CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-030
`
`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
`
`October 15, 2008
`
`Scott Monroe, MD, Director
`Division of Reproductive and Urologic Products
`
`Kellie Taylor, PharmD, MPH, Team Leader
`Denise Toyer, PharmD, Deputy Director
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis
`
`From:
`
`linhee J. Lee, PharmD, Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`Subject:
`
`Final Proprietary Name, Label, and Labeling Review
`
`Drug Name(s):
`
`Toviaz (Fesoterodine Fumarate) Extended-release Tablets
`
`Application Type/Number: NDA # 22-030
`
`Applicant/Applicant:
`
`Pfizer, Inc. (Schwarz Pharma)
`
`OSE RCM #:
`
`2008-8 1 0
`
`**This document contains proprietary and confidential information that should not be released to
`the public.*
`
`

`

`CONTENTS
`
`'
`
`EXECUTIVE SUMMARY ............................................................................................................. 3
`1
`BACKGROUND ..................................................................................................................... 3
`l . 1
`Introduction .................................................................................................................... 3
`
`1.2
`1.3
`
`Regulatory History ........................ -. ................................................................................ 3
`Product Information ....................................................................................................... 3
`
`2 METHODS ANDMATERIALS .......... _. ................. 3
`2.1
`Proprietary Name Risk Assessment ............................................................................... 4
`2.2
`Label and Labeling Risk Assessment ............................................................................ 8
`RESULTS ................................................................................................................................ 9
`
`3
`
`Proprietary Name Risk Assessment ............................................................................... 9
`3.1
`Label and Labeling Risk Assessment .......................................................................... 10
`3.2
`4 DISCUSSION ............................................. 11
`
`4.1
`4.2
`
`Proprietary Name Risk Assessment ............................................................................. 11
`Label and Labeling Risk Assessment .......................................................................... 1 1
`
`5
`
`CONCLUSIONS and RECOMMENDATIONS ................................................................... 13
`5.1
`Comments to the Division............................................................................................ 13
`
`Comments to the Applicant.......................................................................................... 13 '
`5.2
`References ............................................................................................................................. 15
`6
`APPENDICES .......................... 16
`
`

`

`EXECUTIVE SUMMARY
`
`Toviaz, has some similarity to other proprietary and established drug names, but the findings of the
`Failure Modes and Effects Analysis (FMEA) indicates that the proposed name is not vulnerable to name
`confusion that could lead to medication errors. Thus, the Division of Medication Error Prevention and
`, Analysis (DMEPA) has no objections to the use of the proprietary namehToviaz for this product.
`
`However; if any of the proposed product characteristics as stated in this review are altered prior to
`approval of the product, DMEPA rescinds this Risk Assessment finding, and recommends that the name
`be resubmitted for review. Additionally, if the product approval is delayed beyond 90 days from the
`signature date of this review, the proposed name must be resubmitted for evaluation.
`
`The results of the Label and Labeling Risk Assessment find the proposed container labels and labeling
`introduce vulnerabilities that could lead to medication errors. DMEPA’s recommendations for label and
`labeling modifications are found in Section 5.2.
`'
`
`1
`
`BACKGROUND
`
`1 . 1
`
`INTRODUCTION
`
`This review was written in response to a request from the Division of Reproductive and Urologic
`Products (DRUP) to re-evaluate the product for its potential to contribute to medication errors. The -
`proposed proprietary name, Toviaz, is evaluated to determine if the name could be potentially confused
`with other proprietary or established drug names. The container label, carton and insert labeling Were
`submitted to DMEPA at the time of this review.
`
`1.2
`
`REGULATORY HISTORY
`
`DMEPA reviewed the proposed name, Toviaz, previously with no objections to the name in OSE Review
`2007—2078 (dated April 22, 2008). However, the container labels, carton and insert labeling were not
`submitted to DMEPA at the time of that review.
`
`1.3
`
`PRODUCT INFORMATION‘
`
`Toviaz is the proposed name for Fesoterodine Fumarate Extended—release tablets. Fesoterodine fumarate
`is a competitive muscarinic receptor antagonist in an extended-release tablet formulation. Toviaz is
`proposed to be indicated for the treatment of overactive bladder with symptoms of urinary urgency,
`frequency, and/or urge incontinence.
`
`The recommended starting dose is 4 mg once daily. Based upon individual response and tolerability, the
`dose may be increased to 8 mg once daily.
`
`2 METHODS AND MATERIALS
`
`This section describes the methods and materials used by' the DMEPA staff conducting a proprietary
`name risk assessment (see 2.1 Proprietary Name Risk Assessment). The primary focus of the assessment
`is to identify and remedy potential sources of medication error prior to drug approval. 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. I
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://wwwmccmem.orgiaboutMedEn‘orshtml. Last accessed 10/11/2007.
`
`

