U.S. patent application number 12/116941 was filed with the patent office on 2008-11-27 for pill printing identification.
Invention is credited to Robert Joseph Hess, Scott Lindsay Sullivan.
Application Number | 20080290168 12/116941 |
Document ID | / |
Family ID | 39361542 |
Filed Date | 2008-11-27 |
United States Patent
Application |
20080290168 |
Kind Code |
A1 |
Sullivan; Scott Lindsay ; et
al. |
November 27, 2008 |
PILL PRINTING IDENTIFICATION
Abstract
Drug dosages and bar code labels are within a tamperproof,
sealed container. A printer is configured to mark a drug dosage
with an imprint in a form of a machine readable bar code. A method
and product are provided to enable both the source of manufacture
and distributor to be identified based on scanning a barcode from a
label.
Inventors: |
Sullivan; Scott Lindsay;
(San Francisco, CA) ; Hess; Robert Joseph;
(Stamford, CT) |
Correspondence
Address: |
HESS PATENT LAW FIRM, P.C.
9 MIRAMAR LANE
STAMFORD
CT
06902
US
|
Family ID: |
39361542 |
Appl. No.: |
12/116941 |
Filed: |
May 7, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10896781 |
Jul 21, 2004 |
7370797 |
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12116941 |
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09432469 |
Nov 3, 1999 |
6776341 |
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10896781 |
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08866598 |
May 30, 1997 |
5992742 |
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09432469 |
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60018751 |
May 31, 1996 |
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Current U.S.
Class: |
235/462.01 |
Current CPC
Class: |
G06K 17/00 20130101 |
Class at
Publication: |
235/462.01 |
International
Class: |
G06K 7/10 20060101
G06K007/10 |
Claims
1. A method of tracking passage of a container through a channel of
distribution, comprising scanning from a container a machine
readable code, correlating the scanned machine readable code with
information stored in a database to reveal identities of those in a
channel of distribution of the container.
2. The method of claim 1, wherein contents of he container include
an edible or biocompatible item.
3. The method of claim 1, wherein contents of the container include
a drug dosage, the channel of distribution being a drug channel of
distribution.
4. The method of claim 1, wherein the machine readable code is on
the container.
5. The method of claim 1, wherein the machine readable code is
within the container.
6. The method of claim 1, wherein the machine readable code appears
invisible to the unaided human eye.
7. The method of claim 3, wherein the correlating further reveals a
national drug code pertaining to the drug dosage.
8. The method of claim 1, wherein the correlating reveals an
identity of a distributor of the container as one of those in the
channel of distribution.
9. A monitoring system, comprising a scanner arranged to scan a
machine readable code from a container and store same into a
database in correlation with information to reveal identifies of
those in a channel of distribution of the container, and an
indicator that indicates the revealed identities based on the
correlation.
10. The system of claim 9, wherein contents of the container
include a drug dosage, the channel of distribution being a drug
channel of distribution.
11. The system of claim 9, wherein contents of the container
include an edible or biocompatible item.
12. The system of claim 9, wherein the machine readable code is on
the container.
13. The system of claim 9, wherein the machine readable code is
within the container.
14. The system of claim 9, wherein the machine readable code is
configured to appear invisible to the unaided human eye.
15. The system of claim 10, further comprising means for
correlating the scanned machine readable code with information
stored in the database to reveal a national drug code pertaining to
the drug dosage.
16. The system of claim 9, wherein the indicator is configured to
indicate an identity of a distributor of the container as one of
those in the channel of distribution based on the correlation.
17. The system of claim 9, wherein what is stored in the database
includes an electronic identity code, which is stored in the
database in correlation with the scanned machine readable code.
18. A computer readable memory device, comprising computer readable
storage configured to store information from a scanner pertaining
to a code on a container that contains a drug dosage, the computer
readable storage being configured to store the information in
correlation with an electronic identity code to reveal an identify
of a distributor of the drug dosage from the correlation.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of Ser. No. 10/896,781 filed Jul. 21,
2004, now U.S. Pat. No. 7,370,797, issued May 13, 2008, which in
turn is a continuation-in-part of Ser. No. 09/432,469 filed Nov. 3,
1999, now U.S. Pat. No. 6,776,341, issued Aug. 17, 2004, which in
turn is a continuation of Ser. No. 08/866,598 filed May 30, 1997,
now U.S. Pat. No. 5,992,742, issued Nov. 30, 1999, which claims the
benefit of priority from provisional application Ser. No.
60/018,751 filed May 31, 1996.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to a method of distribution of pills
and a pill having a machine readable code.
[0004] 2. Description of Related Art
[0005] Pills are packaged in containers, from single-pill
containers to containers that contain thousands of pills. Pills
encompass, for instance, tablets, caplets, gel-caps, and capsules,
and contain either medication or a placebo. Pills come in a variety
of shapes, sizes and colors to help distinguish one from the
other.
[0006] Aside from possibly serving as an enticement for children,
the configuration (shape, size, and color) of pills generally does
not give one supplier or manufacturer a competitive edge over
another due to the appeal of the particular configuration in the
marketplace. If the pills of different suppliers contain different
medicine, there is no reason for them to have the same
configuration. If they did, one pill could easily be mistaken for
the another, potentially leading to disastrous consequences.
[0007] If the pills of different suppliers contain the same
medication, it makes sense for safety reasons to standardize the
configuration to avoid the potential for mix-up in the event of
switching between brands. Such a mix-up may lead to severe health
risks and could be lethal.
[0008] On the other hand, a brand name may lose market share to a
newcomer that merely copies the same pill configuration and, in a
sense, passes it off as being an equivalent if not identical to the
brand name version. The company owning the brand name may have
spent years developing and promoting the outward appearance or
product configuration of its pills to establish good will and may
be unable to stop the newcomer from flooding the market with a
cheaper, but identical version to capture market share. If sued for
wrongful misappropriation of product configuration, the newcomer
may successfully assert that for public health and safety reasons,
the configurations should be the same to avoid consumer mix-up
between pills containing different medications. In effect, the
successful newcomer is permitted easier access to gain market
share, because of the ability to profit from the consumer feeling
comfortable switching brands due to the familiar configuration of
the pills that the consumer was accustomed to with the brand name.
