CENTER FOR DRUG EVALUATION AND
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`RESEARCH
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`APPLICATION NUMBER:
`20-1023
`20-1023
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`APPLICA TION NUMBER:
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`PROPRIETARY NAME REVIEW(S)
`PROPRIETARY NAME REVIEW! S}
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`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`May 11, 2010
`
`Robert Justice, MD, Division Director
`Division of Drug Oncology Products
`
`Melina Griffis RPh, Team Leader
`Denise Toyer, PharmD, Deputy Director
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis
`
`Lubna Najam, MS, PharmD., Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`Proprietary Name Review
`
`Jevtana (Cabazitaxel) Injection
` 60 mg/1.5 mL Before Initial Dilution
`
`Date:
`
`To:
`
`Through:
`
`From:
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`Subject:
`
`Drug Name(s):
`
`
`
`Application
`Type/Number:
`
`Applicant:
`
`OSE RCM #:
`
`NDA 201023
`
`Sanofi Aventis
`
`2010-695
`
`
`*** This document contains proprietary and confidential information that should not
`be released to the public.***
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`CONTENTS
`EXECUTIVE SUMMARY............................................................................................................. 3
`1. BACKGROUND .................................................................................................................... 3
`1.1 Introduction ...................................................................................................................... 3
`1.2 Product Information.......................................................................................................... 3
`2. METHODS AND MATERIALS............................................................................................ 4
`2.1 Search Criteria ................................................................................................................. 4
`2.2 Prescription Analysis Studies .......................................................................................... 4
`2.3 External Proprietary Name Risk Assessment .................................................................. 5
`3. RESULTS............................................................................................................................... 5
`3.1 Database and Information Sources .................................................................................. 5
`3.2 Expert Panel Discussion................................................................................................... 6
`3.3 Prescription Analysis Studies........................................................................................... 6
`3.4 External Study .................................................................................................................. 6
`3.5 Safety Evaluator Risk Assessment ................................................................................... 6
`3.6 Comments from the Division of Drug oncology Products (DDOP)................................. 7
`4. DISCUSSION......................................................................................................................... 7
`4.1 Promotional Assessment .................................................................................................. 7
`4.2 Safety Assessment............................................................................................................ 7
`5. CONCLUSIONS AND RECOMMENDATIONS..................................................................... 8
`6. COMMENTS TO THE APPLICANT ........................................................................................ 8
`Proprietary Name .......................................................................Error! Bookmark not defined.
`7. REFERENCES........................................................................................................................... 8
`APPENDICES............................................................................................................................... 10
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`EXECUTIVE SUMMARY
`This review summarizes the analysis of the proposed proprietary name, Jevtana, for
`Cabazitaxel Injection. 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 Jevtana
`conditionally 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 Sanofi Aventis dated April 1, 2010 for an
`assessment of the proposed proprietary name, Jevtana, regarding potential name
`confusion with other proprietary or established drug names in the usual practice settings.
`The Applicant submitted an external study conducted by
`
`in support of their proposed proprietary name. The Labels and Labeling included in this
`submission were reviewed separately in OSE review # 2010-714.
`
`1.2 PRODUCT INFORMATION
`Jevtana (Cabazitaxel) is an antineoplastic agent that acts by disrupting the microtubular
`network in cells. Jevtana in combination with Prednisone is indicated for the treatment of
`patients with hormone refractory prostate cancer. The recommended dose of Jevtana is
`25 mg/m2 administered every 3 weeks as a 1- hour infusion. Jevtana is available in
`60 mg/1.5 mL Injection Concentrate which requires a two step dilution process prior to
`administration. The dilution process is as follows:
`
`Step One:
`Each Vial of JEVTANA (cabazitaxel) 60 mg/1.5 mL must first be mixed with the entire contents of
`supplied diluent
` The resultant solution contains 10 mg/mL of JEVTANA.
`
`Step Two:
`Withdraw the required amount of Jevtana from the 10 mg/mL drug solution/diluent mixture prepared in
`step one and further dilute into either 0.9% sodium chloride solution or 5% dextrose solution for infusion.
