`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`0201280Orig1s000
`
`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
`
`April 8, 2011
`NDA 201280
`
`Date:
`Application
`Type/Number:
`Through:
`
`From:
`
`Zachary Oleszczuk, Pharm.D., Team Leader
`Carol Holquist, R.Ph, Director
`Division of Medication Error Prevention and Analysis
`Yelena Maslov, Pharm.D., Safety Evaluator
`Division of Medication Error Prevention and Analysis
`Proprietary Name Review
`Subject:
`Tradjenta (Linagliptin) Tablets, 5 mg
`Drug Name(s):
`Boehringer Ingelheim Pharmaceuticals, Inc.
`Applicant/sponsor:
`2010-2473
`OSE RCM #:
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 2930326
`
`
`
`CONTENTS
`
`EXECUTIVE SUMMARY............................................................................................................. 3
`1 BACKGROUND..................................................................................................................... 3
`1.1
`Introduction.................................................................................................................... 3
`1.2
`Regulatory History......................................................................................................... 3
` 1.3 Product Information…………………………………………………………………….3
`2 METHODS AND MATERIALS ............................................................................................ 3
`2.1
`Search Criteria................................................................................................................ 3
`2.2
`Prescription Analysis Studies......................................................................................... 4
`2.3
`External Proprietary Name Risk Assessment ................................................................ 5
`3 RESULTS................................................................................................................................ 5
`3.1
`Data base and Information Sources................................................................................ 5
`3.2
`Expert Panel Discussion................................................................................................. 5
`3.3
`Prescription Analysis Studies......................................................................................... 5
`3.4
`External Proprietary Name Risk Assessment ................................................................ 6
`3.5
`Comments from the Division of Metabolism and Endocrinology Products .................. 6
`3.6
`Safety Evaluator Search Results .................................................................................... 6
`4 DISCUSSION ......................................................................................................................... 6
`4.1
`Promotional Assessment................................................................................................ 6
`4.2
`Safety Assessment.......................................................................................................... 6
`5 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 7
`6 REFERENCES........................................................................................................................ 8
`APPENDICES............................................................................................................................... 10
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 2930326
`
`2
`
`
`
`EXECUTIVE SUMMARY
`This review summarizes DMEPA’s evaluation of proposed proprietary name, Tradjenta for
`Linagliptin Tablets. Our evaluation did not identify concerns that would render the name
`unacceptable based on product characteristics and safety profile known at the time of this review.
`Thus, DMEPA finds the proposed proprietary name, Tradjenta, acceptable for this product.
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond
`90 days from the date of this review, The Division of Metabolism and Endocrinology Products
`should notify DMEPA because the proprietary name must be re-reviewed prior to the new
`approval date. Additionally, if any of the proposed product characteristics as stated in this review
`are altered, DMEPA rescinds this finding and the name must be re-submitted for review. The
`conclusions upon re-review are subject to change.
`1 BACKGROUND
`1.1 INTRODUCTION
`This review responds to the request from Boehringer Ingelheim Pharmaceuticals, Inc., dated
`February 1, 2011, for an assessment of the proposed proprietary name, Tradjenta, regarding the
`promotional nature and potential name confusion with other proprietary or established drug
`names in the usual practice setting.
`1.2 REGULATORY HISTORY
`This is the third proposed proprietary name for this product. DMEPA found the first proposed
`proprietary name, Ondero, unacceptable in OSE Review #2010-1510, dated
`October 6, 2010
`
`
`
`
`
` DMEPA found the second proposed proprietary name, Trajenta,
` and informed the Applicant of the
`unacceptable
`unacceptability of the name via teleconference held on January 19, 2011.
`1.3 PRODUCT INFORMATION
`Tradjenta (Linagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor proposed as an adjunct to
`diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The
`recommended dose is 5 mg orally once daily. Tradjenta may be taken with or without food. No
`dose adjustment is recommended for patients with renal or hepatic impairment. Tradjenta will be
`available as 5 mg tablets in bottles containing 30, 90, or 1000 tablets and in physician samples
`packaged in blister packs of seven tablets each. The tablets should be stored at 25º C (77º F);
`excursions permitted to 15º to 30º C (59º to 86º F).
`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, Tradjenta.
