CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 22—249
`
`PROPRIETARY NAME REVIEW! S!
`
`

`

`Department of Health and Human Services
`
`Public Health Service
`
` Office of Surveillance and Epidemiology
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Date:
`
`To:
`
`Thru:
`
`From'
`'
`
`Subject:
`
`March 18, 2008
`
`Robert Justice, MD
`Director, Division of Drug Oncology Products,
`HFD—150
`
`Denise Toyer, PharmD, Deputy Director
`Division of Medication Error Prevention
`
`Kristina C. Amwine, PharmD, Acting Team Leader
`Division of Medication Error Prevention
`
`Proprietary Name, Label, and Labeling Review
`
`Drug Name:
`
`Treanda (Bendamustine Hydrochloride) for Injection, 100 mg
`
`Application Type/Number: NDA # 22-249
`
`Applicant/sponsor:
`
`CephalOn, Inc
`
`OSE RCM #:
`
`2007—2064
`
`

`

`CONTENTS
`
`#MNH
`
`Introduction ............................................................................................................................. 3
`MATERIAL REVIEWED ....................................................................................................... 3
`
`DISCUSSION ......................................................................................................................... 3
`
`CONCLUSIONS ..................................................................................................................... 3
`
`

`

`1
`
`INTRODUCTION
`
`This memo is written in response to a request from the Division of Drug Oncology Products
`(HFD-lSO), for clarification with regard to a typographical error in OSE 2007-2064.
`
`2 MATERIAL REVIEWED
`
`OSE review 2007-2064, dated March 10, 2008.
`
`3 DISCUSSION
`
`We note that Appendix D entitled “Products with no numerical overlap in strength and dose”
`contains the incorrect established name for the proposed product, Treanda. Appendix D lists the
`established name as “(choline fenofibrate)”, rather than the correct established name
`“(bendamustine hydrochloride)”. However, all of the information in Appendix D pertaining to
`Treanda is based on the established name bendamustine hydrochloride. Please see the revised
`appendix below.
`
`4
`
`CONCLUSIONS
`
`In Appendix D, the correct established name for the proposed product, Treanda, should read
`“(bendamustine hydrochloride)”.
`
`If you have any questions or need clarifications, please contact Janet Anderson, OSE Project
`Manager, at (301) 796-0675.
`
`
`Appendix D: Products with no numerical overlap in strength and dose.
`
`
`
`:: .(
`‘
`-
`
`Sti
`01’]
`
`
`
`
`
`
`
`One tablet by mouth three times daily with
`
`
`meals
`
`
`
`Look
`
`
`
`
`One tablet by mouth twice daily
`
`Prenatal Multi-vitamin
`One tablet by mouth once daily
`
`
`
`
`0.5 ml as a 5-dose series in infants and
`Look
`Tripedia
`6.7 L0 46.8 mcg/ 5 Lf/ 0.5 mL
`
`
`
`
`children 6 weeks to 7 years of age.
`
`
`
` Triant HC
`Look
`2 mg/ 1.67 mg/S mg
`1 teaspoonfiil to 2 teaspoonsful by mouth
`
`
`eveg 4 to 6 to 8 hours as needed
`
`
` Ziana
`Sound
`l.2/0.025% gel
`Apply topically to affected area at bedtime
`
`, Trientine
`Sound
`250 mg
`750 mg to 1250 mg by mouth per day in 2 to 4
`
`
`divided doses
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Kristina Arnwine
`
`3/18/2008 04:52:01 PM
`DRUG SAFETY OFFICE REVIEWER
`
`Denise Toyer
`3/18/2008 04:54:24 PM
`DRUG SAFETY OFFICE REVIEWER
`
`

`

`Department of Health and Human Services
`
`Public Health Service
`
` Office of Surveillance and Epidemiology
`
`Food and Drug Administration
`
`'Center for Drug Evaluation and Research
`
`Date:
`
`To:
`
`Thru:
`
`From:
`
`March 6, 2008
`
`Robert Justice, MD
`Director, Division of Drug Oncology Products,
`HFD—150
`
`Denise Toyer, PharmD, Deputy Director
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention
`
`Kristina C. Arnwine, PharmD, Acting Team Leader
`Tselaine Jones-Smith, PharmD, Safety Evaluator
`Division of Medication Error Prevention
`
`Subject:
`
`Proprietary Name, Label, and Labeling Review
`
`Drug Name:
`
`Treanda (Bendamustine Hydrochloride) for Injection, 100 mg
`
`Application Type/Number: NDA # 22-249
`
`Applicant/sponsor:
`
`Cephalon, Inc
`
`OSE RCM #:
`
`2007—2064
`
`w Note: This review contains proprietary and confidential information that should not be
`released to the public?”
`
`

