CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
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`021825Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
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`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
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`Proprietary Name Review
`
`July 28, 2011
`
`Loretta Holmes, BSN, PharmD, Safety Evaluator
`Division of Medication Error Prevention and Analysis
`(DMEPA)
`Irene Z. Chan, PharmD, BCPS, Team Leader
`Division of Medication Error Prevention and Analysis
`(DMEPA)
`
`Date:
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`Reviewer:
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`Team Leader
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`
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`Carol A. Holquist, RPh, Director
`Division Director
`Division of Medication Error Prevention and Analysis
`
`(DMEPA)
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`Ferriprox (Deferiprone) Tablets
`Drug Name(s):
`500 mg
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`Application Type/Number: NDA 021825
`Applicant:
`ApoPharma
`OSE RCM #:
`2011-1398
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`***This document contains proprietary and confidential information that should not be
`released to the public.***
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`Reference ID: 2980630
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`CONTENTS
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`1
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`INTRODUCTION................................................................................................................... 1
`1.1
`Regulatory History......................................................................................................... 1
`1.2
`Product Information ....................................................................................................... 1
`2 RESULTS................................................................................................................................ 1
`2.1
`Promotional Assessment................................................................................................ 1
`2.2
`Safety Assessment.......................................................................................................... 1
`3 DISCUSSION ......................................................................................................................... 4
`4 CONCLUSIONS ..................................................................................................................... 5
`5 REFERENCES........................................................................................................................ 6
`APPENDICES................................................................................................................................. 8
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`Reference ID: 2980630
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`1
`INTRODUCTION
`This review evaluates the proposed proprietary name, Ferriprox (Deferiprone), from a
`safety and promotional perspective. The sources and methods used to evaluate the
`proposed name are outlined in the reference section and Appendix A respectively.
`
`1.1
`REGULATORY HISTORY
`DMEPA initially reviewed the name Ferriprox in OSE Review 2006-169, dated January
`30, 2007, and found the name unacceptable due to concerns that the name was misleading
`because the “Ferr” portion of the name may imply that Ferriprox is an iron supplement.
`The name was later resubmitted for reconsideration and re-evaluated in the September 3,
`2009 OSE Review 2009-1153. The Applicant stated there would be a Risk Evaluation
`and Mitigation Strategy (REMS) with restricted distribution plan in place prior to
`marketing the product and this information was considered in our re-evaluation of the
`name. DMEPA found the name acceptable in OSE Review 2009-1153 based on this
`information. A Complete Response action was taken on November 30, 2009. The
`Applicant submitted a Class 2 resubmission and Request for Review of a Proprietary
`Name which were received on April 13, 2011 and April 29, 2011, respectively. No
`REMS was submitted during this cycle.
`Ferriprox is currently marketed in multiple countries outside the United States.
`Additionally, Ferriprox is an Orphan Drug.
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`1.2
`PRODUCT INFORMATION
`Ferriprox is an iron chelator indicated for the treatment of patients with transfusional iron
`overload when current chelation therapy is inadequate. The recommended dosage is
`25 mg/kg to 33 mg/kg body weight, orally, three times a day for a total daily dose of
`75 mg/kg to
` mg/kg body weight. The recommended initial total daily dose of
`Ferriprox is 75 mg/kg body weight. The dose should be rounded to the nearest ½ tablet.
`Ferriprox is a scored tablet and breakable in half. It will be supplied in 100-count bottles.
`Ferriprox has a boxed warning concerning agranulocytosis and neutropenia. The Agency
`has not yet determined whether a REMS and/or restricted distribution plan will be
`required for this product.
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`2 RESULTS
`The following sections provide the information obtained and considered in the evaluation
`of the proposed proprietary name.
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`2.1
`PROMOTIONAL ASSESSMENT
`DDMAC determined the proposed name is acceptable from a promotional perspective.
`DMEPA and the Division of Hematology Products concurred with the findings of
`DDMAC’s promotional assessment of the proposed name.
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`2.2
`SAFETY ASSESSMENT
`The following aspects of the name were considered in the overall evaluation.
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`Reference ID: 2980630
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`(b) (4)
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`2.2.1 United States Adopted Names (USAN) SEARCH
`The United States Adopted Name (USAN) stem search conducted on July 15, 2011,
`identified that a USAN stem is not present in the proposed proprietary name.
