CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`203752Orig1s000
`
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
`
`Date:
`
`Reviewer(s):
`
`Team Leader
`
`
`
`
`
`
`
`
`
`
`
`
`Proprietary Name Review
`
`August 7, 2012
`
`Walter Fava, RPh, MSEd., Safety Evaluator
`Division of Medication Error Prevention and
`Analysis
`Zachary Oleszczuk, Pharm D., Team Leader
`Division of Medication Error Prevention and
`Analysis
`
`
`Deputy Director
`
`
`Division Director
`
`
`
`
`
`
`
`
`
`Kellie Taylor, PharmD, MS, Deputy Director
`Division of Medication Error Prevention and
`Analysis
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention and
`Analysis
`Minivelle (Estradiol) Transdermal System
`Drug Name(s) and Strength(s):
`, 0.0375 mg, 0.05 mg, 0.075 mg, 0.1 mg
`
`
`
`
`
`NDA 203752
`Application Type/Number:
`
`Noven Pharmaceuticals
`Applicant/Sponsor:
`
`2012-1147
`OSE RCM #:
`
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
`
`
`
`DRAFT - Last updated 7/18/11
`Reference ID: 3171044
`
`
`(b) (4)
`
`

`

`
`
`CONTENTS
`
`1
`
`INTRODUCTION................................................................................................................... 1
`1.1
`Regulatory History......................................................................................................... 1
`1.2
`Product Information ....................................................................................................... 1
`2. RESULTS................................................................................................................................ 1
`2.2
`Safety Assessment.......................................................................................................... 1
`3 CONCLUSIONS ..................................................................................................................... 4
`3.1
`Comments to the Applicant............................................................................................ 4
`4 REFERENCES........................................................................................................................ 5
`APPENDICES................................................................................................................................. 8
`
`
`
`
`
`DRAFT - Last updated 7/18/11
`Reference ID: 3171044
`
`
`

`

`1
`
`INTRODUCTION
`
`This review evaluates the proposed proprietary name, Minivelle, 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 originally submitted the proposed name,
`and notified the Applicant in a letter dated, April 5, 2012.
`
`("M which DMEPA denied
`
`1.2
`
`PRODUCT INFORMATION
`
`The following product information is provided in the May 11, 2012 proprietary name
`submission.
`
`0 Active Ingredient: Estradiol
`
`0
`
`Indication of Use: Moderate to severe vasomotor symptoms due to menapause
`
`0 Route of administration: Topical
`
`0 Dosage form: Transdermal Delivery System
`
`.
`
`Strength:
`
`"'"" 0.0375 mg, 0.05 mg, 0.075 mg, 0.1 mg
`
`0 Dose: One patch applied twice a week
`
`0 How Supplied and Container/Closure Sytem: Carton containing 8 individually
`pouch sealed transdermal systems
`
`0
`
`Storage: Room temperature 20°C - 25°C (68°F - 77°F); excursions permitted
`between 15°C and 30°C (59°F and 86°F).
`
`2.
`
`RESULTS
`
`The following sections provide the information obtained and considered in the overall
`evaluation of the proposed proprietary name.
`
`2.1
`
`PROMOTIONAL ASSESSMENT
`
`OPDP determined the proposed name is acceptable from a promotional perspective.
`DMEPA and the Division of Reproductive and Urologic Products concurred with the
`findings of OPDP’S promotional assessment of the proposed name.
`
`2.2
`
`SAFETY ASSESSMENT
`
`The following aspects of the name were considered in the safety evaluation of the
`proposed name.
`
`2.2.1 United States Adopted Names (USAN) SEARCH
`
`On June 29, 2012 the United States Adopted Name (USAN) stem search, identified that a
`USAN stem is not present in the proposed proprietary name.
`
`Reference ID: 3171044
`
`1
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`

