CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`204592Orig1s000
`
`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--Final
`
`Date:
`
`September 5, 2013
`
`Vicky Borders-Hemphill, Pharm.D.
`Reviewer(s):
`Division of Medication Error Prevention and Analysis
`
`Jamie Wilkins Parker, Pharm.D.
`Team Leader
`Division of Medication Error Prevention and Analysis
`
`Drug Name and Strength(s): Zorvolex (Diclofenac acid) Capsules, 18 mg and 35 mg
`Application Type/Number: NDA 204592
`Applicant/Sponsor:
`Iroko Pharmaceuticals, LLC
`OSE RCM #:
`2013-1067
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
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`Reference ID: 3368627
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`CONTENTS
`
`INTRODUCTION ......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION.................................................................................................................. 3
`3 CONCLUSIONS ........................................................................................................................................... 3
`4 REFERENCES .............................................................................................................................................. 4
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`Reference ID: 3368627
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`INTRODUCTION
`1
`This re-assessment of the proposed proprietary name, Zorvolex 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, Zorvolex, acceptable in OSE Review #2013-343 dated April 26, 2013.
`
`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 #2013-343. We note that none of
`the proposed product characteristics were altered. However, we evaluated the previously identified
`names of concern considering any lessons learned from recent post-marketing experience, which may
`have altered our previous conclusion regarding the acceptability of the proposed proprietary name.
`The searches of the databases yielded no new names, thought to look or sound similar to Zorvolex and
`represent a potential source of drug name confusion
`Additionally, DMEPA searched the United States Adopted Names (USAN) list to determine if the
`name contains any USAN stems as of the last USAN updates. The Safety Evaluator did not identify
`any USAN stems in the proposed proprietary name, as of September 5, 2013.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Zorvolex, did not identify any vulnerabilities that
`would result in medication errors with any additional names. Thus, DMEPA has no objection to the
`proprietary name, Zorvolex, 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, then the Division of Analgesia, Anesthesia, and Addiction Products
`should notify DMEPA because the proprietary name must be re-reviewed prior to the new approval
`date.
`If you have further questions or need clarifications, please contact Vaishali Jarral, OSE project
`manager, at 301-796-4248.
`
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`Reference ID: 3368627
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`4 REFERENCES
`1.
`OSE Reviews
`
`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.
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`2.
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`3.
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`4.
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`BRENDA V BORDERS-HEMPHILL
`09/05/2013
`
`JAMIE C WILKINS PARKER
`09/06/2013
`
`Reference ID: 3368627
`
`

`

`
`
`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:
`
`April 26, 2013
`
`Vicky Borders-Hemphill, Pharm.D.
`Reviewer(s):
`Division of Medication Error Prevention and Analysis
`
`Jamie Wilkins Parker, Pharm.D.
`Team Leader
`Division of Medication Error Prevention and Analysis
`
`Carol Holquist, RPh
`Division Director:
`Division of Medication Error Prevention and Analysis
`
`Drug Name and Strength(s): Zorvolex (Diclofenac acid) Capsules, 18 mg and 35 mg
`Application Type/Number: NDA 204592
`Applicant/Sponsor:
`Iroko Pharmaceuticals, LLC
`OSE RCM #:
`2013-343
`
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
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`Reference ID: 3300229
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`
`
`CONTENTS
`
`1
`
`INTRODUCTION................................................................................................................... 1
`1.1
`Product Information......................................................................................................... 1
`2.2
`Safety Assessment........................................................................................................... 1
`3 CONCLUSIONS ..................................................................................................................... 3
`3.1
`Comments to the Applicant............................................................................................. 4
`4 REFERENCES........................................................................................................................ 4
`APPENDICES................................................................................................................................. 7
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`Reference ID: 3300229
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`1
`INTRODUCTION
`This review evaluates the proposed proprietary name, Zorvolex, 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
`PRODUCT INFORMATION
`The following product information is provided in the February 4, 2013, Proprietary name
`submission and March 6, 2013 labeling submission:
`• Active Ingredient: Diclofenac acid
`•
`Indication of Use: for the treatment of mild to moderate acute pain in adults
`• Route of administration: Oral
`• Dosage form: Capsule
`• Strength: 18 mg or 35 mg
`• Dose and Frequency of administration: 18 mg or 35 mg by mouth three times
`daily taken on an empty stomach
`
`• How Supplied: each strength in bottles of 30 capsules, bottles of 90 capsules, and
`blister of 3 capsules
`• Storage: 25°C (77°F), with excursions permitted to 15 to 30°C (59-86°F)
`2.
