CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`203341Orig1s000
`
`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:
`
`
`
`July 26, 2012
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sarah K. Vee, PharmD, Safety Evaluator
`Division of Medication Prevention and Analysis
`Yelena Maslov, PharmD, Acting Team Leader
`Division of Medication Prevention and Analysis
`Bosulif (Bosutinib) Tablets,
`100 mg and 500 mg
`NDA 203341
`
`Wyeth Pharmaceutical, Inc.
`
`Reviewer:
`
`Team Leader
`
`Drug Name and Strengths:
`
`Application Type/Number:
`
`Applicant/sponsor:
`
`2012-1138
`
`OSE RCM #:
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`
`
`
`
`Reference ID: 3165629
`
`
`
`
`
`
`
`
`1
`
`

`

`CONTENTS
`
`INTRODUCTION .......................................................................................................................................... 3 
`1 
`2  METHODS AND DISCUSSION ................................................................................................................... 3 
`3  CONCLUSIONS............................................................................................................................................. 3 
`3.1  Comments to the Applicant...................................................................................................................... 3 
`4  REFERENCES ............................................................................................................................................... 4
`
`APPENDIX A.........................................................................................................................................................5
`
`Reference ID: 3165629
`
`
`2
`
`

`

`1
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Bosulif, 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,
`Bosulif, acceptable in OSE Review #2010-381, dated July 13, 2010, under IND 068268 and
`OSE Review #2011-4348, dated February 3, 2012.
`
`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 2011-4348.
`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 did not alter our previous conclusion regarding the acceptability of the proposed
`proprietary name. The searches of the databases yielded three new names (Duricef, Foradil, and
`Roxilox), thought to look similar to Bosulif 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 Duricef, Foradil, and Roxilox and lead to medication errors. This
`analysis determined that the name similarity between Bosulif and the identified names was unlikely to
`result in medication error for the reasons presented in Appendix A.
`Additionally, DMEPA searched the United States Adopted Names (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 USAN stems in the proposed proprietary name, as of July 23, 2012. The Office of
`Prescription Drug Promotion OPDP re-reviewed the proposed name on June 14, 2012 and had no
`concerns regarding the proposed name from a promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Bosulif, did not identify any vulnerabilities that
`would result in medication errors with any additional names noted in this review. Thus, DMEPA has
`no objection to the proprietary name, Bosulif, 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 Hematology Products 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 Sue Kang, OSE project manager, at
`301-796-4216.
`
`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Bosulif, and have concluded that
`this name is acceptable.
`
`Reference ID: 3165629
`
`
`3
`
`

`

`4. REFERENCES
`1.
`OSE Reviews 2011-4348 Bosulif (Bosutinib) Tablets, 100 mg and 500 mg, Kimberly
`DeFronzo, RPh, MS, MBA, February 3, 2012.
`
`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.
`
`2.
`
`3.
`
`4.
`
`
`
`Reference ID: 3165629
`
`
`4
`
`

`

`Appendix A: FMEA Table
`
`Proposed Name:
`
`Bosulif (bosutinib)
`
`Strength and Dosage
`Form: 100 mg, 500 mg
`oral tablets
`
`Usual Dose: 200 mg to 600
`mg orally once daily with
`food (including dose
`adjustment)
`
`Duricef (cefadroxil)
`
`- 500 mg oral capsules
`
`- 1 gram oral tablets
`
`- 250 mg/5 mL oral
`suspension (50. 100 mL)
`
`— 500 mg/5 mL oral
`suspension (75. 100 mL)
`
`-1t02grams/dayina
`single or divided doses
`(twice daily)
`
`Failure Mode:
`Incorrect Product
`Ordered]
`
`Prevention of Failure Mode
`
`Selected/Dispensed or
`Administered because
`of Name confusion
`
`In the conditions outlined below, the following
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`Causes (could be
`
`multiple)
`
`Orthographic
`Similarities
`
`- ‘Bos’ and ‘Dur’ may
`appear similar when
`scripted
`
`- ‘it‘ and ‘et‘ may
`appear similar when
`scripted
`
`- Both have 7 letters
`
`Overlapping Product
`Characteristics
`
`Orthographic Differences
`
`- 3 up strokes vs. 2 up strokes
`
`- ‘ul‘ and ‘ic’ appear different when scripted
`
`— Strength (100 mg. 500 mg vs. 0.012 mg single strength)
`
`- Pediatrics: 30 mg/kg/day
`in divided doses every 12
`hours
`
`- Strength (500 mg.
`500 mg/5 mL)
`
`- Dosage Form
`- Renal impairment: initial
`(tablets/capsules)
`dose 1 gram then 500 mg
`
`every 12 to 36 hours
`
`Foradil (formoterol)
`
`- 0.012 mg powder in
`capsules for inhalation
`
`- Inhale 1 capsule every 12
`hours
`
`Orthographic
`Similarities
`
`Orthographic Differences
`
`- ‘ul’ and ‘ad’ appear different when scripted
`
`Differing Product Characteristics
`
`- ‘Bos’ and ‘For‘ may
`appear similar when
`scripted
`
`- ‘if‘ and ‘il’ may
`appear similar when
`scripted
`
`- Both have 7 letters
`
`Overlapping Product
`Characteristics
`
`- Dosage Form
`
`(tablets/capsule)
`
`Reference ID: 31 65629
`
`