`

`
`
`2.2.2 Components of the Proposed Proprietary Name
`This proprietary name is comprised of a single word that contains the letter string, ‘Mini’
`which makes reference to the size of the transdermal system relative to other similar
`transdermal systems in this therapeutic class which are currently marketed (i.e. Vivelle
`and Vivelle Dot). The name also contains the letter string, ‘velle’, which is used in
`proprietary names for similar products.
`
`2.2.4 FDA Name Simulation Studies
`Thirty-three practitioners participated in DMEPA’s prescription studies. The
`interpretations did or did not overlap with or appear or sound similar to any currently
`marketed products. Ten participants responded correctly. The majority misinterpretations
`stemmed from participants in the outpatient study responding with ‘Minirelle’ (n = 6).
`Other misinterpretations included ‘Minnelle’ (n = 5), ‘Minival’ (n = 4), ‘Mini-Val’ (n=1),
`and ‘Minivalle’ (n=1). DMEPA noted that the incorrect responses, ‘Minival’, ‘Mini-
`Val’, and ‘Minivalle’, are phonetically and orthographically similar to an over the counter
`product, ‘
` and the prescription product, Menaval-20. However, both
`
`and Menaval-20 were already identified by DMEPA and despite the phonetic and
`orthographic similarity, were found to have differentiating product characteristics which
`will minimize the chance of confusion that could lead to medication errors. See
`Appendix C for the complete listing of interpretations from the verbal and written
`prescription studies.
`
`2.2.5 Comments from Other Review Disciplines
`In response to the OSE, May 30, 2012 e-mail, the Division of Reproductive and Urologic
`Products (DRUP) did not forward any comments or concerns relating to the proposed
`name at the initial phase of the proprietary name review.
`
`2.2.6 Failure Mode and Effects Analysis of Similar Names
`Appendix B lists possible orthographic and phonetic misinterpretations of the letters
`appearing in the proposed proprietary name, Minivelle. Table 1 lists the names with
`orthographic, phonetic, or spelling similarity to the proposed proprietary name, Minivelle
`identified by the primary reviewer, the Expert Panel Discussion (EPD), and other review
`disciplines.
`
`Reference ID: 3171044
`
`
`2
`
`(b) (4)
`
`(b) (4)
`
`

`

`Table l: Collective List of Potentially Similar Names
`
`Lunelle
`
`FDA
`
`FDA
`
`Mircette
`
`'
`
`e Dot
`
`Bravelle
`
`Activella
`
`Nicorette
`FDA
`Nordette
`DAMD M
`
`
`
`
`FDA M FDA
`
`FDA
`
`FDA
`
`FDA
`
`Minute-Gel
`
`FDA
`
`Menaval-20
`————m
`
`FDA
`
`Our analysis of the 30 names contained in Table 1 considered the information obtained in
`the previous sections along with their product characteristics. We determined the 30
`names will not pose a risk for confusion as described in Appendix D through E.
`
`2.2. 7 Failure Mode and Efl'ects Analysis ofthe prefn: ‘Mini’
`
`The proposed proprietary name contains the letter string, ‘Mini’. The prefix, ‘Mini’ is
`used in the proprietary names of other marketed drug products such as ‘Minipress’,
`‘Minizide’, and ‘Minitran’.
`In this case, the prefix, ‘Mini’ of the proposed proprietary
`name, ‘Minivelle’, eludes to the comparative smaller size of the patch relative to the other
`transdermal systems currently marketed, Vivelle and Vivelle dot, as illustrated in Table 2
`below.
`
`Reference ID: 3171044
`
`3
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`