`

`2.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name, Toviaz, and the proprietary and established names of drug products existing in the
`marketplace and those pending IND, BLA, NDA, and ANDA products currently under review by CDER.
`
`For the proprietary name, Toviaz, the medication error staff of DMEPA search a standard set of databases
`and information sources to identify names with orthographic and phonetic similarity (see Sections 2.1.1
`for detail) and held an CDER Expert Panel discussion to gather professional opinions on the safety of the
`proposed proprietary name (see 2.1.1.2).
`
`The Safety Evaluator assigned to the Proprietary Name Risk Assessment is responsible for considering
`the collective findings, and provides an overall risk assessment of the proposed proprietary name (see
`detail 2.1.4). The overall risk assessment is based on the findings of a Failure Modes and Effects
`Analysis (FMBA) of the proprietary name, and is focused on the avoidance of medication errors. FMEA
`is a systematic tool for evaluating a process and identifying where and how it might fail .2 FMEA is used
`to analyze whether the drug names identified with look- or sound-alike similarity to the proposed name
`could cause confusion that subsequently leads to medication errors in the clinical setting. DMEPA uses
`the clinical expertise of the medication error staff to anticipate the conditions of the clinical setting that
`the product is likely to be used in based on the characteristics of the proposed product.
`
`In addition, the product characteristics provide the context for the verbal and written communication of
`the drug names and can interact with the orthographic and phonetic attributes of the names to increase the
`risk of confusion when there is' overlap, or, in some instances, decrease the risk of confusion by helping to
`differentiate the products through dissimilarity. As such, the Staff consider the product characteristics
`associated with the proposed drug throughout the risk assessment, since the product characteristics of the
`proposed may provide a context for communication of the drug name and ultimately determine the use of
`the product in the usual clinical practice setting.
`
`Typical product characteristics considered when identifying drug names that could potentially be
`confused with the proposed drug name include, but are not limited to established name of the proposed
`product, the proposed indication, dosage form, route of administration, strength, unit ofmeasure, dosage
`units, recommended dose, typical quantity or volume, frequency of administration, product packaging,
`storage conditions, patient population, and prescnber population. 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.3
`
`2.1.1 Search Criteria
`
`The medication error staff consider the spelling of the name, pronunciation of the name when spoken, and
`appearance of the name when scripted as outlined in Appendix A.
`
`For this review, particular consideration was given to drug names beginning with the letter ‘T’ when
`searching to identify potentially similar drug names, as 75% of the confused drug names reported by the
`USP-ISMP Medication Error Reporting Program involve pairs beginning with the same letter.”
`
`2 Institute for Healthcare Improvement (1H1). Failure Modes and Effects Analysis. Boston. IHI:2004.
`
`3 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`4 Institute for Safe Medication Practices. Confused Drug name List (1996-2006). Available at
`http://www.ismporgl ! ools/confuseddruggamespdf
`5 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artifical Inteligence in Medicine
`(2005)
`
`