`

`hours as needed)
`
`- l capsuleevery6hoursas
`needed
`
`Orthographic Differences
`
`- ‘if and ‘ox’ appear difi'erent when scripted
`
`- 3 up strokes vs. 2 up strokes
`
`Difl'ering Product Characteristics
`
`- Frequency of Administration (once daily vs. every 6
`
`Roxilox
`
`(acetaminophen/oxycodone)
`
`- 500 mg/5 mg oral
`capsules
`
`Orthographic
`Similarities
`
`- ‘Bosul’ and ‘Roxil’
`
`may appear similar
`when scripted
`
`- Both have 7 letters
`
`Overlapping Product
`Characteristics
`
`- Dosage Form
`(tablets/capsule)
`
`Reference ID: 3165629
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SARAH K VEE
`07/27/2012
`
`YELENA L MASLOV
`07/27/2012
`
`KELLIE A TAYLOR
`07/27/2012
`
`CAROL A HOLQUIST
`07/27/2012
`
`Reference ID: 3165629
`
`

`

`
`
`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
`
`Date:
`
`Reviewer:
`
`
`Team Leader:
`
`
`Division Director:
`
`
`Drug Name and Strength:
`
`
`
`
`Application Type/Number:
`
`Applicant:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Proprietary Name Review
`
`February 3, 2012
`
`Kimberly DeFronzo, RPh, MS, MBA
`Division of Medication Error Prevention and Analysis
`
`
`Todd Bridges, RPh
`Division of Medication Error Prevention and Analysis
`
`Carol Holquist, RPh
`Division of Medication Error Prevention and Analysis
`
`Bosulif (Bosutinib) Tablets
`100 mg and 500 mg
`NDA 203341
`
`Pfizer, Inc. (Wyeth Pharmaceutical, Inc.
`is a wholly-owned subsidiary of Pfizer, Inc.)
`2011-4348
`
`
`
`OSE RCM #:
`
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
`
`
`
`
`
`
`
`Reference ID: 3082405
`
`

`

`
`
`CONTENTS
`
`1
`
`INTRODUCTION....................................................................................................... 1
`1.1
`Regulatory History.............................................................................................. 1
`1.2
`Product Information............................................................................................ 1
`2 RESULTS.................................................................................................................... 2
`2.1
`Promotional Assessment..................................................................................... 2
`2.2
`Safety Assessment .............................................................................................. 2
`3 CONCLUSIONS ......................................................................................................... 4
`3.1
`Comments to the Applicant ................................................................................ 4
`4 REFERENCES ............................................................................................................ 5
`APPENDICES .................................................................................................................... 8
`
`
`
`
`
`
`Reference ID: 3082405
`
`

`

`
`
`1
`INTRODUCTION
`This review evaluates the proposed proprietary name, Bosulif, 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
`The proposed proprietary name, Bosulif, was found acceptable by DMEPA in OSE
`Review #2010-381, dated July 13, 2010, under IND 068268. At the August 18, 2010
`PreNDA meeting, DMEPA did not identify any safety concern during the review of the
`meeting package. The Applicant submitted a proprietary name request on November 17,
`2011 under NDA 203341 for the same name which is the topic of this review.
`
`1.2
`PRODUCT INFORMATION
`The following product information is provided in the November 17, 2011 proprietary
`name submission.
`• Active ingredient: Bosutinib
`•
`Indication of Use: for the treatment of chronic, accelerated, or blast phase Ph+
`chronic myelogenous leukemia (CML) in adult patients with resistance, or
`intolerance to prior therapy.
`• Route of administration: Oral
`• Dosage form: Tablets
`• Dose and Frequency: 500 mg once daily with food. Dose escalation to 600 mg
`once daily with food in patients who failed to reach complete hematological
`response (CHR) by week 8 or a complete cytogenetic response (CCyR) by week
`12, at the recommended starting dosage and who did not have Grade 3 or higher
`adverse reactions. Dose adjustment for non-hematologic toxicities such as
`elevated liver transaminases and diarrhea, include drug interruption and resuming
`at a dose of 400 mg once daily. Dose adjustment for hematologic toxicities such
`as neutropenia and thrombocytopenia, include drug interruption and resuming at a
`dose reduction by 100 mg once daily. A lower starting dose of 200 mg is
`recommended in patients with hepatic impairment. No dose adjustment is
`recommended in patients with renal impairment or the elderly, and no data is
`available in patients less than 18 years of age.
`• How Supplied:
`o 120 tablets per bottle of 100 mg tablets (NDC #0069-0135-01) that are
`yellow, oval, biconvex, film-coated tablets, debossed “Pfizer” on one side
`and “100” on the other
`o 30 tablets per bottle of 500 mg tablets (NDC #0069-0136-01) that are red,
`oval, biconvex, film-coated tablets, debossed “Pfizer” on one side and
`“500” on the other
`
`Reference ID: 3082405
`
`
`1
`
`