`

`Table 2: Estradiol Transdermal System Sizes by Product and Strength
`
`Strength
`
`0.025 mg/day
`
`0.0375 mg/day
`
`0.05 mg/day
`
`0.075 mg/day
`
`0.1 mg/day
`
`Product
`
`Minivelle
`
`Vivelle Dot
`
`Vivelle
`
`"’""
`
`2.5
`
`7.25
`
`:2;
`
`3.75
`
`l 1
`
`Size (cmz)
`
`3.3
`
`5
`
`14.5
`
`4.95
`
`7.5
`
`22
`
`6.6
`
`10
`
`29
`
`Thus, based on the information available to us today, we do not think that this particular
`name would cause errors or is misleading. However, if a smaller patch is developed in
`the future then this name may be misleading because the comparative size reference,
`‘mini’ would no longer be accurate. Although this naming strategy is not cause for
`concern at this time, DMEPA discourages the practice of using comparative language in a
`proprietary name, as it may perpetuate the need to incorporate additional comparative
`size nomenclature in future names to differentiate products as the marketing landscape
`and pharmaceutical technology evolves over time. We previously communicated these
`concerns to the Applicant in a letter dated April 5, 2012, when we notified them of our
`denial of the name, ‘
`(m4) based on its orthographic similarity and overlapping
`product characteristics with
`mar The Applicant agreed with DMEPA’s comments
`and stated they were, ‘ . .. comfortable with your guidance in that regard’.
`
`2.2.8 Communication ofDMEPA ’s Final Decision to Other Disciplines
`
`DMEPA communicated our findings to the Division of Reproductive and Urologic
`Products via e-mail on August 7, 2012. At that time we also requested additional
`information or concerns that could inform our review. Per e-mail correspondence from
`the Division of Reproductive and Urologic Products on August 7, 2012, they stated no
`additional concerns with the proposed proprietary name, Minivelle.
`
`3
`
`CONCLUSIONS
`
`The proposed proprietary name is acceptable from both a promotional and safety
`perspective. The Applicant will be notified of this finding via letter.
`
`The proposed proprietary name, Minivelle, must be re-reviewed upon submission of the
`NDA and 90 days before approval of the NDA.
`
`If you have fiirther questions or need clarifications, please contact Marcus Cato, OSE
`project manager, at 301-796—3903.
`
`3.1 Comrs TO THE APPLICANT
`
`We have completed our review of the proposed proprietary name, Minivelle, and have
`concluded that this name is acceptable. However, if any of the proposed product
`characteristics as stated in your May 11, 2012 submission are altered, DMEPA rescinds
`this finding and the name must be resubmitted for review. Additionally, this proprietary
`name must be re—evaluated 90 days prior to the approval of the application. The
`conclusions upon re-review are subject to change.
`
`Reference ID: 3171044
`
`4
`
`

`

`REFERENCES
`
`
`
`
`
` 4
`
`1. Micromedex Integrated Index (http://csi.micromedex.com)
`Micromedex contains a variety of databases covering pharmacology, therapeutics,
`toxicology and diagnostics.
`
`2. Phonetic and Orthographic Computer Analysis (POCA)
`POCA is a database which was created for the Division of Medication Error
`Prevention and Analysis, FDA. As part of the name similarity assessment, proposed
`names are evaluated via a phonetic/orthographic algorithm. The proposed proprietary
`name is converted into its phonemic representation before it runs through the phonetic
`algorithm. Likewise, an orthographic algorithm exists which operates in a similar
`fashion.
`
`3. Drug Facts and Comparisons, online version, St. Louis, MO
`(http://factsandcomparisons.com )
`Drug Facts and Comparisons is a compendium organized by therapeutic course; it
`contains monographs on prescription and OTC drugs, with charts comparing similar
`products. This database also lists the orphan drugs.
`
`4. FDA Document Archiving, Reporting & Regulatory Tracking System [DARRTS]
`DARRTS is a government database used to organize Applicant and Sponsor
`submissions as well as to store and organize assignments, reviews, and
`communications from the review divisions.
`
`5. Division of Medication Errors Prevention and Analysis proprietary name
`consultation requests
`This is a list of proposed and pending names that is generated by the Division of
`Medication Error Prevention and Analysis from the Access database/tracking system.
`
`6. Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`Drugs@FDA contains most of the drug products approved since 1939. The majority of
`labels, approval letters, reviews, and other information are available for drug products
`approved from 1998 to the present. Drugs@FDA contains official information about FDA
`approved brand name, generic drugs, therapeutic biological products, prescription and over-
`the-counter human drugs and discontinued drugs and “Chemical Type 6” approvals.
`7. U.S. Patent and Trademark Office (http://www.uspto.gov)
`USPTO provides information regarding patent and trademarks.
`
`8. Clinical Pharmacology Online (www.clinicalpharmacology-ip.com)
`Clinical Pharmacology contains full monographs for the most common drugs in
`clinical use, plus mini monographs covering investigational, less common,
`
`Reference ID: 3171044
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`

