U.S. patent application number 14/933363 was filed with the patent office on 2016-02-25 for drug labeling.
The applicant listed for this patent is The General Hospital Corporation. Invention is credited to James Kenneth Davison, Michael Dempsey, Kimberly Donovan, William D. Driscoll, Gayle A. Fishman, Wilton C. Levine, Nathaniel M. Sims.
Application Number | 20160055317 14/933363 |
Document ID | / |
Family ID | 43876792 |
Filed Date | 2016-02-25 |
United States Patent
Application |
20160055317 |
Kind Code |
A1 |
Levine; Wilton C. ; et
al. |
February 25, 2016 |
Drug Labeling
Abstract
Disclosed are systems and methods for enabling transfer of a
drug from a first drug container to a second drug container
including a drug identification component that recognizes a first
drug container to retrieve drug identifying data for the drug, a
storage medium that stores a site-specific database comprising
attributes and associated values for a set of drugs including the
drug in the first drug container, a processor that obtains the drug
identifying data and the attributes and associated values for the
drug and produces information about the drug using the drug
identifying data and the attributes and associated values, a rules
engine that applies one or more rules to the information about the
drug to generate drug handling information, and an output unit that
outputs markings comprising the drug handling information in
human-readable or machine-readable form, or both, to be associated
with the second container.
Inventors: |
Levine; Wilton C.; (Needham,
MA) ; Davison; James Kenneth; (Needham, MA) ;
Dempsey; Michael; (Groton, MA) ; Donovan;
Kimberly; (Milton, MA) ; Driscoll; William D.;
(Salem, MA) ; Fishman; Gayle A.; (Wellesley Hills,
MA) ; Sims; Nathaniel M.; (Milton, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
The General Hospital Corporation |
Boston |
MA |
US |
|
|
Family ID: |
43876792 |
Appl. No.: |
14/933363 |
Filed: |
November 5, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14159047 |
Jan 20, 2014 |
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14933363 |
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12581047 |
Oct 16, 2009 |
8639525 |
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14159047 |
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Current U.S.
Class: |
705/2 |
Current CPC
Class: |
G16H 50/20 20180101;
G06F 19/3468 20130101; G16H 20/10 20180101; G06F 19/326 20130101;
G06F 19/3456 20130101; G16H 20/17 20180101; G16H 70/40 20180101;
G06Q 50/22 20130101; G06F 19/3462 20130101; G16H 10/40 20180101;
G06F 16/22 20190101; G06K 7/10297 20130101; G06F 16/24
20190101 |
International
Class: |
G06F 19/00 20060101
G06F019/00; G06K 7/10 20060101 G06K007/10; G06F 17/30 20060101
G06F017/30 |
Claims
1. A system for labeling a syringe comprising: a drug
identification component comprising a radio frequency reader that
interrogates a RFID tag associated with a first drug container to
read drug identifying data for a drug in the first drug container;
a storage medium that stores a database comprising data for a set
of drugs including the drug in the first drug container; a
processor programmed to obtain, based on the drug identifying data
read from the RFID tag, information from the database corresponding
to the drug and produces label content suitable for labeling the
syringe containing the drug, the label content comprising all of: a
drug name, an expiration date, an expiration time, and a
preparation date; and an output unit that outputs the label content
in human-readable or machine-readable form, or both, to be
associated with the syringe.
2. The system of claim 1, wherein the drug identifying data is
based on a National Drug Code (NDC) number.
3. The system of claim 1, wherein the drug identifying data is
based on one or more proprietary codes.
4. The system of claim 1 further comprising a display device that
displays a virtual label before the output unit outputs the label
content, the virtual label comprising at least the drug name and a
concentration of the drug to be stored in the syringe.
5. The system of claim 1, wherein the processor is further
programmed to include, as part of the label content, dilution
information indicating a diluent used to dilute the drug.
6. The system of claim 1, wherein the output unit prints the label
content to generate a printed label that is color coded in
compliance with a drug labeling standard.
7. The system of claim 1, wherein the processor communicates with a
memory and the storage medium storing the database, wherein one or
both of the memory and the storage medium are local to the
system.
8. The system of claim 1, wherein the processor communicates with a
memory and the storage medium storing the database, wherein one or
both of the memory and the storage medium are located remote from
the system.
9. The system of claim 1, wherein the label content is printed by
the output unit onto an adhesive label to be affixed to the
syringe.
10. The system of claim 9, wherein the processor is further
configured to encode at least a portion of the label content in a
computer-readable format, and the output unit provides the portion
of the label content in the computer-readable format on the
adhesive label.
11. The system of claim 10, wherein at least the expiration date
and the expiration time are encoded in the computer-readable format
and provided in the computer-readable format on the adhesive label
to, when read in the computer-readable format, trigger a warning if
the drug in the syringe has expired.
12. The system of claim 1, wherein at least the expiration date and
the expiration time are encoded in the computer-readable format and
provided in the computer-readable format on the adhesive label to,
when read in the computer-readable format, trigger a warning if the
drug in the syringe has expired.
13. The system of claim 1, wherein the label content further
comprises at least one of: an identity of a clinician who prepared
the syringe, information enabling documentation of drug
administration
14. The system of claim 1, wherein the rules comprise rules for
intercepting recalled, expired, or prohibited drugs.
15. The system of claim 1 further comprising an audio-visual unit
for producing one or more of an audible and visual indication of
information about the drug.
16. The system of claim 1, wherein the label content further
comprises drug handling information that offers guidance to a user
of the drug.
