CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`0201280Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
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`

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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
`Office of Medication Error Prevention and Risk Management
`
`
`Proprietary Name Review--Final
`
`Date:
`
`
`
`January 30, 2012
`
` Yelena Maslov, Pharm.D., Safety Evaluator
`Reviewer:
`Division of Medication Error Prevention and Analysis
`
`
`Irene Chan, Pharm.D., BCPS, Team Leader
`
`Team Leader
`Division of Medication Error Prevention and Analysis
`
`
`Carol Holquist, R.Ph., Director
`
`Division Director
`Division of Medication Error Prevention and Analysis
`
`
` Korlym (Mifepristone) Tablets, 300 mg
`Drug Name and Strength:
`
`NDA 202107
`Application Type/Number:
`
`Corcept Therapeutics, Inc.
`Applicant/sponsor:
`
`2011-4120
`OSE RCM #:
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
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`1
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`Reference ID: 3079678
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`

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`
`
`CONTENTS
`1 INTRODUCTION........................................................................................................................................... 3
`2 METHODS AND DISCUSSION.................................................................................................................. 3
`3 CONCLUSIONS........................................................................................................................................... 3
`4 REFERENCES.............................................................................................................................................. 4
`
`Reference ID: 3079678
`
`
`2
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`

`

`
`
`1 INTRODUCTION
`This re-assessment of the proposed proprietary name, Korlym, 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,
`Korlym, acceptable in OSE Review RCM #2011-2647 dated October 20, 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 RCM #2011-2647. 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
`Korlym 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
`Korlym 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 January 4, 2012. The Office of
`Prescription Drug Promotion (OPDP) re-reviewed the proposed name on December 1, 2011 and had
`no concerns regarding the proposed name from a promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Korlym, 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, Korlym, 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 Metabolism and Endocrinology Products (DMEP) 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 Ermias Zerislassie, OSE project
`manager, at 301-796-0097.
`
`
`
`*** This document contains proprietary information that should not be released to the public
`
`
`Reference ID: 3079678
`
`
`3
`
`(b) (4)
`
`(b) (4)
`
`

`

`
`
`4 REFERENCES
`Maslov, Yelena. Proprietary Name Review for Korlym, OSE Review #2011-2647
`1.
`
`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: 3079678
`
`
`4
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`

`

`Appendix A: Proprietary names not likely to be confused or not used in usual practice settings for
`the reasons described.
`
`Proprietary
`Name
`
`Active Ingredient
`
`(hm)
`
`Ezo ' abine.
`
`Similarity
`to Korlym
`
`Looks alike
`
`Failure Preventions
`
`The product was approved on
`June 10, 2011 under the proprietary
`name, Potiga. Additionally, the
`established name was also changed to
`
`m This document contains proprietary information that should not be released to the public
`
`Reference ID: 3079678
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`YELENA L MASLOV
`01/30/2012
`
`IRENE Z CHAN
`01/30/2012
`
`CAROL A HOLQUIST
`02/02/2012
`
`Reference ID: 3079678
`
`

`

`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:
`
`October 19, 2011
`
`Yelena Maslov, Pharm.D., Safety Evaluator
`Reviewer:
`Division of Medication Error Prevention and Analysis
`
`Zachary Oleszczuk, Pharm.D., Team Leader
`Team Leader
`Division of Medication Error Prevention and Analysis
`
`Carol Holquist, R.Ph., Director
`Division Director
`Division of Medication Error Prevention and Analysis
`
`Korlym (Mifepristone) Tablets, 300 mg
`Drug Name and Strength:
`Application Type/Number: NDA 202107
`Applicant/sponsor:
`Corcept Therapeutics, Inc.
`OSE RCM #:
`2011-2647
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3031519
`
`

`

`CONTENTS
`
`1
`
`2
`
`INTRODUCTION .................................................................................................................. 3
`1.1
`Regulatory History......................................................................................................... 3
`1.2
`Product Information ....................................................................................................... 3
`RESULTS............................................................................................................................... 3
`2.1
`Promotional Assessment................................................................................................ 3
`2.2
`Safety Assessment.......................................................................................................... 3
`CONCLUSIONS .................................................................................................................... 6
`3.1
`Comments to the Applicant............................................................................................ 6
`REFERENCES ....................................................................................................................... 7
`4
`APPENDICES................................................................................................................................. 9
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`3
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`Reference ID: 3031519
`
`2
`
`

