CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
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`022567Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
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`

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`
`
`Date:
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`Application
`Type/Number:
`
`Through:
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`From:
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`Subject:
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`Drug Name:
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`Applicant:
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`OSE RCM #:
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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
`
`November 15, 2010
`
`NDA 022567
`
`Kristina A. Toliver, PharmD, Team Leader
`Denise P. Toyer, PharmD, Deputy Director
`Carol A. Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Loretta Holmes, BSN, PharmD, Safety Evaluator
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Proprietary Name Review
`
`Viibryd (Vilazodone Hydrochloride) Tablets
`10 mg, 20 mg, and 40 mg
`
`PGxHealth, LLC
`
`2010-1849
`
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
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`Reference ID: 2864213
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`CONTENTS
`EXECUTIVE SUMMARY............................................................................................................. 3
`1 BACKGROUND..................................................................................................................... 3
`1.1
`Introduction.................................................................................................................... 3
`1.2
`Regulatory History......................................................................................................... 3
`1.3
`Product Information....................................................................................................... 3
`2 METHODS AND MATERIALS ............................................................................................ 3
`2.1
`Search Criteria................................................................................................................ 4
`2.2
`FDA Prescription Analysis Studies................................................................................ 4
`2.3
`External Proprietary Name Risk Assessment ................................................................ 5
`3 RESULTS................................................................................................................................ 5
`3.1
`Database and Information Sources................................................................................. 5
`3.2
`CDER Expert Panel Discussion..................................................................................... 5
`3.3
`FDA Prescription Analysis Studies................................................................................ 5
`3.4
`External Proprietary Name study................................................................................... 5
`3.5
`Comments from the Division of Psychiatry Products (DPP)......................................... 6
`3.6
`Safety Evaluator Risk Assessment................................................................................. 6
`4 DISCUSSION ......................................................................................................................... 6
`4.1
`Promotional Assessment................................................................................................ 6
`4.2
`Safety Assessment.......................................................................................................... 6
`5 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 7
`5.1
`Comments To The Applicant......................................................................................... 7
`6 REFERENCES........................................................................................................................ 8
`APPENDICES................................................................................................................................. 9
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`Reference ID: 2864213
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`EXECUTIVE SUMMARY
`This review summarizes DMEPA’s proprietary name risk assessment of Viibryd for Vilazodone Hydrochloride
`Tablets, 10 mg, 20 mg, and 40 mg. Our evaluation did not identify concerns that would render the name
`unacceptable based on the product characteristics and safety profile known at the time of this review. Thus,
`DMEPA finds the proposed proprietary name, Viibryd, acceptable for this product. The proposed proprietary
`name must be re-reviewed 90 days before approval of the NDA. The Applicant will be notified via letter of
`these findings.
`Additionally, if any of the proposed product characteristics as stated in this review are altered, DMEPA
`rescinds this finding and the name must be resubmitted for review. The conclusions upon re-review are subject
`to change.
`
`1 BACKGROUND
`
`1.1
`INTRODUCTION
`This review responds to an August 23, 2010 request from PGxHealth, LLC for an assessment of the proposed
`proprietary name, Viibryd, regarding potential name confusion with other proprietary or established drug
`names in the usual practice settings. The Applicant submitted an independent name assessment completed by
`
`Additionally, the container labels, carton and insert labeling are being evaluated for their potential contribution
`to medication errors under separate cover (OSE Review 2010-826).
`
`1.2 REGULATORY HISTORY
` for our evaluation. DMEPA found the name
`The Applicant initially submitted the proposed name,
`unacceptable (see OSE Review 2010-967, dated August 2, 2010)
`
`
`Thus, the Applicant has submitted the proposed name, Viibryd, for our evaluation.
`
`
`
`1.3 PRODUCT INFORMATION
`Viibryd is the proposed proprietary name for Vilazodone Tablets. Viibryd is a dual-acting selective serotonin
`reuptake inhibitor and 5-HT1A receptor partial agonist, indicated for the treatment of major depressive disorder.
`The recommended dosage is 40 mg once daily. Viibryd should be titrated, starting with an initial dose of
`10 mg once daily for seven days followed by 20 mg once daily for an additional seven days. Viibryd will be
`supplied in 10 mg, 20 mg, and 40 mg strengths. The following packaging configurations will be available:
`30-count, 90-count, 500-count, 10 x 10 count blister cards, and a 30-count titration pack. Viibryd should be
`stored at room temperature.
