Generic Drug Labeling:Generic Drug Labeling:

2011 USPHS Symposium2011 USPHS Symposium Pharmacy Category DayPharmacy Category Day

June 21, 2011June 21, 2011

Presented by:Presented by:CAPT Lillie D. Golson, MSA, PharmD CAPT Lillie D. Golson, MSA, PharmD Team Leader, Labeling Review BranchTeam Leader, Labeling Review BranchOffice of Generic DrugsOffice of Generic DrugsFood and Drug AdministrationFood and Drug Administration

Unraveling the MysteriesUnraveling the Mysteries

Learning ObjectivesLearning Objectives Provide an overview of the labeling review process Provide an overview of the labeling review process

in FDA’s Office of Generic Drugsin FDA’s Office of Generic Drugs Describe the types of errors often attributed to Describe the types of errors often attributed to

labelinglabeling Present graphic examples highlighting ways Present graphic examples highlighting ways

labeling can both contribute to and prevent labeling can both contribute to and prevent medication errorsmedication errors

Provide tips to better understand characteristics Provide tips to better understand characteristics unique to generic labelingunique to generic labeling

Heighten awareness of the use of labeling Heighten awareness of the use of labeling statements to communicate important information statements to communicate important information to practitionersto practitioners

Overview:Overview: Labeling Review Branch Labeling Review BranchOffice of Generic Drugs Office of Generic Drugs

(OGD)(OGD)

StaffingStaffing22 Pharmacists:22 Pharmacists:

19 Reviewers19 Reviewers 3 Team Leaders3 Team Leaders

ResponsibilitiesResponsibilities Ensure that the proposed generic Ensure that the proposed generic

labeling is the “same as” that of the labeling is the “same as” that of the branded equivalent or Reference branded equivalent or Reference Listed Drug (RLD)Listed Drug (RLD)

Ensure that healthcare practitioners Ensure that healthcare practitioners are provided sufficient information to are provided sufficient information to safely use the productsafely use the product

Review ToolsReview Tools

Primary Focus Areas Primary Focus Areas of OGD Labeling Reviewsof OGD Labeling Reviews

Labeling TextLabeling Text PackagingPackaging Pharmacy practice (as related to Pharmacy practice (as related to

safety and the prevention of safety and the prevention of medication errors)medication errors)

Labeling Text Focus:Labeling Text Focus:• Is the generic name correct?Is the generic name correct?• Does font size meet regulatory standards?Does font size meet regulatory standards?• Are inappropriate abbreviations used?Are inappropriate abbreviations used?• Are dyes and coloring agents listed in the Are dyes and coloring agents listed in the

DESCRIPTION section?DESCRIPTION section?• Do solid oral dosage forms have unique Do solid oral dosage forms have unique

identifiers described in the HOW identifiers described in the HOW SUPPLIED section?SUPPLIED section?

Packaging Focus:Packaging Focus:• Does the package container differ from the Does the package container differ from the

RLD (e.g., prefilled syringe vs. vial)?RLD (e.g., prefilled syringe vs. vial)?• Is the container color appropriate (e.g., cap Is the container color appropriate (e.g., cap

color for ophthalmics, potassium chloride)?color for ophthalmics, potassium chloride)?• Are individual cartons required (e.g., contains Are individual cartons required (e.g., contains

special dosing instructions)?special dosing instructions)?• Is proposed package size mismatched with the Is proposed package size mismatched with the

recommended dose?recommended dose?• How will medication guides and patient How will medication guides and patient

information leaflets accompany the product?information leaflets accompany the product?

Pharmacy Practice Focus:Pharmacy Practice Focus:• Are adequate instructions provided to ensure the Are adequate instructions provided to ensure the

correct use of a product when package differs from correct use of a product when package differs from the RLD? Is the difference acceptable from a safety the RLD? Is the difference acceptable from a safety standpoint?standpoint?

• Are the established name and strength the most Are the established name and strength the most prominent text appearing on the label/labeling?prominent text appearing on the label/labeling?

• Is the layout of the labeling cluttered or confusing?Is the layout of the labeling cluttered or confusing?• How is the product and labeling being used in the How is the product and labeling being used in the

real world?real world?• Are products sufficiently differentiated?Are products sufficiently differentiated?

Labeling and Medication Labeling and Medication ErrorsErrors

2006 IOM Report2006 IOM Report Indicated that major med error Indicated that major med error

problems involved drug naming, problems involved drug naming, labeling, and packaging of labeling, and packaging of productsproducts

33% of errors caused by labeling 33% of errors caused by labeling and packagingand packaging

30% of fatalities reported 30% of fatalities reported involved labeling and packaginginvolved labeling and packaging

10% of all errors were attributed 10% of all errors were attributed to drug name confusion to drug name confusion

Ways The Labeling and Ways The Labeling and Packaging Cause ConfusionPackaging Cause Confusion

Expression of StrengthExpression of StrengthProminence of Information Prominence of Information Legibility of Information Legibility of Information Trade DressTrade DressPackaging ConfigurationsPackaging ConfigurationsPackaging DesignPackaging DesignProduct Design Product Design

Expression of Strength and Expression of Strength and Total Drug Content Total Drug Content

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Lack of Prominence of Vital Lack of Prominence of Vital InformationInformation

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Poorly Legible InformationPoorly Legible Information

Labeling and PackagingLabeling and PackagingTrade DressTrade Dress

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Poor Packaging DesignPoor Packaging Design

Poor Product DesignPoor Product Design

Ways nomenclature can Ways nomenclature can cause confusioncause confusion

Sound alike – look alike namesSound alike – look alike names Brand name/brand name confusionBrand name/brand name confusion Generic name/generic name confusionGeneric name/generic name confusion Brand to generic name confusionBrand to generic name confusion Generic names lacking unique/brand Generic names lacking unique/brand

identityidentity Use of abbreviations, acronyms, dose Use of abbreviations, acronyms, dose

designations, and various symbolsdesignations, and various symbols

Brand To Generic Name ConfusionBrand To Generic Name Confusion Established names used more with generic Established names used more with generic

products.products. Branded product frequently uses “fanciful” Branded product frequently uses “fanciful”

terms (e.g., sprinkles, rapidly disintegrating, terms (e.g., sprinkles, rapidly disintegrating, caplets, spansules).caplets, spansules).

