CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`200678Orig1s000
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`PROPRIETARY NAME REVIEW(S)
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`Date:
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`Application
`Type/Number:
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`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
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`October 28, 2010
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`NDA 200678
`
`Kristina A. Toliver, PharmD, Team Leader
`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
`
`Kombiglyze XR
`(Saxagliptin and Metformin HCl Extended-release) Tablets
`5 mg/500 mg, 5 mg/1000 mg, and 2.5 mg/1000 mg
`
`Bristol-Myers Squibb Company
`
`2010-387
`
`***This document contains proprietary and confidential information that should not be
`released to the public.***
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`Reference ID: 2856537
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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 ............................................................................................ 4
`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..................................................................................... 6
`3.3
`FDA Prescription Analysis Studies................................................................................ 6
`3.4
`External Proprietary Name study................................................................................... 6
`3.5
`Comments from the Division of Metabolism and Endocrinology Products (DMEP) ... 6
`3.6
`Safety Evaluator Risk Assessment................................................................................. 6
`4 DISCUSSION ......................................................................................................................... 6
`4.1
`Promotional Assessment................................................................................................ 7
`4.2
`Safety Assessment.......................................................................................................... 7
`5 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 7
`5.1
`Comments To The Applicant......................................................................................... 8
`6 REFERENCES........................................................................................................................ 9
`APPENDICES............................................................................................................................... 10
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`EXECUTIVE SUMMARY
`This review summarizes DMEPA’s proprietary name risk assessment of Kombiglyze XR (Saxagliptin and
`Metformin HCl Extended-release) Tablets, 5 mg/500 mg, 5 mg/1000 mg, and 2.5 mg/1000 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,
`Kombiglyze, acceptable for this product. The proposed proprietary name must be re-reviewed 90 days before
`approval of the NDA.
`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 a September 29, 2010 request from Bristol-Myers Squibb Company for assessment of
`the proposed proprietary name, Kombiglyze XR, regarding potential name confusion with other proprietary or
`established drug names in the usual practice settings and promotional concerns. In addition, the Applicant
`submitted an independent name assessment completed by
`.
`
`1.2 REGULATORY HISTORY
` are
`DMEPA previously evaluated three proposed
` (OSE Review 2010-387, dated July
` (OSE Review 2010-387, dated May 27, 2010),
` were found unacceptable by
`13, 2010), and
`. The names
` and conveyed our concerns to the
`DMEPA. We had concerns with the proposed name,
`Applicant in a teleconference held on September 28, 2010. The Applicant withdrew the name
`September 29, 2010. Thus, the name Kombiglyze XR has been submitted for our evaluation.
`
` on
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`1.3 PRODUCT INFORMATION
`Kombiglyze XR is the proposed proprietary name for Saxagliptin/Metformin HCl Extended-release Tablets. It
`contains two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control
`in patients with type 2 diabetes: Saxagliptin (a dipeptidyl peptidase-4 inhibitor) and Metformin Hydrochloride
`(a member of the biguanide class). Kombiglyze XR is indicated as an adjunct to diet and exercise to improve
`glycemic control in adults with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is
`appropriate.
`The dose should be individualized on the basis of the patient’s current regimen, effectiveness and tolerability
`while not exceeding the maximum recommended dose of Saxagliptin 5 mg and Metformin Extended-release
`2000 mg. If therapy with a combination tablet containing Saxagliptin and Metformin is considered appropriate,
`the recommended dose of Saxagliptin is 2.5 mg or 5 mg once daily. The recommended starting dose of
`Metformin Extended-release is 500 mg once daily, which can be titrated to 2000 mg once daily. The maximum
`recommended dose of Kombiglyze XR is 5 mg/2000 mg (taken as two 2.5 mg/1000 mg tablets) once daily.
`Kombiglyze XR will be supplied in the following strengths and quantities: 5 mg/500 mg and 5 mg/1000 mg
`(30-count, 90-count and 500-count bottles) and 2.5 mg/1000 mg (60-count and 500-count bottles).
