CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`202343Orig1s000
`
`
`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
`Office of Medication Error Prevention and Risk Management
`
`Proprietary Name Review
`
`Date:
`
`September 26, 2011
`
`Anne Tobenkin, PharmD
`Division of Medication Error Prevention and Analysis
`Lubna Merchant, PharmD, M.S.
`Division of Medication Error Prevention and Analysis
`Carol Holquist, RPh.
`Division of Medication Error Prevention and Analysis
`Juvisync (Sitagliptin and Simvastatin) Tablets
`
`Reviewer(s):
`
`Team Leader
`
`Division Director
`
`Drug Name(s):
`
`Strengths: 100 mg/10 mg, 100 mg/20 mg, 100 mg/40 mg
`Application Type/Number: NDA 202343
`Applicant/sponsor:
`Merck
`OSE RCM #:
`2011-3271
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
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`Reference ID: 3020088
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`CONTENTS
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`1
`
`INTRODUCTION................................................................................................................... 1
`1.1
`Regulatory History......................................................................................................... 1
`1.2
`Product Information ....................................................................................................... 1
`2 RESULTS................................................................................................................................ 1
`2.1
`Promotional Assessment................................................................................................ 1
`2.2
`Safety Assessment.......................................................................................................... 1
`3 CONCLUSIONS ..................................................................................................................... 3
`3.1
`Comments to the Applicant............................................................................................ 3
`4 REFERENCES........................................................................................................................ 4
`APPENDICES................................................................................................................................. 6
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`Reference ID: 3020088
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`1
`
`INTRODUCTION
`
`This review evaluates the proposed proprietary name, Juvisync, 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 Applicant, Merck, submitted the proprietary name request for Juvisync Tablets on
`September 2, 2011. The Applicant had submitted two names previously,
`M”
`which was found unacceptable in OSE review # 2011-2427 and
`00(4) which was
`withdrawn by the Applicant on September 2, 2011.
`
`Additionally, a label and labeling review (OSE review # 2011-300) was also completed
`on June 20, 2011. The label and labeling recommendations were sent to the Applicant.
`
`1.2
`
`PRODUCT INFORMATION
`
`Juvisync is a combination product which contains Sitagliptin and Simvastatin. Juvisync is
`indicated for glycemic control in the setting of Type 1 diabetes and to decrease
`cholesterol. The proposed strengths of Juvisync include; 100 mg/ 10 mg, 100 mg/20 mg,
`and 100 mg/40 mg tablets. The recommended dose and frequency of Juvisync is one
`tablet by mouth once daily. Juvisync will be available in physician samples and bottles of
`30, 90 and 1000 tablets and can be stored at room temperature.
`
`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 Metabolic and Endocrinology Products 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 September 9, 2011 United States Adopted Name (USAN) stem search identified that
`a USAN stem is not present in the proposed proprietary name.
`
`2.2.2 Components ofthe Proposed Proprietary Name
`
`Per the Applicant and DMEPA’s evaluation of the proprietary name, Juvisync, is a
`coined term that has no intrinsic meaning. This proprietary name is comprised of a single
`word that does not contain any components (i.e. a modifier, route of administration,
`dosage form, etc) that can contribute to medication error or render the name
`unacceptable.
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`Reference ID: 3020088
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`2.2.3 FDA Name Simulation Studies
`
`Twenty nine practitioners participated in DIVIEPA’s prescription studies. The most
`common misinterpretation in the written study was with the first letter ‘J’ for ‘T’ and ‘L’.
`The most common misinterpretations in the voice study was confusion with vowels ‘i’
`for ‘a’, ‘e’, and ‘o’ and ‘y’ for ‘i’. See Appendix C for the complete listing of
`interpretations from the verbal and written prescription studies.
`
`2.2.4 Comments fiam Other Review Disciplines
`
`In response to the OSE, September 14, 2011 e-mail, the Division of Metabolic and
`Endocrinology Products (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 ofSimilar Names
`
`Appendix B lists possible orthographic and phonetic misinterpretations of the letters
`appearing in the proposed name, Juvisync. Table 1 lists the names with orthographic,
`phonetic, or spelling similarity to the proposed proprietary name, Juvisync identified by
`the primary reviewer (PR), the Expert Panel Discussion (EPD), other review disciplines.