RLD slow to change common/usual names to RLD slow to change common/usual names to compendial names.compendial names.

RLD frequently uses “non-official” dosage RLD frequently uses “non-official” dosage forms in its proprietary names (e.g., forms in its proprietary names (e.g., sustained-release, dispersible, long-acting, sustained-release, dispersible, long-acting, controlled-release).controlled-release).

Brand to Generic ConfusionBrand to Generic Confusion(LA, CD, SR are not official dosage forms)(LA, CD, SR are not official dosage forms)

RLDRLDRitalinRitalin

Ritalin LARitalin LAMetadate CDMetadate CDRitalin SRRitalin SR

Metadate ERMetadate ERConcertaConcertaMethylin ERMethylin ER

GenericGenericMethylphenidate HCL TabletsMethylphenidate HCL Tablets

Methylphenidate HCL Methylphenidate HCL Extended-Release CapsulesExtended-Release Capsules

Methylphenidate HCL Methylphenidate HCL Extended-Release TabletsExtended-Release Tablets

RLDRLD

WellbutrinWellbutrin

ZybanZyban

Wellbutrin SRWellbutrin SR

Wellbutrin XLWellbutrin XL

GenericGeneric

Bupropion HCL Bupropion HCL TabletsTablets

Bupropion HCL Bupropion HCL Extended-release Extended-release TabletsTablets

Brand to Generic ConfusionBrand to Generic Confusion(SR not an official dosage form in USP)(SR not an official dosage form in USP)

BrainstormingBrainstorming

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Ways FDA Tries to Communicate Ways FDA Tries to Communicate With With

The Pharmacist and TechnicianThe Pharmacist and Technician

Cross reference common Cross reference common names with compendial names with compendial

namesnames

Place important information Place important information on container and carton on container and carton

labelinglabeling

Tall Man LetteringTall Man Lettering

Color Differentiate ProductsColor Differentiate Products

Use USP Labeling StatementsUse USP Labeling Statements Protect from lightProtect from light Not for injectionNot for injection Not for intrathecal useNot for intrathecal use Must be chewed before swallowingMust be chewed before swallowing Must be dilutedMust be diluted Warning: Paralyzing AgentWarning: Paralyzing Agent

Use CFR Labeling StatementsUse CFR Labeling Statements

21 CFR 201.2021 CFR 201.20 Declaration of presence of FD&C Yellow No. 5 and/or Declaration of presence of FD&C Yellow No. 5 and/or

FD&C Yellow No. 6 in certain drugs for human useFD&C Yellow No. 6 in certain drugs for human use

Contains FD&C Yellow #5 (tartrazine)

21 CFR 201.2121 CFR 201.21Declaration of presence of phenylalanine as a component of aspartame in Declaration of presence of phenylalanine as a component of aspartame in

over-the-counter and prescription drugs for human useover-the-counter and prescription drugs for human use

Phenylketonurics: Contains phenylalanine (4.5 mg per tablet)

21 CFR 208.2421 CFR 208.24Distributing and Dispensing a Medication GuideDistributing and Dispensing a Medication Guide

However…However…

Technicians:Technicians: Familiarize yourselves with the general labeling format.Familiarize yourselves with the general labeling format. Scan the entire label for alerting statements and inform the Scan the entire label for alerting statements and inform the

pharmacist before filling the order. pharmacist before filling the order. Try not to cover directions for use.Try not to cover directions for use. Try not to cover important information before pharmacist sees it.Try not to cover important information before pharmacist sees it. Never assume. Never assume.

ATTENTION:

ATTENTION:

CAUTION:CAUTION:

PHARMACIST:

PHARMACIST:

WARNING:

WARNING:

CONTAINS:CONTAINS:

BOXED STATEMENTSBOXED STATEMENTS

STATEMENTS IN

STATEMENTS IN RED LETTERS

RED LETTERS

Useful LinksUseful Links The Daily Med: The Daily Med:

http://dailymed.nlm.nih.gov/dailymed/about.cfmhttp://dailymed.nlm.nih.gov/dailymed/about.cfm Drugs@FDA:Drugs@FDA:

http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/ USP: http://www.usp.org/USP: http://www.usp.org/ Medication Guides: Medication Guides:

http://www.fda.gov/Drugs/DrugSafety/ucm085729.htmhttp://www.fda.gov/Drugs/DrugSafety/ucm085729.htm Orange Book:Orange Book:

http://www.accessdata.fda.gov/Scripts/cder/ob/default.cfmhttp://www.accessdata.fda.gov/Scripts/cder/ob/default.cfm Medwatch:Medwatch:

http://www.fda.gov/Safety/MedWatch/default.htmhttp://www.fda.gov/Safety/MedWatch/default.htm

Thank you!Thank you!