CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-301
`
`PROPRIETARY NAME REVIEW(S)
`
`

`

`Department of Health and Human Services
`
`Public Health Service
`
`Food and Drug Administration
`
` Office of Surveillance and Epidemiology
`
`Center for Drug Evaluation and Research
`
`Date:
`
`To:
`
`Thru'
`'
`
`From:
`
`October 8, 2008
`
`Donna Griebel, M.D., Director
`Division of Gastroenterology Products
`
`Kellie Taylor, PharmD, MPH, Team Leader
`Carol Holquist, R.Ph. Director
`Division of Medication Error Prevention and Analysis
`
`Melina Griffis, R.Ph., Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`Subject:
`
`Proprietary Name, Label and Labeling Review
`
`Drug Name(s):
`
`Apriso (mesalamine) Extended Release Capsules, 375 mg
`
`Application Type/Number: NDA 22-301
`
`Applicant/sponsor:
`
`Salix Pharmaceuticals, Inc.
`
`OSE RCM #:
`
`2008-1327
`
`-
`
`***Note: This review contains proprietmy and confidential information that should not be
`released to the public. ***
`
`

`

`CONTENTS
`
`EXECUTIVE SUMMARY ........................ L .................................................................................... 2
`1
`BACKGROUND ..................................................................................................................... 2
`1 . 1
`Introduction ................................................................................._. .................................. 2
`1.2
`Product Information ......................................... .............................................................. 2
`2 METHODS AND MATERIALS ...............................~. ............................................................ 2
`2.1
`Proprietary Name Risk Assessment ............................................................................... 2
`2.2
`Label and Labeling Risk Assessment ............................................................................ 8
`RESULTS ................................................................................................................................ 9
`3.1
`Proprietary Name Risk Assessment ................................................................. 9
`3.2
`Label and Labeling Risk Assessment .......................................................................... 10
`DISCUSSION .......... '. ............................................................................................................ 11
`
`3
`
`4
`
`5
`
`Proprietary Name Risk Assessment........... .................................................................. l 1
`4.1
`Label and Labeling Risk Assessment .......................................................................... l 1
`4.2
`CONCLUSIONS and RECOMMENDATIONS ................................................................... 12
`5.1
`Comments To the Division................................,..................................................... 12
`5.2
`Comments To The Applicant ....................................................................................... 13
`REFERENCES ...................................................................................................................... 13
`6
`APPENDICES ............................................................................................................................... 15
`
`

`

`EXECUTIVE SUMMARY
`
`The results of the Proprietary Name Risk Assessment found that the proposed name, Apriso, is
`not vulnerable to name confusion that could lead to medication errors. Thus, the Division Of
`Medication Error Prevention and Analysis does not object to the use of the proprietary name,
`Apriso, for this product. If a_ny 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 recommend
`that the name be resubmitted for review.
`
`Furthermore, this name must be re-evaluated upon submission of the NDA and approximately 90
`days prior to the expected action date of the NDA. A re-review of the name prior to NDA
`approval will rule out any objections based upon approval of other proprietary or established
`names from the signature date of this document.
`
`1
`
`BACKGROUND
`
`1.1
`
`INTRODUCTION
`
`This review is in response to a request from the Division of Gastroenterology Products for
`assessment of the proprietary name, Apriso, regarding potential name confusion with other
`proprietary or established drug names. The proposed product container labels and insert labeling
`were‘provided by the sponsor for our evaluation.
`
`1.2
`
`PRODUCT INFORMATION
`
`Apriso (mesalamine) is a pending NDA with an anticipated action date of October 31, 2008.
`Apriso is a locally acting aminosalicylate indicated for the maintenance of remission of ulcerative
`colitis in patients 18 years of age and older. It is available in one strength, 375 mg capsules, and
`the recommended dose of Apriso is 1500 g/day (4 capsules) to be taken once daily with or
`without food. The label claims that this product exhibits delayed—release and extended-release
`properties.
`‘
`
`Mesalamine is also marketed under the proprietary names Asacol (400 mg and 800mg tablets), ‘
`Pentasa (250 mg and 500 mg capsules), Rowasa (4 GM/60 mL enema), Canasa (1 GM
`suppository), and Lialda (1.2 GM tablets). Generic mesalamine enemas are also available.
`
`2 METHODS AND MATERIALS
`
`This section consists of methods and materials used by medication error staff conducting a
`proprietary name risk assessment (see 2.1 Proprietary Name Risk Assessment). The primary
`focus for this assessment is to identify and remedy potential sources of medication error prior to
`drug approval. The Division of Medication Error Prevention and Analysis 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
`
`2.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the
`proposed proprietary name, Apriso, 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 CDER.
`
`For the proprietary name, Apriso, the medication error staff of the Division of Medication Error
`Prevention and Analysis search 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 2.1.1.2). The Division also conducts internal CDER prescription analysis
`studies (see 2.1.2), and, when provided, external prescription analysis studies results are
`considered and incorporated into the overall risk assessment (see detail 2.1.4).
`
`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 2.1.4). 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. 1 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. The Division of Medication Error
`Prevention and Analysis uses 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 orthographicand 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,
`the Division of Medication Error Prevention and Analysis considers 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.2
`
`2.1.1 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 ‘A’
`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.34
`
`' Institute for Healthcare Improvement (1H1). Failure Modes and Effects Analysis. Boston. IHI:2004.
`
`2 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
`2006.
`
`3 Institute for Safe Medication Practices. Confused Drug name List (1996—2006). Available at
`htt
`://www.ism ..or
`ools/confuseddru names. df
`
`
`
`