`

`CONTENTS
`
`EXECUTIVE SUMMARY ............................................................................................................. 3
`
`1
`
`BACKGROUND ..................................................................................................................... 3
`
`1 . 1
`
`Introduction .................................................................................................................... 3
`
`Product Information ............................._.......................................................................... 3
`1.2
`2 METHODS AND MATERIALS ............................................................................................ 3
`
`2.1
`
`Search Criteria................................................................................................................ 4
`
`CDER Prescription analysis studies ............................................................................... 6
`2.2
`Safety Evaluator Risk Assessment ofthe Proposed Proprietary Name ......................... 6
`2.3
`Label and Labeling Risk Assessment ............................................................................ 8
`2.4
`RESULTS. ............................................................................................................................... 9
`3.1
`Data base and information sources ................................................................................ 9
`3.2
`CDER Prescription Analysis Studies ............................................................................. 9
`3.3
`Safety evaluator risk assessment .................................................................................. 10
`3.4
`Label and Labeling Risk Assessment .......................................................................... 10
`
`DISCUSSION ....................................................................................................................... 12
`
`CONCLUSIONS and Recommendations .............................................................................. 13
`
`5.1
`
`5.2
`
`Comments to the Division ............................................................................................ 13
`
`Comments to the Applicant.......................................................................................... 14
`
`3
`
`4
`
`5
`
`A. Container Label .................................................................................................................... 14
`REFERENCES ...................................................................................................................... 15
`6
`APPENDICES ............................................................................................................................... 17
`
`

`

`EXECUTIVE SUMMARY
`
`The results of the Proprietary Name Risk Assessment found that the proposed name, Treanda, has some
`similarity to other proprietary and established drug names, but the findings of the FMEA indicate that the
`proposed name does not appear to be vulnerable to name confusion that could lead to medication errors.
`Thus, we have no objection to the use of the proprietary name Treanda for this product. This finding was
`consistent with and supported by an independent risk assessment of the proprietary name submitted by the
`sponsor.
`
`The results of the Label and Labeling Risk Assessment found that the presentation of information and
`design of the proposed carton and container labels appears to be vulnerable to confusion that could lead to
`medication errors. Improvements should be made to the container label, carton and package insert
`labeling to increase readability of information presented on the labeling. Such improvements include
`including a “discard
`'“"
`statement and the final milligram per milliliter concentration after
`reconstitution on the labels and labeling, as well as eliminating the use of the abbreviation /"in the
`package insert labeling.
`
`DMETS believes the risks we have identified can be addressed and mitigated prior to drug approval, and
`provides recommendations in Section 5.2 that aim at reducing the risk of medication errors.
`
`This is considered a final decision. However, ifm of the proposed product characteristics as stated in
`this review are altered prior to approval of the product; we rescind this Risk Assessment finding, and
`recommends that the name be resubmitted for review. Additionally, if approval of the NDA is delayed
`beyond 90 days from the signature date of this review, the name must be re-evaluated. A re-review of the
`name before NDA approval will rule out any obj ections' based upon approvals of Other
`proprietary/established names from the signature date of this document.
`
`1
`
`BACKGROUND
`
`1.1
`
`INTRODUCTION
`
`This consult was written in response to a request from the Division of Drug Oncology Products (HFD-
`150), for assessment of the proprietary name, Treanda, regarding potential name confusion with other
`proprietary or established drug names. The sponsor also submitted container labels, carton labeling, and
`package insert labeling for review and comment.
`
`1.2
`
`PRODUCT INFORMATION
`
`Treanda is an antineoplastic agent indicated for the treatment of patients with chronic lymphocytic
`leukemia. Treanda must be diluted and prepared prior to use. The recommended dese is 100 mg/m2
`administered by intravenous infusion over 30 minutes on Days 1 and 2 of a 28-day cycle, for up to
`6 cycles. Treanda will be supplied as single-use 20 mL vials containing 100 mg of bendamustine
`hydrochloride.
`
`2 METHODS AND MATERIALS
`
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name, Treanda, and the proprietary and established names of drug products existing in the
`marketplace and those pending IND, NDA, and ANDA products currently under review by the Agency.
`
`For the proprietary name, Treanda, our medication error staff searches a standard set of databases and
`information sources to identify names with orthographic and phonetic similarity (see Sections 2.1.1 for
`detail) and held an CDER Expert Panel discussion to gather professional opinions on the safety of the
`
`