`

`To identify drug names that may look similar to Toviaz, the Staff also consider the other orthographic
`appearance of the name on lined and unlined orders. Specific attributes taken into consideration include
`the length of the name (six letters), upstrokes (one, capital letter ‘T’), downstrokes (one, if “z” is
`'
`scripted),_cross-strokes (none), and dotted letters (one, ‘i’). Additionally, several letters in Toviaz may be
`vulnerable to ambiguity when scripted, including the letter ‘T’ may appear as ‘F’, ‘L’, or ‘Z’; lower case
`‘0’ appear as a lower case ‘a’ or ‘u’; and ‘-iaz’ may appear as ‘-ior’. As such, the Staff should also
`consider these alternate appearances when identifying drug names that may look similar to Toviaz.
`
`When searching to identify potential names that may sound similar to Toviaz, the Medication Error Staff
`search for names with similar number of syllables (3), stresses (to-VEE-az or TO-vee-az or to-vee-AZ),
`consonant sound pronunciation (“az” versus “as” or ‘v’ versus ‘p’ or ‘b’), and placement of vowel and
`consonant sounds. In addition, several letters in Toviaz may be subject to misinterpretation when spoken,
`including the letter ‘v’ which may be interpreted as ‘b’, ‘f’, or ‘p’ and the letter ‘2’ may be misinterpreted
`as ‘s’. As such, the staff also considers these alternate pronunciations when identifying drug names that
`may sound similar to Toviaz. The Applicant’s intended pronunciation of the proprietary name could not
`be expressly taken into consideration, as this was not provided with the proposed name submission.
`
`The Staff also consider the product characteristics associated with the proposed drug throughout the
`identification of similar drug names, since the product characteristics of the proposed drug ultimately
`determine the use of the product in the clinical practice setting For this review, the medication error staff
`were provided with the following information about the proposed product:
`the proposed proprietary name
`(Toviaz), the established name (fesoterodine furnarate), proposed indication (treatment of overactive
`bladder with symptoms of urinary urgency, frequency, and/or urge continence), strength '
`(4 mg, 8 mg), dose (4 mg daily, titrate up to 8 mg daily based on clinical response), frequency of
`administration (daily), route (oral) and dosage form of the product (tablet). Appendix A provides a more
`detailed listing of the product characteristics the medication error staff general take into consideration.
`
`Lastly, the medication error staff also consider the potential for the proposed 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. As such, these broader safety implications of the name are considered and evaluated
`throughout this assessment and the medication error staff provide additional comments related to the
`safety of the proposed name or product based on their professional experience with medication errors.
`
`2.1.1.1 Databases and Information Sources
`
`The proposed proprietary name, Toviaz, was provided to the medication error staff of DMEPA to conduct
`a search of the internet, several standard published drug product reference texts, and FDA databases to
`identify existing and proposed drug names that may sound-alike or look-alike to Toviaz using the criteria
`outlined in 2.1.1. A standard description of the databases used in the searches is provided in Section 7.
`_To complement the process, the medication error staff use a computerized method of identifying phonetic
`and orthographic similarity between medication names. The program, Phonetic and Orthographic
`Computer Analysis (POCA), uses complex algorithms to select a list of names from a database that have
`some similarity (phonetic, orthographic, or both) to the trademark being evaluated. Lastly, the
`Medication Error Staff review the USAN stem list to determine if any USAN stems are present within the
`proprietary name. The findings of the individual Safety Evaluators were then pooled and presented to the
`Expert Panel.
`
`_
`
`2.1.1.2 CDER Expert Panel Discussion
`
`An Expert Panel Discussion is held by DMEPA to gather CDER professional opinions on the safety of
`the product and the proprietary name, Toviaz. Potential concerns regarding drug marketing and
`
`

`

`promotion related to the proposed names are also discussed. This group is composed of the DMEPA Staff
`and representatives from the Division of Drug Marketing, Advertising, and Communications (DDMAC).
`
`The pooled results of the medication error staff were presented to the Expert Panel for consideration.
`Based on the clinical and professional experiences of the Expert Panel members, the Panel may
`recommend the addition of names, additional searches by the Safety Evaluator to supplement the pooled
`results, or general advice‘to consider when reviewing the proposed proprietary name.
`
`2.1.2 Safety Evaluator Risk Assessment of the Proposed Proprietary Name
`
`Based on the criteria set forth in Section 2.1.1, the Safety Evaluator Risk Assessment applies their
`individual expertise gained from evaluating medication errors reported to FDA to conduct a Failure
`Modes and Effects Analysis and provide an overall risk 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.6 When applying FMEA to assess the risk of a proposed proprietary name, DMEPA seeks to evaluate
`the potential for a proposed name to be confused with another drug name as a result of the name
`confusion and 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 look— or sound-alike drug names prior to
`approval, where actions to overcome these issues are easier and more effective then remedies available in'
`the post-approval phase.
`
`In order to perform an FMEA of the proposed name, the Safety Evaluator must analyze the use of the
`product at all points in the medication use system. Because the proposed product is not yet marketed, the
`Safety Evaluator anticipates the use of the product in the usual practice settings by considering the clinical
`and product characteristics listed in Appendix A. 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 evaluation, and studies, and identifies
`potential failure modes by asking: “Is the name Toviaz convincingly similar to another drug name, which
`may cause practitioners to become confused at any point in the usual practice setting?” An affirmative
`answer indicates a failure mode and represents a potential for Toviaz to be confused with another
`proprietary or established drug name because of look— or sound-alike sirrrilarity. 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 and the name is eliminated from further review.
`
`In the second stage of the Risk Assessment, all potential failure modes are evaluated to determine the
`likely efi’ect of the drug name confusion, by asking “Could the confusion ofthe 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 ultimately not be a source of
`medication errors in the usual practice setting, the name is eliminated 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 that an alternate
`proprietary name be used. In rare instances, the FMEA findings may provide other risk—reduction
`strategies, such as product reformulation to avoid an overlap in strength or an alternate modifier
`designation may be recommended as a means of reducing the risk of medication errors resulting from
`drug name confusion.
`
`6 Institute for Healthcare Improvement (1H1). Failure Modes and Effects Analysis. Boston. IHI:2004.
`
`