`

`To identify drug names that may look similar to Apriso, 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 (six letters), upstrokes (one, capital letter ‘A’),
`downstokes (lowercase ‘p’), cross—strokes (A), and dotted letters (‘i’). Additionally, several letters
`in Apriso may be vulnerable to ambiguity when scripted, including the letter ‘A’ may appear as
`‘Ci, ‘Cl’ or ‘0’, lower case ‘0’ may appear as a lower case ‘e’ or ‘a’ and lower case ‘p’ may
`appear as ‘jo’. As such, the Staff also considers these alternate appearances when identifying
`drug names that may look similar to Apriso.
`
`When searching to identify potential names that may sound similar to Apriso, the Medication
`Error Staff search for names with similar number of syllables (three), stresses (A-pri-SO or AP-ri-
`so), 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 (Apriso), the established name (mesalamine) proposed indication
`(the maintenance of remission of ulcerative colitis), strength (375 mg), dose (4 capsules),
`frequency of administration (daily), route (oral) and dosage form of the product (capsule).
`Appendix A provides a more detailed listing of the product characteristics the Medication Error
`Staff generally 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.
`
`2.1.1.1 Database and Information Sources
`
`The proposed proprietary name, Apriso, was provided to the medication error staff of the
`Division of Medication Error Prevention and Analysis 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 Apriso using the criteria outlined in
`2.1.1. A standard description of the databases used in the searches is provided in Section 7. 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.
`I
`
`4 Kondrack, G and Dorr, B. Automatic Identification of Confiisable Drug Names. Artifical Inteligence in
`Medicine (2005)
`
`

`

`2.1.1.2 CDER Expert Panel Discussion
`
`An Expert Panel Discussion is held by the Division of Medication Error Prevention and Analysis
`to gather CDER professional opinions on the safety of the product and the proprietary name,
`Apriso. Potential concerns regarding drug marketing and promotion related to the proposed
`names are also discussed. This group is composed of the Division of Medication Error Prevention
`and Analysis Medication Errors 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. 1.2
`
`FDA Prescription Analysis Studies
`
`Three separate studies are conducted within the Centers ofthe FDA for the proposed proprietary
`name to determine the degree of confiision of Apriso with marketed US. drug names (proprietary
`and established) due to similarity in visual appearance with handwritten prescriptionsor 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 Apriso in handwriting and verbal
`communication of the name, inpatient medication orders and outpatient prescriptions 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.
`’
`'
`
`conducted on Se temper 23 2003
`Fi ure 1. 0923C Stud
`
`
`:55 2*
`THANDWR’HTE“IL'EPRESCRI'PITONAND’ j;
`_
`.. j,
`
`'*
`
`Inpatient Medication Order:
`
`
`£57,242»,____,4245*éxmtzzfi4m‘ AW.”mu: ”NF-Mg}?
`
`4 caps p0 QD
`
`;;1=-“c PRESCRIPTION.
`
`Apriso 0.375 mg
`
`

