Application Guidelines and Prototypes

Draft 2001-Nov-26

Narrative text

1. Barcoded peel-off stickers

2. Barcoding of outer packaging

3. Uniform vaccine administration record form

4. National Drug Code vaccine database

5. Vaccine Facts information sidebar

6. Standardized vaccine and manufacturer abbreviations

Tradename disclaimer

• Narrative Text [under construction]

• Barcoded peel-off stickers for vaccine vials and prefilled syringes

    For medical practices that remain non-computerized and dependent on manual recording on paper of vaccination events, VISI will propose that peel-off, pressure-sensitive, adhesive stickers be affixed in some way to the vials or prefilled syringes (primary container) of each vaccine for each dose contained therein.  Peel-off vial stickers without barcodes have been marketed for veterinary vaccines and some human vaccines (see below).  Technology exists for the use of multiple peel-off labels superimposed one above another (as pioneered in Sweden for vaccine vials).  Also, stamp-dispenser-type devices for attachment to multi-dose pharmaceutical vials have been invented, e.g. see US patent 5692640.  Stickers packaged loose or attached only to the carton (secondary container) are more likely to lose linkage with the correct vial when health providers store an opened carton separately or discard it. 

veterinary peel-off sticker example

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Swedish peel-off sticker examples

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box  sticker closeup 

U.S.-marketed TriHIBit® peel-off stickers (without barcode; affixed to boxflap, not vial)

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syringes  sticker closeup

U.S.-marketed Vaqta® peel-off stickers (without barcode; on prefilled syringes)

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VISI prototype barcoded stickers

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STICKER SIZE.    The smallest typical single-dose (USP Type I) vaccine vial (~15 mm diameter, ~32 mm high, ~13mm mouth rim diameter) has a label size of ~44 mm wide by ~19 mm high, which does not wrap around fully and does not obscure a view into the contents.  This is likely to be the largest practical size for peel-off stickers.  The maximum size for these peel-off labels is specified by VISI at 98 mm wide by 25 mm high, based on compatibility with the draft Universal Vaccine Administration Record (UVAR) form (see below).  However, no minimum size is specified, and this issue is left to the manufacturer and FDA.  Much smaller sizes than the maximum are preferable and technically feasible. 

NUMBER OF STICKERS PER DOSE.    One sticker could be used for the patient's permanent paper medical record (see UVAR form below).  Additional duplicate or triplicate stickers could be placed into a form (not created by VISI) to be faxed or mailed to immunization registries, and into a patient's take-home immunization "passport" booklet.  It remains to be determined whether VISI will specify such duplicate or triplicate stickers for each dose of vaccine, or whether such features should be left to competitive market forces.  Also undetermined is whether or not a permanent label should remain on the vial after all peel-off stickers have been removed. 

ADHESIVE AND OTHER PERFORMANCE SPECIFICATIONS.    The adhesive on these stickers should be designed for permanent, archival adherence once placed into the paper medical record.  However, a short grace period before full adherence is achieved would be desirable in order to reposition them in case of initial misplacement.  How these stickers might be affixed to the vials, and other performance characteristics are matters left by VISI to individual manufacturers and the FDA.  

REQUIRED STICKER CONTENT.    Each peel-off sticker (and any underlying label remaining on the vial) should contain in plain English text in a typeface height of at least 1.75 mm (or higher as mandated by FDA):

1. the boldfaced standardized abbreviation for the vaccine type (see below);
2. the commercial, registered, or trademarked brandname of the vaccine;
3. the standardized abbreviation for the vaccine manufacturer/distributor (see below);
4. the NDC number, identified by the prefix "NDC";
5. the lot number (or the "pick" number for vaccines combined by the vaccinator from separate lots of different vaccines), identified by the prefix "Lot" or "Pick no."; 
6. the expiration date, identified by the prefix "Exp."; and
7. a Reduced Space Symbology™ (RSS) barcode embedding the NDC, expiration date, and lot number.  

OPTIONAL STICKER CONTENT.    In addition, and space permitting, peel-off stickers optionally may contain:

1. the full, official, generic name of the vaccine; 
2. the full name of the manufacturer and/or distributor; and/or
3. logos, graphic art and embellishments, and any other information desired by the manufacturer and approved by the FDA. 

The layout of VISI-specified and optional components on the stickers should be left to the individual manufacturers and FDA.

BARCODING STANDARDS.    All barcoding symbology, its embedded numerology, and accompanying "human-readable" English or arabic numeric translations of its content, if any, shall be in conformance with applicable standards and application guidelines promulgated by the Uniform Code Council (UCC) and EAN International for small pharmaceutical packages, unless otherwise stated herein.  Complementary standards of the Health Industry Business Communications Council (HIBCC), the National Wholesale Druggists Association, and AIM, Inc. shall also apply, unless incompatible with specifications stated herein or in cited UCC•EAN standards.  