`

`DMEPA will object to the use of proposed proprietary name when the one or more of the following
`conditions are identified in the Safety Evaluator’s Risk Assessment:
`
`1. 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 trade name or otherwise.
`[21 U.S.C 321(n); see also 21 U.S.C. 352(a) & (n)].
`
`2. 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)].
`'
`
`3. FMEA identifies potential for confusion between the proposed proprietary name and other
`proprietary or established drug names, fl demonstrates that medication errors are likely to result
`from the drug name confusion under the conditions of usual clinical practice.
`
`4. The proposed proprietary name contains an USAN stern, particularly in a manner that is
`contradictory to the USAN Council’s definition.
`
`5. Medication error staff identify a potential source of medication error within the proposed
`proprietary name. 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.
`
`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 is awarded approval first has the
`right to the use the name, while DMEPA will recommend that the second product to reach approval seek
`an alternative name.
`
`If none of these conditions are met, then DMEPA will not object to the use of the proprietary name. If
`any of these conditions are met, then DMEPA will object to the use of the proprietary name. The
`threshold set for objection to the proposed proprietary name may seem low to the Applicant; however, the
`safety concerns set forth in criteria 1 through 5 are supported either by FDA Regulation or by external
`healthcare authorities, including the 10M, WHO, JCAHO, and ISMP, have examined medication errors
`resulting from look— or sound-alike drug names and called for Regulatory Authorities to address the issue
`prior to approval.
`
`Furthermore, 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, can be identified and remedied prior to approval to avoid patient
`harm.
`_
`
`'
`
`,
`
`' Additionally, post-marketing experience has demonstrated that medication errors resulting fiom drug
`name confusion are notoriously difficult to remedy post-approval. Educational efforts and so on are low-
`leverage strategies that have proven to have limited effectiveness at alleviating the medication errors
`involving drug name confusion. Higher-leverage strategies, such as drug name changes, have been
`undertaken in the past; but at great financial cost to the Applicant, and at the expense of the public
`welfare, not to mention the Agency’s credibility as the authority responsible for the approving the error-
`prone proprietary name. Moreover, even after Applicant’s have changed a product’s proprietary name in
`the post-approval phase, it is difficult to eradicate the .original proprietary name from practitioner’s
`vocabulary, and as such, the Agency has continued to receive reports of drug name confusion long after a
`name change in some instances. Therefore, DMEPA believes that post-approval efforts at reducing name
`
`

