CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`202788Orig1s000
`
`
`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
`
`Date:
`
`November 7, 2011
`
`Anne Tobenkin, PharmD.
`Reviewer(s):
`Division of Medication Error Prevention and Analysis
`
`Lubna Merchant, PharmD, M.S.
`Team Leader
`Division of Medication Error Prevention and Analysis
`
`Carol Holquist, RPh.
`Division Director
`Division of Medication Error Prevention and Analysis
`
`Drug Name and Strengths: Subsys (Fentanyl) Sublingual Spray, 100 mcg, 200 mcg, 400 mcg,
`600 mcg, 800 mcg per spray
`Application Type/Number: NDA 202788
`Applicant/sponsor:
`Insys Therapeutics
`OSE RCM #:
`2011-1671
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`Reference ID: 3040697
`
`
`

`

`
`
`CONTENTS
`
`INTRODUCTION .......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION ................................................................................................................... 3
`3 CONCLUSIONS............................................................................................................................................. 3
`4 REFERENCES ............................................................................................................................................... 4
`
`Reference ID: 3040697
`
`
`2
`
`

`

`
`
`1
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Subsys 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,
`Subsys, acceptable in OSE Review 2011-1017, dated June 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 2011-1017. Because none of the
`proposed product characteristics were altered we did not re-evaluate previous names of concern. The
`searches of the databases yielded four new names (
` Synagis, Safyral,
`
`thought to look or sound similar to Subsys and represent a potential source of drug name confusion.
`DMEPA bases the overall risk assessment on the findings of a Failure Mode and Effects Analysis
`(FMEA) of the proposed proprietary name, and focuses on the avoidance of medication errors.
`Failure mode and effects analysis was applied to determine if the proposed proprietary name could
`potentially be confused with Subsys and lead to medication errors. This analysis determined that the
`name similarity between Subsys and the identified names was unlikely to result in medication error
`for the reasons presented in Appendix A.
`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 October 28, 2011. OPDP re-reviewed
`the proposed name on October 27, 2011 and had no concerns regarding the proposed name from a
`promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Subsys, did not identify any vulnerabilities that
`would result in medication errors with the additional names noted in this review. Thus, DMEPA has
`no objection to the proprietary name, Subsys, for this product at this time.
`DMEPA considers this a final review; however, if approval of the NDA 202788 is delayed beyond
`90 days from the date of this review, the Division of Analgesia and Anesthesia 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 Danyal Chaudhry, OSE project
`manager, at 301-796-3813.
`
`
`Reference ID: 3040697
`
`
`3
`
`(b) (4)
`
`(b) (4)
`
`

`

`
`
`4 REFERENCES
`1.
`OSE Reviews
`
`OSE Review # 2011-1017. Subsys Proprietary Name Review. Tobenkin, Anne. June 7, 2011.
`
`2.
`
`3.
`
`4.
`
`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/category/4782.html)
`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.
`
`Reference ID: 3040697
`
`
`4
`
`