`

`. proposed proprietary name (see 2.1.2). We also conduct internal CDER prescription analysis studies (see
`2. 2), and, when provided, 'extemal prescription analysis studies results are considered and incorporated
`into the overall risk assessment (see detail 2.3).
`
`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 (see
`detail 2.3). The overall risk assessment is based on the findings of a Failure Modes and Effects Analysis
`(FMEA) of the proprietary name, and is focused on the avoidance of medication errors. FMEA is a
`systematic tool for evaluating a process and identifying where and how it might fail. I FMEA is used to
`analyze whether the drug names identified with look— or sound-alike similarity to the proposed name
`could cause confusion that subsequently leads to medication errors in the clinical setting. We define 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. 2
`We use the clinical expertise of the medication error staff to anticipate the conditions of the clinical
`setting that the product is likely to be used in 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. As such, the Staff considers the product characteristics
`associated with the proposed drug throughout the risk assessment, since 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 drug name include, but are not limited to established name of the proposed
`product, the proposed indication, 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, we consider the potential for confusion throughout the entire
`US. medication use process, including drug procurement, prescribing and ordering, dispensing,
`administration, and monitoring the impact of the medication.3
`
`2.1
`
`SEARCH CRITERIA
`
`The Medication Error Staff consider the spelling of the name, pronunciation of the name when spoken,
`and appearance of the name when scripted as outlined in Appendix A.
`
`For this review, 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 reported by the
`USP-ISMP Medication Error Reporting Program involve pairs beginning with the same letter.45
`
`1 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
`
`2 National Coordinating Council for Medication Error Reporting and Prevention.
`
`http://www.nccmerp.org/aboutMedErrorshtr‘nl. Last accessed 10/11/2007.
`
`3 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`
`4 Institute for Safe Medication Practices. Confused Drug name List (1996-2006). Available at
`http://www.ismp.org/Tools/confuseddrugnamespdf
`
`5 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artifical Inteligence in Medicine
`(2005)
`
`

`

`To identify drug names that may look similar to Treanda, the Staff also consider the other orthographic '
`appearance of the name on lined and unlined orders. Specific attributes taken into consideration include
`the length of the name (seven letters), upstrokes (one, lower case ‘d’), downstrokes (none), cross-strokes
`(none), and dotted letters (none). Additionally, several letters in Treanda may be vulnerable to ambiguity
`when scripted, including the letter ‘T’ may appear as ‘F’; lower case ‘r’ may appear as a lower case ‘5’,
`‘a’ or ‘n’; lower case ‘e’ may appear as ‘a’ or ‘i’; lower case ‘a’ may appear as ‘r,’ ‘e,’ or ‘5’; lower case
`‘n’ may appear as ‘r’ or ‘s’; and ‘da’ may appear as ‘do’, ‘cla’, or ‘clo’. As such, the Staff also considers
`these alternate appearances when identifying drug names that may look similar to Treanda.
`
`When searching to identify potential names that may sound similar to Treanda, the Medication Error Staff
`search for names with similar number of syllables (three), stresses (Tre-AN-da, TRE-an-da, or
`Tre-an-DA), and placement of vowel and consonant sounds. The Sponsor’s intended pronunciation of the
`proprietary name could not be expressly taken into consideration, as this was not provided with the
`proposed name submission.
`'
`
`The Staff also consider the product characteristics associated with the proposed drug throughout the
`identification of similar drug names, since the product characteristics of the proposed drug ultimately
`determine the use of the product in the clinical practice setting For this review, the Medication Error
`Staff were provided with the following information about the proposed product:
`the proposed proprietary
`name (Treanda), the established name (bendamustine hydrochloride), proposed indication (chronic
`lymphocytic leukemia), strength (100 mg), dose (100 mg/mz), frequency of administration (Days 1 and 2
`of a 28—day cycle, up to 6 cycles), route (intravenous) and dosage form of the product (for injection).
`Appendix A provides a more detailed listing of the product characteristics the Medication Error Staff
`general take into consideration.
`
`Lastly, the Medication Error Staff also consider the potential for the proposed 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. As such, these broader safety implications of the name are considered and evaluated
`throughout this assessment and the Medication Error Staff provide additional comments related to the
`safety of the proposed name or product based on their professional experience with medication errors.
`
`2.1.1 Data base and information sources
`
`The proposed proprietary name, Treanda, was provided to the medication error staff to conduct a search
`of the intemet, 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 Treanda using the criteria
`outlined in 2.1. A standard description of the databases used in the searches is provided in Appendix A.
`To complement the process, the Medication Error 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 Medication Error Staff review the USAN stem list to determine if any USAN stems are present
`within the proprietary name. The findings of the individual Safety Evaluators were then pooled and
`presented to the Expert Panel.
`
`2.1.2 CDER Expert Panel Discussion
`
`An Expert Panel Discussion is held to gather CDER professional opinions on the safety of the product
`and the proprietary name, Treanda. Potential concerns regarding drug marketing and promotion related to
`the proposed names are also discussed. This group is composed of Medication Error Prevention Staff and
`representatives from the Division of Drug Marketing, Advertising, and Communications (DDMAC).
`
`