`
`2 METHODS AND MATERIALS
`Appendix A describes the general methods and materials used by the Division of Medication Error Prevention
`and Analysis (DMEPA) when conducting a proprietary name risk assessment for all proprietary names.
`Sections 2.1, 2.2, and 2.3 identify specific information associated with the methodology for the proposed
`proprietary name, Viibryd.
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`Reference ID: 2864213
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`2.1 SEARCH CRITERIA
`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.1,2
`To identify drug names that may look similar to Viibryd, the DMEPA Safety Evaluators also consider the
`orthographic appearance of the name on lined and unlined orders. Specific attributes taken into consideration
`include the length of the name (seven letters), upstrokes (two, lower case ‘b’ and ‘d’), downstrokes (one, lower
`case ‘y’), cross strokes (none), and dotted letters (two, lower case ‘i’ and ‘i’). Additionally, several letters in
`Viibryd may be vulnerable to ambiguity when scripted (see Appendix B). As a result, the DMEPA Safety
`Evaluators also considers these alternate appearances when identifying drug names that may look similar to
`Viibryd.
`When searching to identify potential names that may sound similar to Viibryd, the DMEPA Safety Evaluators
`search for names with similar number of syllables (two), stresses (VII-bryd or vii-BRYD), and placement of
`vowel and consonant sounds. Additionally, the DMEPA Safety Evaluators consider that pronunciation of parts
`of the name can vary (see Appendix B). The Applicant’s intended pronunciation of the name is
`“VYE-brid”. However, names are often mispronounced and/or spoken with regional accents and dialects, so
`other potential pronunciations of the name are considered.
`
`2.2 FDA PRESCRIPTION ANALYSIS STUDIES
`In order to evaluate the potential for misinterpretation of the proposed proprietary name in handwriting and
`verbal communication of the name, the following inpatient medication order, outpatient and verbal prescription
`was communicated during the FDA prescription studies.
`
`Figure 1. Viibryd Prescription Studies (conducted on September 2, 2010)
`
`
`HANDWRITTEN REQUISITION MEDICATION
`ORDER
`
`VERBAL
`PRESCRIPTION
`
`Inpatient Medication Order:
`
`“Viibryd 40 mg po once
`daily”
`
`Outpatient Prescription:
`
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`1 Institute for Safe Medication Practices. Confused Drug Name List (1996-2006). Available at
`http://www.ismp.org/Tools/confuseddrugnames.pdf
`2 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artificial Intelligence in Medicine
`(2005)
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`Reference ID: 2864213
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`2.3 EXTERNAL PROPRIETARY NAME RISK ASSESSMENT
`
`For this product, the Applicant submitted an external evaluation of the proposed proprietary name. The
`Division of Medication Error Prevention and Analysis conducts an independent analysis and evaluation of the
`data provided, and responds to the overall findings of the assessment. When the external proprietary name risk
`assessment identifies potentially confusing names that were not captured in DMEPA’s database searches or in
`the Expert Panel Discussion, these names are included in the Safety Evaluator’s Risk Assessment and analyzed
`independently by the Safety Evaluator to determine if the potentially confusing name could lead to medication
`errors in usual practice settings.
`
`After the Safety Evaluator has determined the overall risk associated with the proposed name, the Safety
`Evaluator compares the findings of their overall risk assessment with the findings of the proprietary name
`risk assessment submitted by the Applicant. The Safety Evaluator then determines whether the Division’s
`risk assessment concurs or differs with the findings. When the proprietary name risk assessments differ,
`the Division of Medication Error Prevention and Analysis provides a detailed explanation of these differences.
`
`3 RESULTS
`The following sections describe DMEPA’s findings from the database searches, CDER Expert Panel
`Discussion, FDA prescription analysis studies, and the external proprietary name study.
`
`3.1 DATABASE AND INFORMATION SOURCES
`The DMEPA searches yielded a total of 17 names as having some similarity to the name Viibryd.
`Eight of the 17 names were thought to look like Viibryd. These names are Velban, Valcyte, Librium, Vazobid,
`Vidaza, Nuvigil, Uracid, and Urised. Two of the names were thought to sound like Viibryd. These names are
`Zegerid and Vpriv. The remaining seven names, Vibradox, Vibramycin, Veripred, Vibra-Tabs, Vibativ,
`VIGIV, and Viread were thought to look and sound similar to Viibryd.
