CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`202324Orig1s000
`
`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
`Office of Medication Error Prevention and Risk Management
`
`
`Proprietary Name Review--Final
`
`Date
`
`
`
`January 19, 2012
`
`Reviewer(s)
`
`
`
`Team Leader
`
`
`
`Division Director
`
`
`Drug Name(s) and Strength(s)
`
`
`
`
`
`Application Type/Number:
`
`Applicant
`
`OSE RCM #
`
`
`
`
` Denise V. Baugh, PharmD, BCPS
`Division of Medication Error Prevention and Analysis
`Lubna Merchant, PharmD, M.S.
`Division of Medication Error Prevention and Analysis
`Carol Holquist, R.Ph.
`Division of Medication Error Prevention and Analysis
`Inlyta (Axitinib) Tablets
`1 mg, 5 mg
`NDA 202324
`Pfizer, Inc.
`2011-3245
`
`
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`
`
`
`
`Reference ID: 3074298
`
`
`
`
`
`
`
`
`
`
`
`
`1
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`

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`
`
`CONTENTS
`INTRODUCTION......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION.................................................................................................................. 3
`3 CONCLUSIONS........................................................................................................................................... 3
`4 REFERENCES.............................................................................................................................................. 4
`
`Reference ID: 3074298
`
`
`2
`
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`
`
` 1
`
`
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Inlyta is written in response to the anticipated
`approval of this NDA within 90 days from the date of this review. DMEPA found the proposed name,
`Inlyta, acceptable in OSE Review 2011-1314 dated July 7, 2011.
`
`2 METHODS AND DISCUSSION
`For re-assessments of proposed proprietary names, DMEPA searches a standard set of databases and
`information sources (see section 4) to identify names with orthographic and phonetic similarity to the
`proposed name that have been approved since the previous OSE proprietary name review. For this
`review we used the same search criteria described in OSE Review # 2011-1314. Since none of the
`proposed product characteristics were altered we did not re-evaluate previous names of concern. The
`searches of the databases yielded no new names, thought to look or sound similar to Inlyta and
`represent a potential source of drug name confusion.
`Additionally, DMEPA searched the USAN stem list to determine if the name contains any USAN
`stems as of the last USAN updates. The Safety Evaluator did not identify any United States Adopted
`Names (USAN) stems in the proposed proprietary name, as of January 9, 2012. The Office of
`Prescription Drug Promotion (OPDP) re-reviewed the proposed name on November 10, 2011 and had
`no concerns regarding the proposed name from a promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Inlyta, did not identify any vulnerability that
`would result in medication errors with any additional name(s) noted in this review. Thus, DMEPA has
`no objection to the proprietary name, Inlyta, for this product at this time.
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days
`from the date of this review, the Office of Drug Oncology Products should notify DMEPA because
`the proprietary name must be re-reviewed prior to the new approval date.
`If you have further questions or need clarifications, please contact Mark Liberatore, OSE project
`manager, at 301-796-2221.
`
`
`
`
`Reference ID: 3074298
`
`
`3
`
`