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`
`
`combination, nutraceutical and nutritional products. It also provides a keyword search
`engine.
`
`9. Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available at
`(www.thomson-thomson.com)
`The Pharma In-Use Search database contains over 400,000 unique pharmaceutical
`trademarks and trade names that are used in about 50 countries worldwide. The data
`is provided under license by IMS HEALTH.
`
`10. Natural Medicines Comprehensive Databases (www.naturaldatabase.com)
`Natural Medicines contains up-to-date clinical data on the natural medicines, herbal
`medicines, and dietary supplements used in the western world.
`
`11. Access Medicine (www.accessmedicine.com )
`Access Medicine® from McGraw-Hill contains full-text information from
`approximately 60 titles; it includes tables and references. Among the titles are:
`Harrison’s Principles of Internal Medicine, Basic & Clinical Pharmacology, and
`Goodman and Gilman’s The Pharmacologic Basis of Therapeutics.
`
`12. USAN Stems (http://www.ama-assn.org/ama/pub/about-ama/our-people/coalitions-
`consortiums/united-states-adopted-names-council/naming-guidelines/approved-
`stems.shtml)
`USAN Stems List contains all the recognized USAN stems.
`
`13. Red Book Pharmacy’s Fundamental Reference
`Red Book contains prices and product information for prescription, over-the-counter
`drugs, medical devices, and accessories.
`
`14. Lexi-Comp (www.lexi.com)
`Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
`
`15. Medical Abbreviations Book
`Medical Abbreviations Book contains commonly used medical abbreviations and
`their definitions.
`
`16. CVS/Pharmacy (www.CVS.com)
`This database contains commonly used over the counter products not usually
`identified in other databases.
`
`17. Walgreens (www.walgreens.com)
`This database contains commonly used over the counter products not usually
`identified in other databases.
`
`Reference ID: 3171044
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`

`
`
`18. Rx List (www.rxlist.com)
`RxList is an online medical resource dedicated to offering detailed and current
`pharmaceutical information on brand and generic drugs.
`
`19. Dogpile (www.dogpile.com)
`Dogpile is a Metasearch engine that searches multiple search engines including
`Google, Yahoo! and Bing, and returns the most relevant results to the search.
`
`
`Reference ID: 3171044
`
`
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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 OPDP. OPDP evaluates proposed proprietary names to determine if they
`are overly fanciful, so as to misleadingly imply unique effectiveness or composition, as
`well as to assess whether they contribute to overstatement of product efficacy,
`minimization of risk, broadening of product indications, or making of unsubstantiated
`superiority claims. OPDP provides their opinion to DMEPA for consideration in the
`overall acceptability of the proposed proprietary name.
`The safety assessment is conducted by DMEPA. DMEPA staff search a standard set of
`databases and information sources to identify names that are similar in pronunciation,
`spelling, and orthographically similar when scripted to the proposed proprietary name.
`Additionally, we consider inclusion of USAN stems or other characteristics that when
`incorporated into a proprietary name may cause or contribute to medication errors (i.e.,
`dosing interval, dosage form/route of administration, medical or product name
`abbreviations, names that include or suggest the composition of the drug product, etc.).
`DMEPA defines a medication error as any preventable event that may cause or lead to
`inappropriate medication use or patient harm while the medication is in the control of the
`health care professional, patient, or consumer. 1
`Following the preliminary screening of the proposed proprietary name, DMEPA gathers
`to discuss their professional opinions on the safety of the proposed proprietary name.
`This meeting is commonly referred to the Center for Drug Evaluation and Research
`(CDER) Expert Panel discussion. DMEPA also considers other aspects of the name that
`may be misleading from a safety perspective. DMEPA staff conducts a prescription
`simulation studies using FDA health care professionals. When provided, DMEPA
`considers external proprietary name studies conducted by or for the Applicant/Sponsor
`and incorporates the findings of these studies into the overall risk assessment.
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name is
`responsible for considering the collective findings, and provides an overall risk
`assessment of the proposed proprietary name. DMEPA bases the overall risk assessment
`on the findings of a Failure Mode and Effects Analysis (FMEA) of the proprietary name
`and misleading nature of the proposed proprietary name with a focus on the avoidance of
`medication errors.
`DMEPA uses the clinical expertise of its staff to anticipate the conditions of the clinical
`setting where the product is likely to be used based on the characteristics of the proposed
`product. DMEPA considers the product characteristics associated with the proposed
`product throughout the risk assessment because the product characteristics of the
`
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 3171044
`
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`