`RESULTS
`The following sections provide the information obtained and considered in the 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 Anesthesia, Analgesia, and Addiction Products (DAAAP)
`concurred with the findings of OPDP’s promotional assessment of the proposed name.
`
`
`
`SAFETY ASSESSMENT
`2.2
`The following aspects of the name were considered in the overall safety evaluation.
`
`2.2.1 United States Adopted Names (USAN) SEARCH
`On February 11, 2013 the United States Adopted Name (USAN) stem search, identified
`that a USAN stem is not present in the proposed proprietary name.
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant stated the name did not have any intended meaning or derivation. This
`proprietary name is comprised of a single/multiple word(s) that does not contain any
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`Reference ID: 3300229
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`components (i.e. a modifier, route of administration, dosage form, etc.) that is misleading
`or can contribute to medication error.
`
`2.2.4 FDA Name Simulation Studies
`Eighty Nine (89) practitioners participated in DMEPA’s prescription studies. Thirty Nine
`(39) of the participants interpreted the name correctly as ‘Zorvolex’, with correct
`interpretation occurring in the inpatient and outpatient written studies and voice
`prescription. Misinterpretations occurred with expected orthographically and
`phonetically similar letter strings. None of the misinterpreted names overlap with
`marketed products. 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, April 25, 2013 e-mail, the Division of Anesthesia, Analgesia, and
`Addiction Products (DAAAP) 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, Zorvolex. Table 1 lists the names with
`orthographic, phonetic, or spelling similarity to the proposed proprietary name, Zorvolex,
`identified by the primary reviewer, the Expert Panel Discussion (EPD), and other review
`disciplines. The February 4, 2013, proprietary name submission cover letter refers to an
`external name study conducted by
` that was submitted to the IND 103880 on
`September 23, 2011. This external name study was previously evaluated in DMEPA
`review dated March 16, 2012 (OSE review #2011-3627).
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`Table 1: Collective List of Potentially Similar Names (DMEPA, EPD, Other Disciplines, and
`FDA Name Simulation Studies)
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`------
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`n-----
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`Our analysis of the 31 names contained in Table 1 considered the infonnation obtained in the
`previous sections along with their product characteristics. We determined that all 31 names will
`not pose a risk for confusion as described in Appendices D through E.
`
`2.2. 7 Communication ofDMEPA ’s Final Decision to Other Disciplines
`
`DIVIEPA communicated our findings to the Division of Analgesia, Anesthesia, and
`Addiction Products (DAAAP) via e-mail on April 25, 2013. At that time we also
`requested additional information or concerns that could inform our review. Per e—mail
`correspondence from the Division of Analgesia, Anesthesia, and Addiction Products
`(DAAAP)) on April 26, 2013, they stated no additional concerns with the proposed
`proprietary name, Zorvolex.
`
`3 CONCLUSIONS
`
`The proposed proprietary name, Zorvolex, is acceptable from both a promotional and
`safety perspective.
`
`Ifyou have further questions or need clarifications, please contact Teena Thomas, OSE
`project manager, at 301—796-0549.
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`Reference ID: 3300229
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`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Zorvolex, and have
`concluded that this name is acceptable. The proposed proprietary name must be re-
`reviewed 90 days prior to approval of NDA 204592. The results are subject to change. If
`any of the proposed product characteristics as stated in your February 4, 2013 submission
`are altered, the name must be resubmitted for review.
`
` 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.
`
`Reference ID: 3300229
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`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,
`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.
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`Reference ID: 3300229
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`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.
`
`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.
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`Reference ID: 3300229
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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.
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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 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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`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
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`
`
`
`
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`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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`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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`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
`
`
`3 Institute for Healthcare Improvement (IHI). Failure Mode and Effects Analysis. Boston. IHI:2004.
`
`Reference ID: 3300229
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`characteristics listed in Section 1.2 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 c