomin
`
`Elizac
`
`Elspar
`
`Flagyl
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`Folgard
`Tablet
`
`Climara
`
`Clindagel
`
`EpiQuin
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`Alesse
`
`External
`
`aliskiren
`
`External
`
`Reference ID: 3054251
`
`2
`
`

`

`Elaprase
`
`FDA
`
`Clinoril
`
`FDA
`
`Elase
`
`External
`
`Micardis
`
`External
`
`Eldepryl
`
`External
`
`Nyquil
`
`External
`
`
`
`
`
`Equagesic
`
`External
`
`Equanil
`
`External
`
`Excedrin
`
`External
`
`
`Aloxi
`
`External
`
`
`
`Lasix
`Levaqum
`
`Eldoquin
`
`Elocon
`
`Elavil
`
`Elidel
`
`Eligard
`
`External
`External ____
`
`Sound Similar
`
`Look and Sound Similar
`
`Elimite
`
`Both
`
`
`
`
`Elitek
`Both
`
`
`
`Both
`
`Both
`
`Both
`
`Both
`
`Both
`
`Our analysis of the 37 names contained in Table 1 considered the information obtained in
`the previous sections along with the product characteristics. We determined the 37 names
`will not pose a risk for confusion as described in Appendices D and E. Additionally,
`DMEPA re—reviewed previously identified names in the IND due to changes in the
`product characteristics. We determined the previous names reviewed in the IND also do
`not pose a risk for confusion with Eliquis.
`
`2.2.6 Communication ofDMEPA ’5 Final Decision to Other Disciplines
`
`DMEPA communicated these findings to the Division of Cardiovascular and Renal
`Products (DCRP) via e—mail on October 28, 2011. At that time we also requested
`additional information or concerns that could inform our review. Per e-mail
`
`correspondence from the Division of Cardiovascular and Renal Products (DCRP) on
`November 7, 2011, they stated no additional concerns with the proposed proprietary
`name, Eliquis.
`
`3 CONCLUSIONS
`
`The proposed proprietary name is acceptable from both a promotional and safety
`perspective.
`
`If you have fiuther questions or need clarifications, please contact Nina Ton, OSE project
`manager, at 301—796—1648.
`
`Reference ID: 3054251
`
`3
`
`

`

`
`
`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Eliquis, and have
`concluded that this name is acceptable. However, if any of the proposed product
`characteristics as stated in your October 4, 2011 submission are altered, DMEPA rescinds
`this finding and the name must be resubmitted for review. Additionally, this proprietary
`name must be re-evaluated 90 days prior to the approval of the application. The
`conclusions upon re-review are subject to change.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3054251
`
`
`4
`
`

`

`
`
`4 REFERENCES
`
`1. OSE Review:
`
` RCM # 2010-654: Proprietary Name Review for Eliquis. September 9, 2010
`
`2. Micromedex Integrated Index (http://csi.micromedex.com)
`Micromedex contains a variety of databases covering pharmacology, therapeutics,
`toxicology and diagnostics.
`
`3. Phonetic and Orthographic Computer Analysis (POCA)
`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.
`
`4. Drug Facts and Comparisons, online version, St. Louis, MO
`(http://factsandcomparisons.com )
`Drug Facts and Comparisons is a compendium organized by therapeutic course; it
`contains monographs on prescription and OTC drugs, with charts comparing similar
`products.
`
`5. FDA Document Archiving, Reporting & Regulatory Tracking System [DARRTS]
`DARRTS is a government database used to organize Applicant and Sponsor
`submissions as well as to store and organize assignments, reviews, and
`communications from the review divisions.
`
`6. Division of Medication Errors Prevention and Analysis proprietary name
`consultation requests
`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.
`
`7. Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`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.
`
`Reference ID: 3054251
`
`
`5
`
`

`

`
`
`8. Electronic online version of the FDA Orange Book
`(http://www.fda.gov/cder/ob/default.htm)
`The FDA Orange Book provides a compilation of approved drug products with
`therapeutic equivalence evaluations.
`
`9. U.S. Patent and Trademark Office (http://www.uspto.gov)
`USPTO provides information regarding patent and trademarks.
`
`10. Clinical Pharmacology Online (www.clinicalpharmacology-ip.com)
`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.
`
`11. 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.
`
`12. Natural Medicines Comprehensive Databases (www.naturaldatabase.com)
`Natural Medicines contains up-to-date clinical data on the natural medicines, herbal
`medicines, and dietary supplements used in the western world.
`
`13. Access Medicine (www.accessmedicine.com )
`Access Medicine® from McGraw-Hill contains full-text information from
`approximately 60 titles; it includes tables and references. Among the titles are:
`Harrison’s Principles of Internal Medicine, Basic & Clinical Pharmacology, and
`Goodman and Gilman’s The Pharmacologic Basis of Therapeutics.
`
`14. USAN Stems (http://www.ama-assn.org/ama/pub/about-ama/our-people/coalitions-
`consortiums/united-states-adopted-names-council/naming-guidelines/approved-
`stems.shtml)
`USAN Stems List contains all the recognized USAN stems.
`
`15. Red Book Pharmacy’s Fundamental Reference
`Red Book contains prices and product information for prescription, over-the-counter
`drugs, medical devices, and accessories.
`
`16. Lexi-Comp (www.lexi.com)
`Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
`
`Reference ID: 3054251
`
`
`6
`
`