`
`The final JEVTANA dilution for infusion should be administered intravenously as a 1-
`hour infusion at room temperature.
`Jevtana will be packaged as a kit containing a Jevtana vial (60 mg/1.5 mL) and a diluent
`vial
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`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,
`Jevtana.
`
`2.1 SEARCH CRITERIA
`For this review, particular consideration was given to drug names beginning with the
`letter ‘J’ 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 Jevtana, 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 (seven letters), upstrokes (two,
`letters ‘J’ and ‘T’), down strokes (none), cross strokes (one, letter‘t’), and dotted letters
`(none). Additionally, several letters in Jevtana 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 Jevtana.
`When searching to identify potential names that may sound similar to Jevtana, the
`DMEPA staff search for names with similar number of syllables (three), stresses (JEV-ta-
`na or jev-tana or jev-ta-NA), and placement of vowel and consonant sounds. (See
`Appendix B) The Applicant’s intended pronunciation (Jev-ta-na) was also taken into
`consideration. Moreover, names are often mispronounced and/or spoken with regional
`accents and dialects, so other potential pronunciations of the name are considered.
`
`2.2 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 and verbal prescription was communicated during the FDA prescription
`studies.
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`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)
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`Figure 1. Jevtana Study (conducted on April 09, 2010)
`
`
`HANDWRITTEN REQUISITION
`MEDICATION ORDER
`
`VERBAL
`PRESCRIPTION
`
`Inpatient prescription- 1:
`
`Inpatient prescription-2:
`
`Jevtana 45 mg IV infusion
`over 1 hour
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`2.3 EXTERNAL PROPRIETARY NAME RISK ASSESSMENT
`For this product, the Applicant submitted an external evaluation of the proposed
`proprietary name. 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 their 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.
`
`3. RESULTS
`3.1 DATABASE AND INFORMATION SOURCES
`The searches yielded a total of 22 names as having some similarity to the name Jevtana.
`Twenty of the names were thought to look like Jevtana. These include: Jevtana, Januvia,
`Janumet, Jenloga, Gentasol, Gentak, Gentran 40, Tekturna, Taxotere, Fentora, Jolessa,
`Forteo, Jevity,
` Senatec, Levitra, Lexiva, Sentra AM, Leukine and Extina. The
`remaining two names were thought to look and sound similar to Jevtana. These include
`Jantoven and Teveten.
`Additionally, DMEPA staff did not identify any United States Adopted Names (USAN)
`stems in the proposed proprietary name, as of April 8, 2010.
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`*** This is proprietary and confidential information that should not be released to the public.
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`3.2 EXPERT PANEL DISCUSSION
`The Expert Panel reviewed the pool of names identified by DMEPA staff (See Section
`3.1 above) and noted no additional names thought to have orthographic or phonetic
`similarity to Jevtana.
`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 PRESCRIPTION ANALYSIS STUDIES
`A total of 44 practitioners responded, none of the responses overlapped with any existing
`drug names. Thirteen (n=13) of the participants interpreted the name correctly as
`“Jevtana,” with correct interpretation occurring more frequently in the written studies.
`The remaining written responses misinterpreted the drug name. The letter ‘J’ was
`misinterpreted as the letter ‘Z’ or ‘L’, and the letter ‘e’ was misinterpreted as the letters
`‘i’ and ‘u.’ In the verbal studies, most of the responses were misspelled phonetic
`variations of the proposed name.
`See Appendix C for the complete listing of interpretations from the verbal and written
`prescription studies.
`
`3.4 EXTERNAL STUDY
`The proprietary name risk assessment submitted by the Sanofi Aventis found the
`proposed proprietary name acceptable.