`

`1
`
`INTRODUCTION
`
`This review evaluates the proposed proprietary name, Korlym, 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. The proposed product
`characteristics are provided in Section 1.2.
`
`1.1
`
`REGULATORY HISTORY
`
`This review responds to a request from Corcept Therapeutcis, dated July 28, 2011, for an
`assessment of the proposed proprietary name, Korlym, regarding potential name
`confusion with other proprietary or established drug names in the usual practice setting.
`The name, Korlym, is the third proposed proprietary name for Mifepristone Tablets,
`300 mg. The first proposed proprietary name, Corlux, was found unacceptable by
`DMEPA in OSE Review #2010—1719, dated December 28, 2010, while the product was
`in IND stage of development (IND 076480). The name was found unacceptable due to
`vulnerability to name confusion with Cortef and Avelox, based on ortho
`phic
`
`similarities and shared product characteristics. The second nameifwas found
`
`table b DMEPA in OSE Review #2011-1353, dated Jul 14, 2011.
`
`
`unacc
`
`1.2
`
`PRODUCT INFORMATION
`
`Korlym (Mifepristone) Tablets is a cortisol receptor blocking agent indicated to treat the
`clinical and metabolic effects of hypercortisolism in patients with endogenous Cushing’s
`syndrome. The recommended dose of Korlym is 300 mg to 1200 mg (1-4 tablets)
`administered orally once daily. It will be available in a sin e siren
`of 300
`acka ed in bottles of 28 and 280 counts.
`
`
`
`
`
`2 RESULTS
`
`The following sections provide the information obtained and considered in the evaluation
`of the proposed proprietary name.
`
`2.1
`
`PROMOTIONAL ASSESSMENT
`
`DDMAC determined the proposed name is acceptable from a promotional perspective.
`DMEPA and the Division of Metabolism and Endocrinology Products (DMEP)
`concurred with the findings of DDMAC’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
`
`The United States Adopted Name (USAN) stem search conducted on August 16, 2011,
`identified that a USAN stem is not present in the proposed proprietary name.
`
`Reference ID: 3031519
`
`

`

`2.2.2 Components of the Proposed Proprietary Name
`The proposed name is a single word that does not contain any components (i.e., modifier,
`dosage form, frequency, indications, etc.) that can contribute to medication error.
`
`2.2.3 FDA Name Simulation Studies
`Forty practitioners participated in DMEPA’s prescription studies. Twenty-three
`practitioners interpreted the proposed name, ‘Korlym’ correctly with correct
`interpretations occurring with inpatient (n=10) and outpatient (n=13) prescription studies.
`The remaining seventeen practitioners misinterpreted the name. The most common
`misinterpretation occurred with the 14 voice study participants misinterpreting the letter
`‘K’ as the letter ‘C’. See Appendix C for the complete listings of interpretations from the
`verbal and written prescription studies.
`
`2.2.4 Comments from Other Review Disciplines
`In response to the OSE email, dated August 11, 2011, DMEP did not forward any
`comments or concerns relating to the proposed name at the initial phase of the name
`review.
`
`2.2.5 Failure Mode and Effects Analysis of Similar Names
`Table 1 (page 5) lists the names with orthographic, phonetic, or spelling similarity to the
`proposed proprietary name, Korlym. These names were identified by the primary
`reviewer and the Expert Panel Discussion (EPD), and other disciplines. Table 1 (next
`page) also included the names identified by external name study conducted by the Drug
`Safety Institute, Inc. (DSI) that were not previously identified by DMEPA and require
`further evaluation.
`
`
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`Reference ID: 3031519
`
`4
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`

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`Table l: Collective List of Potentially Similar Names (DMEPA, EPD, other disciplines, and
`D81)
`
`Look Similar
`
`Sound Similar
`
`Look and Sound Similar
`
`
`
`
`
`
`
`
`
`
`
`
`m—
`
`Kinevac
`
`Orlaam
`
`DSI
`
`D81 and EPD
`Keralyt
`
`
`Kerlix
`D81
`
`Kerlon
`D81 and EPD
`
`Kons l
`D81 and EPD
`
`
`(Ia)
`
`
`EPD
`Crolom
`EPD
`
`
`
`
`EPD
`Corluxu-
`Cotrim
`
`
`
`
`EPD
`
`
`
`
`
`
`
`
`
`
`
`
`(b)
`
`Our analysis of the thirty-one names contained in Table 1 considered the information
`obtained in the previous sections along with the product characteristics for the names. We
`determined that all thirty-one names will not pose a risk for confusion as described in
`Appendices D and E.
`
`DMEPA communicated these findings to the Division of Metabolism and Endocrinology
`Products (DMEP) via e-mail on September 2, 2011. At that time we also requested
`additional information or concerns that could inform our review. Per e-mail
`
`correspondence from the Division of Metabolism and Endocrinology Products (DMEP)
`on September 14, 2011, stated they have no additional concerns with the proposed
`proprietary name, Korlym.
`
`333
`
`This document contains proprietary information that should not be released to the public
`
`Reference ID: 3031519
`
`

`

`3 CONCLUSIONS
`DMEPA concludes the proposed proprietary name, Korlym, is acceptable from both a
`promotional and safety perspective. The Applicant will be notified of this finding via
`letter.
`
`3.1
`COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Korlym and have
`concluded that it is acceptable.
`The proposed proprietary name, Korlym, must be re-reviewed 90 days prior to 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 your submission, dated
`July 28, 2011, are altered prior to approval of marketing application, DMEPA rescinds
`this finding and the name must be resubmitted for review. The conclusions upon re-
`review are subject to change.
`
`
`
`Reference ID: 3031519
`
`6
`
`