Indeed, the newcomer's pill may provide the same impression of
quality and efficacy as the brand name.
[0009] When a product shipped to one distributor finds its way to
the territory of some other distributor in violation of the
trademark rights of that other distributor, the product traveling
in this manner is considered to be gray goods. The distributor who
has trademark rights for the territory into which the gray goods
travel may sue to stop such shipment of product between
territories.
[0010] One difficulty, however, lies in determining the origin of
the goods, particularly if the goods themselves are not marked in
such as way as to distinguish them from one trademark territory to
another. This has often been the case with pills. A problem is that
although a package containing pills may include a territorial
designation code, the pill itself is not assigned such a code and
may therefore be easily repackaged to hide its channel of
distribution. The absence of such a code fails to assist in the
identification of the distributor licensee that was
responsible.
[0011] Often pill containers are properly marked and sealed so that
the manufacturing source can be identified by lot number. Since the
container is sealed, one would expect that the pills inside the
container match the lot number on the container. Regrettably, as
the cost of medication rises, the temptation grows for merchants or
suppliers to substitute some or all of the pills of the container
with a cheaper generic version, seal the container, and pass it off
as containing the pills from the original name brand. It is likely
that the consumer will not suspect the switch, although may notice
that the medication is less effective than expected. Regardless,
the merchant profits handsomely. The manufacturer of the brand name
product, however, in effect loses a sale and, worse, loses some of
its good will as the consumer wrongfully blames the brand name
manufacturer for the poor quality over which the manufacturer had
no control. If the consumer suffers medically from the switched
medication, the integrity of the brand name is damaged. In
addition, the consumer did not get the brand name product for which
he or she paid a premium. This problem arose because the consumer
has no way of checking whether the pills in the container are the
proper pills made by the labeled manufacturer.
[0012] Some medical institutions handle huge volumes of pills each
day. Their employees go through the daily ritual of sorting the
pills and dispensing them to the appropriate patients in accordance
with each patient's specific dosage schedule. Mistakes do happen
and pills get mixed up, particularly if they resemble each other in
appearance. Any improperly administered medication can, of course,
be life threatening to a patient. If generic versions are being
used, then even the level of identification often afforded by brand
name logo on the pill is absent. This problem arises because the
pills may not have markings on them to correctly apprise staff of
their medical content. If there is any question as to the content
of a pill in the hospital environment, the pill is simply
discarded. The cost of such discarded pills can only add to the
ever increasing cost of medical care and insurance.
[0013] During clinical trials that test for efficacy of new
medication, a select group of patients are given active medication,
while another group take a placebo pill. It is preferred that these
tests be conducted as single-blind or double-blind tests wherein
even the doctor who administers the medication is not told which
pills are active and which are placebo. However, as the doctor
divides the medication consistently between the two groups,
recording which patient receives which pill (as each pill is marked
with a letter, number, or color code), the content of the pills for
each patient becomes apparent to the doctor by observing the health
of each particular patient during the trial. A doctor, following
the Hippocratic Oath of medicine, may compromise the clinical trial
by giving all the patients only those pills that the doctor
perceives to contain the active medication. Also, the patients
themselves may assess which pills are placebo and which are active
by comparing the markings on the pills with the apparent
effectiveness of the particular pill. Eventually, the test taker
may become uncooperative and refuse to take any pill with markings
that indicate a placebo, arguing that his or her health warrants
taking real medication. The reliability of the clinical trial
diminishes if an insufficient number of tests are conducted with
the placebo.
[0014] These problems in clinical testing may lead to delays in
gaining government drug regulatory approval. The problem may be
especially acute with life sustaining drugs or cures for otherwise
fatal diseases, because patients will become uncooperative when
they know that only a placebo is being given. Here, of course, the
problem is that the pills are marked in such a manner that the
human eye can readily distinguish between them.
[0015] A Pharmacist generally fills all the prescriptions of a
customer and thus should know the customer's medical history, which
medication the customer may take and is currently taking. If a new
prescription comes in, the Pharmacist is supposed to check for
contra-indications regarding other medication currently prescribed
to the customer. Unfortunately, the pills do not have warnings on
them to let the Pharmacist know that filling the particular
prescription may be dangerous if the customer is already on certain
kinds of medication. Too much responsibility is placed on the
Pharmacist and invariably mistakes are made, leading to life
threatening consequences. The problem here is that no markings are
provided either on the pill or container that the Pharmacist could
readily check to avoid prescribing medically dangerous combinations
of medications. In some cases, the Pharmacist has access to a
computer having a software program designed to remind the
Pharmacist of potential interactions of a particular drug. To
activate the program, the Pharmacist must type in the National Drug
Code pertaining to the particular drug or its drug name into the
computer. This relatively simple task may sometimes be ignored or
misused by Pharmacists.
[0016] Once a pill leaves its container, it becomes impossible to
check its efficacy expiration date, its medication contents, etc.
unless the container remains accessible. If the container is
emptied and lost or otherwise discarded, unused pills will be
unidentifiable, particularly if the pill lacks any brand name
identification. It may be dangerous to take such a pill, depending
upon the person's particular medical condition and the expiration
date. The problem arises due to a lack of information on the pill
itself.
[0017] The current distribution system requires that pills destined
for off-the-shelf sales be packaged in their own sealed container
to guard against tampering and contamination. The packaging is
sized to contain a certain number of pills, from single-pill
packaging, to bulk-size containers. This arrangement is necessary
because pills are not marked in a manner that would permit the
pills to be sorted from others at the place of purchase or
dispensement. Only the containers are adequately marked to avoid
confusion. Thus, the consumer has little choice in selecting the
quantity of medication to purchase.
[0018] Persons whose vision is impaired or are blind are most
susceptible to mixing up pills if different kinds of pills have the
same feel and taste and such persons do not seek the assistance of
others who can see. Such persons would find it beneficial to a
device or system that assists in distinguishing between pills by
relying upon their other senses, in particular, their hearing.