`
`Table l: Collective List of Potentially Similar Names (DMEPA, EPD and Other Disciplines)
`
`Sound Similar
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`Look and Sound Similar
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`Look Similar
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`Reference ID: 3020088
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`Our analysis of the twenty two names contained in Table 1 considered the information
`obtained in the previous sections along with their product characteristics. We determined
`the 22 names will not pose a risk for confusion as described in Appendix D through E.
`
`DMEPA communicated these findings to the Division of Metabolic and Endocrinology
`Products @MEP) via e—mail on September 16, 2011. At that time we also requested
`additional information or concerns that could inform our review. Per e-mail
`
`correspondence from the DMEP on September 19, 2011 they stated no additional
`concerns with the proposed proprietary name, Juvisync.
`
`3 CONCLUSIONS
`
`DMEPA concludes the proposed proprietary name, Juvisync, is acceptable from both a
`promotional and safety perspective. However, 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.
`
`Ifyou have fluther questions or need clarifications, please contact Margarita Tossa, OSE
`Project Manager, at 301-796-4053.
`
`3.1
`
`COMMENTS T0 TI-[E APPLICANT
`
`We have completed our review of the proposed proprietary name, Juvisync, and have
`concluded that this name is acceptable.
`
`If any of the proposed product characteristics as stated in your September 09, 2011,
`submission are altered prior to approval of the marketing application, the proprietary
`name should be resubmitted for review.
`
`Reference ID: 3020088
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`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.
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`Reference ID: 3020088
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`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: 3020088
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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
`
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
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`Reference ID: 3020088
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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).
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`2 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
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`Reference ID: 3020088
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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
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`Reference ID: 3020088
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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 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
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`Reference ID: 3020088
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`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
`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 name, DMEPA seeks to evaluate the potential for a proposed
`proprietary name to be confused with another drug name because of name confusion and,
`thereby, cause errors to occur in the medication use system. FMEA capitalizes on the
`predictable and preventable nature of medication errors associated with drug name
`confusion. FMEA allows the Agency to identify the potential for medication errors due
`to orthographically or phonetically similar drug names prior to approval, where actions to
`overcome these issues are easier and more effective than remedies available in the post-
`approval phase.
`In order to perform an FMEA of the proposed name, the primary Safety Evaluator must
`analyze the use of the product at all points in the medication use system. Because the
`proposed product is has not been marketed, the primary Safety Evaluator anticipates the
`use of the product in the usual practice settings by considering the clinical and product
`
`
`3 Institute for Healthcare Improvement (IHI). Failure Mode and Effects Analysis. Boston. IHI:2004.
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`Reference ID: 3020088
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`characteristics listed in Appendix B1 of this review. The Safety Evaluator then analyzes
`the proposed proprietary name in the context of the usual practice setting and works to
`identify potential failure modes and the effects associated with the failure modes.
`In the initial stage of the Risk Assessment, the Safety Evaluator compares the proposed
`proprietary name to all of the names gathered from the above searches, Expert Panel
`Discussion, and prescription studies, external studies, and identifies potential failure
`modes by asking:
`“Is the proposed proprietary name convincingly similar to another drug name,
`which may cause practitioners to become confused at any point in the usual
`practice setting? And Are there any components of the name that may function
`as a source of error beyond sound/look-alike”
`An affirmative answer indicates a failure mode and represents a potential for the
`proposed proprietary name to be confused with another proprietary or established drug
`name because of look- or sound-alike similarity or because of some other component of
`the name. If the answer to the question is no, the Safety Evaluator is not convinced that
`the names posses similarity that would cause confusion at any point in the medication use
`system, thus the name is eliminated from further review.