`

`
`
`4 REFERENCES
`1.
`OSE Reviews
`OSE Review# 2009-150. DMEPA Proprietary Name Review for Inlyta (Axitinib) Tablets 1mg and 5 mg;
`Richard Abate, RPh, MS, May 22, 2009.
`OSE Review# 2011-1314. DMEPA Proprietary Name Review for Inlyta (Axitinib) Tablets 1mg and 5 mg;
`Denise V. Baugh, PharmD, BCPS, July 7, 2011.
`
`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`Drugs@FDA contains most of the drug products approved since 1939. The majority of labels,
`approval letters, reviews, and other information are available for drug products approved from 1998 to
`the present. Drugs@FDA contains official information about FDA approved brand name, generic
`drugs, therapeutic biological products, prescription and over-the-counter human drugs and discontinued
`drugs and “Chemical Type 6” approvals.
`
`USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical-science/united-states-
`adopted-names-council/naming-guidelines/approved-stems.page?)
`USAN Stems List contains all the recognized USAN stems.
`
`Division of Medication Error Prevention and Analysis Proprietary Name Consultation Request
`Compiled list of proposed proprietary names submitted to the Division of Medication Error Prevention
`and Analysis for review. The list is generated on a weekly basis from the Access database/tracking
`system.
`
`2.
`
`3.
`
`4.
`
`
`
`
`
`Reference ID: 3074298
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`4
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`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`DENISE V BAUGH
`01/19/2012
`
`LUBNA A MERCHANT
`01/19/2012
`
`CAROL A HOLQUIST
`01/19/2012
`
`Reference ID: 3074298
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`July 7, 2011
`
`NDA 202324
`
`
`
`Date:
`
`Application
`Types/Numbers:
`
`Through:
`
`From:
`
`Subject:
`
`Todd Bridges, RPh, Team Leader
`Kellie Taylor, PharmD, MPH, Associate Director
`Carol Holquist, RPh, Division Director
`Division of Medication Error Prevention and Analysis
`
`Denise V. Baugh, PharmD, BCPS, Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`Proprietary Name Review
`
`Inlyta (Axitinib) Tablets
`1 mg, 5 mg
`
`Pfizer, Inc.
`
`2011-1314
`
`*** Note: This review contains proprietary and confidential information that should not be
`released to the public.**
`
`
`Drug Name and
`Strengths:
`
`Applicant:
`
`OSE RCM #:
`
`
`
`
`
`
`
`Reference ID: 2970765
`
`
`
`

`

`
`
`CONTENTS
`
`EXECUTIVE SUMMARY............................................................................................................. 1
`1 BACKGROUND..................................................................................................................... 1
`1.1
`Introduction.................................................................................................................... 1
`1.2
`Regulatory History......................................................................................................... 1
`1.3
`Product Information ....................................................................................................... 1
`2 METHODS AND MATERIALS ............................................................................................ 1
`2.1
`Search Criteria................................................................................................................ 2
`2.2
`FDA Prescription Analysis Studies................................................................................ 2
`3 RESULTS................................................................................................................................ 4
`3.1
`Data base and information sources ................................................................................ 4
`3.2
`CDER Expert panel discussion ...................................................................................... 4
`3.3
`FDA Prescription analysis studies ................................................................................. 4
`3.4
`Comments from the Division of Drug Oncology Products (DDOP) ............................. 4
`3.5
`Safety evaluator risk assessment.................................................................................... 5
`4 DISCUSSION ......................................................................................................................... 5
`4.1
`Promotional Assessment................................................................................................ 5
`4.2
`Safety Assessment.......................................................................................................... 5
`5 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 5
`6
`PRIOR OSE REVIEW ............................................................................................................ 6
`7 REFERENCES........................................................................................................................ 6
`APPENDICES................................................................................................................................. 8
`
`
`
`
`
`Reference ID: 2970765
`
`
`
`

`

`
`
`EXECUTIVE SUMMARY
`This review summarizes DMEPA’s evaluation of the proposed proprietary name, Inlyta for
`Axitinib Tablets. 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, Inlyta, acceptable for this product.
`DMEPA will notify the Applicant of these findings via letter.
`
`1 BACKGROUND
`
`1.1
`INTRODUCTION
`This review responds to a request received from Pfizer, Inc., submitted April 13, 2011, to
`evaluate the proposed proprietary name, Inlyta, regarding promotional concerns and potential
`name confusion with other proprietary or established drug names based on the product
`characteristics provided by the Applicant.
`The Applicant also submitted container labels and carton labeling which will be reviewed under
`separate cover (OSE Review #2011-1316).
`
`1.2 REGULATORY HISTORY
`Axitinib is the established name for the proposed proprietary name, Inlyta, previously found
`acceptable by DMEPA (OSE Review # 2009-150 dated May 22, 2009) under IND# 63,662. No
`product characteristic changes have been made since our last review of this name.
`
`1.3 PRODUCT INFORMATION
`Inlyta (axitinib) tablets is a tyrosine kinase inhibitor which will be indicated for the treatment of
`metastatic renal cell carcinoma after disease progression on prior systemic therapy. The product
`will be available in 1 mg and 5 mg tablets. The intended starting dose for Inlyta will be 5 mg
`(one tablet) taken orally twice a day. The dose may be adjusted upward based on patient
`tolerance or downward based upon adverse drug effects to Inlyta. The other possible doses of
`Inlyta include 2 mg (2 x 1 mg tablets), 3 mg (3 x 1 mg tablets), 7 mg ( 2 x 1 mg and 1 x 5 mg
`tablets) or 10 mg (2 x 5 mg tablets) taken twice daily. Inlyta will be available in bottles
`containing
` tablets which will 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 and 2.2 identify specific information associated with the
`methodology for the proposed proprietary name, Inlyta.
`
`
`
`
`
`
`Reference ID: 2970765
`
`
`1
`
`(b) (4)
`
`(b) (4)
`
`