`
`
`proposed may provide a context for communication of the drug name and ultimately
`determine the use of the product in the usual clinical practice setting.
`Typical product characteristics considered when identifying drug names that could
`potentially be confused with the proposed proprietary name include, but are not limited
`to; established name of the proposed product, proposed indication of use, dosage form,
`route of administration, strength, unit of measure, dosage units, recommended dose,
`typical quantity or volume, frequency of administration, product packaging, storage
`conditions, patient population, and prescriber population. DMEPA considers how these
`product characteristics may or may not be present in communicating a product name
`throughout the medication use system. Because drug name confusion can occur at any
`point in the medication use process, DMEPA considers the potential for confusion
`throughout the entire U.S. medication use process, including drug procurement,
`prescribing and ordering, dispensing, administration, and monitoring the impact of the
`medication.2 The product characteristics considered for this review appears in Appendix
`B1 of this review.
`The DMEPA considers the spelling of the name, pronunciation of the name when spoken, and
`appearance of the name when scripted. DMEPA compares the proposed proprietary name
`with the proprietary and established name of existing and proposed drug products and names
`currently under review at the FDA. DMEPA compares the pronunciation of the proposed
`proprietary name with the pronunciation of other drug names because verbal communication
`of medication names is common in clinical settings. DMEPA examines the phonetic
`similarity using patterns of speech. If provided, DMEPA will consider the Sponsor’s intended
`pronunciation of the proprietary name. However, DMEPA also considers a variety of
`pronunciations that could occur in the English language because the Sponsor has little control
`over how the name will be spoken in clinical practice. The orthographic appearance of the
`proposed name is evaluated using a number of different handwriting samples. DMEPA
`applies expertise gained from root-cause analysis of postmarketing medication errors to
`identify sources of ambiguity within the name that could be introduced when scripting
`(e.g.,“T” may look like “F,” lower case ‘a’ looks like a lower case ‘u,’ etc). Additionally,
`other orthographic attributes that determine the overall appearance of the drug name when
`scripted (see Table 1 below for details).
`
`
`
`
`
`
`
`
`
`2 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
`
`Reference ID: 3171044
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`
`
`Table 1. Criteria Used to Identify Drug Names that Look- or Sound-Similar to a
`Proposed Proprietary Name.
`
`Considerations when Searching the Databases
`
`Attributes Examined to Identify
`Similar Drug Names
`
`Potential Effects
`
`Potential
`Causes of Drug
`Name
`Similarity
`
`Similar spelling
`
`
`Type of
`Similarity
`
`
`
`
`
`
`Look-
`alike
`
`Orthographic
`similarity
`
`Identical prefix
`Identical infix
`Identical suffix
`Length of the name
`Overlapping product
`characteristics
`
`• Names may appear similar
`in print or electronic media
`and lead to drug name
`confusion in printed or
`electronic communication
`• Names may look similar
`when scripted and lead to
`drug name confusion in
`written communication
`• Names may look similar
`when scripted, and lead to
`drug name confusion in
`written communication
`
`Similar spelling
`Length of the name/Similar
`shape
`Upstrokes
`Down strokes
`Cross-strokes
`Dotted letters
`Ambiguity introduced by
`scripting letters
`Overlapping product
`characteristics
`Identical prefix
`Identical infix
`Identical suffix
`Number of syllables
`Stresses
`Placement of vowel sounds
`Placement of consonant sounds
`Overlapping product
`characteristics
`Lastly, DMEPA considers the potential for the proposed proprietary name to
`inadvertently function as a source of error for reasons other than name confusion. Post-
`marketing experience has demonstrated that proprietary names (or components of the
`proprietary name) can be a source of error in a variety of ways. Consequently, DMEPA
`considers and evaluates these broader safety implications of the name throughout this
`assessment and the medication error staff provides additional comments related to the
`
`Sound-
`alike
`
`Phonetic
`similarity
`
`
`• Names may sound similar
`when pronounced and lead
`to drug name confusion in
`verbal communication
`
`Reference ID: 3171044
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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 (OPDP). 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: 3171044
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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 OPDP’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
`
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`3 Institute for Healthcare Improvement (IHI). Failure Mode and Effects Analysis. Boston. IHI:2004.
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`Reference ID: 3171044
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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. OPDP finds the proposed proprietary name misleading from a promotional
`perspective, and the Review Division concurs with OPDP’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
`