CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 22-253 & 22-254
`
`. 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 28, 2008
`
`Russell Katz, MD, Director
`Division of Neurology Products
`
`Bob Rappaport, MD, Director
`Division of Anesthesia, Analgesia and Rheumatology Products
`
`Kristina C. Amwine, PharmD, Acting Team Leader
`Denise P.‘ Toyer, PharmD, Deputy Director
`Carol A. Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis
`
`Loretta Holmes, BSN, PharmD, Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`Proprietary Name Review
`
`Vimpat (Lacosamide) Tablets (50 mg, 100 mg, 150 mg, 200 mg,
`250 mg, and 300 mg), #5 7 and Injection
`(10 mg/mL)
`
`Thru:
`
`From:
`
`Subject:
`
`Drug Name:
`
`Application Type/Number:
`
`NDA 22—253, NDA-22—254, m _
`
`Applicant:
`
`OSE RCM #:
`
`Schwartz Biosciences, Inc.
`
`2008-1418
`
`*1“
`W Note: This review contains proprietary and confidential information that should not be
`released to the public.
`
`W)
`
`hi4}
`
`

`

`Contents
`
`EXECUTIVE SUMMARY .......................................................................................................................... 3
`1
`BACKGROUND .................................................................................................................................. 3
`1 . 1
`Introduction ................................................................................................................................... 3
`1.2
`Regulatory History.....:.................................................................................................................. 3
`1.3
`Product Information ...................................................................................................................... 4
`2 METHODS AND MATERIALS .......................................................................................................... 4
`2.1
`Proprietary Name Risk Assessment .............................................................................................. 4
`RESULTS ............................................................................................................................................. 9
`3.1
`Proprietary Name Risk Assessment ...........................................I................................................... 9
`DISCUSSION ..................................................................................................................................... 10
`4.1
`Proprietary Name Risk Assessment ..........................................................................r................. 10
`CONCLUSIONS ................................................................................................................................. 10
`RECOMMENDATIONS .................................................................................................................... 11
`6.1 ' Cements to the Division........................................................................................................... 11
`6.2
`Comments to the Applicant......................................................................................................... 11
`7 REFERENCES ............................................................... 11
`APPENDICES ............................................................................................................................................ 12
`
`5
`6
`
`3
`
`4
`
`, WWW.“
`‘ Vet; ORIGIM‘L
`
`

`

`EXECUTIVE SUMMARY
`
`The Division of Medication Error Prevention and Analysis has no objection to the use of the proprietary
`name, Vimpat, for this product. The results of the Proprietary Name Risk Assessment found that the
`proposed name, Vimpat, has some similarity to other proprietary and established drug names, but the
`findings of the FMEA indicate that the proposed name is not vulnerable to name confusion that could lead
`to medication errors.
`'
`'
`
`Additionally, in OSE Review 2007—1610, we WM
`
`/
`/—/_ /+
`Furthermore, during last minute label/labeling negotiations, the Applicant agreed to provide revised
`labels/labeling to DMEPA for review prior to marketing the 50 mg, 100 mg, 150 mg, 200 mg, 250 mg,
`and,300 mg tablets and 10 mg/mL injection.
`
`(4)
`
`1 BACKGROUND
`
`1.1
`
`INTRODUCTION
`
`This review was written in response to a request from the Division of Neurology Products (DNP) for
`re-assessment of the proposed proprietary name, Vimpat, regarding potential name confiision with other
`proprietary or established drug names.
`
`1.2
`
`REGULATORY HISTORY
`
`The Division of Medication Error Prevention and Analysis previously reviewed the proposed tradename,
`Vimpat, in OSE Review 2007-1610, dated May 13, 2008 and had no objections to the use of the proposed
`proprietary name at that time.
`.
`
`
`Additionally,
`
`review.
`
`/
`
`/
`
`/
`
`/
`
`_
`
`82(4)
`
`'
`
`:. Thus, these issues will not be addressed in this
`
`The container labels and carton labeling were reviewed in OSE Review 2008-633. Our label/labeling
`comments from that review had not yet been sent to the Applicant as of October 23, 2008. However, the
`Applicant submitted revised professional sample blister card labels.
`
`Due to the upcoming PDUFA date and the short time DMEPA was afforded to conduct this review, the
`Division requested comments on the revised professional sample blister card on October 23, 2008.
`Appendix J contains a copy of the email forwarded with DMEPA’s cements. The Division forwarded
`DMEPA’s recommendations (from OSE 2008-633 and the October 23, 2008 email) to the Applicant
`during the labeling negotiations.
`
`DMEPA notes that NDA w (lacosamide tablets for the management of neuropathic pain associated
`with diabetic peripheral neuropathy) received a not approvable actior ———¥_
`
`Vimpat was recently approved (September 2008) in Europe for the treatment of partial-onset seizures.
`
`