[0019] Keeping track of the efficacy of pills is a labor intensive
task, requiring the patient or care giver to manually record when a
pill is taken and when its effects wear off. Since the recording
process is labor intensive, it is subject to human error and errors
in recording the proper time. Nutrition may affect the efficacy of
medication and recording information on nutrition is also a labor
intensive task. Once the record is made, to be of lasting value, it
must be stored in a data base. This requires some further manual
effort in converting the manual entries from a journal into data
entries into the computer.
[0020] Micro bar code is known. It is about one tenth the size of
standard (MF=1) UPC bar code (Magnification Factor (MF)=1).
Scanners for reading micro bar code are available commercially,
such as from Neorex Corporation in Japan and Symbol Technologies,
Inc. of Holtsville, N.Y. Symbol Technologies, Inc. has developed a
2D, high density bar code called PDF-417 and a corresponding
scanner. The PDF-417 code is considered a high-density code capable
of containing more information per area than standard UPC code.
[0021] It would be desirable to identify the source, distributor,
medication contents and/or potency expiration date of a pill after
the pill is dispensed, preferably through a scanner of machine
readable code. Where identification of the code by reading it
directly with the unaided eye poses a problem, it is preferred that
the patterns within the code be too small to be resolved by an
unaided eye.
SUMMARY OF THE INVENTION
[0022] One aspect of the invention resides in a product that
includes a sealed and tamperproof container, a drug dosage and a
label on which is machine readable bar code. The drug dosage and
the label are within the container. The machine readable bar code
has a code pattern that enables identification of the medication
contents of the drug dosage by correlating the code pattern with
information in a data base that pertains to the coded pattern.
Another aspect resides in a drug identification printer configured
to mark a drug dosage with an imprint in a form of a machine
readable bar code. A further aspect resides in identifying both the
source of manufacture and distributor from scanning a barcode from
a label.
BRIEF DESCRIPTION OF THE DRAWING
[0023] FIG. 1 shows a perspective view of a tamper-proof container
with a bar code label inside facing outward.
[0024] FIG. 2 shows a perspective view of the label of FIG. 1.
[0025] FIG. 3 shows a schematic representation of a scanner
positioned to read a bar code label.
[0026] FIG. 4 shows a schematic representation of an ink jet
printer printing a bar code onto an oral dosage form of
medication.
[0027] FIG. 5 shows a schematic representation of a transfer ink
printer printing a bar code onto an oral dosage form of
medication.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0028] The contents of pending patent application Ser. No.
08/286,785, filed Aug. 5, 1994 is incorporated herein by reference.
The term pill is defined as any type of tablet, caplet, gel-cap,
pellet, gum-piece, capsule, or other edible (or at least
biocompatible) item that contains any consumable herb, chemical,
mineral, vitamin, plant or animal product, or drug including an
active medication or a placebo. A bar-type code may be either
printed directly on an outer surface of the pill, on another layer
located beneath the outer layer of the pill yet visible from the
exterior of the pill, or printed on a label that is secured to any
outer surface layer or underlying layer of the pill.
[0029] The code may be edible and/or digestible and be part of the
medication contents of the pill. The pill be made of layers,
including an inner layer, an outer layer and an intermediate layer
between the inner and outer layers. This intermediate layer may be
formed by printing, such as with a conventional ink-jet type
printer, but is used to dispense ink onto the pill. The "ink" may
be any substance including the medication of the pill and/or a drug
such as a time release. Indeed, different "inks" may be used each
providing a different time release drug and be interspersed between
different layers.
[0030] If the bar code is printed on a label, the label may be made
of a digestible substance, such as a protein base material
including gelatin, collagen, hard or soft keratin, and other
materials including waxes, polymeric materials (water-based or
otherwise), sugar based substrate or certain water-soluble plastics
such as polyvinyl alcohol (PVOH), or made of an indigestible
substance including certain plastics, such as MYLAR or
ethylene-vinyl alcohol (EVOH) sheet or film, so that the label
passes through the body without damage. In this later case, the
label may permit subsequent analysis in which case the code itself
should be made of a material resistant to the environment within
the human body so that the code may be read after it leaves the
body with stool. Once separated from the stool, the code may be
read. The read information may be useful in verifying to clinical
trial testing authorities that the pill in fact was digested.
[0031] According to the invention, it is preferred that the
patterns of the codes located on the pills are too tiny and complex
for the unaided eye to discern differences in the patterns of the
codes of two pills. It is preferred that only an optical scanner
(or other suitable electronic device) be capable of reading such
machine readable code. This may be of particular help during
clinical trials, as discussed below.
[0032] One of the problems with clinical trial testing of pills is
that a placebo pill is eventually recognized by those taking it (or
those observing the patients) due to the absence of any relief in
the patients' symptoms. Such patients may become uncooperative and
refuse to participate further in the trials on the basis that the
placebo pills are not helping them at all. When this happens, the
reliability of the clinical trials diminishes, because there is no
longer any comparison being made with a "control" group of
placebo-pill takers.
[0033] One solution to this problem may be to set aside a group of
codes that designate a placebo and another group of codes that
designate the active medication. In this manner, the placebo takers
will be given pills having different markings on them and therefore
will not be able to associate a particular code with the absence of
effectiveness. Eventually, however, the placebo taker may catch on
that the code is being changed strictly for his/her benefit and
refuse to participate in the trials any longer.
[0034] Regardless of the type of coding used, as a generally rule,
the coding scheme will eventually be determined by those involved
with clinical trials because, each code (or groups of codes)
representing active medication and placebos will be different.
Since the codes on prior art pills may be read by the human eye, it
is relatively easy to connect which codes on which pills yield
healthy results in the patients that take them.
[0035] In accordance with the invention, one way to defeat the
placebo taker from figuring out the code system is to give a false
sense of security that the pill being taken is the same as that of
another whose pill does relieve the symptom. Under such conditions,
contact between trial participants should be encouraged. The false
sense of security comes about by marking both the placebo and the
medication with the same readable code, such as letters and/or
numbers. Thus, both participants believe they are taking the same
medication, but it only works for one of them (since the other is
taking the placebo).