`

`Out atient Prescri tion Order:
`
`2.1.3
`
`External Proprietary Name Risk Assessment
`
`For this product, the Sponsor submitted a Proprietary Name Safety Assessment conducted by the
`Drug Safety Institute (DSI) to evaluate the proposed proprietary name Apriso. The Division of
`Medication Error Prevention conducts an independent analysis and evaluation of the data
`provided, and responds to the overall findings of the assessment. When the external proprietary
`name risk assessment identifies potentially confusing names that were not captured in the
`Division’s Medication Error Staff’s database searches or in the Expert Panel Discussion, these
`names are included in the Safety Evaluator’s Risk Assessment and analyzed independently by the
`Safety Evaluator to determine if the potentially confusing name could lead to medication errors in
`usual practice settings.
`‘
`
`After the Safety Evaluator has determined the overall risk assessment of the proposed name, the
`Safety Evaluator compares the findings oftheir overall risk assessment with the findings of the
`proprietary name risk assessment submitted by the Sponsor. 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 provides a
`detailed explanation of these differences.
`
`2.1.4
`
`Safety Evaluator Risk Assessment ofthe 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 (FMBA) is a systematic tool for evaluating a process and identifying
`where and how it might fail? When applying FMEA to assess the risk of a proposed proprietary
`name, the Division of Medication Error Prevention and Analysis 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 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 ofthe 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
`
`5 Institute for Healthcare Improvement (II-II). Failure Modes and Effects Analysis. Boston. II-ll:2004.
`
`

`

`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 Apriso convincingly
`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 Apriso to be confused 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 as a means of
`reducing the risk of medication errors resulting from drug name confusion.
`
`The Division of Medication Error Prevention and Analysis 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 review Division 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. The Division of Medication Error Prevention and Analysis identifies 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, Ed 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 name and another drug product.
`
`

`

`In the event that the Division of Medication Error Prevention and Analysis objects to the use of
`the proposed proprietary name, based upon the potential for confusion with another proposed (but
`not yet approved) proprietary name, the Division 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 the Division will recommend that the second product to reach approval seek an
`alternative name.
`
`If none of these conditions are met, then the Division of Medication Error Prevention and
`Analysis will not object to the use of the proprietary name. If any of these conditions are met,
`then the Division will object to the use ofthe 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 lSMP, 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, the Division of Medication Error Prevention and Analysis contends 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 fiom
`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,
`the Division of Medication Error Prevention and Analysis believes 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 the Division of Medication Error Prevention and Analysis objects 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. The Division of Medication
`Error Prevention and Analysis is likely to recommend that the Sponsor select an alternative
`proprietary name and submit the alternate name to the Agency for the Division of Medication
`Error Prevention and Analysis 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 the Division of Medication Error Prevention and Analysis may be able to provide the
`Sponsor with recommendations that reduce or eliminate the potential for error would render the
`proposed name acceptable.
`
`2.2
`
`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.6
`
`Because DMEPA staff analyze reported misuse of drugs, DMEPA staff are able to use this
`experience to identify potential errors with all medication similarly packaged, labeled or
`prescribed. DMEPA uses FMEA 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 the following labels and insert labeling-for our review (see
`Appendix K , L, M for images):
`
`0 Retail and Physician Sample Container Label
`
`0
`
`0
`
`0
`
`Physician Sample Carton Labels
`
`Physician Sample Tray Label
`
`Package Insert (images not included)
`
`3 RESULTS
`
`3.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`3.1.] Database and Information Sources
`
`Our search of the intemet, several standard published databases and information sources (see
`Section 7 References) identified 19 names as having some similarity to the name Apriso:
`Vaprisol, Apresoline, Aplisol, Apri, Apriza,,Optison, Afrinol, Aprocin, Apra, M Aspirin,
`Afrin, Uprima, Avapro, Cipro, Aprela, Apidra, Aprobit, and Aprobal.
`
`-——- Aspirin,
`Twelve of the 19 names were thought to look like Apriso (Aprocin, Apra,
`Afrin, Uprima, Avapro, Cipro, Aprela, Apidra, Aprobit, and Aprobal) and 6 names (Apresoline,
`Aplisol, Apri, Apriza, Optison and Afrinol) were thought to look and sound similar to Apriso.
`One name (Vaprisol) was thought to sound like Apriso.
`
`No USAN stems were identified in Apriso as of September 18, 2008.
`
`3.1.2 CDER Expert Panel Discussion
`
`The Expert Panel reviewed the pool of names identified by the Division of Medication Error
`Prevention and Analysis staff (see section 3.1.]. above), but did not identify any additional names
`with similarity to Apriso.
`’
`
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did
`not offer any additional comments relating to the proposed name.
`
`3.1.3 FDA Prescription Analysis Studies
`
`A total of 32 practitioners responded, but none of the responses overlapped with any existing or
`proposed drug names. About 66% of the participants (n=21) interpreted the name correctly as
`
`6 Institute of Medicine. Preventing Medication En'ors. The National Academies Press: Washington DC.
`2006. p275.
`
`