`

`The pooled results of the medication error staff were presented 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 Safety Evaluator to supplement the pooled
`results, or general advice to consider when reviewing the proposed proprietary name.
`
`2.2 CDER 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 Treanda with marketed US. drug names (proprietary and
`established) due to similarity in visual appearance with handwritten prescriptions or verbal pronunciation
`of the drug name. The studies employ a total of 123 healthcare professionals (pharmacists, physicians,
`and nurses), and attempts to simulate the prescription ordering process. The results are used by the Safety
`Evaluator to identify any orthographic or phonetic vulnerability of the proposed name to be
`misinterpreted by healthcare practitioners.
`
`In order to evaluate the potential for misinterpretation of Treanda in handwriting and verbal
`communication of the name, inpatient medication orders are written, each consisting of a combination of
`marketed and unapproved drug products, including the proposed name. These prescriptions are optically
`scanned and one prescription is delivered to a random sample of 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 verbal prescription orders, the participants send their interpretations
`of the orders via e-mail to the medication error staff.
`
`a VERBAL ,«
`PRESCRIPTION
`
`latterly * Mm ZvifitrrttMQomtt‘e rim W
`
`......................i.......r«we» mu J3 Mm; mam {1m
`
`Treanda, infuse 200 mg over 30
`.
`minutes on Days 1 and 2.
`
`Inpatient Medication Order :
`
`2.3
`
`SAFETY EVALUATOR RISK ASSESSMENT OF THE PROPOSED PROPRIETARY NAME
`
`Based on the criteria set forth in Section 2.1.1, the Safety Evaluator Risk Assessment applies their
`individual expertise gained from evaluating medication errors reported to FDA to conduct a Failure
`Modes and Effects Analysis and provide an overall risk of name confusion. Failure Mode and Effects
`Analysis (FMEA)IS a systematic too] for evaluating a process and identifying where and how it might
`fail.6 When applying FMEA to assess the risk of a proposed proprietary name, the Medication Error
`Prevention staff seeks to evaluate the potential for a proposed name to be confused with another drug
`name as a result of the name confusion and cause errors to occur in the medication use system. FMEA
`capitalizes on the predictable and preventable nature of medication errors associated with drug. name
`
`6 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
`
`