`Additionally, DMEPA Safety Evaluators did not identify any United States Adopted Names (USAN) stems in
`the proposed proprietary name as of September 2, 2010.
`
`3.2 CDER EXPERT PANEL DISCUSSION
`The Expert Panel reviewed the pool of names identified by DMEPA Safety Evaluators (see Section 3.1 above)
`and noted no additional names thought to have orthographic or phonetic similarity Viibryd. However, the
`panel commented: “Analyze the name with one ‘i’, two e’s, one ‘u’, ‘ie’, and ‘w’.”
`DDMAC had no concerns regarding the proposed name from a promotional perspective and did not offer any
`additional comments relating to the proposed name.
`
`3.3 FDA PRESCRIPTION ANALYSIS STUDIES
`A total of 34 practitioners responded. Eleven practitioners interpreted the name correctly as “Viibryd”. The
`remainder of the practitioners misinterpreted the drug name. None of the responses overlapped with any
`existing or proposed drug names. In the verbal studies, all responses were misspelled phonetic variations of the
`proposed name, Viibryd. See Appendix C for the complete listing of interpretations from the verbal and
`written prescription studies.
`
`3.4 EXTERNAL PROPRIETARY NAME STUDY
` concluded
`The proposed name risk assessment submitted by the Applicant and conducted by
`that the proposed name did not pose a risk for confusion.
` identified and evaluated a total of
`six drug names for their potential confusion with the proposed proprietary name Viibryd.
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`Reference ID: 2864213
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`Five of the six names (Nuvigil, Vibra-Tabs, Vibramycin, Veetids, and Viread) were identified by DMEPA
`Safety Evaluators. The one name not identified by DMEPA, Vicodin, was added to the list and evaluated in
`our risk assessment of this name (see Section 4.2).
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`3.5
`
` COMMENTS FROM THE DIVISION OF PSYCHIATRY PRODUCTS (DPP)
`
`3.5.1 Initial Phase of Review
`In response to the email sent to the Division of Psychiatry Products (DPP) on September 2, 2010, DPP stated
`“We have no concerns.”
`
`3.5.2 Midpoint of Review
`On November 3, 2010, DMEPA notified DPP via e-mail that we had no objections to the proposed proprietary
`name, Viibryd. Per e-mail correspondence from DPP on November 8, 2010, the Division stated “We have no
`objections.”
`
`3.6 SAFETY EVALUATOR RISK ASSESSMENT
`Independent searches by the primary Safety Evaluator resulted in identification of four additional names which
`were thought to look or sound similar to Viibryd and represent a potential source of drug name confusion. The
`names identified to have look-alike similarities are Lubrin, Lubrex, and Valtrex. The name, Veetids, was
`identified to have look-alike and sound-alike similarities .
`
`was added to the list of names for inclusion in this review.
`Thus, we evaluated a total of 23 names: 17 identified in Database and Information Sources (Section 3.1), one
`identified in the External Study (Section 3.4), and five identified in this section by the primary Safety
`Evaluator.
`
`
` Therefore, Vyvanse
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`4 DISCUSSION
`This proposed name was evaluated from a safety and promotional perspective based on the product
`characteristics provided by the Applicant. We sought input from pertinent disciplines involved with the review
`of this application and considered it accordingly.
`
`4.1 PROMOTIONAL ASSESSMENT
`DDMAC evaluated the name Viibryd from a promotional perspective and determined the name was acceptable.
`The Division of Psychiatry Products and the Division of Medication Error Prevention and Analysis concurred
`with this assessment.
`
`4.2 SAFETY ASSESSMENT
`In total, 23 names were identified as potential sources of name confusion with the proposed proprietary name,
`Viibryd. DMEPA did not identify other aspects of the name that could function as a source of error. Ten of the
`23 names were eliminated for the following reasons: nine names lack orthographic and/or phonetic similarity
`and one name is a foreign drug name (see Appendices D and E).
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`Reference ID: 2864213
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`Failure mode and effects analysis (FMEA) was then conducted to determine if the proposed name could
`potentially be confused with the remaining 13 names and lead to medication errors.
`This analysis determined that the name similarity between Viibryd and these 13 products is unlikely to result in
`medication errors for the reasons presented in Appendices F and G. This finding is consistent with and
`supported by an independent risk assessment of the proprietary name submitted by the Applicant.
`
`5 CONCLUSIONS AND RECOMMENDATIONS
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Viibryd, is not promotional
`nor is it vulnerable to name confusion that could lead to medication errors. Thus, the Division of Medication
`Error Prevention and Analysis (DMEPA) has no objection to the proprietary name, Viibryd, for this product at
`this time.