[0036] Marking both with the same code runs the risk that the
placebo and the medication pills may be mixed-up with each other by
those conducting the test. To avoid this, a high-density,
2-dimensional micro bar code (such as PDF-417 from Symbol
Technologies, Inc.) is either printed directly on the pill or on a
label secured to the pill and read by a scanner just prior to
distribution. The micro bar code can not be read with the unaided
eye and is extremely difficult to discern any differences in the
patterns of two codes, so the clinical trial participants (and
their medical nurses, doctors and clinicians) do not know which is
which.
[0037] For example, during a clinical trial, a company sends to a
doctor at least two containers of pills, one container contains
pills having active ingredients, the other, placebo pills. Ideally,
the trial is run as a double blind trial wherein neither the doctor
nor the patients know which container contains which pills.
According to the invention, the doctor is also given a scanner gun
connected to a computer having memory. The computer includes a
monitor screen and a software program. The software program "asks"
the doctor (or assistant) questions directed to the particulars of
each patient within the study. At prescribed times, the computer
will alert the doctor (or assistant) to give a particular pill to a
particular patient from a particular container. The bar code
located on each pill must be scanned by the scanning gun. The gun
is directly connected to the computer and will read the bar code
information off of each pill prior to the pill being administered
to a particular patient. The bar code is preferably a
2-dimensional, high density-type micro bar code so that only the
scanning gun may read the code and only the computer (following the
particular software program) may interpret the code on each pill.
As each pill is scanned, the computer will read and store the bar
code information from the pill and store the information in its
memory. It is preferred that the computer includes safeguards
against tampering so that the information in the memory of the
computer may be read only by authorized personal, similar to the
function of a "black box" as a data collector in an aircraft.
[0038] As the gun scans each bar code form each pill, the
information displayed on the monitor screen may be the actual code
(shown in numeric form) or may be another code, as instructed by
the software, which indicates to the doctor or assistant, neutral
or misleading information regarding the scanned code of the
particular pill.
[0039] According to another aspect of the invention, the pill may
have a label with a bar code, that is removable so that the label
may be directly adhered to a patient's chart, and later scanned
into a central computer. Also, the container of pills may have
multiple labels that can be selectively removed for placement onto
pills within the container. These labels may include projecting
tabs which facilitate their easy removal from the container. The
label may be made of paper, plastic, such as MYLAR, or other
biocompatible material. As discussed above, the label may or may
not be digestible, depending on the application.
[0040] As discussed above, according to the invention, the code is
preferably a mosaic code such as a 2 dimension, high density micro
bar code, such as PDF-417 developed by Symbol Technologies, Inc.
This type of code is essentially impossible to distinguish with the
naked eye. Only an appropriate scanner (also available from Symbol
Technologies, Inc.) is capable of deciphering the intricate
patterns of each code.
[0041] The code may be read by a scanner for the purpose of
identifying the source of the pill manufacture and the distributor
responsible for its dissemination. Such information may be useful
in an effort to prevent product tampering, unauthorized product
repackaging and entry of gray goods.
[0042] The code may be read by a scanner for purposes of
identifying the contents of the pill. This is useful for verifying
information such as the medication contained within the pill and
its potency or efficacy expiration date. This is done by
correlating the code pattern read with information stored in a data
base pertaining to the code pattern. Such a data base may be from a
microprocessor-based personal computer system, a dedicated
centralized computer system or from on-line services or even an
INTRANET computer network service or an INTERNET computer network
service or other microprocessor based systems.
[0043] According to the invention, emergency personnel at the scene
of accident involving a person who overdosed or took any
medication, for instance, may quickly use portable bar code
scanners to read the code on unused pills to ascertain exactly what
medication was taken in the overdose. This is desirable where the
pill container holding the pills is unmarked or can not be
found.
[0044] Different types of medication may be harmful if taken in
combination together, although safe if taken separately, over a
period of time. According to another aspect of the invention, prior
to taking different medications, therefore, the code on each pill
may be read and, by using appropriate software, the reading system
may check for harmful combinations when pills are read in
succession from the bar code scanner. The system may include the
display of information regarding the ill effects that may occur if
the combination of medication is taken. In this way, a warning is
provided as a safeguard against taking the pills together in
combination.
[0045] Alternatively, instead of checking pills in succession, a
data base storing information on the medication that a particular
patient/consumer is taking may be checked automatically to
determine whether taking the new pill medication in combination
with those identified from the data base poses any health risk. If
so, a warning is issued of the potential health risks.
[0046] According to the invention, any machine readable code that
is in a form other than human-readable alpha-numeric characters may
be used. Such a code may be micro bar code, 2 dimensional codes, 3
dimensional codes, high or low density codes, as long as the
particular code may fit onto a pill in a manner that allows the
code to be read by a scanner. Other codes that may be used include
UPC/EAN/JAN, Code 128, Code 39, Code Interleaved 2 of 5, EAN 128*,
Codabar, PDF417, UPC-A, UPC-E, EAN 8, EAN 13, UPC/EAN 128. Each of
these codes, if sized according to the particular pill size would
be suitable for use on pills in accordance with the invention.
[0047] If PDF-417 micro bar code is used, according to the
invention, a code with dimensions of about 8 mm long and about 4 mm
wide may convey up to 10 digits of addressable information. This
information may be actual data, such as an expiration date,
National Drug Code, or lot number for the particular medication, or
may simply be an address that directs a user to additional data
located in a data base, including date of manufacture, the identity
and location of the manufacturer, recommended dosage, dietary and
related drug-usage information, contraindications, and the
recommended price of the medication.
[0048] High density bar code is the preferred coding scheme,
according to this invention, because it may be read quickly and
accurately and may convey a great number of characters in very
little space. The reason alpha-numeric characters are excluded for
this invention is because they have been printed onto pills for
many years and because they convey information in a spatially
inefficient manner. A pill has a small surface area that does not
lend itself to supporting many alpha-numeric characters. Also,
pattern recognition software, while capable of recognizing
alpha-numeric characters, deciphers the alpha-numeric character
code slower and less reliably than would a bar code type scanner
deciphering a bar code.