`Kombiglyze XR should be stored at 20ºC to 25 ºC (68ºF to 77ºF).
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`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, Kombiglyze XR.
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`2.1 SEARCH CRITERIA
`For this review, particular consideration was given to drug names beginning with the letter ‘K’ 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 Kombiglyze XR, 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 (10 letters), upstrokes (two, lower case ‘b’ and ‘l’), downstrokes
`(three, lower case ‘g’, ‘y’, and ‘z’), cross strokes (none), and dotted letters (one, lower case ‘i’). Additionally,
`several letters in Kombiglyze XR 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 Kombiglyze XR.
`When searching to identify potential names that may sound similar to Kombiglyze XR, the DMEPA Safety
`Evaluators search for names with similar number of syllables (three), stresses (KOM-bi-glyze XR, kom-BI-
`glyze XR, or kom-bi-GLYZE XR), 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 “Kom-bee-glyz XR”. However, names are often mispronounced and/or
`spoken with regional accents and dialects, so other potential pronunciations of the name are considered.
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`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.
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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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`Figure 1. Kombiglyze XR Prescription Studies (conducted on October 7, 2010)
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`HANDWRITTEN REQUISITION MEDICATION
`ORDER
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`VERBAL
`PRESCRIPTION
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`Inpatient Medication Order:
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`Outpatient Prescription:
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`Kombiglyze XR
`5 mg/500mg take 1 tab po
`qday. Dispense #30
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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.
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`3 RESULTS
`
`3.1 DATABASE AND INFORMATION SOURCES
`The DMEPA searches yielded a total of 11 names as having some similarity to the name Kombiglyze XR.
`Five of the 11 names were thought to look like Kombiglyze XR. These names are Ranolazine, Razadyne ER,
`Rosiglitazone, Combivent, and Glucophage XR. One of the names, Onglyza, was thought to sound like
`Kombiglyze XR. The remaining five names, Combiflex, Combipres, Combipatch, Combigan, and
`were thought to look and sound similar to Kombiglyze XR.
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`Additionally, DMEPA Safety Evaluators did not identify any United States Adopted Names (USAN) stems in
`the proposed proprietary name as of October 7, 2010.
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`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 to Kombiglyze XR.
`DDMAC had no concerns regarding the proposed name from a promotional perspective and did not offer any
`additional comments relating to the proposed name.
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`3.3 FDA PRESCRIPTION ANALYSIS STUDIES
`A total of 23 practitioners responded. None of the practitioners interpreted the name correctly as “Kombiglyze
`XR”. None of the responses overlapped with any existing or proposed drug names. In the studies, all
`responses were misspelled variations of the proposed name, Kombliglyze XR. In the outpatient written study
`seven of the 12 practitioners misinterpreted the letter ‘K’ as the letter ‘R’ due to the way the letter ‘K’ was
`scripted. See Appendix C for the complete listing of interpretations from the verbal and written prescription
`studies.
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`3.4 EXTERNAL PROPRIETARY NAME STUDY
` found the proposed proprietary
`In the proposed name risk assessment submitted by the Applicant,
`name Kombiglyze XR acceptable.
` did not identify any names that may be vulnerable to confusion
`with the proposed name, Kombiglyze XR. They concluded that Kombiglyze XR has a low vulnerability rating
`which means there were no significant safety issues identified with the name.
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`3.5
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` COMMENTS FROM THE DIVISION OF METABOLISM AND ENDOCRINOLOGY PRODUCTS
`(DMEP)
`
`3.5.1 Initial Phase of Review
`In response to the email sent to the Division of Metabolism and Endocrinology Products (DMEP) on October
`12, 2010, the DMEP clinical reviewer assigned to this application stated “I don't have objections to the
`proposed name Kombiglyze XR (NDA 200678).”