The following normative documents contain provisions which, through reference in this text, constitute provisions of these application guidlines.  For dated references, subsequent amendments to, or revisions of, any of these publications do not apply.  However, users of these application guidelines are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below.  For undated references, the latest edition of the normative document referred to applies.  

• Uniform Code Council • EAN International  1993-1 (revised and reprinted 1995-7); UCC/EAN-128 Application Identifier Standard
• AIM Inc.  ITS/99-001:1999-10-29; International Symbology Specification: Reduced Space Symbology (RSS)
• AIM Inc.  ITS/99-002:1999-10-26; International Symbology Specification: EAN•UCC Composite Symbology™
• National Wholesale Druggists' Association  1992-12; NWDA Numerical and Automated Identification of Drug Products.  
• Health Industry Business Communications Council.  1998; The Health Industry Bar Code (HIBC) Supplier Labeling Standard

BARCODING ON STICKER.    The Reduced Space Symbology (RSS) barcode will be in (preferably) the RSS Limited Composite format or (alternatively) in RSS-14 Stacked Composite format.  These RSS barcodes will contain the same embedded data (NDC number, lot number, expiration date) as conventional 1-dimensional barcodes to be specified for the secondary packaging (cardboard container).  (These links provide further information and background on RSS from AIM and from the Uniform Code Council's news, space-constrained, healthcare, and technical working group pages.)  

BARCODE ORIENTATION AND ELEMENT SIZE.    The axis of the 1-dimensional component of the RSS barcode when the sticker is affixed to the vial and visible should be parallel with the axis of the vial, in order to minimize curvature and provide a non-curved line of scan to enhance scannability.  The minimum " x-dimension" (thickness of smallest bar) for the barcode on peel-off stickers should be ~7.5 mils (0.0075 inch, 0.19 mm), although larger settings are preferable to ensure successful reading with a wide variety of scanning equipment and conditions.   

READING RSS BARCODES.    The 2-dimensional RSS barcode formats specified above cannot be read by conventional, inexpensive laser scanner pens or wands costing as little as ~$100.  Reading RSS barcodes requires specialized laser or imaging scanners with list prices of ~$800 - ~$1,200 each (mid-2000 prices, which may be available at discount and may drop in time).  The latter might be appropriate for hospital or clinic pharmacies or recordkeeping units, and central immunization registries.  But such equipment may not be affordable for many physician offices.  In such cases, inexpensive pen or wand scanners can still read the conventional one-dimensional barcodes that will be on the vaccine carton.

CHALLENGES TO PRINTING RSS BARCODES.    An obstacle to RSS barcoding of peel-off stickers is that printing of the lot number and expiration date onto vaccine vial labels and cartons occurs relatively late in the manufacturing process, usually performed in-house around the time of filling and labeling the final containers of vaccine.  This "online" printing currently uses ink-jet or other flexible and economical technologies.  However, many such printing techniques may not be precise enough to generate RSS barcodes.  This contrasts with the higher quality of printing used for other information on vial labels and cartons, including the NDC and its UPC barcode, which can occur "offline" well in advance of the filling and labeling stage.  Thus, manufacturers will need to work with the printing and labeling industries to identify or develop higher-resolution online printing methods.

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• Barcoding of NDC, lot number, and expiration date on vaccine cartons

    VISI will propose that secondary vaccine packaging (cardboard carton containing vials or syringes) include barcodes embedding (1) the National Drug Code (NDC), (2) the expiration date, and (3) the lot number, according to UCC/EAN-128 standards for small pharmaceutical packages.

(Click and scroll down to page bottoms to see examples 

for   DTP_a-HIB,   HIB,   PNUps,   and   Td   vaccines.)

PREPRINTING NDC VIA UCC/EAN 128 vs. UPC.    Since cardboard packaging is preprinted well before the filling process and intended for use with a variety of lot numbers and expiration dates, the preprinted barcode can contain only the NDC.  Most current vaccine cartons barcode the NDC in a full-height Universal Product Code (UPC) symbol capable of being scanned by omnidirectional point-of-sale scanners.  However, VISI proposes that a UCC/EAN 128 barcode be used instead, at a height of 6.0 mm, or 15 percent of its width, whichever is higher, in order to save space on the carton.  The UPC and its omnidirectional feature is not necessary for vaccines, as such items are not purchased at retail outlets.  As UPC and UCC/EAN 128 barcodes and their embedded numerologies are compatible and interchangeable by international standards, either barcode should be readable by most handheld hardware/software setups in current use.  Either are capable of being read by the least expensive one-dimensional scanning hardware that some physician's offices might already use.