[0049] Even the alpha-numeric character readers require that the
entire pattern be read (as opposed to a cross-section as would be
the case when scanning vertical bar code lines) so that the pills
must be oriented in a particular manner and held in that position
while the scanner completes its scan. By using codes other than
those containing alpha-numeric characters, therefore, both the
reading time and deciphering time is faster and the orientation of
the pill relative to the scanner is somewhat more flexible. For
instance, reading an alpha-numeric character string upside down or
sideways may cause some problems for pattern recognition software
(e.g., M versus W and U versus C), but causes really no problem for
bar code readers that can scan in many directions very rapidly to
check for vertical bar code lines. By alpha-numeric, oriental
characters and symbolic languages are also envisioned in addition
to the alphabet and numbering system.
[0050] Up to now, there has been little incentive to develop
scanners for reading at the micro bar code level. Since pills are
three dimensional objects whose surfaces may or may not be flat and
may or may not be oriented in a particular manner relative to a
scanner, the preferred embodiment of a scanner is one that
rotationally sweeps rapidly at least up to 180 degrees to ensure
that the full code is read no matter the pill's orientation. It is
assumed, of course, that the surface of the pill bearing the micro
bar code faces the scanner and the scanning beam is aimed at the
code. If this may not be the case, then multiple scanners (or one
scanner and one or more mirrors) should be used, each positioned so
that the full surface area of the pill will be scanned.
[0051] Another application of the invention includes a quick
cross-check between the pills and their container (e.g., a sealed,
tamperproof container 10 of FIG. 1). By comparing the code pattern
of a bar code on each pill after scanning with an appropriate
machine code reader for a matching pattern with the code pattern of
a bar code on or within the container, a determination can be made
readily as to whether the pills originally belonged in that
container. The bar code 16 itself may be on a label 14 (FIGS. 1
& 2) secured (such as by adhering, heat sealing or ultrasonic
weld techniques) to the inside surface of a tamper-proof 12, sealed
container 10, thereby taking advantage of the tamper-proof sealing
technology to ensure the integrity of bar code information
associated with the container to help thwart counterfeiters from
passing off expired medication as new by simply changing the
markings on the outside of the container.
[0052] Additional safeguards can be incorporated into the bar code,
such as hidden code portions that are invisible to the naked eye or
even if aided with a magnifier (e.g., only visible under infrared
or ultra-violet light). The presence or absence of such hidden code
portions within the code on the pill may help counter unauthorized
or unintentional exchanges of pills in a container. A pill
container, according to another embodiment of the invention, is
made from (either entirely or in part, defining a scanning window)
a material, such as plastic that permits at least one pill located
therein to be scanned using a scanner located outside the container
(see FIG. 3). In this manner, pill information may be decoded from
the actual pill without opening a sealed container.
[0053] In another embodiment, the scanner has a built-in clock, or
is connected to a clock (for example, through a computer), and the
time the pill is scanned (and presumably the time the pill is
taken) is recorded. This information helps assess the track record
of the pill's efficacy and the conditions under which the pill was
effective or ineffective. The scanning equipment may be connected
via an electronic link-up to an on-line service or the INTERNET,
and suitable software may automatically forward the statistical
data gathered by the readers to a centralized compliance monitoring
system or to a centralized evaluation center.
[0054] Often, nutrition plays a role in the efficacy of a
medication. Recording a patient's diet before and after taking a
medication (e.g., a pill) is a labor intensive task. Once obtained,
it must be painstakingly converted as a data entry into a computer
data base for storage purposes, but unless the record keeper is
meticulous, the value of the data is subject to human error.
[0055] At present, catalogs are available that include a listing of
products and, next to each picture (or listing) of the product, is
a corresponding bar code. A consumer may scan the bar code to
initiate an order for delivery of a selected product. In accordance
with the invention, a similar concept may be applied to record
dietary information of a patient before, during and after a pill is
ingested.
[0056] According to the invention, a book is provided for the
patient's use while following a medication schedule. The book
contains pictures of different types of foods with an associated
bar code next to each picture. The above-described micro bar code
scanner/reader that reads the micro bar code on the pill is used to
read the bar code in the catalog associated with a selected food
item. If the reading is correlated with the time of day, such as
with an electronic clock in electrical connection with the micro
bar code scanner/reader, information may be recorded concerning the
pill taken and the food item eaten and the time of day when both
were taken. If the patient is instructed to take the medication as
soon as the benefits wear off from the last medication taken, then
the information would represent some measure of the efficacy of the
pills. Since all the information is in digital form, no manual
labor is necessary either to record the pill type, quantity, time
of day or food items eaten. A statistical profile on efficacy is
automatically generated and, when combined with profiles concerning
the same medication but taken by other patients, a fairly reliable
indicator of the duration of efficacy and the nutritional effects
on efficacy is realized.
[0057] Alternatively, if a patient is instructed to take pills at
set intervals throughout the day, provisions could be made for the
patient to actuate a signal indicative of when the medication
started to take effect and another signal indicative of when the
medication efficacy ended. Such a signal could be generated by
actuating a key on the scanner/reader. The actuation of the key
would be tied into the electronic clock that runs to record the
time of day when the code on the pill is read.
[0058] In addition, the scanner may read the bar code on the pill
container, in the same manner as it is capable of reading micro bar
code on a pill (as described above), and store the scanned
information into a data base, yet avoid the need to manual record
keeping on pill efficacy. Under such circumstances, the pills would
not require micro bar coding because the record keeping could be
done by reading the bar code on the container.
[0059] If the user of the scanner/reader makes a mistake, an error
button could be actuated to retract entry of the last key actuation
and substitute it by the next key actuation. The reader may have a
speaker to enunciate confirmation of what was read. The operation
may be as follows:
[0060] (1) Patient or care provider scans code on pill with the
reader. A beep sound is enunciated by the reader to confirm
recognition of reading of the code.
[0061] (2) The patient scans code associated with the food/drink
item consumed if any. The scanning may be of a food group
containing the food/drink item or may also include scanning a
quantity of the food/drink item consumed.