`

`1.3
`
`PRODUCT INFORMATION
`
`Vimpat (Lacosamide) is a new molecular entity indicated for the treatment of partial-onset seizures in
`patients with epilepsy aged 16 years and older and for management of neuropathic pain associated with
`diabetic peripheral neuropathy. The dosing and administration are as follows:
`
`Vimpat Dosage
`
`Partial-onset seizures in
`patients with epilepsy
`aged 16 years and older.
`(The tablets
`...-.
`and
`injection are indicated for
`
`partial-onset seizures)
`
`The total daily dose should be divided and given two times daily. Initiate with 50 mg
`twice daily (100 mg/day). Can be increased at weekly intervals by 100 mg/dav un tn
`therapeutic doses of 200 mg/day to 400 mg/day. _ -—-—————‘\_I .
`
`:
`‘
`
`.
`
`M4}
`
`Replacement therapy for partial-onset seizures: When switching from oral to
`intravenous therapy, the initial total daily intravenous dosage should be equivalent to
`the oral total daily dosage and frequency. Vimpat can be administered without further
`—_‘_¢I
`dilution or may be mixed with a compatible diluent and infused over at least
`
`
`
`
`
`Neuropalhic Pain
`Associated With Diabetic
`Peripheral Neuropathy
`
`
`
`M4) _
`
`Vimpat will be supplied in the following dosage forms and strengths: Tablets: 50 mg, 100 mg, 150 mg,
`
`200 mg, 250 mg, and 300 mg (60-, 180- V count bottles): W
`and Injection: 10 mg/mL (20 mL single—use vial).
`
`2 METHODS AND MATERIALS
`
`This section describes the methods and materials used by the Division of Medication Error Prevention
`and Analysis conducting a proprietary name risk assessment (see 2.1 Proprietary Name Risk Assessment).
`The primary focus for the assessment is to identify and remedy potential sources of medication error prior
`to drug approval. The Division of Medication Error Prevention and Analysis 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
`
`2.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name, Vimpat, and the proprietary and established names of drug products existing in the
`marketplace and those pending IND, BLA, NBA, and ANDA products currently under review by CDER.
`
`I National Coordinating Council for Medication Error Reporting and Prevention.
`hm;://www.nccmem.org/aboutMedErrors.html. Last accessed 10/11/2007.
`
`

`

`For the proprietary name, Vimpat, the medication error staff of the Division of Medication Error
`Prevention and Analysis 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 a CDER Expert Panel
`discussion to gather professional opinions on the safety of the proposed proprietary name (see 2.1.1.2).
`The Division of Medication Error Prevention and Analysis normally conducts internal CDER prescription
`analysis studies and, when provided, external prescription analysis studies results are considered and
`incorporated into the overall risk assessment. However, because this name was previously evaluated,
`CDER prescription analysis studies were not repeated and a re—analysis of the external prescription
`analysis was not conducted upon this re—review of Vimpat.
`
`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 2.1.2). The overall risk assessment is based on the findings of a Failure Modes and Effects Analysis
`(FMEA) 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. The Division of
`Medication Error Prevention and Analysis 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 cormnunication 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 considers 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 of measure, dosage
`units, recommended dose, typical quantity or volume, frequency of administration, product packaging,
`storage conditions, patient population, and prescriber population. Because drug name confusion can
`occur at any point in the medication use process, the Division of Medication Error Prevention and
`Analysis 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 ‘V’ 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."'5
`
`2 Institute for Healthcare Improvement (IHI). 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
`hflzllwwszmpcrgz I ools/confuseddrugnamespdf
`
`