` identified and evaluated eighteen drug names
`with some potential for confusion with the name Jevtana: Fentanyl, Januvia, Jantoven,
`Jevity, Extina, Ben-Tann, Daytrana, Detane, Femara, J-Tann, Je-vax, Metanx, Pentasa,
`Revina, Enjuvia, Opana, Simvastatin, and Ziana. Of the names identified by
` five
`were also identified by DMEPA during the database searches: Januvia, Jantoven, Jevity,
`Extina, and Fentanyl. The remaining 13 names were added to the safety evaluator
`assessment. It was noted in the evaluation of the
` study that
` considered the
`Jevtana vial concentration as 60 mg/15 mL in their evaluation; however Jevtana is
`available as 60 mg/1.5 mL. DMEPA considered this inconsistency when evaluating the
`names identified by
`
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`3.5 SAFETY EVALUATOR RISK ASSESSMENT
`Independent searches by the primary Safety Evaluator resulted in identification of sixteen
`additional names which were thought to look or sound similar to Jevtana represent a
`potential source of drug name confusion. The names identified to have look-alike
`similarities are
` Fenobam, Fentanyl, Genatopn, Fertinex, Geritonic, Fareston,
`Fortaz, Fortamet,
` Feraheme, Fostimon***,
` Gantanol, Gentian, and
`Genelan.
`One name “Jevtana” was not evaluated further since it was identified on the U.S. Patent
`and Trademark Office website registered to the Applicant likely for this product. Thus,
`we evaluated a total of fifty names: 16 identified by the primary safety evaluator, 13
`identified by
` and 21 identified in section 3.1 above.
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`*** This is proprietary and confidential information that should not be released to the public.
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`3.6 COMMENTS FROM THE DIVISION OF DRUG ONCOLOGY PRODUCTS (DDOP)
`
`3.6.1 Initial Phase of Review
`In response to the OSE, April 12, 2010 e-mail, Division of Drug Oncology Products
`(DDOP) did not forward any concerns on the proposed name at the initial phase of the
`name review.
`
`3.6.2 Midpoint of Review
`DMEPA notified the Division of Drug Oncology Products via e-mail that we had no
`concerns with the proposed proprietary name, Jevtana, on April 28, 2010. Per e-mail
`correspondence from the Division of Drug Oncology Products on May 05, 2010, they
`indicated the Division had no other issues with the proposed proprietary name, Jevtana.
`
`4. DISCUSSION
`Jevtana is the proposed proprietary name for Cabazitaxel Injection. This proposed name
`was evaluated from a safety and promotional perspective based on the product
`characteristics provided by the Sanofi Aventis. We sought input from pertinent
`disciplines involved with the review of this application and considered it accordingly.
`
`4.1 PROMOTIONAL ASSESSMENT
`DDMAC found the proposed proprietary name acceptable from a promotional
`perspective, and did not offer any additional comments relating to the proposed name.
`DMEPA and the Division of Drug Oncology Products concurred with the findings of
`DDMAC’s promotional assessment of the proposed name.
`
`4.2 SAFETY ASSESSMENT
`Fifty names were identified as having potential similarity to the proposed proprietary
`name, Jevtana. No other aspects of the name were considered to pose potential confusion
`with the name. Fifteen of the fifty names did not undergo failure mode and effect analysis
`(FMEA) for the following reasons: Four names lacked convincing orthographic and/or
`phonetic similarity to the proposed proprietary name Jevtana (see Appendix D), eleven
`other names did not undergo failure mode and effect analysis (FMEA) because they were
`either herbal products or supplements not dispensed pursuant to a prescription, products
`discontinued or not marketed in the U.S, proposed proprietary names for products later
`approved under a different proprietary name or withdrawn (see Appendices E, F, and G).
`Failure modes and effects analysis (FMEA) was applied to determine if the proposed
`proprietary name could potentially be confused with the remaining 35 names and lead to
`medication errors. This analysis determined that the name similarity between Jevtana
`and all of the identified names was unlikely to result in medication error for the reasons
`presented in Appendices H and I.
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`5. CONCLUSIONS AND RECOMMENDATIONS
`The Proprietary Name Risk Assessment findings indicate that the proposed name,
`Jevtana, is not vulnerable to name confusion that could lead to medication errors, nor is it
`considered promotional. Thus, the Division of Medication Error Prevention and Analysis
`(DMEPA) has no objection to the proprietary name, Jevtana, for this product at this time.