`2.1 SEARCH CRITERIA
`For this review, a particular consideration was given to drug names beginning with the letter ‘T’
`when searching to identify potentially similar drug names, as 75% of the confused drug names
`
`
`
`Reference ID: 2930326
`
`3
`
`(b) (4)
`
`(b) (4)
`
`
`
`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 Tradjenta, the DMEPA safety evaluators also
`consider the orthographic appearance of the name on the lined and unlined orders. Specific
`attributes taken into the consideration include the length of the name (nine letters), upstrokes
`(three, the first capital letter ‘T’ and lower case letters ‘d’ and ‘t’), down strokes
`(one, lower case letter ‘j’), cross-strokes (one, lower case letter ‘t’), and dotted letters (one, lower
`case letter ‘j’). Additionally, several letters in the proposed name, Tradjenta, may be vulnerable to
`ambiguity when scripted (See Appendix B). As such, the DMEPA staff also considers these
`alternate appearances when identifying drug names that may look similar to Tradjenta.
`When searching to identify potential names that may sound similar to Tradjenta, the DMEPA
`safety evaluators search for names with similar number of syllables (three), stresses (TRAD-jen-
`ta, trad-JEN-ta, or trad-jen-TA), and placement of vowel and consonant sounds. Additionally,
`DMEPA safety evaluators consider that pronunciation of part of the name can vary (see Appendix
`B). The Applicant’s intended pronunciation [TRAD-gen-ta] was also taken into consideration, as
`it was included in the Proprietary Name Review Request. Moreover, names are often
`mispronounced or spoken with regional accents and dialects, so other pronunciations of the
`names 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 and verbal orders
`were communicated during FDA prescription studies on February 11, 2011.
`
`Figure 1: Tradjenta study samples
`
`Handwritten Requisition Medication Order
`
`Verbal Prescription
`
`
`Medication Order
`
`
`
`
`
`
`
`
`
`Outpatient Prescription
`
`
`
`
`
`Tradjenta 5 mg po qd
`
`
`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: 2930326
`
`4
`
`
`
`2.3 EXTERNAL PROPRIETARY NAME RISK ASSESSMENT
`For this product, the Applicant submitted an external evaluation of the proposed proprietary name
`conducted by Pharmaceutical Nomenclature Consultant. The Division of Medication Error
`Prevention and Analysis conducts an independent analysis and evaluation of the data provided,
`and responds to the overall finding 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 the usual practice settings.
`After the Safety Evaluator has determined the overall risk associated with the proposed name, the
`Safety Evaluator compares the findings to their overall 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 findings from our database searches, expert panel discussion,
`prescription analysis study, external name study, and safety evaluator search results.
`3.1 DATA BASE AND INFORMATION SOURCES
`The DMEPA safety evaluator searches yielded a total of twelve names (n=12) as having some
`similarity to the name, Tradjenta.
`Nine (n=9) of the twelve names were thought to look like Tradjenta by the safety evaluators.
`These names are Trandate, Trental, Trionate, Twynsta, Trileptal, TriLyte, Truvada, Travatan, and
`
`The remaining three names (n=3), Trajenta***, Sufenta, and Alfenta were thought to look like and
`sound like Tradjenta by safety evaluators.
`3.2 EXPERT PANEL DISCUSSION
`The Expert Panel reviewed the pool of names identified by DMEPA staff (see Section 3.1 above)
`and noted no additional names thought to have orthographic or phonetic similarity to Tradjenta.
`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 forty-three practitioners responded to the prescription analysis studies. None of the
`responses overlapped with currently marketed products. Twenty-one practitioners interpreted the
`proposed name correctly as ‘Tradjenta’ with correct interpretation occurring with inpatient (n=8)
`and outpatient prescription studies (n=13). The remaining twenty-two participants misinterpreted
`the name. The most common misinterpretation of the outpatient orders has letter ‘d’ being
`omitted from the name (n=15) and letter ‘j’ misinterpreted as the letter ‘g’ (n=11) . Additionally,
`the most common misinterpretation in the inpatient and outpatient orders occurred with letter ‘e’
`
`
`*** This document contains proprietary and confidential information that should not be released to the
`public.***
`
`
`
`Reference ID: 2930326
`
`5
`
`(b) (4)
`
`
`
`misinterpreted as the letter ‘i’ (n=5). See Appendix C for the complete listing of interpretations
`from the verbal and written prescription studies.