ON-LINE PRINTING OF EXPIRATION DATE AND LOT NUMBER.    During the filling process when "human-readable" (English) lot number and expiration date are printed "online", this information should be barcoded onto the carton using one-dimensional barcodes in UCC/EAN 128 format capable of being read by the least expensive one-dimensional scanning hardware.  The UCC/EAN application identifiers to be embedded in the barcode are "(17)" for expiration date and "(10)" for lot number. 

LOCATION OF PREPRINTED AND ONLINE PRINTED BARCODES.  The barcodes for the preprinted NDC and for the online-printed expiration date and lot number should be located on the same face of the package.  There is no requirement for any fixed or special alignment between the two barcodes.  However, to avoid problems with hand-held pen and wand scanners, they should be located one above another along parallel axes, rather than side by side along one axis. 

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• Uniform Vaccine Administration Record (UVAR) Form (ver. 2001-Oct-03)

     In medical practices that do not have barcode scanning systems to transfer vaccine identity into electronic patient records, a Uniform Vaccine Administration Record (UVAR) form is proposed.  The form includes most of the data already collected on existing immunization forms developed by various states and the American Academy of Pediatrics.  

     This form would accept either peel-off stickers from the vaccine vial, as well as pen or pencil entry of vaccine identifying information if stickers are lost or unavailable.  The form could serve as the provider's permament, legal, medical record of the vaccination.  Different forms might be developed to receive duplicate or triplicate peel-off stickers and be mailed to immunization registries (the design of such registry forms is not within the scope of VISI).  The barcoding on the stickers will permit the form to be scanned at any time after the immunization event, in order to permit vaccine identifying information to be pulled into electronic records.   

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• National Drug Code (NDC) Vaccine Database

     VISI proposes to use the National Drug Code as the unique number to identify vaccines for barcoding purposes. The NDC is a 10-digit number that appears on every pharmaceutical vial ("1° packaging") and box ("2° packaging") distributed in the United States.  (NDC background.)  

CONVERSION TABLES REQUIRED.    One vaccine type from a particular manufacturer may have multiple NDCs because its middle 3-or-4-digit "product string" differs for various pediatric and adult formulations, and its final 1-or-2-digit "packaging string" distinguishes single-dose, multi-dose, 10-pack of single-doses, prefilled syringes, and other presentations.  Thus conversion tables are needed to convert NDC numbers into recognizable vaccine types.

NDC DATA ACCESSIBILITY.     The main obstacle to the use of the NDC within the scope of the VISI is that there has been no authoritative, universally-accessible, free-of-charge, easy-to-use, up-to-date database linking NDC numbers to the corresponding manufacturer, product identity and other information (and vice versa).  Such a database would be helpful for developers of software programs for medical practice record-keeping and billing, and for immunization registries.  Such software will require "lookup tables" to translate NDC numbers received from bar code scanners into their plain-English screen identities and into their HL7 codes, CPT™ codes, and perhaps other codesets. 

PROTOTYPE NDC DATABASE.    VISI has created such an NDC database.  Although it remains to be determined which organizational unit or agency would assume long-term responsibility for maintenance of this resource, CDC/NIP's Vaccine Safety and Development Branch (VSDB) is currently serving this role.

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• Vaccine Facts information sidebar (.pdf format) (.wpd format)

Vaccine Facts prototypes (.wpd)

    VISI proposes a section of the secondary packaging (cardboard carton) of vaccines be used for a sidebar to contain "Vaccine Facts".  To facilitate finding key information nurses and physicians may need before administering a vaccine, it would be provided in a format and layout that would be uniform among all manufacturers and products.  This sidebar would contain much of the data now found on vaccine cartons, which is too important to leave only as fine print in the detailed product insert within the package.  Vaccine Facts would be analogous to the popular and successful "Nutrition Facts" sidebar mandated by FDA for all retail food packages in the United States, and which permit consumers to quickly find the calories, fat, sodium, or other key information desired.  Meanwhile, FDA is phasing in by early 2001 a similar "Drug Facts" sidebar requirement for over-the-counter drug products. 

COMMON STYLE OF TEXT.    Current Vaccine Facts prototypes borrow the existing language now provided on the vaccine packages upon which they were based.  VISI recognizes that a more uniform language and narrative style for the content of each field ought to be developed, and this remains to be done.

FIELDS.    The information to be included in Vaccine Facts would be as follows:

Title

Vaccine Facts

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Grouping 1

Type:  full official, generic name of vaccine

Type Abbrev.:  standardized vaccine abbreviation

Brand:  commercial, trademarked brandname of vaccine

Manuf. Abbrev.:  vaccine manufacturer abbreviation (in products for which the manufacturer and distributor are different entities or have different names, only the distributor's abbreviation shall be provided and the field renamed  Dist. Abbrev: ) 

NDC:  the National Drug Code number; 10 digits with hyphens separating labeler, product, and packaging subfields. 