`

`Appendix A: Proprietary names not likely to be confused or not used in usual practice settings for
`the reasons described.
`
`
`
`Appendix B: FMEA Table
`
`
`
`Reference ID: 3040697
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`5
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`Causes of Failure Mode
`
`Prevention of Failure Mode:
`
`Resulting in Medication
`Error: Incorrect Product
`
`Orthographic/PhonetielProduet Characteristic
`Ditferenees
`
`Ordered/ Selected! Dispensed
`or Administered Because of
`Name confusion
`
`Proposed name:
`Sushsys (Feutauyl)
`
`Strength: 100 meg,
`200 mcg, 400 meg,
`600 meg, 800 meg per
`spray
`
`Dose: 1 to 2 sprays
`sublingually every
`4 hours as needed
`
`
`
`
`Safyral
`(Drosperinone/Ethinyl
`Estradiol/Levomefolate
`
`Orthographic similarity
`- Both names begin with ‘S’
`- Both names have a
`
`and Levomefolate)
`
`- 3 mg/0.04 mg/
`0.451 mg oral tablets and
`0.451 oral tablets
`
`- One tablet once daily or
`as directed
`
`downslroke ‘y’
`- Both names are similar in
`
`length
`
`Product characteristics
`
`- Route of administration (oral)
`
`Synagis (Palivizumab)
`
`Phonetic
`
`- Both names begin with the
`sound “S”
`- Both names end with the
`
`sound “ys”
`
`- 50 mg/0.5 mL.
`100 mg/1 mL injection
`solution
`
`- 15 mg/kg
`intramuscularly once a
`month during
`Respiratory Synctial
`Virus season
`
`Orthographic differences
`- Subsys has two upstrokes vs. Safyral has three
`upstrokes
`- Subsys has one letter after the downstroke vs.
`Safyral has three letters after the downslroke
`
`Differing product characteristics
`- Strength (100 meg: 200 meg. 400 meg. 600 meg:
`800 meg per spray vs. 3 mg/0.04 mg/0.451 mg oral
`tablets and 0.451 oral tablets. single strength, not
`required on prescription)
`- Frequency of administration (every 4 hours as
`needed for ain vs. once dail
`
`Orthographic differences
`- Subsys has two syllables vs. Synagis has three
`syllables
`- The first syllable in Subsys ends with the sound
`“uhb” vs. “in” in Synagis
`
`Differing product characteristics
`- Strength (100 meg, 200 meg. 400 meg, 600 meg,
`800 meg per spray v5.15 mg/kg. weight based
`regimen)
`- Route of administration (oral vs. intramuscular)
`- Frequency of administration (every 4 hours as
`needed for ain vs. once monthl )
`
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`Reference ID: 3040697
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`ANNE C TOBENKIN
`11/07/2011
`
`LUBNA A MERCHANT
`11/07/2011
`
`CAROL A HOLQUIST
`11/08/2011
`
`Reference ID: 3040697
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Medication Error Prevention and Risk Management
`Office of Surveillance and Epidemiology
`
`
`
`Date:
`To:
`Through:
`
`From:
`
`June 7, 2011
`Bob Rappaport
`Melina Griffis, RPh, Team Leader
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`Anne Crandall, RPh, PharmD, Safety Evaluator
`Division of Medication Error Prevention and Analysis (DMEPA)
`Proprietary Name Review
`Subsys (Fentanyl) Sublingual Spray
`100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg per spray
`Application Type/Number: NDA 202788
`Applicant:
`Insys Therapeutics
`OSE RCM #:
`2011-1017
`*** This document contains proprietary and confidential information that should not be released
`to the public. ***
`
`
`
`
`Subject:
`Drug Name(s):
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 2956881
`
`

`

`CONTENTS
`EXECUTIVE SUMMARY............................................................................................................. 3
`1 BACKGROUND..................................................................................................................... 3
`1.1
`Introduction.................................................................................................................... 3
`1.2
`Product Information ....................................................................................................... 3
`2 METHODS AND MATERIALS ............................................................................................ 3
`2.1
`Search Criteria................................................................................................................ 3
`2.2
`FDA Prescription Analysis Studies................................................................................ 4
`2.3
`External Proprietary Name Risk Assessment ................................................................ 4
`3 RESULTS................................................................................................................................ 4
`3.1
`Database and Information Sources................................................................................. 5
`3.2
`Expert Panel Discussion................................................................................................. 5
`3.3
`FDA Prescription Analysis Studies................................................................................ 5
`3.4
`External Proprietary Name Risk Assessments............................................................... 5
`3.5
`Comments from the Review Division............................................................................ 5
`3.6
`Safety Evaluator Risk Assessment................................................................................. 6
`4 DISCUSSION ......................................................................................................................... 6
`4.1
`Promotional Assessment................................................................................................ 6
`4.2
`Sound-alike and Look-alike Assessment of Subsys....................................................... 6
`5 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 6
`5.1
`Comments To The Applicant......................................................................................... 7
`6 REFERENCES........................................................................................................................ 8
`APPENDICES................................................................................................................................. 9
`
`
`
`Reference ID: 2956881
`
`2
`
`

`

`
`EXECUTIVE SUMMARY
`This review summarizes the proprietary name evaluation of Subsys (Fentanyl) Sublingual Spray. 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. Our findings are consistent with the
`findings of the findings of the External Proprietary Name Risk Assessment submitted by the Applicant.
`Thus, DMEPA finds the proposed proprietary name, Subsys, acceptable for this product.
`The proposed proprietary name, Subsys, 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.
`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 the March 14, 2011 request from Insys Therapeutics, for DMEPA’s assessment
`of the proposed proprietary name, Subsys, regarding potential name confusion with other proprietary or
`established drug names, as well as promotional review. The Applicant submitted an Independent Name
`Assessment with the proprietary name review request. Container labels, carton and package insert
`labeling were submitted on March 3, 2011 and will be reviewed under a separate cover, OSE review #
`2011-1019.
`
`1.2 PRODUCT INFORMATION
`The proposed indication for Subsys (Fentanyl) sublingual spray is for the management of breakthrough
`cancer pain in opioid-tolerant patients. Subsys will be available as 100 mcg, 200 mcg, 400 mcg, 600 mcg
`and 800 mcg per spray single use bottles which are contained in individually sealed child-resistant blister
`packages. The recommended starting dose is 100 mcg. The usual dose is 1 or 2 sprays sublingually
`administered at no more then every four hours. The maximum daily dose is 6400 mcg. Subsys will be
`supplied in a single use spray device in individually wrapped, child-resistant, protective blister packs
`packaged in 6, 14 and 28 cartons.
`
`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, Subsys.
`
`2.1 SEARCH CRITERIA
`The DMEPA safety evaluators consider the spelling of the name, pronunciation of the name when
`spoken, and appearance of the name when scripted as outlined in Appendix A.
`
`Reference ID: 2956881
`
`3
`
`