`

`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.
`
`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. 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.
`
`
`
`Reference ID: 3031519
`
`7
`
`

`

`8. U.S. Patent and Trademark Office (http://www.uspto.gov)
`USPTO provides information regarding patent and trademarks.
`
`9. 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.
`
`10. Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available at
`(www.thomson-thomson.com)
`The Pharma In-Use Search database contains over 400,000 unique pharmaceutical
`trademarks and trade names that are used in about 50 countries worldwide. The data
`is provided under license by IMS HEALTH.
`
`11. 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.
`
`12. 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.
`
`13. 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.
`
`14. Red Book Pharmacy’s Fundamental Reference
`Red Book contains prices and product information for prescription, over-the-counter
`drugs, medical devices, and accessories.
`
`15. Lexi-Comp (www.lexi.com)
`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.
`
`
`
`
`
`
`Reference ID: 3031519
`
`8
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`

`

`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 DDMAC. DDMAC 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. DDMAC 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
`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.
`
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`
`
`Reference ID: 3031519
`
`9
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`

`

`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
`
`Similar spelling
`
`
`Attributes Examined to Identify
`Similar Drug Names
`
`Potential Effects
`
`Identical prefix
`Identical infix
`Identical suffix
`
`• Names may appear similar
`in print or electronic media
`and lead to drug name
`
`
`2 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
`
`
`
`Reference ID: 3031519
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`10
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`

`

`
`
`
`Look-
`alike
`
`Length of the name
`Overlapping product
`characteristics
`
`Orthographic
`similarity
`
`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
`safety of the proposed proprietary name or product based on professional experience with
`medication errors.
`
`Sound-
`alike
`
`Phonetic
`similarity
`
`
`• Names may sound similar
`when pronounced and lead
`to drug name confusion in
`verbal communication
`
`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
`
`
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`Reference ID: 3031519
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`trademark being evaluated. Lastly, DMEPA reviews 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. DMEPA
`also evaluates if there are characteristics included in the composition that may render the
`name unacceptable from a safety perspective (abbreviation, dosing interval, etc.).
`
`2. Expert Panel Discussion
`DMEPA gathers gather CDER professional opinions on the safety of the proposed
`product and discussed the proposed proprietary name (Expert Panel Discussion). 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). We also consider input from other review disciplines
`(OND, ONDQA/OBP). 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 database and information
`searches to the Expert Panel for consideration. Based on the clinical and professional
`experiences of the Expert Panel members, the Panel may recommend additional 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 Simulation 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 prescriptions or verbal pronunciation of the drug name. The
`studies employ healthcare professionals (pharmacists, physicians, and nurses), and
`attempts to simulate the prescription ordering process. The primary Safety Evaluator
`uses the results to identify orthographic or phonetic vulnerability of the proposed name to
`be misinterpreted by healthcare practitioners.
`In order to evaluate the potential for misinterpretation of the proposed proprietary name
`in handwriting and verbal communication of the name, inpatient medication orders and/or
`outpatient prescriptions are written, each consisting of a combination of marketed and
`unapproved drug products, including the proposed name. These orders are optically
`scanned and one prescription is delivered to a random sample of participating health
`professionals via e-mail. In addition, a verbal prescription is recorded on voice mail.
`The voice mail messages are then sent to a random sample of the participating health
`professionals for their interpretations and review. After receiving either the written or
`verbal prescription orders, the participants record their interpretations of the orders which
`are recorded electronically.
`
`4. Comments from Other Review Disciplines
`DMEPA requests the Office of New Drugs (OND) and/or Office of Generic Drugs
`(OGD), ONDQA or OBP for their comments or concerns with the proposed proprietary
`name, ask for any clinical issues that may impact the DMEPA review during the initial
`phase of the name review. Additionally, when applicable, at the same time DMEPA
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`Reference ID: 3031519
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`requests concurrence/non-concurrence with DDMAC’s decision on the name. The
`primary Safety Evaluator addresses any comments or concerns in the safety evaluator’s
`assessment.
`
`The OND/OGD Regulatory Division is contacted a second time following our analysis of
`the proposed proprietary name. At this point, DMEPA conveys their decision to accept
`or reject the name. The OND or OGD Regulatory Division is requested to provide any
`further information that might inform DMEPA’s final decision on the proposed name.
`Additionally, other review disciplines opinions such as ONDQA or OBP may be
`considered depending on the proposed proprietary name.
`
`5. Safety Evaluator Risk Assessment of the Proposed Proprietary Name
`The primary Safety Evaluator applies his/her individual expertise gained from evaluating
`medication errors reported to FDA, considers all aspects of the name that may be
`misleading or confusing, conducts a Failure Mode and Effects Analysis, and provides an
`overall decision on acceptability dependent on their risk assessment of name confusion.
`Failure Mode and Effects Analysis (FMEA) is a systematic tool for evaluating a process
`and identifying where and how it might fail.3 When applying FMEA to assess the risk of
`a proposed proprietary