`Our analysis is consistent with the external risk assessment conducted by
` that was
`provided by the Applicant. The Applicant will be notified via letter.
`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.
`If you have further questions or need clarifications, please contact Sarah Simon, project
`manager, at 301-796-5205.
`
`6. COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Jevtana, and have
`concluded that it is acceptable.
`Jevtana 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.
`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.
`7. REFERENCES
`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
`3.
`(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.
`
`FDA Document Archiving, Reporting & Regulatory Tracking System [DARRTS]
`4.
`DARRTS is a government database used to organize Applicant and Applicant
`submissions as well as to store and organize assignments, reviews, and communications
`from the review divisions.
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`Division of Medication Errors Prevention and Analysis proprietary name consultation
`5.
`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.
`
`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
`7.
`(http://www.fda.gov/cder/ob/default.htm)
`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.
`
`Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available
`10.
`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/about-ama/our-
`13.
`people/coalitions-consortiums/united-states-adopted-names-council/naming-
`guidelines/approved-stems.shtml)
`USAN Stems List contains all the recognized USAN stems.
`
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`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 search 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.
`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
`
`3 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`4 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
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`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 one.
`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
`(see Table 1 below for details). 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. If provided, DMEPA will consider the
`Applicant’s intended pronunciation of the proprietary name. However, DMEPA also considers a
`variety of pronunciations that could occur in the English language because the Applicant has little
`control over how the name will be spoken in clinical practice.
`
`
`
`Table 1. Criteria used to identify drug names that look- or sound-similar to a proposed
`proprietary name.
`
`Type of
`similarity
`
`Potential causes
`of drug name
`
`Considerations when searching the databases
`Attributes examined to identify
`Potential Effects
`similar drug names
`
`
`5 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
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`Look-
`alike
`
`similarity
`Similar spelling
`
`
`Orthographic
`similarity
`
`Sound-
`alike
`
`Phonetic
`similarity
`
`
`Identical prefix
`Identical infix
`Identical suffix
`Length of the name
`Overlapping product
`characteristics
`
`Similar spelling
`Length of the name
`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
`
`• 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
`
`• Names may sound similar when
`pronounced and lead to drug name
`confusion in verbal communication
`
`
`Lastly, the DMEPA staff also 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 safety of the proposed proprietary name or product based on professional
`experience with medication errors.
`
`1. Database and Information Sources
`DMEPA staff conducts searches of 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 using the criteria outlined in Section 2.1.
`Section 6 provides a standard description of the databases used in the searches. To complement
`the process, the DMEPA staff use 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
`
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`that have some similarity (phonetic, orthographic, or both) to the trademark being evaluated.
`Lastly, the DMEPA staff review the USAN stem list to determine if any USAN stems are present
`within the proprietary name. The individual findings of multiple safety evaluators are pooled and
`presented to the CDER Expert Panel.
`
`2. CDER Expert Panel Discussion
`DMEPA conducts an Expert Panel Discussion to gather CDER professional opinions on the
`safety of the proposed product and the proposed proprietary name. The Expert Panel is composed
`of Division of Medication Errors Prevention (DMEPA) staff and representatives from the
`Division of Drug Marketing, Advertising, and Communications (DDMAC). The Expert Panel
`also discusses potential concerns regarding drug marketing and promotion related to the proposed
`names.
`The primary Safety Evaluator presents the pooled results of the DMEPA staff to the Expert Panel
`for consideration. Based on the clinical and professional experiences of the Expert Panel
`members, the Panel may recommend the addition of names, additional searches by the primary
`Safety Evaluator to supplement the pooled results, or general advice to consider when reviewing
`the proposed proprietary name.
`
`3. FDA Prescription Analysis Studies
`Three separate studies are conducted within the Centers of the FDA for the proposed proprietary
`name to determine the degree of confusion of the proposed proprietary name with marketed U.S.
`drug names (proprietary and established) due to similarity in visual appearance with handwritten
`pre