`

`For this review, particular consideration was given to drug names beginning with the letter ‘S’ 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 Subsys, 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 (six letters), upstrokes (two, capital letter ‘S’ and lower case
`letter ‘b’); downstrokes (one, ‘y’), cross-strokes (none), and dotted letters (none). Additionally, several
`letters in Subsys may be vulnerable to ambiguity when scripted (see Appendix B). As a result, the
`DMEPA safety evaluators also consider these alternate appearances when identifying drug names that
`may look similar to Subsys
`When searching to identify potential names that may sound similar to Subsys, DMEPA safety evaluators
`search for names with similar number of syllables (two), stresses (SUB-sys, sub-SYS), and placement of
`vowel and consonant sounds. Additionally, several letters in Subsys may be subject to interpretation
`when spoken (see Appendix B). The Applicant’s intended pronunciation of the proprietary name
`(sub’ sis) was taken into consideration, as this was provided with the proposed name submission, however
`DMEPA understands that pronunciation of the product will vary greatly from region to region and be
`based upon cultural background.
`
`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, an inpatient medication order, outpatient and verbal prescription
`was communicated during the FDA prescription studies (see Appendix C).
`
`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 the results of the proprietary name analysis that were identified during
`this review.
`
`
`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. Artifical Inteligence in Medicine
`(2005)
`
`Reference ID: 2956881
`
`4
`
`