`

`To identify drug names that may look similar to Vimpat, the Staff also consider the orthographic
`appearance of the name on lined and unlined orders. Specific attributes taken into consideration include
`the length of the name (6 letters), upstrokes (2, uppercase letter ‘V’ and lowercase‘t’), downstrokes (one,
`lowercase‘p’,) cross—strokes (one, lowercase‘t’,) and dotted letters (one, lowercase‘i’). Additionally,
`several letters in Vimpat may be vulnerable to ambiguity when scripted, including the letter ‘V’ which
`may appear as ‘L’, ‘N’, ‘U’, ‘Y’ or ‘Z’; lowercase ‘1’ appear as a lowercase ‘e’ or ‘1’; lowercase ‘rn’
`appear as a lowercase‘n’ or‘
`,’lowercase‘p’ appear as lowercase ‘j’, ‘p’ or ";.q lowercase ‘a’ appear as
`lowercase “ce’, ‘ci’ or ‘e’; and lowercase ‘t’ appear as lowercase ‘1’ (when the letter ‘t’ is uncrossed) or
`x’. As such, the Staff also consider these alternate appearances when identifying drug names that may
`look similar to Vimpat.
`
`When searching to identify potential names that may sound similar to Vimpat, the medication error staff
`search for names with similar number of syllables (two), stresses (VIM-pat or vim-PAT), and placement
`of vowel and consonant sounds In addition, several letters1n Vimpat may be subject to interpretation
`when spoken, including the letters “Vim ’,which may be interpreted as “Vern”, “Vin”, “Ven”, “Bim”,
`“Bern”, “Bin”, and “Ben”. The Applicant’s intended pronunciation of the proprietary (VIM-pat), was
`also taken into consideration.
`
`The Staff also considers the product characteristics associated with the proposed drug throughout the
`identification of similar drug names, since the product characteristics of the preposed 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
`(Vimpat), the established name (Lacosamide), proposed indication of use (partial--onset seizures and
`diabetic peripheral neuropathic pain), strengths (50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg
`tablets; “—— md 10 mg/mLinjection), dose.M
`V—A—vv-‘for diabetic peripheral neuropathic pain; initially 100 mg/day may
`graduallyIncrease to ‘ ng/day for partial onset seizures), frequency of administration (total daily dose
`should be divided into twice-daily dosing), route of administration (oral or intravenous) and dosage forms
`of the product (tablet, “'
`and injection). Appendix A provides a more detailed listing of the product
`characteristics the medication error staff generally 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, Vimpat, was provided to the medication error staff 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 Vimpat 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 stern list to determine if any USAN stems are present within the proprietary
`
`5 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artifical Inteligence in Medicine
`(2005)
`
`

`

`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 the Division of Medication Error Prevention and Analysis to
`gather CDER professional opinions on the safety of the product and the proprietary name, Vimpat.
`Potential concerns regarding drug marketing and promotion related to the proposed names are also
`discussed. This group is composed of the Division of Medication Error Prevention and Analysis 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 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, we seek 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 than remedies available in the post-approval phase.
`
`In order to perform a 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 Vimpat 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 Vimpat to be confused with
`another proprietary or established drug name because of look— or sound-alike similarity. If the answer to
`the question is no, the Safety Evaluator is not convinced that the names possess similarity that would
`cause confiision 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 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 ultimately not be a source of
`
`6 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
`
`

`

`medication errors in the usual practice setting, the name is eliminated from fiirther 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.
`
`The Division of Medication Error Prevention and Analysis will object to the use of proposed proprietary
`name when 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
`madeor 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 2.1 U.S.C. 352(a) & (n)].
`
`2. The Division of Medication Error Prevention and Analysis 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 .lO.(c)(5)].
`
`'
`
`3. FMEA identifies potential for confusion between the proposed proprietary name and other
`proprietary or established drug names, an_d 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 the Division of Medication Error Prevention and Analysis objects to the use of the
`proposed proprietary name, based upon the potential for confusion with another proposed (but not yet
`approved) proprietary name, we 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 we will recommend
`that the second product to reach approval seek an alternative name.
`
`If none of these conditions are met, then we will not object to the use of the proprietary name. If any of
`these conditions are met, then we will object to the use of the proprietary name. The threshold set for
`objection to the proposed proprietary name may seem low to the Sponsor/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 Institute of Medicine, World Health Organization, Joint Commission,
`and Institute for Safe Medication Practices, 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, the Division of Medication Error Prevention and Analysis 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 from 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 Sponsor, 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 Sponsor’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, we believe that post—approval efforts at reducing name
`confusion errors should be reserved for those cases in which the potential for name confiision could not
`be predicted prior to approval (e.g. new form introduced like Lamisil) (see limitations of the process in
`Section 4).
`
`If the Division of Medication Error Prevention and Analysis 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. The Division of Medication Error Prevention and
`Analysis is likely to recommend that the Sponsor select an alternative proprietary name and submit the
`alternate name to the Agency for the Division of Medication Error Prevention and Analysis 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 we may be able to provide the Sponsor with
`recommendations that reduce or eliminate the potential for error would render the proposed name
`acceptable.
`
`3 RESULTS
`
`3.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`3.1.1 Database and Information Sources
`
`The search identified 18 names as having some similarity to the name Vimpat.
`Sixteen of the 18 names were thought to look like Virnpat, which include: Simplet, Nimbex, Zanfel,
`Zemplar, Vingate,
`--—‘—
`Semate, Vingel, Vimpo-Zine, Vimax, Urispas, Umi-Pex 30, Viracept,
`Venspan,
`/‘_“—'—_‘
`_ and Ramipril. One name, Fempatch, was thought to sound like
`Vimpat. One name, Vinac, was thought to look and sound similar to Vimpat.
`
`§®§
`
`Additionally, the Division of Medication Error Prevention and Analysis did not identify any USAN stems
`in the name Vimpat as of October 3, 2008.
`
`3.1.2 Expert Panel Discussion
`
`The Expert Panel reviewed the pool of names identified by the Division of Medication Error Prevention
`and Analysis staff (see seetion 3.1.1. above), and did not note any additional names thought to have
`orthographic or phonetic similarity to Vimpat and have the potential for confusion.
`
`DDMAC had no concerns regarding the proposed name from a promotional perspective, anddid not offer
`any additional comments relating to the proposed name.
`
`3.1.3 Safety Evaluator Risk Assessment of Proposed Proprietary Name
`
`'
`Independent searches by the primary Safety Evaluator identified three additional names (Comvax,
`Relpax, and Compat) thought to look similar to and represent a potential source of drug name confusion.
`
`W Note: This review contains proprietary and confidential information that should not be released to the
`public".
`
`