`

`confusion. FMEA allows the Agency to identify the potential for medication errors due to look- or
`sound-alike drug names prior to approval, where actions to overcome these issues are easier and more
`effective then remedies available in the post—approval phase.
`
`In order to perform an FMEA of the proposed name, the Safety Evaluator must analyze the use of the
`product at all points in the medication use system. Because the proposed product is not yet marketed, the
`Safety Evaluator anticipates the use of the product in the usual practice settings by considering the clinical
`and product characteristics listed in Appendix A. The Safety Evaluator then analyzes the proposed
`proprietary name in the context of the usual practice setting and works to identify potential failure modes
`and the effects associated with the failure modes.
`
`In the initial stage of the Risk Assessment, the Safety Evaluator compares the proposed proprietary name
`to all of the names gathered from the above searches, expert panel evaluation, and studies, and identifies
`potential failure modes by asking: “Is the name Treanda convincing similar to another drug name, which
`may cause practitioners to become confused at any point in the usual practice setting?” An affirmative
`answer indicates a failure mode and represents a potential for Treanda to be confilsed with another
`proprietary or established drug name because of look— or sound-alike similarity. If the answer to the
`question is no, the Safety Evaluator is not convinced that the names posses similarity that would cause
`confusion at any point in the medication use system and the name is eliminated from further review.
`
`In the second stage of the Risk Assessment, all potential failure modes are evaluated to determine the
`likely eflect of the drug name confusion, by asking “Could the confusion of the drug names conceivably
`result in medication errors in the usual practice setting?” The answer to this question is a central
`component of the Safety Evaluator’s overall risk assessment of the proprietary name. If the Safety
`Evaluator determines through FMEA that the name similarity would ultimately not be a source of
`medication errors in the usual practice setting, the name is eliminated from further analysis. However, if
`the Safety Evaluator determines through FMEA that the name similarity could ultimately cause
`medication errors in the usual practice setting, the Safety Evaluator will then recommend that an alternate
`proprietary name be used. In rare instances, the FMEA findings may provide other risk-reduction
`strategies, such as product reformulation to avoid an overlap in strength or an alternate modifier
`designation may be recommended asa means of reducing the risk of medication errors resulting from
`drug name confusion.
`
`We will object to the use of proposed proprietary name when the one or more of the following conditions
`are identified in the Safety Evaluator’s Risk Assessment:
`
`1. DDMAC finds the proposed proprietary name misleading from a promotional perspective, and
`the reviewDivision concurs with DDMAC’s findings. The Federal Food, Drug, and Cosmetic
`Act provides that labeling or advertising can misbrand a product if misleading representations are
`made or suggested by statement, word, design, device, or any combination thereof, whether
`through a trade name or otherwise.
`[21 U.S.C 321(n); see also 21 U.S.C. 352(a) & (n)].
`
`2. We identify that the proposed proprietary name is misleading because of similarity in spelling or
`pronunciation to another proprietary or established name of a different drug or ingredient [CFR
`201.10.(C)(5)].
`
`3. FMEA identifies potential for confusion between the proposed proprietary name and other
`proprietary or established drug names, m demonstrates that medication errors are likely to result
`from the drug name confusion under the conditions of usual clinical practice.
`
`4. The proposed proprietary name contains an USAN stem, particularly in a manner that is
`contradictory to the USAN Council’s definition.
`‘
`
`5. Medication Error Staff identify a potential source of medication error within the proposed
`proprietary name. The proprietary name may be misleading, or inadvertently introduce ambiguity
`
`