`3.4 EXTERNAL PROPRIETARY NAME RISK ASSESSMENT
`The proposed name risk assessment submitted by the Applicant and conducted by Pharmaceutical
`Nomenclature Consultant found the proposed proprietary name, Tradjenta, acceptable.
`Pharmaceutical Nomenclature Consultant evaluated seven names for their potential similarity to
`the name, Tradjenta. Two of these names, Travatan and Trental, were also identified by
`DMEPA’s safety evaluators as look-alike and sound-alike names. The remaining five names,
`Tracleer, Trazadone, Trientine, Cogentin, and Gentamicin, were thought to look-like and
`sound-like Tradjenta by the Consultant. These names were added to the proprietary name risk
`assessment by the primary safety evaluator.
`3.5 COMMENTS FROM THE DIVISION OF METABOLISM AND ENDOCRINOLOGY
`PRODUCTS (DMEP)
`3.5.1 Initial Phase of Review
`DMEP did not have any comments or concerns regarding the proposed proprietary name,
`Tradjenta, at the initial point of review.
`3.5.2 Mid-Point of Review
`In response to DMEPA’s email on March 31, 2010, DMEP indicated that the name Tradjenta is
`acceptable to them.
`3.6 SAFETY EVALUATOR SEARCH RESULTS
`The primary safety evaluator identified an additional seven names (n=7) which were thought to
`look similar to Tradjenta and represent a potential source of drug confusion. These names are
`Treagan, Tagamet, Trilafon, Tripedia, Fragmin,
` and Triglide.
`Thus, twenty four names (n=24) were identified as having some similarity to the proposed name,
`Tradjenta (12 names from DMEPA searches, 5 names from external study, and 7 names were
`identified by the primary safety evaluator).
`4 DISCUSSION
`The proposed proprietary name, Tradjenta, was evaluated from a safety and promotional
`perspective based on the product characteristics provided by the Applicant. We sought input
`from pertinent disciplines involved with the review of this application and considered it
`accordingly.
`4.1 PROMOTIONAL ASSESSMENT
`DDMAC did not find the name Tradjenta promotional on February 10, 2011. DMEPA and
`DMEP concurred with this finding.
`4.2 SAFETY ASSESSMENT
`The safety assessment considered the orthographic and phonetic similarity of the proposed
`proprietary name to the currently marketed drugs, the results of the prescription studies, and other
`aspects of the name that might be a source of confusion.
`
`
`*** This document contains proprietary and confidential information that should not be released to the
`public.***
`
`
`
`Reference ID: 2930326
`
`6
`
`(b) (4)
`
`
`
`A total of 24 names were identified and evaluated as being potentially similar to the proposed
`proprietary name, Tradjenta.
`Six (n=6) of the 24 names were eliminated from the further analysis for the following reasons:
`five names (n=5) lack orthographic or phonetic similarity to Tradjenta and one name (n=1) has
`never been marketed (See Appendices D and E).
`Failure Mode and Effect Analysis (FMEA) was then applied to determine whether the proposed
`proprietary name could potentially be confused with the remaining 18 names; and thereby, lead to
`medication errors. This analysis determined that the name similarity between Tradjenta was
`unlikely to result in medication errors with all 18 of the remaining products for the reasons
`presented in Appendices F and G.
`5 CONCLUSIONS AND RECOMMENDATIONS
`Our assessment of the proposed proprietary name indicates that the proposed name, Tradjenta, is
`not vulnerable to name confusion that could lead to medication errors, nor is the name considered
`promotional. Thus, DMEPA has no objection to the proposed name, Tradjenta, for this product at
`this time.
`Additionally, DMEPA considers this a final review; however, if approval of the NDA is delayed
`beyond 90 days from the date of this review or 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. The Applicant will be notified
`via letter.
`If you have further questions or need clarifications, please contact Margarita Tossa, project
`manager, at 301-796-4053.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 2930326
`
`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.
`
`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.
`
`The Document Archiving, Reporting, and Regulatory Tracking System (DARRTS)
`4.
`DARRTS is a government database used to track individual submissions and assignments in
`review divisions.
`
`Division of Medication Errors Prevention and Analysis proprietary name
`5.
`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)
`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.
`
`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.
`
`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: 2930326
`
`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.
`
`Access Medicine Database (http://www.accessmedicine.com/drugs.aspx)
`12.