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`2.2.2 Components of the Proposed Proprietary Name
`The proposed name Ferriprox is misleading due to the “Ferr” prefix in the name which
`may imply that Ferriprox is an iron supplement product when, in fact, it is a product used
`to treat iron overload. Although “fer-” and “ferr-” are not USAN stems, there are
`multiple prescription and non-prescription iron-containing products on the market that
`begin with these letters, for example, Ferrlecit, Fergon, Feratab, and Fer-In-Sol, to name
`a few. All of the aforementioned products are iron supplements. Additionally, there are
`two currently available iron chelators, Desferal (deferoxamine mesylate) and Exjade
`(deferasirox). Neither of these proprietary names begin with “Fer” or “Ferr”. Because the
`name Ferriprox strongly suggests that the product is an iron supplement when in fact it is
`indicated as a treatment for iron overload, DMEPA believes that confusion can ensue
`regarding the product’s suggested versus its actual indication.
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`2.2.3 FDA Adverse Event Reporting System (AERS) Selection of Cases
`Ferriprox is currently marketed in countries throughout Europe, Asia, Africa, South
`America and elsewhere. Therefore, DMEPA searched the Adverse Event Reporting
`System (AERS) database on June 3, 2011 using the MedDRA High Level Group Terms
`“Medication Errors” and “Product Quality Issues”, active ingredient “Deferiprone”, trade
`name “Ferriprox”, and verbatim “Ferr%” and “Defer%”.
`The reports were manually reviewed to determine if a medication error occurred.
`Duplicate reports were combined into cases. Cases that described a medication error
`were categorized by type of error. We reviewed the cases within each category to
`identify factors that contributed to the medication errors. If the root cause(s) were
`associated with name confusion involving Ferriprox, the cases were considered pertinent
`to this review. Those cases that did not describe a medication error or did not describe an
`error applicable to this review were excluded from further analysis.
`The search yielded one foreign case from Greece (ISR #5523063) which described a
`chelation overdose involving Ferriprox and another agent. Thus, this case does not
`inform this review and will not be discussed further.
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`2.2.4 FDA Name Simulation Studies
`Twenty-nine practitioners participated in DMEPA’s prescription studies. See Appendix
`C for the complete listing of interpretations from the verbal and written prescription
`studies.
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`2.2.5 Comments from Other Review Disciplines
`In response to the OSE email dated May 12, 2011, the Division of Hematology Products
`(DHP) did not forward any comments or concerns relating to the proposed name at the
`initial phase of the name review.
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`Reference ID: 2980630
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`2.2.6 Failure Mode and Effects Analysis of Similar Names
`Table 1 lists the names with orthographic, phonetic, or spelling similarity to the proposed
`proprietary name, Ferriprox (see Appendix B). These names were identified by the
`primary reviewer, the Expert Panel Discussion (EPD), and other review disciplines.
`
`Table 1: Collective List of Potentially Similar Names (DMEPA, EPD and Other Disciplines)
`
`Look Similar
`Name
`Source
`Folplex
`EPD Panel
`Ferro-Sequels
`EPD Panel
`Femogen
`EPD Panel
`Femara
`EPD Panel
`Femstat
`EPD Panel
`Femcon
`EPD Panel
`Fempatch
`EPD Panel
`Femring
`EPD Panel
`Femtrace
`EPD Panel
`Propinox
`EPD Panel
`Tussplex DM
`EPD Panel
`Ferrlecit
`EPD Panel
`Fertinex
`EPD Panel
`Ferragen
`EPD Panel
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`EPD Panel
`Firmagon
`EPD Panel
`Feraplex
`EPD Panel
`Ferroflex
`EPD Panel
`Ferralet
`Primary Safety
`Evaluator
`Primary Safety
`Evaluator
`Primary Safety
`Evaluator
`Primary Safety
`Evaluator
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`Ferralet Plus
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`Ferralet 90
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`Tussplex
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`Reference ID: 2980630
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`Sound Similar
`Name
`Source
`None
`None
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`Look and Sound Similar
`Name
`Source
`Ferrex
`EPD Panel
`Ferric PS
`EPD Panel
`Ferraplus
`EPD Panel
`Feridex IV
`EPD Panel
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`3
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`(b) (4)
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`Our analysis of the 26 names contained in Table 1 considered the information obtained in
`the previous sections along with the product characteristics for the names indentified in
`Table 1 above. We determined the 26 names will not pose a risk for confusion as
`described in Appendices D and E.