`

`3.1 DATABASE AND INFORMATION SOURCES
`DMEPA safety evaluator searches of the databases and DMEPA’s information sources yielded a total of
`27 names as having some similarity to the name, Subsys.
`Twenty-three (Galzin, Sabril, Anbesol, Ambien, Sulzee, Jujube, Colcrys, Solodyn, Sronyx, Staxyn,
`Sebizon, Lybrel, Symlin, Zyban, Symbyax, Sulamyd, Folotyn, Pegasys, Gilenya, Salagen, Selsun, Soliris,
`and
` of the 27 names were thought to look like Subsys. Three (Subys, Subutex and Subsys) of the
`27 names were thought to both look and sound like Subsys. The remaining name (Saphris) was thought to
`sound like Subsys.
`DMEPA safety evaluators did not identify any United States Adopted Names (USAN) stems in the
`proposed proprietary name, as of April 4, 2011.
`
`3.2 EXPERT PANEL DISCUSSION
`The Expert Panel reviewed the pool of names identified by DMEPA safety evaluators (See Section 3.1
`above) and noted one additional name, Ionsys, thought to have orthographic or phonetic similarity to
`Subsys. The name Ionsys was added to the proprietary name analysis.
`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 thirty (n=31) practitioners responded to the prescription analysis studies. None of the
`practitioner responses overlapped with any existing or proposed drug names, however five of the nine
`respondents in the verbal study misinterpreted the name as “sepsis”. Sixteen (n=16) of the practitioners
`interpreted the name correctly as “Subsys.” The remainder of the practitioners misinterpreted the drug
`name (n=15). The most common misinterpretation was between the letter pair ‘S’ and ‘F’, ‘s’ and ‘a’ and
`‘y’ and ‘i’. See Appendix D for the complete listing of interpretations from the verbal and written
`prescription studies.
`
`3.4 EXTERNAL PROPRIETARY NAME RISK ASSESSMENTS
`The August 24, 2010, submission from the Applicant included a proprietary name analysis conducted by
`the
`
`found the proposed proprietary name, Subsys, acceptable. Their
`study identified and evaluated a total of two names, Pegasys and Stasis, for potential confusion with
`Subsys. DMEPA identified one of the two names (Pegasys) during our database searches. The remaining
`name, Stasis, was added to the DMEPA safety evaluator risk assessment.
`
`3.5 COMMENTS FROM THE REVIEW DIVISION
`
`3.5.1 Initial Phase of Review
`In a response to the OSE April 4, 2011, e-mail, the Division of Anesthesia and Analgesia Products
`(DAAP) did not forward any comments and/or concerns on the proposed name at the initial phase of the
`name review.
`
`Reference ID: 2956881
`
`5
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`3.5.2 Midpoint of Review
`On June 7, 2011, DMEPA notified DAAP via e-mail that we have no objection to the use of the
`proprietary name, Subsys. DAAP indicated that they concur with our assessment of the proposed
`proprietary name, Subsys.
`
`3.6 SAFETY EVALUATOR RISK ASSESSMENT
`Independent searches by the primary safety evaluator identified three additional proprietary names which
`were thought to look or sound similar to Subsys and represent a potential source of drug name confusion.
`All three (Sufenta, Salacyn, and Solage) names were thought to look like Subsys. A total of 32 names
`were identified as having some potential similarity to the proposed name Subsys; 27 from safety evaluator
`searches, one from EPD, one from the external name study, and three from the primary safety evaluator
`search.
`
`4 DISCUSSION
`The proposed name, Subsys, was evaluated from a safety and promotional perspective based on the
`product characteristics provided by the Applicant.
`
`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. DMEPA and the Division of Anesthesia and
`Analgesia products concurred with the findings of the promotional assessment.
`
`4.2 SAFETY ASSESSMENT
`DMEPA identified 32 names with potential similarity to the proposed name, Subsys. No other aspects of
`the proposed proprietary name were identified as a potential source of failure that may lead to medication
`error. Three of the 32 names were not evaluated further for the reasons identified in Appendix E.
`Failure Mode and Effects Analysis was then applied to determine if the proposed name, Subsys, could
`potentially be confused with the remaining 29 names and lead to medication errors. This analysis
`determined that the name similarity between Subsys was unlikely to result in medication errors with any
`of the 29 products for the reasons presented in Appendix F. This finding was consistent with and
`supported by the independent risk assessment of the proprietary name submitted by the Applicant.
`Additionally, DMEPA noted that study participants in the prescription studies thought the name Subsys
`sounded like Sepsis. Although there are phonetic similarities, confusion between Subsys and sepsis will
`be mitigated by dose instructions and frequency of administration following the proprietary name,
`Subsys, which will identify the name as a drug product, rather then a diagnosis or indication.
`
`
`5 CONCLUSIONS AND RECOMMENDATIONS
`The Proprietary Name Risk Assessment findings indicate that the proposed name, Colcrys, is not
`vulnerable to name confusion that could lead to medication errors, nor is it considered promotional. This
`finding was consistent with and supported by an independent risk assessment of the proprietary name
`submitted by the Sponsor. Thus the Division of Medication Error Prevention and Analysis (DMEPA) has
`no objection to the proprietary name, Colcrys, for this product at this time.
`If you have further questions or need clarifications, please contact Danyal Chaudhry, OSE Project
`Manager at 301-796-3813.
`
`
`Reference ID: 2956881
`
`6
`
`

`

`5.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Subsys, and have concluded that it is
`acceptable.
`The proposed proprietary name, Subsys, will be re-reviewed in 90 days prior to the approval of the
`NDA. If we find the name unacceptable following the re-review, we will notify you.
`If any of the proposed product characteristics are altered prior to approval of the marketing application,
`the proprietary name should be resubmitted for review. The conclusions upon re-review are subject to
`change.
`
`
`
`
`
`
`Reference ID: 2956881
`
`7
`
`

`

`6 REFERENCES
`
`Micromedex Integrated Index (http://csi.micromedex.com)
`1.
`Micromedex contains a variety of databases covering pharmacology, therapeutics, toxicology and
`diagnostics.
`
`Phonetic and Orthographic Computer Analysis (POCA)
`2.
`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.
`
`Drug Facts and Comparisons, online version, St. Louis, MO (http://factsandcomparisons.com)
`3.
`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 [DARRTS]
`
`4.
`
`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.
`
`Division of Medication Errors Prevention and Analysis proprietary name consultation requests
`5.
`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)
`6.
`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.
`
`Electronic online version of the FDA Orange Book (http://www.fda.gov/cder/ob/default.htm)
`7.
`The FDA Orange Book provides a compilation of approved drug products with therapeutic equivalence
`evaluations.
`
`U.S. Patent and Trademark Office (http://www.uspto.gov)
`8.
`USPTO provides information regarding patent and trademarks.
`
`Clinical Pharmacology Online (www.clinicalpharmacology-ip.com)
`9.
`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.
`
`Reference ID: 2956881
`
`8
`
`

`

`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.
`
`Medical Abbreviations Book
`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 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.
`
`Reference ID: 2956881
`
`9
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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,