`Access Medicine contains full-text information from approximately 60 medical titles: it includes
`tables and references. Among the database titles are: Goodman and Gilman’s The
`Pharmacological Basis of Therapeutics, Current Medical Diagnosis and Treatment, Tintinalli’s
`Emergency Medicine, and Hurst’s the Heart.
`
`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.
`17. LabelDataPlus Database (http://www.labeldataplus.com/index.php?ns=1)
`LabelDataPlus database covers a total of 36773 drug labels. This includes Human prescription
`drug labels as well as Active Pharmaceutical Ingredients (APIs), OTC (Application and
`Monograph) drugs, Homeopathic drugs, Unapproved drugs, and Veterinary drugs.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 2930326
`
`9
`
`
`
`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,
`DMEPA staff considers the potential for confusion throughout the entire U.S. medication use
`process, including drug procurement, prescribing and ordering, dispensing, administration, and
`
`
`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: 2930326
`
`10
`
`
`
`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 Sponsor’s intended
`pronunciation of the proprietary name. However, DMEPA also considers a variety of
`pronunciations that could occur in the English language because the Sponsor 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.
`
`Considerations when searching the databases
`
`Type of
`similarity Potential causes
`of drug name
`similarity
`
`Similar spelling
`
`
`
`
`
`
`
`Look-
`alike
`
`Attributes examined to identify
`similar drug names
`
`Identical prefix
`Identical infix
`Identical suffix
`Length of the name
`Overlapping product characteristics
`
`Potential Effects
`
`• Names may appear similar in print or
`electronic media and lead to drug
`name confusion in printed or
`electronic communication
`• Names may look similar when
`scripted and lead to drug name
`confusion in written communication
`• Names may look similar when
`scripted, and lead to drug name
`confusion in written communication
`
`Orthographic
`similarity
`
`Similar spelling
`Length of the name
`Upstrokes
`Down strokes
`
`
`5 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
`
`
`
`Reference ID: 2930326
`
`11
`
`
`
`Sound-
`alike
`
`Phonetic similarity
`
`
`Cross-strokes
`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
`
`• 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 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 staff review the USAN stem list to determine if any USAN stems are present
`within the proprietary name. The individual findings of multiple safety evaluators are pooled and
`presented to the CDER Expert Panel.
`
`2. CDER Expert Panel Discussion
`DMEPA conducts an Expert Panel Discussion to gather CDER professional opinions on the
`safety of the proposed product and the proposed proprietary name. The Expert Panel is composed
`of Division of Medication Errors Prevention (DMEPA) staff and representatives from the
`Division of Drug Marketing, Advertising, and Communications (DDMAC). The Expert Panel
`also discusses potential concerns regarding drug marketing and promotion related to the proposed
`names.
`
`
`
`Reference ID: 2930326
`
`12
`
`
`
`The primary Safety Evaluator presents the pooled results of the DMEPA staff to the Expert Panel
`for consideration. Based on the clinical and professional experiences of the Expert Panel
`members, the Panel may recommend the addition of names, additional searches by the primary
`Safety Evaluator to supplement the pooled results, or general advice to consider when reviewing
`the proposed proprietary name.
`
`3. FDA Prescription Analysis Studies
`Three separate studies are conducted within the Centers of the FDA for the proposed proprietary
`name to determine the degree of confusion of the proposed proprietary name with marketed U.S.
`drug names (proprietary and established) due to similarity in visual appearance with handwritten
`prescriptions or verbal pronunciation of the drug name. The studies employ healthcare
`professionals (pharmacists, physicians, and nurses), and attempts to simulate the prescription
`ordering process. The primary Safety Evaluator uses the results to identify orthographic or
`phonetic vulnerability of the proposed name to be misinterpreted by healthcare practitioners.
`In order to evaluate the potential for misinterpretation of the proposed proprietary name in
`handwriting and verbal communication of the name, inpatient medication orders and/or outpatient
`prescriptions are written, each consisting of a combination of marketed and unapproved drug
`products, including the proposed name. These orders are optically scanned and one prescription
`is delivered to a random sample of the 123 participating health professionals via e-mail. In
`addition, a verbal prescription is recorded on voice mail. The voice mail messages are then sent
`to a random sample of the participating health professionals for their interpretations and review.
`After receiving either the written or v