`DMEPA communicated these findings to the Division of Hematology Products via e-mail
`on July 14, 2011. At that time we also requested additional information or concerns that
`could inform our review. Per e-mail correspondence from the Division of Hematology
`Products on July 20, 2011 they stated they had no issues with the proposed proprietary
`name, Ferriprox.
`
`3 DISCUSSION
`The Agency has not yet determined that this NDA will require a REMS and/or restricted
`distribution plan. Thus, DMEPA re-reviewed the names that were evaluated in our
`previous proprietary name reviews for Ferriprox (OSE Reviews 2006-169 and 2009-
`1153, dated January 30, 2007 and September 2009, respectively). We determined that if
`Ferriprox does not have a REMS or restricted distribution plan, those names do not pose
`a risk for confusion because they lack convincing orthographic or phonetic similarity to
`the name Ferriprox and/or have product characteristics that differentiate them from
`Ferriprox.
`Although we did not identify any look-alike or sound-alike names of concern, we were
`concerned that the name could be misleading because of the “Fer(r)” prefix which may
`infer that this product is an iron supplement rather than a product that is used to treat iron
`overload. This misconception could lead to confusion in the marketplace given the fact
`that a REMS or restricted distribution program may not be in place when the product is
`marketed.
`DMEPA held a teleconference with the Applicant on July 26, 2011, and communicated
`our concerns that the name could be misleading and confused as an iron supplement
`rather than treatment for iron overload. We requested the Applicant provide justification
`or supporting evidence that their proposed name would not lead to confusion if marketed.
`On July 27, 2011, the Applicant submitted an amendment to the request for review of a
`proprietary name (see Appendix F). The amendment included justification in support of
`their proposed proprietary name, Ferriprox, with particular emphasis on their
`committment to a restricted distribution program through a single specialty pharmacy.
`Additionally, the Applicant believes that given the rarity of the condition for which the
`product is indicated, only a small number of specialists will be responsible for prescribing
`Ferriprox. These providers will be required to enroll in a registry per the Applicants own
`initiative regardless of whether a Risk Evaluation and Mitigation Strategy (REMS) is
`required for this product. Additionally, the Applicant has been supplying Ferriprox to
`patients through a treatment IND for over a decade. The Applicant believes that
`introduction of a different name may lead to more confusion because Ferriprox is already
`being used and has some recognition in the United States.
`Restricted distribution programs that are not part of a REMS are not enforceable by the
`Agency and typically can be removed from the market at any time. However, there is
`precedence for this type of voluntary program with another iron chelation product,
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`Reference ID: 2980630
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`Exjade, that shares some overlap in its adverse event profile with Ferriprox. Given the
`justification provided by the Applicant and the existing model in practice for this type of
`voluntary oversight program with iron chelation products, DMEPA believes that the risk
`for confusion is adequately addressed at this point in time. However, we reserve the right
`to re-examine the proprietary name if confusion in the marketplace is detected after
`marketing.
`
`4 CONCLUSIONS
`DMEPA concludes the proposed proprietary name is acceptable from both a promotional
`and safety perspective. However, if any of the proposed product characteristics and
`commitments made by the Applicant 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 proposed proprietary name, Ferriprox, must be re-reviewed if NDA approval is
`delayed beyond 90 days.
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`Reference ID: 2980630
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`5 REFERENCES
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`1. Micromedex Integrated Index (http://csi.micromedex.com)
`Micromedex contains a variety of databases covering pharmacology, therapeutics,
`toxicology and diagnostics.
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`2. 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.
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`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.
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`4. FDA Document Archiving, Reporting & Regulatory Tracking System [DARRTS]
`DARRTS is a government database used to organize Applicant and Sponsor
`submissions as well as to store and organize assignments, reviews, and
`communications from the review divisions.
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`5. Division of Medication Errors Prevention and Analysis proprietary name
`consultation requests
`This is a list of proposed and pending names that is generated by the Division of
`Medication Error Prevention and Analysis from the Access database/tracking system.
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`6. Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`Drugs@FDA contains most of the drug products approved since 1939. The majority
`of labels, approval letters, reviews, and other information are available for drug
`products approved from 1998 to the present. Drugs@FDA contains official
`information about FDA approved brand name, generic drugs, therapeutic biological
`products, prescription and over-the-counter human drugs and discontinued drugs and
`“Chemical Type 6” approvals.
