Application Guidelines and Prototypes
of outer packaging
vaccine administration record form
Drug Code vaccine database
Facts information sidebar
vaccine and manufacturer abbreviations
Text [under construction]
peel-off stickers for vaccine vials and
[Overarching narrative text
will contain the background, rationale, methodology, principles, and detail of
all the VISI components, references, and background tables in typical
normative standards format. Such narrative remains to be drafted for
working group review, dissemination for public comment, receipt, review and
tabulation of such comment, formatting, editing, and final publication.
Personnel and/or contracting resources need to be identified to complete
related editorial, database, webmastering, graphics, and other tasks, and to
shepherd VISI through public comment and final publication stages.]
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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
peel-off sticker examples
peel-off stickers (without barcode; affixed to boxflap, not vial)
U.S.-marketed Vaqta® peel-off
stickers (without barcode; on prefilled syringes)
VISI prototype barcoded stickers
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):
- the boldfaced standardized
abbreviation for the vaccine type (see below);
- the commercial, registered, or trademarked
brandname of the vaccine;
- the standardized
abbreviation for the vaccine manufacturer/distributor (see below);
- the NDC number, identified by the prefix
- 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
- the expiration date, identified by the
prefix "Exp."; and
- 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:
- the full, official, generic name of the
- the full name of the manufacturer and/or
- 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
BARCODING STANDARDS. All
barcoding symbology, its
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
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
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,
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.
scroll down to page bottoms to see examples
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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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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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
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, 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 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.
information to be included in Vaccine Facts would be as follows:
Type: full official, generic
name of vaccine
Type Abbrev.: standardized vaccine
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
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
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.
requirements, warnings about storage temperatures and discard times after
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
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.)
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
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
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
Facts sidebars in 21 CFR 101.9(d).
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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
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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).