`

`and confusion that leads to errors. Such errors may not necessarily involve confusion between
`the proposed drug and another drug product.
`
`In the event that we object to the use of the proposed proprietary name, based upon the potential for
`confusion with another proposed (but not yet approved) proprietary name, we will provide a contingency
`objection based on the date of approval: whichever product is awarded approval first has the right to the
`use the name, while we will recommend that the second product to reach approval seek an alternative
`name.
`
`If none of these conditions are met, then we will not object to the use of the proprietary name. If any of
`these conditions are met, then we will object to the use of the proprietary name. The threshold set for
`objection to the proposed proprietary name may seem low to the Sponsor; however, the safety concerns
`set forth in criteria 1 through 5 are supported either by FDA Regulation or by external healthcare
`authorities, including the IOM, WHO, JCAHO, and ISMP, have examined medication errors resulting
`from look— or sound-alike drug names and called for Regulatory Authorities to address the issue prior to
`approval.
`
`Furthermore, we contend that the threshold set for the Proprietary Name Risk Assessment is reasonable
`because proprietary drug name confusion is a predictable and preventable source of medication error that,
`in many instances, can be identified and remedied prior to approval to avoid patient harm.
`
`Additionally, post-marketing experience has demonstrated that medication errors resulting from drug
`name confusion are notoriously difficult to remedy post-approval. Educational efforts and so on are low-
`leverage strategies that have proven to have limited effectiveness at alleviating the medication errors
`involving drug name confusion. Higher-leverage strategies, such as drug name changes, have been
`undertaken in the past; but at great financial cost to the Sponsor, and at the expense of the public welfare,
`not to mention the Agency’s credibility as the authority responsible for the approving the error-prone
`proprietary name. Moreover, even after Sponsor’s have changed a product’s proprietary name in the
`post-approval phase, it is difficult to eradicate the original proprietary name from practitioner’s
`vocabulary, and as such, the Agency has continued to receive reports of drug name confusion long after a
`name change in some instances. Therefore, we believe that post-approval efforts at reducing name
`confusion errors should be reserved for those cases in which the potential for name confusion could not
`be predicted prior to approval (see limitations of the process).
`
`If we object to a proposed proprietary name on the basis that drug name confusion could lead to
`medication errors, the FMEA process is used to identify strategies to reduce the risk of medication errors.
`We are likely to recommend that the Sponsor select an alternative proprietary name and submit the
`alternate name to the Agency for us to review. However, in rare instances FMEA may identify plausible
`strategies that could reduce the risk of medication error of the currently proposed name, and so we may be
`able to provide the Sponsor with recommendations that reduce or eliminate the potential for error would
`render the proposed name acceptable.
`
`2.4
`
`LABEL AND LABELING RISK ASSESSMENT
`
`The label and labeling of a drug product are the primary means by which practitioners and patients
`(depending on configuration) interact with the pharmaceutical product. The container labels and carton
`labeling communicate critical information including proprietary and established name, strength, form,
`container quantity, expiration, and so on. The insert labeling is intended to communicate to practitioners
`all information relevant to the approved uses of the drug, including the correct dosing and administration.
`
`

`

`Given the critical role that the label and labeling has in the safe use of drug products, it is not surprising
`that 33 percent of medication errors reported to the USP-ISMP Medication Error Reporting Program may
`be attributed to the packaging and labeling of drug products, including 30 percent of fatal errors.7
`
`Because the staff analyzes reported misuse of drugs, we staff are able to use this experience to identify
`potential errors with all medication Similarly packaged, labeled or prescribed. We use FMBA and the
`principles of human factors to identify potential sources of error with the proposed product labels and
`insert labeling, and provided recommendations that aim at reducing the risk of medication errors.
`
`For this product the Sponsor submitted on September 20, 2007 the following labels and insert labeling for
`our review (see Appendix F and G for images):
`
`0 Container: 100 mg vial
`
`o Carton
`
`o
`
`Prescribing Information
`
`Additionally, on February 20, 2008, the Division forwarded a working draft of the package insert that
`reflects all of the Division’s revisions to the package insert to date.
`
`3 RESULTS
`
`3.1
`
`DATA BASE AND INFORMATION SOURCES
`
`Our search of the intemet, several standard published databases and information sources (see Section 7
`References) for existing drug names which sound-alike or look-alike to Treanda to a degree where
`potential confusion between drug names could occur and result in medication errors in the usual clinical
`practice settings identified twelve names as having some similarity to the name Treanda.
`
`Seven of the twelve names were thought to look like Treanda, which include: Trecator, Namenda,
`Truvada,
`”‘7 ‘ , Trionate, Trinate, and Tripedia.
`
`Two names were thought to sound similar to Treanda: Ziana and Trientine.
`
`‘ Three names were thought to have look and sound similar to Treanda: Trandate, Trental, and Trendar
`
`None of the twelve names contained a US. Adopted Name (USAN) stern.
`
`3.1.1 CDER Expert panel discussion
`
`The Expert Panel reviewed the pool of names identified by the medication error staff (see section 3.1.1.
`above), and noted one additional name, Triant HC, as having both orthographic and phonetic similarity to
`Treanda.
`
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and-did not offer
`any additional comments relating to the proposed name.
`
`3.2 CDER PRESCRIPTION ANALYSIS STUDIES
`
`A total of 31 practitioners responded, and none of the responses overlapped with any existing or proposed
`drug names. About half of the participants (n=16) interpreted the name correctly as “Treanda,” with
`correct interpretation occurring more frequently in the written studies. The remainder of the responses
`
`7 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`p275.
`‘
`
`W Note: This is proprietary and confidential information that should not be released to the public.m
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`

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`misinterpreted the drug name. The majority of misinterpretations occurred in the second written
`prescription study