`

`
`
`• Storage: at 25°C (77 °F); excursions permitted to 15- 30°C (59-86°F) [see USP
`Controlled Room Temperature].
`• Container and Closure Systems: The commercial container closure system for
`Bosutinib 100 mg and 500 mg tablets consists of a high-density polyethylene
`bottle/closure system with desiccant as outlined in the table below.
`
`
`
`Additionally, the insert labeling suggests the following:
`• Procedures for proper disposal of anticancer drugs should be considered. Any
`unused product or waste material should be disposed of in accordance with local
`requirements, or drug take back programs.
`
`2 RESULTS
`The following sections provide the information obtained and considered in the evaluation
`of the proposed proprietary name.
`
`2.1
`PROMOTIONAL ASSESSMENT
`The Office of Prescription Drug Promotion determined the proposed name is acceptable
`from a promotional perspective. DMEPA and the Division of Hematology Products
`(DHP) 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.
`
`2.2.1 United States Adopted Names (USAN) SEARCH
`On December 1, 2011 the United States Adopted Name (USAN) stem search identified
`that a USAN stem is not present in the proposed proprietary name.
`
`2.2.2 Components of the Proposed Proprietary Name
`
`This proprietary name comprised of a single word that does not contain any components
`such as a modifier, route of administration, or dosage form that is misleading or can
`contribute to medication error. The Applicant notes in their submission that the
`proprietary name is an invented name with no meaning and is derived from the prefix of
`the established name.
`
`2.2.3 FDA Name Simulation Studies
`Thirty-nine practitioners participated in DMEPA’s prescription studies. Two
`interpretations cited the name “Bacillus” which is a genus of bacteria and therefore, will
`not be further evaluated. The most common misinterpretation in the written studies was
`
`Reference ID: 3082405
`
`
`2
`
`

`

`the lowercase letter ‘u’ for the lowercase letter ‘a’ and lowercase letter ‘b’ for lowercase
`
`letter ‘1’. The most common misinterpretation in the verbal study was the sound from
`letter ‘B’ for the letters ‘0’ and ‘P’. See Appendix C for the complete listing of
`interpretations from the verbal and written prescription studies.
`
`2.2.4 Comments from Other Review Disciplines
`
`In response to the OSE’s December 2, 2011 e-mail, DHP did not forward any comments
`or issues relating to the proposed name at the initial phase of the proprietary 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 proprietary name, Bosulif. Table 1 lists the names with
`orthographic, phonetic, or spelling similarity to the proposed proprietary name, Bosulif,
`identified by the primary reviewer, the Expert Panel Discussion (EPD), and other review
`disciplines. Table 1 also includes the names identified from the FDA Prescription
`Simulation.
`
`Table l: Collective List of Potentially Similar Names (DNIEPA, EPD, Other
`
`Disciplines, FDA Name Simulation Studies, and External Name Study if applicable)
`
`Look Similar
`
`Look Similar
`
`Look and Sound Similar
`
`Name
`
`Source
`
`Name
`
`Source
`
`Name
`
`Source
`
`“M"
`
`Basulin
`
`Paralit
`
`Borobag
`
`Biscolax
`
`Beelith
`
`Bosentan
`
`Bisacodyl
`
`Disulfiram
`
`Banzel
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`Bismuth
`
`Lescol XL
`
`Bontril
`
`Velosef
`
`Bionect
`
`Dexilant
`
`Baclofen
`
`Rosanil
`
`Roxilox
`
`Derifil
`
`Bosulif"**
`
`FDA
`
`Bosutinib
`
`FDA
`
`Busulfex
`
`FDA
`
`Fusilev
`
`Busulfan
`
`Rosula
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA
`
`FDA —
`
`FDA
`
`Name
`
`Source
`
`Brevital Sodium FDA
`
`Buspar
`
`FDA
`
`Dosaflex
`
`FDA
`
`Diastat
`
`FDA
`
`Reference ID: 3082405
`
`3
`
`