`

`
`
`
`
`2.1 SEARCH CRITERIA
`For this review, particular consideration was given to drug names beginning with the letter ‘I’
`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 Inlyta, the DMEPA staff also considers the
`orthographic appearance of the name on lined and unlined orders. Specific attributes taken into
`consideration include the length of the name (six letters), upstrokes (three, capital letter ‘I’, and
`lowercase ‘l’ and ‘t’), down strokes (one, lower case ‘y’), cross strokes (one, lower case ‘t’ ), and
`dotted letters (none). Additionally, several letters in Inlyta may be vulnerable to ambiguity when
`scripted (See Appendix B). As a result, the DMEPA staff also considers these alternate
`appearances when identifying drug names that may look similar to Inlyta.
`When searching to identify potential names that may sound similar to Inlyta, the DMEPA staff
`search for names with similar number of syllables (three), stresses (IN-lie-tah, in-LIE-tah, or in-
`lie-TAH), and placement of vowel and consonant sounds. Additionally, the DMEPA staff
`considers that pronunciation of parts of the name can vary such as ‘Inly-‘ may sound like ‘Inligh-’
`or ‘Enlie’(See Appendix B). The Applicant’s intended pronunciation (in-LIE-tah) was also taken
`into consideration, as it was included in the Proprietary Name Review Request. 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, outpatient
`and verbal prescriptions were communicated during the FDA prescription studies.
`
`
`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)
`
`Reference ID: 2970765
`
`
`2
`
`

`

`HANDWRITTEN
`PRESCRIPTION and
`MEDICATION ORDER
`
`Inpatient Prescription:
`
`VERBAL PRESCRIPTION
`
`“lnlyta 5 mg tablets — take 1 tablet
`orally twice daily
`
`Dispense #60"
`
`Reference ID: 2970765
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`3
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`

`
`
` 3
`
` RESULTS
`The following sections describe DMEPA’s findings from the database searches, CDER Expert
`Panel Discussion, and FDA prescription analysis studies.
`
`3.1 DATA BASE AND INFORMATION SOURCES
`The DMEPA safety evaluator searches yielded a total of 23 names as having some similarity to
`the proposed proprietary name Inlyta.
`Eighteen of the 23 names (Trilyte, Levlite, Colyte, Embeda, Ionil-T, Indian Ink, Intal, Infalyte,
`Inspra, Isolyte, Lufyllin, Benlysta, Introl, Intron A, Enlon, Nalfon, Nulev, and Lubrin) were
`thought to look like Inlyta. Five names,
`Onglyza, Emcyt, Kinlytic, and Inlyta were
`thought to look and sound like Inlyta.
`A search of the United States Adopted Name stem list on June 19, 2011, did not identify any
`United States Adopted Names (USAN) stem within the proposed name, Inlyta.
`
`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 did not identify additional names which were thought to have phonetic or
`orthographic similarity to Inlyta.
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did
`not offer any additional comments relating to the proposed proprietary name.
`
`3.3 FDA PRESCRIPTION ANALYSIS STUDIES
`A total of 27 practitioners responded and none of the names overlapped with existing names.
`Seventeen (n = 17) of the participants interpreted the name correctly as ‘Inlyta’ with correct
`interpretation occurring in the inpatient (n = 8) and outpatient (n = 9) studies. The remainder of
`the responses misinterpreted the drug name. Common misinterpretations included mistaking the
`first letter ‘I’ for the letter ‘E and the letter ‘y’ for ‘i’ or ‘ee’ or ‘ea’. See Appendix C for the
`complete listing of interpretations from the verbal and written prescription studies.
`
`3.4 COMMENTS FROM THE DIVISION OF DRUG ONCOLOGY PRODUCTS (DDOP)
`
`3.4.1 Initial Phase of Review
`In response to the OSE April 28, 2011, e-mail, the Division of Drug Oncology Products stated
`that the Division is “fine with the name Inlyta, no issues”.
`
`3.4.2 Midpoint of Review
`On June 30, 2011, DMEPA notified DDOP via e-mail that we find the name, Inlyta, acceptable.
`Per e-mail correspondence from DDOP on July 7, 2011, they “had no objections” to the proposed
`name, Inlyta.
`
`Reference ID: 2970765
`
`
`4
`
`(b) (4)
`
`

