Transcript Present
Generic Drug Labeling: Unraveling the Mysteries 2011 USPHS Symposium Pharmacy Category Day June 21, 2011 Presented by: CAPT Lillie D. Golson, MSA, PharmD Team Leader, Labeling Review Branch Office of Generic Drugs Food and Drug Administration Learning Objectives Provide an overview of the labeling review process in FDA’s Office of Generic Drugs Describe the types of errors often attributed to labeling Present graphic examples highlighting ways labeling can both contribute to and prevent medication errors Provide tips to better understand characteristics unique to generic labeling Heighten awareness of the use of labeling statements to communicate important information to practitioners Overview: Labeling Review Branch Office of Generic Drugs (OGD) Staffing 22 Pharmacists: 19 Reviewers 3 Team Leaders Responsibilities Ensure that the proposed generic labeling is the “same as” that of the branded equivalent or Reference Listed Drug (RLD) Ensure that healthcare practitioners are provided sufficient information to safely use the product Review Tools Primary Focus Areas of OGD Labeling Reviews Labeling Text Packaging Pharmacy practice (as related to safety and the prevention of medication errors) Labeling Text Focus: • • • • • Is the generic name correct? Does font size meet regulatory standards? Are inappropriate abbreviations used? Are dyes and coloring agents listed in the DESCRIPTION section? Do solid oral dosage forms have unique identifiers described in the HOW SUPPLIED section? Packaging Focus: • • • • • Does the package container differ from the RLD (e.g., prefilled syringe vs. vial)? Is the container color appropriate (e.g., cap color for ophthalmics, potassium chloride)? Are individual cartons required (e.g., contains special dosing instructions)? Is proposed package size mismatched with the recommended dose? How will medication guides and patient information leaflets accompany the product? Pharmacy Practice Focus: • • • • • Are adequate instructions provided to ensure the correct use of a product when package differs from the RLD? Is the difference acceptable from a safety standpoint? Are the established name and strength the most prominent text appearing on the label/labeling? Is the layout of the labeling cluttered or confusing? How is the product and labeling being used in the real world? Are products sufficiently differentiated? Labeling and Medication Errors 2006 IOM Report Indicated that major med error problems involved drug naming, labeling, and packaging of products 33% of errors caused by labeling and packaging 30% of fatalities reported involved labeling and packaging 10% of all errors were attributed to drug name confusion Ways The Labeling and Packaging Cause Confusion Expression of Strength Prominence of Information Legibility of Information Trade Dress Packaging Configurations Packaging Design Product Design Expression of Strength and Total Drug Content www.medicalinspection.net/.../02/Figure31.png Lack of Prominence of Vital Information www.medicalinspection.net/.../02/Figure12.png Poorly Legible Information Labeling and Packaging Trade Dress http://abcnews.go.com/Blotter/slideshow?id=9981722 Poor Packaging Design Poor Product Design Ways nomenclature can cause confusion Sound alike – look alike names Brand name/brand name confusion Generic name/generic name confusion Brand to generic name confusion Generic names lacking unique/brand identity Use of abbreviations, acronyms, dose designations, and various symbols Brand To Generic Name Confusion Established names used more with generic products. Branded product frequently uses “fanciful” terms (e.g., sprinkles, rapidly disintegrating, caplets, spansules). RLD slow to change common/usual names to compendial names. RLD frequently uses “non-official” dosage forms in its proprietary names (e.g., sustained-release, dispersible, long-acting, controlled-release). Brand to Generic Confusion (LA, CD, SR are not official dosage forms) RLD Ritalin Ritalin LA Metadate CD Ritalin SR Metadate ER Concerta Methylin ER Generic Methylphenidate HCL Tablets Methylphenidate HCL Extended-Release Capsules Methylphenidate HCL Extended-Release Tablets Brand to Generic Confusion (SR not an official dosage form in USP) RLD Generic Wellbutrin Bupropion HCL Tablets Bupropion HCL Extended-release Tablets Zyban Wellbutrin SR Wellbutrin XL Brainstorming Ways FDA Tries to Communicate With The Pharmacist and Technician Cross reference common names with compendial names Place important information on container and carton labeling Tall Man Lettering Color Differentiate Products Use USP Labeling Statements Protect from light Not for injection Not for intrathecal use Must be chewed before swallowing Must be diluted Warning: Paralyzing Agent Use CFR Labeling Statements 21 CFR 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use Contains FD&C Yellow #5 (tartrazine) 21 CFR 201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use Phenylketonurics: Contains phenylalanine (4.5 mg per tablet) 21 CFR 208.24 Distributing and Dispensing a Medication Guide However… BOXED STATEMENTS Technicians: Familiarize yourselves with the general labeling format. Scan the entire label for alerting statements and inform the pharmacist before filling the order. Try not to cover directions for use. Try not to cover important information before pharmacist sees it. Never assume. Useful Links The Daily Med: http://dailymed.nlm.nih.gov/dailymed/about.cfm Drugs@FDA: http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/ USP: http://www.usp.org/ Medication Guides: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm Orange Book: http://www.accessdata.fda.gov/Scripts/cder/ob/default.cfm Medwatch: http://www.fda.gov/Safety/MedWatch/default.htm Thank you!