`

`10
`
`As such, a total of 21 names were analyzed to determine if the drug names could be confused with
`Vimpat, and if the drug name confusion would likely result in a medication error.
`
`Failure modes and effects analysis was then applied to determine if the proposed name, Vimpat, could
`potentially be confused with any of the 21 names and lead to medication errors. This analysis determined
`that the name similarity between Vimpat and the identified names was unlikely to result in medication
`errors for all 21 products for reasons described/outlined in Appendices B through I.
`
`4 DISCUSSION
`
`4.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`The results of the Proprietary Name Risk Assessment found that the proposed name, Vimpat, has some
`similarity to other proprietary drug names, but the findings of the FMEA indicate that the proposed name
`is not vulnerable to name confusion that could lead to medication errors.
`
`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 confusing
`name. Also, there is some possibility that our Risk Assessment failed to consider a circumstance in which
`confusion could arise. However, we believe that these limitations are sufficiently minimized by the use of
`an Expert Panel.
`
`However, our risk assessment also faces limitations beyond the control of the Agency. First, our risk
`assessment is based on current health care practices and drug product characteristics, future changes to
`either could increase the vulnerability of the proposed name to confiision. Since these changes cannot be
`predicted for or accounted by the current Proprietary Name Risk Assessment process, such changes limit
`our findings. To help counterbalance this impact, we recommend that the proprietary name be
`re-subrnitted for review if approval of the product is delayed beyond 90 days.
`
`5 CONCLUSIONS
`
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Vimpat, is not
`vulnerable to name confusion that could lead to medication errors. As such, the Division of Medication
`Error Prevention and Analysis does not object to the use of the proprietary name, Vimpat, for this
`product. Additionally, DDMAC does not object to the proposed name, Vimpat, from a promotional
`perspective.
`
`If 31111 of the proposed product characteristics as stated in this review are altered prior to approval of the
`product; the Division of Medication Error Prevention and Analysis rescinds this Risk Assessment finding,
`and recommends that the name, labels, and labeling be resubmitted for review. In the event that our Risk
`Assessment finding is rescinded, the evaluation of the name on resubmission is independent of the
`previous Risk Assessment, and as such, the conclusions on re-review of the name are subject to change.
`Additionally, if the product approval is delayed beyond 90 day from the date of this review, the proposed
`name must be resubmitted for evaluation.
`
`

`

`11
`
`6 RECOMMENDATIONS
`
`6.1
`
`COMMENTS To THE DIVISION
`
`The Division of Medication Error Prevention and Analysis has no objections to the use of the proprietary
`name Vimpat for this product.
`
`We would appreciate feedback on the final outcome of this consult. We would be willing to meet with
`the Division for further discussion, if needed. Please copy the Division of Medication Error Prevention
`and Analysis on any correspondence to the Applicant pertaining to this issue. If you have further
`questions or need clarifications, please contact Daniel Brounstein, OSE Project Manager, at
`301-796-0674.
`
`6.2
`
`COMMENTS TO THE APPLICANT
`
`Not applicable since the Division will be sending the regulatory action letter with all comments.
`
`7 REFERENCES
`
`1.
`
`Micromedex Integrated Index (httng/csimicromedex.com)
`
`Contains a variety of databases covering pharmacology, therapeutics, toxicology and diagnostics.
`
`2.
`
`Phonetic and Orthographic Computer Analysis (POCA)
`
`As part of the name similarity assessment, proposed names are evaluated via a pho