`

`confusion errors should be reserved for those cases in which the potential for name confusion could not
`be predicted prior to approval (see limitations of the process).
`
`If DMEPA objects to a proposed proprietary name on the basis that drug name confusion could lead to
`medication errors, the FMEA process is used to identify strategies to reduce the risk of medication errors.
`DMEPA is likely to recommend that the Applicant select an alternative proprietary name and submit the
`alternate name to the Agency for DMEPA to review. HoWever, in rare instances FMEA may identify
`plausible strategies that could reduce the risk of medication error of the currently proposed name, and so
`DMEPA may be able to provide the Applicant with 1‘ecomr’nendations that reduce or eliminate the
`potential for error would render the proposed name acceptable.
`
`2.2
`
`LABEL AND LABELING RISK ASSESSMENT
`
`This section describes the methods and materials used by the DMEPA medication error staff to conduct a
`label, labeling, and/or packaging risk assessment (see Section 3, Results). The primary focus of the
`assessments is to identify and remedy potential sources of medication errors prior to drug approval.
`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. 7
`'
`
`The label and labeling of a drug product are the primary means by which practitioners and patients
`(depending on configuration) interact with the pharmaceutical product. The container label and carton
`labeling communicate critical information including proprietary and established name, strength, form,
`container quantity, expiration, and so on. The insert labeling is intended to communicate to practitioners
`all information relevant to the approved uses of the drug, including the correct dosing and administration.
`
`Given the critical role that the label and labeling has in the safe use of drug products, it is not surprising
`that 33 percent of medication errors reported to the United States Pharmacopeia—Institute for Safe
`Medication Practices Medication Error Reporting Program may be attributed to the packaging and
`labeling of drug products, including 30 percent of fatal errors.8
`
`Because the DMEPA staff analyzes reported misuse of drugs, the DMEPA staff is able to use this
`experience to identify potential errors with _all medications similarly packaged, labeled or prescribed.
`DMEPA uses FMEA and the principles of human’factors to identify potential sources of error with the
`proposed product labels and insert labeling, and provide recommendations that aim at reducing the risk of
`medication errors.
`
`DMEPA reviewed the following labels and labeling submitted by the Applicant on May 1, 2008. See
`Appendices G through P for pictures of the labels and labeling.
`
`. Commercial Container Labels (30 tablet and 90 tablet) '
`
`0
`
`Sample Container Labels (7 tablet, l4 tablet, :m
`
`0 Commercial Unit Dose Blister Labels (4 mg and 8 mg)
`
`0
`
`Sample Dose Pack Blister Cards (4 mg and 8 mg)
`
`0 Commercial Unit Dose Pack Carton Labeling (100 tablet)
`0 Km
`
`lNational Coordinating Council for Medication Error Reporting and Prevention.
`http://wwwnccme‘yp.orglaboutMedErrorshtml. Last accessed 10/11/2007.
`
`8 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`p275.
`
`agar
`
`

`

`0
`
`O
`
`0
`.
`
`0
`
`Sample Carton Labelin W"
`
`Sample Blister Carton Labeling
`
`Sample Blister Carton Labeling (Shelf display)
`c___~__,,
`
`Package Insert Labeling (no image)
`
`3 RESULTS
`
`3.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`3.1.1 Databases and Information Sources
`
`33(4)
`
`The search of the internet and several standard published databases and information sources (see Section
`6 References) identified a total of 23 names as having some similarity to the name Toviaz.
`
`
`
`Sixteen of the 23 names were thought to look like Toviaz, which include: “m“ Fortaz
`Fovane, Lariam, Lovaza, Taztia ~ Tenex, Tiazac, Topex, Toriac, Torisel, Tovalt ODT, Trovan, and
`Zo'virax. Two names I g and Toprol) were thought to sound like Toviaz. Five names (Tavist, Tobi,
`Tovalt, Triaz, and Zovia) were thought to look and sound similar to Toviaz.
`
`53(4)
`
`A search of the United States Adopted Name (USAN) stem list on September 8, 2008 identified no
`USAN stems within the proposed name, Toviaz. As such, a total of 27 names were analyzed to determine
`if the drug names could be confused with Toviaz and if the drug name confusion would likely result in a
`medication error.
`
`3.1.2 CDER Expert Panel Discussion
`
`The Expert Panel reviewed the pool of names identified by the DMBPA staff (see section 3.1.1 . above),
`and noted no additional names.
`
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did not offer
`any additional comments relating to the proposed name.
`
`3.1.3 Safety Evaluator Risk Assessment of the Proposed Proprietary Name
`
`Independent searches by the primary Safety Evaluator four additional names (Toviaz, Lovas, Lovina, and
`Kovia) thought to look similar to Toviaz and represent a potential source of drug name confusion.
`
`Fifteen of the 27 names (Fovane, Lovaza, .9,- l‘iazac, Topex, Toriac, Tovalt and Tovalt ODT,
`Trovan, Zovirax, Toprol, Tavist, Tobi, Triaz, and Zovia) were identified in 0813 # 2007-2078, dated April
`22, 2008). Toviaz’s product characteristics have not changed, and during the aforementioned analysis
`these names were determined not to pose a risk of confusion and error with Toviaz. Thus, these names
`were eliminated from further analysis.
`
`2 m4;
`
`Four of the 12 remaining names lacked orthographic and phonetic similarity (Appendix B). The
`remaining eight names were determined to have some orthographic similarity to Toviaz, and thus
`determined to present some risk for confusion. Failure modes and effects analysis was then applied to
`determine if the’proposed name, Toviaz, could potentially be confused with any of the eight names and
`lead to medication error.
`
`This analysis determined that the name similarity between Toviaz and the identified names was unlikely
`to result in medication errors for all eight products for reasons described/outlined in Appendices C
`through F.
`
`