[0062] (3) An electronic clock is used to help record the time of
day when the scanning of the codes took place. The scanner
preferably contains this clock.
[0063] (4) The patient actuates a button when the pill works and
actuates another button when the medication from the pill wears
off. The time of day for both events is recorded based on the time
of day being tracked by the clock.
[0064] (5) After an entry is made, confirmation is enunciated
through speakers of the scanner.
[0065] (6) Immediately after making a mistake in actuating, the
mistake may be removed entirely by actuating yet another button and
then entering another entry as a substitute.
[0066] (7) All the scanned information may be used to establish a
data base. Each scanner, therefore, may be given its own electronic
identity code that is stored along with whatever other information
is retrieved from memory of the scanner.
[0067] (8) The buttons of the scanner may have different colors,
sizes and shapes to help distinguish between them. For instance,
the button associated with signifying that the pill is taking
effect could be green while that signifying that the pill no longer
is taking effect could be red. The scanner could have a light that
illuminates after one of the buttons is actuated and remains lit
until the other button is actuated to serve as an indicator of the
last button actuated. The reason for giving the buttons a different
shape and size is to help visually impaired persons distinguish
between the buttons. The error button could be a different size,
shape and color from the other buttons.
[0068] By distributing such scanners to a large number of patients,
there will be an ever increasing amount of information collected
and stored in digital form. When combined together, statistical
profiles could be generated to show how long different types of
pills remain effective and under what circumstances they remain so,
i.e., the relationship between pill effectiveness and nutrition
could be depicted graphically. The concentration of medication in
the pills could be varied and the effect of this variance on how
quickly the pill takes effect and lasts could be analyzed from the
data collected. Based on such analysis, the optimal conditions for
taking medication could be determined. Other factors, such as the
weight of the patient, that may affect how quickly the pill works
and lasts could also be entered as data by being programmed into
the scanner, preferably to read out automatically with the scanner
identification number.
[0069] Since the scanner identification number is stored in
association with information read from or entered into the scanner,
any aberrations could be easily screened out from the statistical
analysis to remove the effect of such information whose reliability
is suspect. On the other hand, doctors or health care providers
could retrieve information pertaining to a particular patient,
analyze it, and change the medication accordingly as warranted by
the analysis.
[0070] In addition, the scanner could be interactive in the sense
of warning the patient that taking whatever was just scanned may
not be recommended medically or may not be optimal. For instance,
some studies suggest that taking grapefruit juice with pills helps
to quicken the pill's absorption into the body because of its
acidity while other drinks, such as apple juice, may have the
reverse effect (because of its sugar content). Thus, if apple juice
is scanned, a warning could be made by the scanner to recommend
avoiding the selected type of juice and choose switch a different
type of juice.
[0071] In view of the many different kinds of foods, it may be
simpler for the patient to scan a bar code next to a picture of the
particular type of food group instead of the actual food/drink
item. On the other hand, if the patient regularly consumes the same
food more often than not when taking the medication, this could be
automatically programmed to speed up entry of information, e.g.,
unless the patient actuates a button, it will be assumed that the
patient is taking the same type of juice with the pill.
[0072] Labeling the pill with micro bar code may be done in any
conventional manner, such as is taught in marking a logo or code on
a label and applying the label to the pill according to U.S. Pat.
No. 4,478,658, whose subject matter is incorporated by reference.
Of course, the adhesive, if any, and the ink, if any, should be
non-toxic and otherwise biocompatible. Conventional water-based
inks such as food coloring may be used.
[0073] It is preferred that the machine-readable bar code is
printed onto a code-receiving layer made from a protein based film,
such as keratin and gelatin, which is, in turn, adhered to the
surface of the pill, preferably using water. Application of water,
in a controlled manner, partially dissolves the water-soluble
gelatin or keratin film and adheres the code-receiving layer to the
surface of the pill. It is preferred that the code-receiving layer
is "established" or formed on one surface of an appropriate release
backing. The release backing is used to support the delicate
protein-base code-receiving layer, as the code-receiving layer
receives the bar code ink and is later applied to the surface of
the pill. After a bar code is printing onto one exposed surface of
the code-receiving layer, the release backing is pried away thereby
leaving the code-receiving layer (with the code printed thereon)
adhered to the surface of the pill. It is preferred that another
layer (such as one made from gelatin) be located outside (on top
of) the code-receiving layer to protect the printed code from the
environment, in particular, moisture and abrasion.
[0074] Uncoated tablets differ from capsules, caplets, gelcaps and
coated tablets in that their outer surface is porous and is not
sealed or hardened as is the case for these other types. When the
outer surface is sealed or hardened, it is easier to print with wet
ink onto the surface directly or adhere a label to its surface than
for a porous outer surface of an uncoated surface. It such
instance, a portion of the outer surface of the uncoated tablet is
sprayed (or otherwise coated) with a substance to aid in the
printing onto the tablet or adhering to the tablet. The substance
may be made from a material based on sugar, wax, gelatin, keretin,
collagen, polymers or protein.
[0075] Some conventional techniques of suitable printing on
uncoated tablets or uncoated tablet cores include U.S. Pat. No.
4,548,825, issued Oct. 22, 1985 to Voss et al. and entitled METHOD
FOR INK-JET PRINTING ON UNCOATED TABLET CORES, and U.S. Pat. No.
5,006,362, issued Apr. 9, 1991 to Hilborn and entitled BRANDING
PHARMACEUTICAL DOSAGE FORMS, FOOD AND CONFECTIONERY PRODUCTS WITH
AQUEOUS INGESTIBLE INKS. Printing a human-readable symbology onto
machine-readable symbology is known from U.S. Pat. No. 4,889,367,
issued Dec. 26, 1989 to Miller and entitled MULTI-READABLE
INFORMATION SYSTEM and may be applied as well. Further, a suitable
code reading system for reading invisible bar codes is disclosed in
U.S. Pat. No. 5,331,140, issued Jul. 19, 1994 to Stephany and
entitled CODE READING SYSTEMS. These patents reveal, for instance,
ink-jet printers or transfer printers that transfer ink from an ink
bath (see FIGS. 4 and 5). In accordance with the invention, such
printers may be configured to mark a drug dosage with an imprint in
a form of a machine readable bar code. The contents of each of
these patents is incorporated herein by reference.