`

`
`
`Our analysis of the 30 names contained in above Table 1 considered the information
`obtained in the previous sections along with their product characteristics. We determined
`these 30 names will not pose a risk for confusion as described in Appendix E through F.
`
`2.2.7 Communication of DMEPA’s Final Decision to Other Disciplines
`DMEPA communicated our findings to the DHP via e-mail on January 23, 2012. At that
`time we also requested additional information or concerns that could inform our review.
`Per e-mail correspondence from DHP on January 25, 2012, they stated no issues with the
`proposed proprietary name, Bosulif.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable from both a promotional and safety
`perspective. If you have further questions or need clarifications, please contact Sue
`Kang, OSE Project Manager, at 301-796-4216.
`
`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Bosulif, and have
`concluded that this name is acceptable. 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.
`However, if any of the proposed product characteristics as stated in your November 17,
`2011 submission are altered, DMEPA rescinds this finding and the name must be
`resubmitted for review.
`
`Reference ID: 3082405
`
`
`4
`
`

`

`
`
`REFERENCES
`
`1. Micromedex Integrated Index (http://csi.micromedex.com)
`Micromedex contains a variety of databases covering pharmacology, therapeutics,
`toxicology and diagnostics.
`
`2. 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.
`
`3. 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. This database also lists the orphan drugs.
`
`4. 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.
`
`5. 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.
`
`6. 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.
`7. U.S. Patent and Trademark Office (http://www.uspto.gov)
`USPTO provides information regarding patent and trademarks.
`
`8. 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,
`
`Reference ID: 3082405
`
`
`5
`
`

`

`
`
`combination, nutraceutical and nutritional products. It also provides a keyword search
`engine.
`
`9. 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.
`
`10. 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.
`
`11. 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.
`
`12. 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.
`
`13. Red Book Pharmacy’s Fundamental Reference
`Red Book contains prices and product information for prescription, over-the-counter
`drugs, medical devices, and accessories.
`
`14. Lexi-Comp (www.lexi.com)
`Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
`
`15. Medical Abbreviations Book
`Medical Abbreviations Book contains commonly used medical abbreviations and
`their definitions.
`
`16. CVS/Pharmacy (www.CVS.com)
`This database contains commonly used over the counter products not usually
`identified in other databases.
`
`17. Walgreens (www.walgreens.com)
`This database contains commonly used over the counter products not usually
`identified in other databases.
`
`Reference ID: 3082405
`
`
`6
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`

`

`
`
`18. Rx List (www.rxlist.com)
`RxList is an online medical resource dedicated to offering detailed and current
`pharmaceutical information on brand and generic drugs.
`
`19. Dogpile (www.dogpile.com)
`Dogpile is a Metasearch engine that searches multiple search engines including
`Google, Yahoo! and Bing, and returns the most relevant results to the search.
`
`20. OSE Reviews
`Pincock, Laura L. OSE Review 2010-381: Proprietary Name Review for Bosulif,
`July 13, 2010.
`
`
`Reference ID: 3082405
`
`
`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: 3082405
`
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`
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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).
`
`
`
`
`
`
`
`
`
`2 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
`
`Reference ID: 3082405
`
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`Table 1. Criteria Used to Identify Drug Names that Look- or Sound-Similar to a
`Proposed Proprietary Name.
`
`Considerations when Searching the Databases
`
`Attributes Examined to Identify
`Similar Drug Names
`
`Potential Effects
`
`Potential
`Causes of Drug
`Name
`Similarity
`
`Similar spelling
`
`
`Type of
`Similarity
`
`
`
`
`
`
`Look-
`alike
`
`Orthographic
`similarity
`
`Identical prefix
`Identical infix
`Identical suffix
`Length of the name
`Overlapping product
`characteristics
`
`• Names may appear similar
`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 names (or components of the
`proprietary name) can be a source of error in a variety of ways. Consequently, DMEPA
`considers and evaluates these broader safety implications of the name throughout this
`assessment and the medication error staff provides additional comments related to the
`
`Sound-
`alike
`
`Phonetic
`similarity
`
`
`• Names may sound similar
`when pronounced and lead
`to drug name confusion in
`verbal communication
`
`Reference ID: 3082405
`
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`safety of the proposed proprietary name or product based on professional experience with
`medication errors.
`
`1. Database and Information Sources
`DMEPA searches the internet, several standard published drug product reference texts,
`and FDA databases to identify existing and proposed drug names that may sound-alike or
`look-alike to the proposed proprietary name. A standard description of the databases
`used in the searches is provided in the reference section of this review. To complement
`the process, the DMEPA uses a computerized method of identifying phonetic and
`orthographic similarity between medication names. The program, Phonetic and
`Orthographic Computer Analysis (POCA), uses complex algorithms to select a list of
`names from a database that have some similarity (phonetic, orthographic, or both) to the
`trademark being evaluated. Lastly, DMEPA reviews the USAN stem list