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`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.
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`8. U.S. Patent and Trademark Office (http://www.uspto.gov)
`USPTO provides information regarding patent and trademarks.
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`9. 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.
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`10. Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available at
`(www.thomson-thomson.com)
`The Pharma In-Use Search database contains over 400,000 unique pharmaceutical
`trademarks and trade names that are used in about 50 countries worldwide. The data
`is provided under license by IMS HEALTH.
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`11. Natural Medicines Comprehensive Databases (www.naturaldatabase.com)
`Natural Medicines contains up-to-date clinical data on the natural medicines, herbal
`medicines, and dietary supplements used in the western world.
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`12. Access Medicine (www.accessmedicine.com )
`Access Medicine® from McGraw-Hill contains full-text information from
`approximately 60 titles; it includes tables and references. Among the titles are:
`Harrison’s Principles of Internal Medicine, Basic & Clinical Pharmacology, and
`Goodman and Gilman’s The Pharmacologic Basis of Therapeutics.
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`13. USAN Stems (http://www.ama-assn.org/ama/pub/about-ama/our-people/coalitions-
`consortiums/united-states-adopted-names-council/naming-guidelines/approved-
`stems.shtml)
`USAN Stems List contains all the recognized USAN stems.
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`14. Red Book Pharmacy’s Fundamental Reference
`Red Book contains prices and product information for prescription, over-the-counter
`drugs, medical devices, and accessories.
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`15. Lexi-Comp (www.lexi.com)
`Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
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`16. Medical Abbreviations Book
`Medical Abbreviations Book contains commonly used medical abbreviations and
`their definitions.
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`Reference ID: 2980630
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`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment considers the promotional and safety aspects
`of a proposed proprietary name. The promotional review of the proposed name is
`conducted by DDMAC. DDMAC evaluates proposed proprietary names to determine if
`they are overly fanciful, so as to misleadingly imply unique effectiveness or composition,
`as well as to assess whether they contribute to overstatement of product efficacy,
`minimization of risk, broadening of product indications, or making of unsubstantiated
`superiority claims. DDMAC provides their opinion to DMEPA for consideration in the
`overall acceptability of the proposed proprietary name.
`The safety assessment is conducted by DMEPA. DMEPA staff search a standard set of
`databases and information sources to identify names that are similar in pronunciation,
`spelling, and orthographically similar when scripted to the proposed proprietary name.
`Additionally, we consider inclusion of USAN stems or other characteristics that when
`incorporated into a proprietary name may cause or contribute to medication errors (i.e.,
`dosing interval, dosage form/route of administration, medical or product name
`abbreviations, names that include or suggest the composition of the drug product, etc.).
`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. 1
`Following the preliminary screening of the proposed proprietary name, DMEPA gathers
`to discuss their professional opinions on the safety of the proposed proprietary name.
`This meeting is commonly referred to the Center for Drug Evaluation and Research
`(CDER) Expert Panel discussion. DMEPA also considers other aspects of the name that
`may be misleading from a safety perspective. DMEPA staff conducts a prescription
`simulation studies using FDA health care professionals. When provided, DMEPA
`considers external proprietary name studies conducted by or for the Applicant/Sponsor
`and incorporates the findings of these studies into the overall risk assessment.
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name 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 misleading nature of the proposed proprietary name with a focus on the avoidance of
`medication errors.
`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. DMEPA considers the product characteristics associated with the proposed
`product throughout the risk assessment because the product characteristics of the
`
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`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
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`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. DMEPA considers how these
`product characteristics may or may not be present in communicating a product name
`throughout the medication use system. Because drug name confusion can occur at any
`point in the medication use process, DMEPA 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.2 The product characteristics considered for this review appears in Appendix
`B1 of this review.
`The DMEPA considers the spelling of the name, pronunciation of the name when spoken, and
`appearance of the name when scripted. DMEPA compares the proposed proprietary name
`with the proprietary and established name of existing and proposed drug products and names
`currently under review at the FDA. DMEPA 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. DMEPA examines the phonetic
`similarity using patterns of speech. 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. The orthographic appearance of the
`proposed name is evaluated using a number of different handwriting samples. DMEPA
`applies expertise gained from root-cause analysis of postmarketing 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).
`Table 1. Criteria Used to Identify Drug Names that Look- or Sound-Similar to a
`Proposed Proprietary Name.