`

`3.2
`
`LABEL AND LABELING RISK ASSESSMENT
`
`Our analysis of the labels and labeling determined the following areas of vfilnerability.
`
`3.2.1 General Comments
`
`"\
`\.
`
`3.2.2 Commercial (3 0 tablet and 90 tablet) and Sample (7 tablet, 14 tablet '\_
`Container Labels
`
`See General Comments.
`
`3.2.3 Unit Dose Blister Labels (4 mg and 8 mg)
`
`c.
`
`3.2.4 Sample Dose Pack Blister Cards
`
`10
`
`.3
`
`”(4)
`
`2
`
`0(4)
`
`3.2.5 Commercial Unit Dose Carton Labeling (100 tablet)
`See General Comments.
`
`3.2.6 Sample Carton Labeling (30 tablet)
`See General Comments.
`
`C/
`
`3.2.7 Sample Carton Labeling Q j
`C/
`
`3.2.8 Sample Carton Labeling (Blister and
`m
`
`.,
`
`4 ‘ "-7!
`
`(um '
`
`3
`
`D
`
`“(4‘
`
`

`

`3.2.9 L’/‘
`
`3.2.10 Insert Labeling
`No comments.
`
`4 DISCUSSION
`
`ll
`
`2
`
`4.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`We analyzed 27 names for their similarity to the proposed name Toviaz. The findings of the FMEA
`indicate that the proposed name does not appear to be vulnerable to name confusion that could lead to .
`medication errors with any of the names evaluated.
`
`The findings of the Proprietary Name Risk Assessment are based upon current understanding of factors
`that contribute to medication errors involving name confusion. Although we believe the findings of the
`Risk Assessment to be robust, our findings do have limitations. First, because our assessment involves a
`limited number of practitioners, it is possible that the analysis did not identify a potentially confilsing
`name. Also, there is some possibility that our Risk Assessment failed to consider a circumstance in which
`confusion could arise once the product is commercially marketed. However, DMEPA believes that these ’
`limitations are sufficiently minimized by the use of an Expert Panel.
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`4.2
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`LABEL AND LABELING RISK ASSESSMENT
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`Our Label and Labeling Risk Assessment noted several areas of needed improvement.
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`5
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`CONCLUSIONS AND RECOMMENDATIONS
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`The Proprietary Name Risk Assessment findings indicate that the proposed name, Toviaz, is not
`vulnerable to name confusion that could lead to medication errors. As such, DMEPA does not object to
`the use of the proprietary name, Toviaz, for this product at this time. However, ifm of the proposed
`product characteristics as stated in this review are altered prior to submission of the NDA or approval of
`the product, DMEPA rescinds this Risk Assessment finding. If the product approval is delayed beyond
`90 days from the date of this review, the proposed name must be resubmitted for evaluation. Ifthe
`product approval1s delayed beyond 90 days from the date of this review, the proposed name must be
`resubmitted for evaluation
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`The Label and Labeling Risk Assessment findings indicate that the presentation of information and design
`of the proposed container labels and carton labeling introduces vulnerability to confusion that could lead
`to medication errors. Specifically, DMEPA notes problems with the prominence, presentation, and
`consistency of information that15 vital to the safe use of the product. DMEPA believes the risks we have
`identified can be addressed and mitigated prior to drug approval, and provides recommendationsin
`Section 52 that aim at reducing the risk of medication errors.
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`5.1
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`COMMENTS TO THE DIVISION
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`DMEPA would appreciate feedback on the final outcome of this