`

`
`
`
`
`3.5 SAFETY EVALUATOR RISK ASSESSMENT
`Nine names (Trilyte, Colyte, Intal, Inspra, Isolyte, Emcyte, Kinlytic, Inlyta, and Enlon) were
`identified in our databases as well as in our previous review (OSE Review # 2009-150 dated May
`22, 2009) and there were no changes in product characteristics. Therefore, these names were not
`evaluated further. Additionally, the primary safety evaluator identified one additional name,
`‘Isoptin’, thought to look similar to Inlyta and represent a potential source of drug name
`confusion.
`As such, a total of 15 names were further analyzed to determine if the drug names could be
`confused with Inlyta and if the drug name confusion would likely result in a medication error in
`the usual practice setting. Fourteen new names were identified in our database search and one
`name was identified in our independent search of names similar to Inlyta.
`
`4 DISCUSSION
`The proposed name, Inlyta, was evaluated from a safety and promotional perspective based on the
`product characteristics provided by the Applicant. Furthermore, we sought input from pertinent
`disciplines involved with the review of this application and considered it accordingly.
`
`4.1 PROMOTIONAL ASSESSMENT
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did
`not offer any additional comments relating to the proposed name. The Division of Drug
`Oncology Products (DDOP), and DMEPA concurred with the promotional assessment.
`
`4.2 SAFETY ASSESSMENT
`DMEPA identified 15 names for their potential similarity to the proposed name, Inlyta. No other
`aspect of the name was identified as a potential source of confusion. Upon evaluation of the
`similar names, ten of the 15 names were eliminated from further consideration for the reasons
`stated in Appendices D through F.
`Failure mode and effects analysis (FMEA) was then applied to determine if the proposed
`proprietary name could potentially be confused with the remaining five names and lead to
`medication errors. This analysis determined that the name similarity between Inlyta and the
`identified names was unlikely to result in medication errors with all of the products identified for
`the reasons presented in Appendix G.
`
`5 CONCLUSIONS AND RECOMMENDATIONS
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Inlyta, is not
`vulnerable to name confusion that could lead to medication errors, nor is it considered
`promotional. Thus, the Division of Medication Error Prevention and Analysis (DMEPA) has no
`objection to the proposed proprietary name, Inlyta, for this product at this time. DMEPA will
`notify the Applicant of this determination via letter.
`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.
`If you have further questions or need clarifications, please contact Sarah Simon, OSE Project
`Manager for the Division of Drug Oncology Products, at 301-796-5205.
`
`Reference ID: 2970765
`
`
`5
`
`

`

`
`
` 6
`
` PRIOR OSE REVIEW
`OSE Review# 2009-150. DMEPA Proprietary Name Review for Inlyta (Axitinib) Tablets 1mg
`and 5 mg; Richard Abate, RPh, MS, May 22, 2009.
`
`7 REFERENCES
`
`1.
`
`2.
`
`Micromedex Integrated Index (http://csi.micromedex.com)
`Micromedex contains a variety of databases covering pharmacology, therapeutics, toxicology
`and diagnostics.
`
`Phonetic and Orthographic Computer Analysis (POCA)
`POCA is a database which was created for the Division of Medication Error Prevention and
`Analysis, FDA. As part of the name similarity assessment, proposed names are evaluated via
`a phonetic/orthographic algorithm. The proposed proprietary name is converted into its
`phonemic representation before it runs through the phonetic algorithm. Likewise, an
`orthographic algorithm exists which operates in a similar fashion.
`
`3.
`
`Drug Facts and Comparisons, online version, St. Louis, MO
`(http://factsandcomparisons.com)
`Drug Facts and Comparisons is a compendium organized by therapeutic course; it contains
`monographs on prescription and OTC drugs, with charts comparing similar products.
`
` FDA Document Archiving, Reporting & Regulatory Tracking System
`4.
`[DARRTS]
`DARRTS is a government database used to organize Applicant and Applicant submissions as
`well as to store and organize assignments, reviews, and communications from the review
`divisions.
`
`5.
`
`6.
`
`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.
`
`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)
`The FDA Orange Book provides a compilation of approved drug products with therapeutic
`equivalence evaluations.
`
`Reference ID: 2970765
`
`
`6
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`