[0076] In accordance with the present invention, any type of
machine-readable code including micro bar code, holograms, two or
three dimensional machine-readable codes, and other high-density
codes, is imprinted either directly or indirectly onto the surface
of a medication tablet or capsule (i.e., pill). The type of ink or
coating material used to imprint the machine-readable code on the
pill is non-harmful (i.e., biocompatible) to humans (and/or
animals) when digested and furthermore is machine readable by
scanning equipment, i.e., meets the minimum absorption requirements
of bar code reading. The code pattern is either printed directly on
the pill, or is first printed on a carrier or code-receiving layer,
as described above, such as paper, thin plastic film (e.g., PVOH or
EVOH), a protein-based material, such as gelatin and keratin film
or related collagen-based films, or a biocompatible polymeric sheet
or film. The carrier is then preferably applied to the pill during
the manufacturing process, as described above, or at a later time,
perhaps by a doctor, nurse, or pharmacist, depending on the
specific application of the invention.
[0077] According to another embodiment, the ink or coating used in
making the entire code, or a predetermined portion of the code, is
machine readable in non-visible wavelengths and is otherwise
invisible to the human eye. Invisible codes on medication tablets
(or capsules) provides a high level of tamper-proof security and
control of the medications.
[0078] The specific location of the code on the pill will vary
depending on the type of code used, the type of scanner used to
read the code, and the size, shape and type of the pill being
coded. For capsules wherein two interfitting hollow shells made
from a bio-compatible material (such as gelatin) are used to
contain a prescribed dosage of a drug, the code is either printed
on the exterior surface of either capsule or on the interior
surface of either capsule (assuming that the code may be scanned
through the capsule material) or on both the exterior and interior
surfaces wherein a preferably simple, special tamper-proof code
(invisible or visible) is located along the interior surface.
Coding the interior capsule shell wall prevents accidental or
deliberate damage or tampering of the code. Codes located on the
exterior surface of the pill (regardless of the type) are
preferably protected against abrasion or tampering by a clear
coating or layer. This layer may function as the carrier substrate
material wherein the code is located on a rear surface of the
carrier substrate material.
[0079] In accordance with the invention, pills are of the type that
are coated tablets (such as an Advil brand tablet); again the code
may be either directly imprinted on the hard exterior shell using
the same technology used to print the logo of the manufacturer or
name of the medication (such as "Advil"), or a carrier material, as
described above, may be used. In either case, either the carrier
material or the exterior shell of the tablet (or capsule) must meet
the requirements for the scanner to effectively and accurately read
the code (i.e., the difference in reflectivity between the ink (the
bars in a bar code, for example) and the carrier surface (the
spaces in a bar code, for example) is at least a minimum
percentage. These minimum scanning requirements are known by those
skilled in the art.
[0080] In accordance with the invention, pills of the type that are
non-coated tablets, such as aspirin or Rolaids brand antiacid
medications or are otherwise porous and/or have a chalk-like
exterior surface, a "patch" of a non-absorbent bio-compatible
material in the form of a coating or applied film, such as a wax,
gelatin, keratin, collagen, other protein based materials,
polymeric films, EVOH or PVOH is first (or simultaneously) applied
to a predetermined location on the exterior surface of the pill.
The code may then be directly applied to the non-absorbent patch.
The purpose of the patch is to provide a surface for carrying the
ink used to make the machine-readable code meeting the
above-described reflectance requirements. The above-described
carrier material supporting a pre-printed code may also be used
with such non-coated pills in place of, or in addition to the
above-described applied patch. Furthermore, the ink or coating
material used to convey or imprint the code on non-coated type
pills may be a non-spreading type ink adapted to be directly
applied to chalky surfaces without losing resolution of the
code.
[0081] In accordance with the invention, the code is preferably
imprinted in such a manner to be easily machine readable by an
appropriate laser scanner. The orientation of the code will depend
on the type and shape of the pill. For example, elongated,
cylindrical capsule-type pills may include a code that is made up
of bars which completely surround the exterior of the pill
following the longitudinal axis. In this arrangement, the
capsule-type pill may be easily directed down a transparent chute
or pipe and be simultaneously read by a single scanner located
adjacent to the chute or pipe.
[0082] For ovaloid-shape pills (i.e., pills shaped like an M&M
candy), the code may be imprinted on either or both sides, and
include concentric rings of varying thickness bars and spaces,
depending on the type of code. In this case, the chute may be
elliptical in cross-section to receive and guide this type of pill.
Again, one or more adjacent scanners. may be used to read the code
as the pills pass through the chute. The most efficient location of
the bar code on the surface of a pill may be determined by one
skilled in the art of bar code scanning.
[0083] In accordance with another embodiment of the invention, the
ink used to make the code and the carrier material used to carry
the code may be intentionally made of a non-digestible material so
that after consumption of a particular coded medication, the
information conveyed by the code will be passed by the patient. The
code may then be recovered from the patients excrement, treated as
necessary (i.e., washed), and scanned. This particular embodiment
of the invention is useful in clinical studies where patients
either consume several different types of medications during a
trial period and/or consume one of either a placebo or active pill.
Since the codes of this embodiment are not destroyed after the pill
is consumed, the information encoded on the pill prior to
consumption may be later extracted to investigate symptoms or
fatalities of the patient or to check the integrity of the study
(i.e., to ensure that the patient did take the prescribed
medication). The above-described embodiment could also be applied
to all types of over-the-counter and prescription pills. In this
manner, any death or unexplained illness to any human or animal due
to a consumed medication or drug could be easily and quickly
investigated or accurately treated. Furthermore, should the quality
of a particular medication be at fault, the entire lot or related
batch of the medication could be isolated and further illness
prevented.
