Registers – Coded record sensors – Particular sensor structure
Reexamination Certificate
2000-03-17
2001-07-17
Frech, Karl D. (Department: 2876)
Registers
Coded record sensors
Particular sensor structure
C235S375000
Reexamination Certificate
active
06260761
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a system and method for accurately dispensing prescriptions in a pharmacy including a conversion of at least one piece of data into a pharmaceutical standard NDC number.
2. Description of Related Art
Universal Product Code (UPC) symbols arc displayed on a myriad of products throughout the country. Often, the UPC symbol is displayed in a “bar code” format, whereby an intermittent pattern of alternating black and white vertical lines of varying widths signifies a string of alphanumeric characters. Bar codes serve as a language which functions to place the string of characters into a machine-readable form. In addition, bar codes have a number of formats which typically must be determined before a machine can read a bar code.
FIG. 1
shows examples of different types of bar codes with the generally-accepted name of the type of bar code shown directly above the bar code.
UPC symbols, in the form of bar codes, are commonly displayed on all kinds of products, including those in the pharmaceutical industry such as medicine containers.
FIGS. 2-5
show examples of medicine containers which have been provided with UPC symbols by a product source, such as a manufacturer or distributor.
FIG. 2
shows a bottle
10
having a label
12
provided with bar code indicia
14
thereon.
FIG. 3
shows a box
16
having a sidewall
18
provided with bar code indicia
20
thereon.
FIG. 4
shows a shrink wrapped package
22
of multiple bottles
10
having an upper surface
24
on which a label
26
provided with bar code indicia
28
thereon has been affixed.
FIG. 5
shows a carton
30
having a label
32
provided with bar code indicia
34
thereon.
Bar codes are typically read by a device called a “scanner.” An example of a system which includes a scanner is shown in FIG.
6
. The system, shown generally by reference numeral
36
, comprises a computer
38
and a scanner
40
interconnected by a conduit
42
. The computer
38
generally comprises a processing unit
44
, a keyboard
46
and a monitor
48
. It will be understood that the monitor
48
and the processing unit
44
are interconnected in a manner well known in the art. The conduit
42
comprises a Y-shaped cable having first, second and third portions
50
,
52
and
54
, respectively, each provided with a suitable connector
56
at a distal end.
The scanner
40
is typically interconnected intermediate the keyboard
46
and the processing unit
44
by the conduit
42
. For example, the connector
56
on the first portion
50
is interconnected to a suitable socket (not shown) on the scanner
40
. The connector
56
on the second portion
52
is interconnected to a suitable socket
58
on the keyboard
46
. The connector
56
of the third portion
54
is interconnected to a suitable socket (not shown) on the processing unit
44
.
Thus, signals can be provided to the processing unit
44
by either the keyboard
46
through the portions
50
-
54
or by the scanner
40
through the portions
50
and
54
.
FIG. 7
shows the operation of the scanner
40
. The scanner
40
typically includes an illumination emitting device therein, such as a laser or intense light, which is actuatable by a trigger (not shown). When the trigger is depressed, a beam
60
is oscillated across a bar code
62
. desired to be read. The bar code
62
is converted to an alphanumeric signal by the scanner
40
and sent through the conduit
42
to the processing unit
44
. Because the scanner
40
is interconnected intermediate the keyboard
46
and the processing unit
44
and is able to generate alphanumeric characters, the scanner
40
acts as a “second keyboard,” providing alphanumeric input to the processing unit
44
.
As shown in
FIGS. 2-5
, bar codes in the form of UPC symbols are marked on packaging for medicine and other pharmaceuticals. With continuing pressure to reduce health care costs there is a need to use technology to improve the quality and accuracy of pharmaceutical distribution. The National Drug Code (NDC) was developed as a universal identification system for pharmaceutical products distributed in the U.S. Since 1969, the Food and Drug Administration (FDA) has required that all drug products be identified clearly with the NDC, which provides pharmaceutical products with a unique all-numeric system identifying the pharmaceutical source, product and package size. Because the industry uses the NDC to order, track and report on pharmaceutical products, bar coding of this number has provided a faster and more accurate way to move both products and information.
The NDC for prescription pharmaceuticals is the single basic identifier for all forms of pharmaceutical products in the health industry. Pharmacy computer systems, third-party prescription claims processing, and sale tracking, reporting and industry support services typically use the NDC to identify, describe and pay for pharmaceutical services. For pharmacy providers, legislation now mandates the use of the NDC for all Medicaid claims. The Department of Justice and the Drug Enforcement Administration require monthly reporting of all incoming and outgoing controlled substance transactions and inventories on a system which mandates use of NDC numbers. From drug manufacturer to wholesaler to drug provider, computer systems are often required to depend on NDC numbers for identifying what is being ordered, paid, returned and credited. It is a proven method of enhancing the efficiency and accuracy of pharmaceutical distribution.
The NDC, by federal regulation, is a 10-digit numeric code preceded with the letter N or letters NDC. It consists of three numeric fields of information: a source identification field, a product identification field, and a trade package field. The FDA assigns the labeler portion of the code, while the labeler assigns the product identification and trade package portions according to format standards.
The FDA originally assigned the source identification field as four digits, starting at 0002. The system was designed not to exceed a source identification field of 0999. When it became apparent to the FDA that the number of product sources applying for labeler codes would exceed 0999, they reformatted the source I.D. field to comprise a five-digit numeric field beginning with 10000.
The product identification and trade package fields together comprise five digits, with the product identification field being three or four digits and the trade package field being two or one.
The NDC is presented in one of three formats: 4-4-2, 5-3-2 or 5-4-1 referred to in order of the above-identified three fields. The first field of four or five numbers corresponds to the source identification field. The next field of three or four numbers corresponds to the product identification field. The final field of one or two numbers corresponds to the trade package field.
Whenever an NDC is printed, all leading, imbedded and trailing zeros must be included. Each of the three fields are typically separated by a hyphen when printed in a human readable fonn, for example, 51999-432-10 for a 5-3-2 NDC number.
In their catalogs and on price lists, manufacturers and labelers are encouraged to include NDC numbers for each listed item. Labelers are typically urged to discontinue use of internal or traditional list, order or product numbers, as these identifiers are not generic to the pharmaceutical industry.
Because the NDC is the single basic means of product identification for all pharmaceutical products, it is desirable to have the NDC numbers encoded into a bar code and labeled onto products. Therefor, drug manufacturers and labelers are urged to identify their drug products with an NDC and to encode this number in bar code formats. However, there are many different bar code types as shown by example in
FIG. 1 and a
growing number of applications for each. Problems have arisen in that the various bar code types have different character lengths which do not correspond to the ten-digit NDC number.
SUMMARY OF THE INVENTION
In
Cyr Daniel St.
Frech Karl D.
Rader, Fishman, Grauer & McGarry, an Office of Rader, Fishman &
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