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Grouping 2

Doses:  total number of individual doses in container

Packaging:  description of packaging presentation (single or multiple vials, single or multiple prefilled-syringes, separate lyophilate and diluent vials, etc.) [not illustrated in prototypes shown]

Volume:  total volume if a single container, or number of vials and volumes of each if multiple primary containers in package.  

In case there exist multiple products from the same manufacturer of the same vaccine type, but with varying absolute amounts or concentrations of active antigen(s) per dose, the concentration of antigen mass per dose volume should be stated in this field.  For example,  HAV_(SBB)'s 0.5 mL (360 EL.U.) versus 0.5 mL (720 EL.U.), or HBV_(MRK)'s 0.5 mL (5 mcg) versus 1.0 mL (10 mcg) versus 1.0 mL (40 mcg).  

Active Ingredients:  an optional field for the active ingredient component antigen(s), optionally its (their) concentrations, and adjuvants.  This information may otherwise be located elsewhere on the package carton or insert due to space constraints within Vaccine Facts.  Sample text: "Each 0.5 mL dose contains" . . . . "5 µg hepatitis B surface antigen", or "12.5 Lf diphtheria toxoid", or "5 Lf tetanus toxoid", or "10µg Haemophilus b capsular saccharide conjugated to 15 µg diphtheria CRM197 protein", or "40 µg pertussis toxoid", or "rubella vaccine strain Wistar RA 27/3", or "yellow fever vaccine strain 17D", etc.  

Storage:  refrigeration requirements, warnings about storage temperatures and discard times after reconstitution, etc. 

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Grouping 3

Dosing:  volume of individual dosage, route of administration (intramuscular, subcutaneous, intradermal, oral, intranasal, etc.) 

Caution:  various key warnings deemed by manufacturer and FDA important enough to include on carton, even if duplicated on insert within package.  This location may be used for routine "See enclosed instructions." and "Rx only." statements.

Trace Components:  Ingredients which may have allergenic potential or be of clinical interest to the person administering the vaccine, such as preservatives, adjuvants, excipients, antibiotics, tissue culture origins, cell components, egg proteins and other residual materials from the manufacturing process.  If there are no such trace components, the field may be omitted.  (This field does not routinely include the nature and quantities of the active antigenic components and adjuvants of the vaccine, which may appear in the optional Active Ingredients: field, above, or elsewhere on the package.)

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Grouping 4

Manuf.:  full name, city, state, postal code, and state (or country, if outside U.S.A.) of the manufacturer(s) of the vaccine

Dist:  full name, city, zip code, and state of U.S. headquarters of the distributor of the vaccine responsible for its marketing, sale, end-user and consumer inquiries, and monitoring of adverse events, plus a U.S.-toll-free telephone contact number (1-###-###-#### in numeric characters). 

If the manufacturer and distributor of the vaccine are the same entity and have the same name, then the Manuf: and Dist.: fieldnames are combined into one:  Manuf. and Dist.:

 

PLACEMENT ON CARTON.    If necessary, the Vaccine Facts sidebar could run over one or even two edges to occupy adjacent faces of typical 6-sided packaging.  Information contained in Vaccine Facts need not be duplicated elsewhere on the secondary packaging, except for the generic and brandnames of the product, and the name(s) of the manufacturer(s) and distributor.  Other data now furnished on vaccine packaging which are not proposed for inclusion in Vaccine Facts -- such as the composition and quantities of active antigens, vaccine license numbers, and other information -- would remain printed elsewhere on the package.

TYPEFACE AND FORMAT DETAILS.    Vaccine Facts sidebars should otherwise conform to the font, style, rule size, and other formatting specifications as promulgated by the FDA for the Nutrition Facts sidebars in 21 CFR 101.9(d).

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• Standardized vaccine abbreviations

• Standardized manufacturer abbreviations

    Uniform, standard abbreviations for vaccine types and manufacturers/distributors are proposed.  One purpose is to minimize misinterpretation of a variety of ad hoc notations used in medical records.  These may lead to erroneous conclusions as to the actual vaccine type and brand administered to a patient.  Another advantage of standardized abbreviations is when space limitations on very small peel-off stickers prevent printing the full generic names of very large combination vaccines, and the full names of manufacturers or distributors.

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Tradename disclaimer:  Mention and portrayal of trademarks, brandnames, commercial products, and manufacturers/distributors is for identification only and does not imply endorsement or recommendation by the Vaccine Identification Standards Initiative (VISI), the National Immunization Program (NIP), the Centers for Disease Control and Prevention (CDC), the United States Public Health Service (USPHS), nor the U.S. Department of Health and Human Services (DHHS).