[0084] According to another embodiment of the invention, a
container is provided to transport and dispense a plurality of
pills in bulk. Manufacturers use the containers to supply pills to
hospitals, for example. The containers are sealed and are
tamper-proof prior to and upon arrival at the hospital. Each
container is adapted to be received into a dispensing machine.
These dispensing machines are located throughout the hospital
(e.g., emergency room, supply room, etc.) and are lockable. Once
locked, the containers located within open to allow their contained
pills to be dispensed in a controlled manner from the machine. In
operation, the dispensing machine first receives an authorization
code from a keypad (as typed in by a nurse, for example) or scanned
in information from a bar code located on a nurse's ID badge. The
user then inputs a patient or medication request code and
thereafter either selects and/or receives the proper pill
combination from the various containers located within the machine
in an appropriate transportable, preferably sealed, and perhaps
tamper-proof container. Just prior to being dispensed, each
selected pill traverses an internal chute wherein an information
code located on the pill is machine read. The information of the
code of each selected pill is sent to a local computer or local
area network to verify the request, update billing, and verify and
update scheduling for the particular patient. If the request is
verified and approved, the pill (or pill combination) is released
from the chute. Otherwise, the pill is diverted to an internal
holding bin which is not-accessible to the user of the machine.
[0085] The purpose of the above-described dispensing machine and
sealable container is to keep track of each pill within the
hospital and to save the expense of individual packing.
Furthermore, since the exact number of pills sent to the hospital
is known, the number of pills remaining is also known. Such
information may be transmitted to the hospitals inventory computer
to automatically signal appropriate personnel to reload a
particular container prior to it becoming completely empty, and/or
signal the pill supplier to send another bulk loaded container. In
either case, no one has direct unaccounted access to the
medication. Tampering and pilfering of medication is either
prevented or evident once it occurs.
[0086] Once dispensed, the nurse may enter a patient's room and
administer the medication. According to the invention, the protocol
followed by the nurse may include scanning his or her ID badge,
room code, and patient ID bracelet upon entering a room using a
hand-held scanning wand plugged into a wall connector which links
the scanner to the hospital computer network. The nurse then scans
the medication from pre-printed coded labels in the case of a
liquid medicant, or scans a suspended bar code element located in
the liquid, as described below, and/or scans the code located on
the pill surface, as described above. The network then verifies
that the patient information, the nurse information, the room
information and the medication information is correct and
authorized and records all of this information in a secured memory
storage. The billing computer is updated to account for the cost of
the exact medication scanned and the scheduling computer is
interrogated to ensure that the medication is proper and timely
(not too early or late) administered. If all is correct, a green
light or appropriate sound or signal is activated in the patient's
room, signaling the nurse to give the medication. Once given, the
nurse transmits a verification signal back to the computer to be
recorded and later used as proof of the nurse witnessing the
patient taking the medication. If the medication is improper, or
the nurse is not on a predetermined list, to or the medication is
too early or late, as prescribed by the attending doctor or any
other conflict is detected), an alarm (or other signal) is
activated to appropriate security and/or a red stop signal is
provided to the nurse. As used in this application, a drug dosage
encompasses medicines in liquid or solid form or as a spray.
[0087] U.S. Pat. No. 5,502,944, issued Apr. 2, 1996 to Kraft et
al., entitled MEDICATION DISPENSER SYSTEM is incorporated by
reference. It teaches automating the dispensement process with
robotics manipulating a selected container to transfer medication
units from the container directly to the package. Medication is
directly transferred from the container to the package so that no
cross-contamination occurs. The present invention may be
incorporated into this teaching by use a scanner that reads the
machine readable code on pills to make the appropriate
identification for the robotics manipulation.
[0088] Another embodiment of the invention incorporates a bar code
onto an element that is suspended into a liquid. The element may be
a small strip of clear or white MYLAR (or other suitable) plastic.
A plurality of these elements are placed into a container of
liquid. As the liquid is poured into a dispensing cup, at least a
portion of the suspended elements, each bearing identical bar code
information also enters the dispensing cup. Preferably, the
elements are invisible or at least barely noticeable to the naked
eye so that the patient drinking the liquid will not see, taste, or
feel the elements in the liquid as the liquid is swallowed. As any
given moment, the liquid in the dispensing cup may be scanned by a
bar code laser-type scanner. The laser beam will eventually read
one of the many elements in suspension in the liquid and the
information conveyed in the form of the bar code will be read and
understood.
[0089] According to an embodiment of the invention, a pill has an
outer surface that includes a machine readable bar code
[0090] According to another embodiment of the invention, a pill has
a transparent layer defining an outer surface and an inner surface.
The pill includes a machine readable bar code on the inner surface
under the transparent layer.
[0091] According to another embodiment of the invention, a pill
includes a label having an outer surface and an adhering surface. A
machine readable bar code is located on the outer surface of the
label. The adhering surface of the label is adhered to an outer
surface of the pill. According to another embodiment of the
invention, a pill includes a label having an outer surface and an
adhering surface. A machine readable bar code is located on the
outer surface of the label. The adhering surface is adhered to an
outer surface of the pill. At least a portion of the bar code is
only readable using a wavelength that is located outside the
visible spectrum (i.e., not visible by a human eye).
[0092] According to another embodiment of the invention, an element
made from a biocompatible material has a printable surface onto
which a micro bar code is printed. At least one, preferably many
elements are suspendible in a liquid. The bar code information
located on each element may be read through the liquid.
[0093] According to another embodiment of the invention, a
medication dispenser includes at least one supply chamber for
receiving a bulk-container of pills, a chute through which selected
pills may be dispensed, a control gate located adjacent to the
chute for controlling the transport of a pill into the chute, and a
scanner adapted to read bar code. The control gate is connected to
and controlled by a computer. Each pill has a machine readable bar
code. Prior to being dispensed, a pill is guided through the chute
past the scanners so that the bar code information located on the
pill may be read and the information sent to the computer.
[0094] According to another embodiment of the invention, a pill
includes a machine readable bar code. The bar code includes a
pattern that has a dimension and complexity that prevents (or
otherwise discourages) a human to distinguish, at a glance, any
difference within the patterns of two or more pills.
* * * * *