DANIEL
M.
ASHBY,
M.S., FASHP
DIRECTOR OF PHARMACY#
MEMORANDUM
July 12,2002
DEPARTMENT OF PHARMACY600 North Wolfe Street / Carnegie180Baltimore, MD 2 1287-6 180410-955-6249J FAX 410-955-0287
To: Mary C. Gross
Office of Drug SafetyCenter for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers Lane - Room 156-32Rockville, MD 20857grossm@cder.fda.gov andDockets Management Branch (HFA-305)Food and Drug Administration5630 Fishers Lane - Room 1061Rockville, MD 20852fdadockets@oc.fda.qov
Re:Comments for the Public Meeting to address Bar Code Labeling Requirements forHuman Drug ProductsDear Ms. Gross:In follow up to my previous request please find attached comments for the public meeting toaddress Bar Code Label Requirements for Human Drug Products.Thank you for the opportunity to comment.Sincerely,ti7LwLkY+vLDaniel M. Ashby, M.S., FASHPDirector of Pharmacy
Affiiiutes of the Johns Hopkhs Hedtlr SystemThe JohnsHopkins JohnsHopkins Bayview MedicalCenter Howard CountyGeneralHospital JohnsHopkins Connnunity Physicians JohnsHopkinsHome
CareGroup
FDA Bar Code Label Requirements For
Human Drug Products1%[ 7 2“62 ,thfb 123 ;‘i9 125
July 26,2002A.General QuestionsRelated o Drugs and Biologics:1. Which medical products should carry a bar code? For example: should allprescription and over-the-counterdrugs be bar coded?Drug manufacturers should provide all prescription and over-the-counter drugs in bar coded packages down to the single unit dose orunit of use level. All drugs and all dosage orms would be included inthe bar code labeling requirement (tablets, capsules, suppositories,ointments, creams, otics, opthalmics and drugs for injection). The barcode should be present for each individual dose that goes to the patient.Bar coding is needed n hospitals and health-systems for the followingreasons:
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Ensuring the accuracy of medication identification
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Ensuring the accuracy of the medication administration process
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Improving efficiencies within the medication distribution systemin hospitals
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Reducing the number or medication errors
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Improving the efficiency of the supply system, ncludingordering, receipt, storage and dispensing, billing, administrationdocumentation and tracking of drug productsThe most important benefit of bar code technology is the improvementof patient safety. These benefits will be obtained only when the barcode technology is utilized at the hospital or patient facility level.In the hospital pharmacy, the availability of bar codes will assist withordering, receipt, storage, dispensing and administration of drugs forpatients.2.What information should be contained n the bar code?The following information should be included on the label:* National Drug Code (NDC)
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Drug name, strength and unit of measure
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Lot number (for recall purposes)
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Expiration dates (to prevent the utilization of expiredmedications)What do you consider o be critical bar code nformation that will reducemedicalproduct errors?The critical bar code nformation that will reduce dispensing errors isthe National Drug Code, drug name, strength and unit of measure oidentify the product. The information such as ot number andexpiration date is of limited value with respect o reducing dispensingerrors.It may be advisable o implement these recommendations n two stages.The first priority for patient safety would be to have the National DrugCode (NDC), drug name, strength and unit of measure. A secondphase, possibly mplemented in the future, would be to add the lotnumber and expiration date. Thesewill have value for patient safetyfor the purposes of inventory control; supply chain management andthe managementof a complex recall process.3.Consideringcurrent scanners nd heir ability to read certain symbologies, houldthe rule adopt a specificbar code symbology e.g. RSS (reduced pace ymbology)and composite Z-dimensional) yrnbology?No comment.Shouldwe adopt one symbologyover another,or shouldwe allow for “machine
readable” ormats?No comment.What are he pros and consof eachapproach?4.Assuming hat we require bar codeson all human drug products,where on thepackage hould he bar codesbe placed?The bar codes or unit doseblister package should be placed on thedrug label.The NDC bar code should be placed above or below thehuman readable NDC.The bar code should be placed on the package that is ultimately used bythe patient. Ointments, creamsand containers for otic products,opthalmic products, ampules and vials and inhalation products, that
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US Food and Drug Administration: 80018539
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