`

`
`
`
`
`U.S. Patent and Trademark Office (http://www.uspto.gov)
`USPTO provides information regarding patent and trademarks.
`
`Clinical Pharmacology Online (www.clinicalpharmacology-ip.com)
`Clinical Pharmacology contains full monographs for the most common drugs in clinical use,
`plus mini monographs covering investigational, less common, combination, nutraceutical and
`nutritional products. It also provides a keyword search engine.
`
`8.
`
`9.
`
`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.
`
`Natural Medicines Comprehensive Databases (www.naturaldatabase.com)
`11.
`Natural Medicines 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)
`Stat!Ref contains full-text information from approximately 30 texts; it includes tables and
`references. Among the database titles are: Handbook of Adverse Drug Interactions, Rudolphs
`Pediatrics, Basic Clinical Pharmacology, and Dictionary of Medical Acronyms
`Abbreviations.
`
`USAN Stems (http://www.ama-assn.org/ama/pub/category/4782.html)
`13.
`USAN Stems List contains all the recognized USAN stems.
`
`Red Book Pharmacy’s Fundamental Reference
`14.
`Red Book contains prices and product information for prescription, over-the-counter drugs,
`medical devices, and accessories.
`
`Lexi-Comp (www.lexi.com)
`15.
`Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
`
`16. Medical Abbreviations Book
`Medical Abbreviations Book contains commonly used medical abbreviations and their
`definitions
`
`Reference ID: 2970765
`
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`
`
`
`
`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 staff 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 staff also conducts 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 proposed proprietary name could cause confusion that subsequently leads to
`medication errors in the clinical setting. DMEPA uses the clinical expertise of its staff to
`anticipate the conditions of the clinical setting where the product is likely to be used based on the
`characteristics of the proposed product.
`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 staff considers 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,
`
`
`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.
`
`Reference ID: 2970765
`
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`
`
`DMEPA staff 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.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
`staff also examines 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 staff applies 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 staff compares the pronunciation of the
`proposed proprietary name with the pronunciation of other drug names because verbal communication
`of medication names is common in clinical settings. 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.
`Table 1. Criteria used to identify drug names that look- or sound-similar to a proposed
`proprietary name.
`
`Type of
`similarity Potential causes
`of drug name
`similarity
`
`Considerations when searching the databases
`
`Attributes examined to identify
`similar drug names
`
`Potential Effects
`
`
`
`
`
`
`Look-
`alike
`
`Similar spelling
`
`
`Identical prefix
`Identical infix
`Identical suffix
`Length of the name
`Overlapping product characteristics
`
`Orthographic
`similarity
`
`Similar spelling
`Length of the name
`Upstrokes
`Down strokes
`Cross-strokes
`Dotted letters
`Ambiguity introduced by scripting
`
`• 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
`
`
`5 Institute of Medicine. Preventing Medication Errors. The National Academies Press:
`Washington DC. 2006.
`
`Reference ID: 2970765
`
`
`9
`
`

`

`Sound-
`alike
`
`Phonetic similarity
`
`
`
`
`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
`
`• Names may sound similar when
`pronounced and lead to drug name
`confusion in verbal communication
`
`
`Lastly, the DMEPA staff also considers the potential for the proposed proprietary name to
`inadvertently function as a source of error for reasons other than name confusion. Post-marketing
`experience has demonstrated that proprietary names (or components of the proprietary name) can
`be a source of error in a variety of ways. Consequently, DMEPA considers and evaluates these
`broader safety implications of the name throughout this assessment and the medication error staff
`provides additional comments related to the safety of the proposed proprietary name or product
`based on professional experience with medication errors.
`
`1. Database and Information Sources
`DMEPA staff conducts 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 staff use a computerized me