`

`
`
`17. Medical Abbreviations Book
`Medical Abbreviations Book contains commonly used medical abbreviations and
`their definitions.
`
`Reference ID: 3054251
`
`
`7
`
`

`

`
`
`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment considers the promotional and safety aspects
`of a proposed proprietary name. The promotional review of the proposed name is
`conducted by OPDP. OPDP evaluates proposed proprietary names to determine if they
`are overly fanciful, so as to misleadingly imply unique effectiveness or composition, as
`well as to assess whether they contribute to overstatement of product efficacy,
`minimization of risk, broadening of product indications, or making of unsubstantiated
`superiority claims. OPDP provides their opinion to DMEPA for consideration in the
`overall acceptability of the proposed proprietary name.
`The safety assessment is conducted by DMEPA. DMEPA staff search a standard set of
`databases and information sources to identify names that are similar in pronunciation,
`spelling, and orthographically similar when scripted to the proposed proprietary name.
`Additionally, we consider inclusion of USAN stems or other characteristics that when
`incorporated into a proprietary name may cause or contribute to medication errors (i.e.,
`dosing interval, dosage form/route of administration, medical or product name
`abbreviations, names that include or suggest the composition of the drug product, etc.).
`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. 1
`Following the preliminary screening of the proposed proprietary name, DMEPA gathers
`to discuss their professional opinions on the safety of the proposed proprietary name.
`This meeting is commonly referred to the Center for Drug Evaluation and Research
`(CDER) Expert Panel discussion. DMEPA also considers other aspects of the name that
`may be misleading from a safety perspective. DMEPA staff conducts a prescription
`simulation studies using FDA health care professionals. When provided, DMEPA
`considers external proprietary name studies conducted by or for the Applicant/Sponsor
`and incorporates the findings of these studies into the overall risk assessment.
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name 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 misleading nature of the proposed proprietary name with a focus on the avoidance of
`medication errors.
`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. DMEPA considers the product characteristics associated with the proposed
`product throughout the risk assessment because the product characteristics of the
`
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 3054251
`
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`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. DMEPA considers how these
`product characteristics may or may not be present in communicating a product name
`throughout the medication use system. Because drug name confusion can occur at any
`point in the medication use process, DMEPA 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.2 The product characteristics considered for this review appears in Appendix
`B1 of this review.
`The DMEPA considers the spelling of the name, pronunciation of the name when spoken, and
`appearance of the name when scripted. DMEPA compares the proposed proprietary name
`with the proprietary and established name of existing and proposed drug products and names
`currently under review at the FDA. DMEPA 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. DMEPA examines the phonetic
`similarity using patterns of speech. If provided, DMEPA will consider the Sponsor’s intended
`pronunciation of the proprietary name. However, DMEPA also considers a variety of
`pronunciations that could occur in the English language because the Sponsor has little control
`over how the name will be spoken in clinical practice. The orthographic appearance of the
`proposed name is evaluated using a number of different handwriting samples. DMEPA
`applies expertise gained from root-cause analysis of postmarketing 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 (see Table 1 below for details).
`Table 1. Criteria Used to Identify Drug Names that Look- or Sound-Similar to a
`Proposed Proprietary Name.
`
`Considerations when Searching the Databases
`
`Type of
`Similarity
`
`Potential
`Causes of Drug
`Name
`Similarity
`
`Attributes Examined to Identify
`Similar Drug Names
`
`Potential Effects
`
`
`
`Similar spelling
`
`Identical prefix
`
`• Names may appear similar
`
`
`2 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
`
`Reference ID: 3054251
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`Look-
`alike
`
`Identical infix
`Identical suffix
`Length of the name
`Overlapping product
`characteristics
`
`Orthographic
`similarity
`
`in print or electronic media
`and lead to drug name
`confusion in printed or
`electronic communication
`• Names may look similar
`when scripted and lead to
`drug name confusion in
`written communication
`• Names may look similar
`when scripted, and lead to
`drug name confusion in
`written communication
`
`Similar spelling
`Length of the name/Similar
`shape
`Upstrokes
`Down strokes
`Cross-strokes
`Dotted letters
`Ambiguity introduced by
`scripting letters
`Overlapping product
`characteristics
`Identical prefix
`Identical infix
`Identical suffix
`Number of syllables
`Stresses
`Placement of vowel sounds
`Placement of consonant sounds
`Overlapping product
`characteristics
`Lastly, DMEPA considers the potential for the proposed proprietary name to
`inadvertently function as a source of error for reasons other than name confusion. Post-
`marketing experience has demonstrated that proprietary name