`However, if any of the proposed product characteristics as stated in this review are altered prior to approval of
`this product, DMEPA rescinds this Risk Assessment finding and the name must 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. If the approval of this application is delayed beyond 90 days from the signature date of this
`review, the proposed name must be re-evaluated. If you have further questions or need clarifications, please
`contact Sandra Griffith, OSE Project Manager, at 301-796-2445.
`
`5.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Viibryd, and have concluded that it is
`acceptable. Viibryd will be re-reviewed 90 days prior to the approval of the NDA. If we find the name
`unacceptable following the re-review, we will notify you.
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`Reference ID: 2864213
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`6 REFERENCES
`
`1. Micromedex Integrated Index (http://csi.micromedex.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 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. This is a database which was created for the Division of Medication Error Prevention and
`Analysis, FDA.
`
`3. Drug Facts and Comparisons, online version, St. Louis, MO (http://factsandcomparisons.com)
`Drug Facts and Comparisons is a compendium organized by therapeutic course; contains monographs on
`prescription and OTC drugs, with charts comparing similar products.
`
`4. FDA Document Archiving, Reporting & Regulatory Tracking System [DARRTS]
`DARRTS is a government database used to organize Applicant and Sponsor submissions as well as to
`store and organize assignments, reviews, and communications from the review divisions.
`
`5. Division of Medication Errors Prevention and Analysis proprietary name consultation requests
`This is a list of proposed and pending names that is generated by the Division of Medication Error
`Prevention and Analysis from the Access database/tracking system.
`
`6. Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`Drugs@FDA contains most of the drug products approved since 1939. The majority of labels, approval
`letters, reviews, and other information are available for drug products approved from 1998 to the present.
`Drugs@FDA contains official information about FDA approved brand name, generic drugs, therapeutic
`biological products, prescription and over-the-counter human drugs and discontinued drugs and
`“Chemical Type 6” approvals.
`
`7. Electronic online version of the FDA Orange Book (http://www.fda.gov/cder/ob/default.htm)
`Provides a compilation of approved drug products with therapeutic equivalence evaluations.
`
`8. U.S. Patent and Trademark Office (http://www.uspto.gov)
`Provides information regarding patent and trademarks.
`
`9. Clinical Pharmacology Online (www.clinicalpharmacology-ip.com)
`Contains full monographs for the most common drugs in clinical use, plus mini monographs covering
`investigational, less common, combination, nutraceutical and nutritional products. Provides a keyword
`search engine.
`
`Reference ID: 2864213
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`10. Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available at (www.thomson-
`thomson.com)
`The Pharma In-Use Search database contains over 400,000 unique pharmaceutical trademarks and trade
`names that are used in about 50 countries worldwide. The data is provided under license by IMS
`HEALTH.
`
`11. Natural Medicines Comprehensive Databases (www.naturaldatabase.com)
`Contains up-to-date clinical data on the natural medicines, herbal medicines, and dietary supplements used
`in the western world.
`
`12. Stat!Ref (www.statref.com)
`Contains full-text information from approximately 30 texts. Includes tables and references. Among the
`database titles are: Handbook of Adverse Drug Interactions, Rudolph’s Pediatrics, Basic Clinical
`Pharmacology and Dictionary of Medical Acronyms Abbreviations.
`
`13. USAN Stems (http://www.ama-assn.org/ama/pub/category/4782.html)
`List contains all the recognized USAN stems.
`
`14. Red Book Pharmacy’s Fundamental Reference
`Contains prices and product information for prescription, over-the-counter drugs, medical devices, and
`accessories.
`
`15. Lexi-Comp (www.lexi.com)
`A web-based searchable version of the Drug Information Handbook.
`
`16. Medical Abbreviations Book
`Contains commonly used medical abbreviations and their definitions.
`
`APPENDICES
`Appendix A:
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name and the proprietary and established names of drug products existing in the marketplace and
`those pending IND, NDA, BLA, and ANDA products currently under review by the Center. 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. 3
`For the proposed proprietary name, DMEPA Safety Evaluators search a standard set of databases and
`information sources to identify names with orthographic and phonetic similarity and hold a Center for Drug
`Evaluation and Research (CDER) Expert Panel discussion to gather professional opinions on the safety of the
`proposed proprietary name. DMEPA Safety Evaluators also conduct internal CDER prescription analysis
`studies. When provided, DMEPA considers external prescription analysis study results and incorporate into the
`overall risk assessment.