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`3.5.2 Midpoint of Review
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`On October 14, 2010, DMEPA notified DMEP via e-mail that we had no objections to the proposed proprietary
`name, Kombiglyze. DMEP voiced no concerns about the proposed proprietary name, Kombiglyze XR.
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`3.6 SAFETY EVALUATOR RISK ASSESSMENT
`Independent searches by the primary Safety Evaluator resulted in identification of one additional name,
`Xomazyme, which was thought to look similar to Kombiglyze XR and represent a potential source of drug
`name confusion.
`Thus, we evaluated a total of 12 names: 11 identified in Database and Information Sources (Section 3.1) and
`one identified in this section by the primary Safety Evaluator.
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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.
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`4.1 PROMOTIONAL ASSESSMENT
`DDMAC evaluated the name Kombiglyze XR from a promotional perspective and determined the name was
`acceptable. The Division of Metabolism and Endocrinology Products and the Division of Medication Error
`Prevention and Analysis concurred with this assessment.
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`4.2 SAFETY ASSESSMENT
`The safety review considered all sources of potential confusion with the proposed name including orthographic
`and phonetic similarities with currently marketed products and use of the modifier “XR”.
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`4.2.1 Look-Alike and Sound-Alike Analysis
`In total, 12 names were identified as potential sources of name confusion with the proposed proprietary name,
`Kombiglyze XR. DMEPA did not identify other aspects of the name that could function as a source of error.
`Three of the 12 names were not evaluated further for the following reasons: two names lack orthographic
`and/or phonetic similarity and one lacked product characteristic information (see Appendices D and E).
`Failure mode and effects analysis (FMEA) was then applied to determine if the proposed name could
`potentially be confused with the remaining nine names and lead to medication errors.
`This analysis determined that the name similarity between Kombiglyze XR and these nine 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.
`Kombiglyze XR represents a product line extension to the currently marketed product Onglyza (Saxagliptin)
`Tablets 2.5 mg and 5 mg. The applicant has chosen to include the modifier XR to communicate the product is
`an extended-release formulation.
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`4.2.2 Use of the Modifier “XR”
`Kombiglyze XR is being developed as an extended-release formulation with once daily administration. The
`modifier “XR” is commonly used to communicate that a product is an extended-release dosage form with
`once daily or twice daily administration, however, most products with the modifier XR are dosed once daily.
`Since the modifier XR has been used for marketed products taken once daily and has not been cited as a source
`of confusion postmarketing, the modifier is appropriate for this product.
`Additionally, we note there is no currently marketed product that has the root name “Kombiglyze”. Thus, if the
`modifier is dropped from Kombiglyze XR, there is no “Kombiglyze” product available that would present a
`potential source of confusion. Although there is no “Kombiglyze”, we acknowledge that Kombiglyze XR is an
`extended-release product and, thus, the “XR” immediately conveys to healthcare practitioners the extended-
`release properties of the dosage form as well as the frequency of administration that “XR” dosage forms imply.
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`5 CONCLUSIONS AND RECOMMENDATIONS
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Kombiglyze XR, 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, Kombiglyze
`XR, 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 NDA, 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
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`proposed name must be re-evaluated. If you have further questions or need clarifications, please contact
`Margarita Tossa, OSE Project Manager, at 301-796-4053.
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`5.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Kombiglyze XR, and have concluded that it
`is acceptable. Kombiglyze XR 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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`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.
`
`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.
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`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.
`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
`
`3 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerp.org/aboutMedErrors.html. Last accessed 10/11/2007.
`4 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
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`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.
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`5 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
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`Table 1. Criteria used to identify drug names that look- or sound-similar to a proposed proprietary
`name.
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`Considerations when searching the databases
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`Attributes examined to identify
`similar drug names
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`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
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`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
`
`Reference ID: 2856537
`
`
`
`12
`
`

`

`are present within the proprietary name. The individual findings of multiple safety