`

`l3(4)
`
`“Apriso,” with correct interpretation occurring more frequently in the written studies. The
`remainder of the responses misinterpreted the drug name. The majority of misinterpretations
`occurred in the phonetic prescription study, 3 respondents misinterpreted ‘Apriso’ as ‘Prefill’. In
`the written prescription studies, the letter ‘i’ was misinterpreted as ‘e’ by six respondents. One
`respondent in the written study misinterpreted ‘Apriso’ for ‘Cipriso’ which is similar to the
`marketed drug Cipro and discussed later in this review. See Appendix A for the complete listing
`of interpretations from the verbal and written prescription studies.
`
`3.1.4
`
`External Proprietary Name Risk Assessment
`
`In the proposed name risk assessment submitted by the Sponsor, DSI identified and evaluated a
`total of 89 drug names (Afrin, Afrinol, Apidra, Aplisol, Apra, Apresoline, Apri, Cipro, Avapro,
`Abilify, Abreva, Aciphex, Aciphex, Acrisorcin, ——-
`,Aerohist, Ahist, AK-Pred, Akpro,
`Akrinol, Algisorb, Aloprim, Alprazolam, Ambisome, Amrix, Amvisc, Anusol, Apap, .
`-—--
`Aplitest, Appearex, Apptrim, Aprazone, Aprepitant, Apresodex, Aprodine, Aprozide, Aptivus,
`Aricept, Aricin, Aridol, Aspridox, Asprimox, Atenolol, Atretol, Atridox, Atrohist, Atropisol,
`Aurasol, Auroto, Aurinol, Avinza, Caprex,
`-——-
`, Elaprase, Enpresse—28, Epifoam, Episeal,
`Eprex, Ery—sol, Eycette, I-Prin, Lamotrigine, Marpres, Napril, Naprosyn, Natrico, Pap urea,
`Perisol, Presate, Precef, Precise, Pressorol, Presun, Primsol, Prestiq, _... Prosof, Prosol,
`Prosom, Rimso, Sarisol, Singulair, Tearisol, Trisudo, Trisol, Trycet, Trysul and Vaprisol) thought
`tohave some potential for confusion with the name Apriso.
`
`Ten of the 89 names (Afrin, Afrinol, Apidra, Aplisol, Apra, Apresoline, Apri, Cipro, Avapro and
`Vaprisol) were previously identified in the Division of Medication Error Prevention and Analysis
`Staff searches, the Expert Panel Discussion, or FDA prescription studies.
`
`3.1.5 Safety Evaluator Risk Assessment
`
`Independent searches by the primary Safety Evaluator did not identify any additional names
`thought to lock similar to Apriso. As such, a total of 98 names (19 identified by the CDER
`Expert panel discussion and 79 additional from the DSI report submitted by the sponsor) were
`analyzed to determine if the drug names could be confused with Apriso and if the drug name
`confusion would likely result in a medication error.
`
`All of the identified nam