`
`
`3 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerp.org/aboutMedErrors.html. Last accessed 10/11/2007.
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`Reference ID: 2864213
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`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. DMEPA bases
`the overall risk assessment on the findings of a Failure Mode and Effects Analysis (FMEA) of the proprietary
`name, and focuses on the avoidance of medication errors.
`FMEA is a systematic tool for evaluating a process and identifying where and how it might fail. 4 DMEPA
`uses FMEA to analyze whether the drug names identified with orthographic or phonetic similarity to the
`proposed proprietary name could cause confusion that subsequently leads to medication errors in the clinical
`setting. DMEPA uses the clinical expertise of its Safety Evaluators to anticipate the conditions of the clinical
`setting where the product is likely to be used 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. Accordingly, the DMEPA Safety Evaluators consider the product
`characteristics associated with the proposed drug throughout the risk assessment because 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 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. Because drug name confusion can occur at any point
`in the medication use process, DMEPA Safety Evaluators consider 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.5 DMEPA provides the product characteristics
`considered for this review in section one.
`The Division of Medication Error Prevention and Analysis considers the spelling of the name, pronunciation of the
`name when spoken, and appearance of the name when scripted. DMEPA also compares the spelling of the
`proposed proprietary name with the proprietary and established name of existing and proposed drug products
`because similarly in spelled names may have greater likelihood to sound similar to one another when spoken or look
`similar to one another when scripted. DMEPA Safety Evaluators also examine the orthographic appearance of the
`proposed name using a number of different handwriting samples. Handwritten communication of drug names has a
`long-standing association with drug name confusion. Handwriting can cause similarly and even dissimilarly spelled
`drug name pairs to appear very similar to one another. The similar appearance of drug names when scripted has led
`to medication errors. The DMEPA Safety Evaluators apply expertise gained from root-cause analysis of such
`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). In addition, the
`DMEPA Safety Evaluators compare 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. If provided,
`DMEPA will consider the Applicant’s intended pronunciation of the proprietary name. However, DMEPA also
`considers a variety of pronunciations that could occur in the English language because the Applicant has little
`control over how the name will be spoken in clinical practice.
`
`
`4 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
`5 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
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`Reference ID: 2864213
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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
`
`Identical prefix
`Identical infix
`Identical suffix
`Length of the name
`Overlapping product characteristics
`
`Similar spelling
`Length of the name
`Upstrokes
`Down strokes
`Cross-stokes
`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
`
`Potential Effects
`
`• 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
`
`• Names may sound similar when
`pronounced and lead to drug name
`confusion in verbal communication
`
`Type of
`similarity Potential causes
`of drug name
`similarity
`
`
`
`
`
`
`Look-
`alike
`
`Similar spelling
`
`
`Orthographic
`similarity
`
`Sound-
`alike
`
`Phonetic similarity
`
`
`
`Lastly, the DMEPA Safety Evaluators also consider 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 safety of
`the proposed proprietary name or product based on professional experience with medication errors.
`
`1. Database and Information Sources
`DMEPA Safety Evaluators conduct searches 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
`the proposed proprietary name using the criteria outlined in Section 2.1. Section 6 provides a standard
`description of the databases used in the searches. To complement the process, the DMEPA Safety Evaluators
`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 DMEPA Safety Evaluators review the USAN stem list to determine if any USAN stems
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`Reference ID: 2864213
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`are present within the proprietary name. The individual findings of multiple safety evaluators are pooled and
`presented to the CDER Expert Panel.
`
`2. CDER Expert Panel Discussion
`DMEPA conducts an Expert Panel Discussion to gather CDER professional opinions on the safety of the
`proposed product and the proposed proprietary name. The Expert Panel is composed of Division of Medication
`Errors Prevention (DMEPA) Safety Evaluators and representatives from the Division of Drug Marketing,
`Advertising, and Communications (DDMAC). 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 DMEPA staff 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 primary Safety Evaluator to supplement the
`pooled results, or general advice to consider when reviewing the proposed proprietary name.
`
`3. FDA Prescription Analysis 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 outpatient prescriptions are written, each
`consisting of a combination of marketed and unapproved drug products, including the proposed name. These
`orders are optically scanned and one prescription is delivered to a random sample of the 123 participating
`health professionals via e-mail. In addition, a verbal prescription is recorded on voice mail. The v