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`Considerations when Searching the Databases
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`Type of
`Similarity
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`Potential
`Causes of Drug
`Name
`Similarity
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`Attributes Examined to Identify
`Similar Drug Names
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`Potential Effects
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`Similar spelling
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`Identical prefix
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`• Names may appear similar
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`2 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
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`Look-
`alike
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`Identical infix
`Identical suffix
`Length of the name
`Overlapping product
`characteristics
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`Orthographic
`similarity
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`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
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`Similar spelling
`Length of the name/Similar
`shape
`Upstrokes
`Down strokes
`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
`Lastly, DMEPA 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.
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`Sound-
`alike
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`Phonetic
`similarity
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`• Names may sound similar
`when pronounced and lead
`to drug name confusion in
`verbal communication
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`1. Database and Information Sources
`DMEPA searches 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. A standard description of the databases
`used in the searches is provided in the reference section of this review. To complement
`the process, the DMEPA uses a computerized method of identifying phonetic and
`orthographic similarity between medication names. The program, Phonetic and
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`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, DMEPA reviews 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. DMEPA
`also evaluates if there are characteristics included in the composition that may render the
`name unacceptable from a safety perspective (abbreviation, dosing interval, etc.).
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`2. Expert Panel Discussion
`DMEPA gathers gather CDER professional opinions on the safety of the proposed
`product and discussed the proposed proprietary name (Expert Panel Discussion). 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). We also consider input from other review disciplines
`(OND, ONDQA/OBP). The Expert Panel also discusses potential concerns regarding
`drug marketing and promotion related to the proposed names.
`The primary Safety Evaluator presents the pooled results of the database and information
`searches to the Expert Panel for consideration. Based on the clinical and professional
`experiences of the Expert Panel members, the Panel may recommend additional names,
`additional searches by the primary Safety Evaluator to supplement the pooled results, or
`general advice to consider when reviewing the proposed proprietary name.
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`3. FDA Prescription Simulation 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 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
`verbal prescription orders, the participants record their interpretations of the orders which
`are recorded electronically.
`
`4. Comments from Other Review Disciplines
`DMEPA requests the Office of New Drugs (OND) and/or Office of Generic Drugs
`(OGD), ONDQA or OBP for their comments or concerns with the proposed proprietary
`
`Reference ID: 2980630
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`name, ask for any clinical issues that may impact the DMEPA review during the initial
`phase of the name review. Additionally, when applicable, at the same time DMEPA
`requests concurrence/non-concurrence with DDMAC’s decision on the name. The
`primary Safety Evaluator addresses any comments or concerns in the safety evaluator’s
`assessment.
`
`The OND/OGD Regulatory Division is contacted a second time following our analysis of
`the proposed proprietary name. At this point, DMEPA conveys their decision to accept
`or reject the name. The OND or OGD Regulatory Division is requested to provide any
`further information that might inform DMEPA’s final decision on the proposed name.
`Additionally, other review disciplines opinions such as ONDQA or OBP may be
`considered depending on the proposed proprietary name.
`
`5. Safety Evaluator Risk Assessment of the Proposed Proprietary Name
`The primary Safety Evaluator applies his/her individual expertise gained from evaluating
`medication errors reported to FDA, considers all aspects of the name that may be
`misleading or confusing, conducts a Failure Mode and Effects Analysis, and provides an
`overall decision on acceptability dependent on their risk assessment of name confusion.
`Failure Mode and Effects Analysis (FMEA) is a systematic tool for evaluating a process
`and identifying where and how it might fail.3 When applying FMEA to assess the risk of
`a proposed proprietary name, DMEPA seeks to evaluate the potential for a proposed
`proprietary name to be confused with another drug name because of name confusion and,
`thereby, cause errors to occur in the medication use system. FMEA capitalizes on the
`predictable and preventable nature of medication errors associated with drug name
`confusion. FMEA allows the Agency to identify the potential for medication errors due
`to orthographically or phonetically similar drug names prior to approval, where actions to
`overcome these issues are easier and more effective than remedies available in the post-
`approval phase.
`In order to perform an FMEA of the proposed name, the primary Safety Evaluator must
`analyze the use of the product at all points in the medication use system. Because the
`proposed product is has not been marketed, the primary Safety Evaluator anticipates the
`use of the product in the usual practice settings by considering the clinical and product
`characteristics listed in Appendix B1 of this review.