`In the second stage of the Risk Assessment, the primary Safety Evaluator evaluates all
`potential failure modes to determine the likely effect of the drug name confusion, by
`asking:
`“Could the confusion of the drug names conceivably result in medication errors
`in the usual practice setting?”
`The answer to this question is a central component of the Safety Evaluator’s overall risk
`assessment of the proprietary name. If the Safety Evaluator determines through FMEA
`that the name similarity would not ultimately be a source of medication errors in the
`usual practice setting, the primary Safety Evaluator eliminates the name from further
`analysis. However, if the Safety Evaluator determines through FMEA that the name
`similarity could ultimately cause medication errors in the usual practice setting, the
`Safety Evaluator will then recommend the use of an alternate proprietary name.
`Moreover, DMEPA will object to the use of proposed proprietary name when the primary
`Safety Evaluator identifies one or more of the following conditions in the Overall Risk
`Assessment:
`a. DDMAC finds the proposed proprietary name misleading from a promotional
`perspective, and the Review Division concurs with DDMAC’s findings. The Federal
`Food, Drug, and Cosmetic Act provides that labeling or advertising can misbrand a
`product if misleading representations are made or suggested by statement, word,
`design, device, or any combination thereof, whether through a PROPRIETARY
`name or otherwise [21 U.S.C 321(n); See also 21 U.S.C. 352(a) & (n)].
`b. DMEPA identifies that the proposed proprietary name is misleading because of
`similarity in spelling or pronunciation to another proprietary or established name of a
`different drug or ingredient [CFR 201.10.(C)(5)].
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`Reference ID: 3020088
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`c. FMEA identifies the potential for confusion between the proposed proprietary name
`and other proprietary or established drug name(s), and demonstrates that medication
`errors are likely to result from the drug name confusion under the conditions of usual
`clinical practice.
`d. The proposed proprietary name contains an USAN (United States Adopted Names)
`stem.
`e. DMEPA identifies a potential source of medication error within the proposed
`proprietary name. For example, the proprietary name may be misleading or,
`inadvertently, introduce ambiguity and confusion that leads to errors. Such errors
`may not necessarily involve confusion between the proposed drug and another drug
`product but involve a naming characteristic that when incorporated into a proprietary
`name, may be confusing, misleading, cause or contribute to medication errors.
`If DMEPA objects to a proposed proprietary name on the basis that drug name confusion
`could lead to medication errors, the primary Safety Evaluator uses the FMEA process to
`identify strategies to reduce the risk of medication errors. DMEPA generally
`recommends that the Sponsor select an alternative proprietary name and submit the
`alternate name to the Agency for review. However, in rare instances FMEA may identify
`plausible strategies that could reduce the risk of medication error of the currently
`proposed name. In that instance, DMEPA may be able to provide the Sponsor with
`recommendations that reduce or eliminate the potential for error and, thereby, would
`render the proposed name acceptable.
`In the event that DMEPA objects to the use of the proposed proprietary name, based upon
`the potential for confusion with another proposed (but not yet approved) proprietary
`name, DMEPA will provide a contingency objection based on the date of approval.
`Whichever product, the Agency approves first has the right to use the proprietary name,
`while DMEPA will recommend that the second product to reach approval seek an
`alternative name.
`The threshold set for objection to the proposed proprietary name may seem low to the
`Applicant/Sponsor. However, the safety concerns set forth in criteria a through e above
`are supported either by FDA regulation or by external healthcare authorities, including
`the Institute of Medicine (IOM), World Health Organization (WHO), the Joint
`Commission, and the Institute for Safe Medication Practices (ISMP). These
`organizations have examined medication errors resulting from look- or sound-alike drug
`names, confusing, or misleading names and called for regulatory authorities to address
`the issue prior to approval. Additionally, DMEPA contends that the threshold set for the
`Proprietary Name Risk Assessment is reasonable because proprietary drug name
`confusion is a predictable and preventable source of medication error that, in many
`instances, the Agency and/or Sponsor can identify and rectify prior to approval to avoid
`patient harm.
`Furthermore, post-marketing experience has demonstrated that medication errors
`resulting from drug n