17. The system of claim 1, wherein the output unit outputs the
label content in at least the machine-readable form to be provided
to the label, and the label content uniquely identifies the syringe
to which the label is to be associated.
18. The system of claim 1, wherein the output unit outputs the
label content in at least the machine-readable form to be provided
to the label, and the label content further comprises drug
utilization information that establishes a record for tracking at
least utilization of the drug.
19. A system for labeling a syringe comprising: a drug
identification component comprising a radio frequency reader that
interrogates a RFID tag associated with a first drug container to
read drug identifying data for a drug in the first drug container;
a storage medium that stores a database comprising data for a set
of drugs including the drug in the first drug container; a
processor programmed to obtain, based on the drug identifying data
read from the RFID tag, information from the database corresponding
to the drug and produces label content suitable for labeling the
syringe containing the drug, the label content comprising at least
one of: a drug name, expiration information, a date on which the
drug was prepared, and a time at which the drug was prepared; and
an output unit that outputs the label content in human-readable and
machine-readable form, to be associated with the syringe.
20. The system of claim 19, wherein the label content further
comprises information indicative of an identity of a person
responsible for preparing the drug.
Description
TECHNICAL FIELD
[0001] This disclosure relates to systems and methods for providing
labeling for drug containers.
BACKGROUND
[0002] Drugs, such as anesthetics, are sometimes mixed and
administered to patients at the point of care. For example, in
operating rooms, anesthesiologists often transfer drugs from an
original container to a second container, e.g. a syringe, for
administration to patients and they can also dilute a drug from a
concentrated form to a less concentrated form for administration to
a particular patient. Regulations and standards of good practice
require the prepared drug be labeled with information such as the
drug name, its concentration, who prepared it, and the date/time of
its creation and expiration. The labels can be color coded based on
a standard color coding scheme promulgated by the American Society
of Anesthesiologists (ASA) to help physicians quickly identify the
type of drug that is in a container, for example, a syringe, during
busy or emergency situations.
[0003] Other materials including, for example, stock chemicals in a
medical laboratory or hazardous waste being transported or stored
also require labels in which standard colors and/or symbols have
specific meanings.
SUMMARY
[0004] This invention is based, at least in part, on the discovery
of new systems and methods that significantly enhance the safety
and speed of the transfer of a drug from a first container, e.g., a
multi-dose, large volume container, to a second container, e.g., an
individual dose container, such as a syringe or IV bag. The new
systems and methods accomplish this safe and efficient transfer by
not only identifying the drug in the first drug container, but also
by automatically retrieving multiple drug attributes from a
site-specific database and applying one or more predetermined rules
to values associated with the attributes to automatically produce
markings on, for example, drug labels, that include critical safety
and handling information regarding the drug.
[0005] In one aspect, the invention features systems for enabling
transfer of a drug from a first drug container to a second drug
container. These systems include a drug identification component
that retrieves drug identifying data for a drug in a first drug
container, e.g., by scanning the container; a storage medium that
stores a site-specific database including attributes and associated
values for a set of drugs including the drug in the first drug
container; a processor that obtains the drug identifying data and
the attributes and associated values for the drug and produces
information about the drug using the drug identifying data and the
attributes and associated values; a rules engine that applies one
or more rules to the information about the drug to generate drug
handling information; and an output unit that outputs markings that
include the drug handling information in human-readable or
machine-readable form, or both, to be associated with the second
container.
[0006] In various embodiments of these systems, the drug
identifying data can be based on a National Drug Code (NDC) number
or one or more proprietary codes. In some embodiments, the drug
identifying data is derived from a barcode affixed to or on the
first drug container, from an image of the first drug container, or
from a radio frequency identification (RFID) tag associated with
the first drug container. In these systems, the processor can
communicate with a memory and the storage medium storing the
site-specific database, wherein one or both of the memory and the
storage medium are local to, or remote from, the system.
[0007] In some embodiments, the markings are included on a data
carrier for affixing on a syringe, on a vial, or on an intravenous
administration container, and the markings can include information
for controlling an intravenous pump or other drug delivery device.
In various embodiments, the rules can include one or more of mixing
rules, diluting rules, and reconstituting rules, and the rules can
include rules for intercepting recalled, expired, or prohibited
drugs, or for drug interactions or drug allergies. The markings can
also include information about the pedigree of a drug, or one or
more of a warning that the drug contains a paralyzing agent, a
warning that the drug contains latex, a warning that the drug
should be protected from light, and a warning that the drug should
be administered directly into a muscle. The markings can also
include information enabling documentation of drug
administration.
[0008] In other embodiments, the markings can include information
enabling a safety system to, based on the information, provide
feedback to a clinician regarding one or more of a drug name, an
allergic reaction to the drug, a drug amount, and an expiration
date, and/or information enabling a documentation system to, based
on the information, document administration of the drug.
[0009] The systems described herein can optionally include one or
more audio-visual units for producing one or more of an audible and
visual indication of information about the drug.
[0010] In another aspect, the invention features systems to record
the utilization of a drug transferred from a first drug container
to a second drug container. These systems include a drug
identification component that retrieves drug identifying data for a
drug in a first container, e.g. by scanning the container; a
storage medium that stores a site-specific database including
attributes and associated values for a set of drugs including the
drug in the first drug container; and a processor that obtains the
drug identifying data and the attributes and associated values for
the drug, and using the drug identifying data and the attributes
and associated values, records information regarding the transfer
of the drug and administration of the drug into an information
management system.
[0011] In these systems, the information management system can be
an anesthesia information management system. In some embodiments,
one or more of the information regarding the transfer of the drug
and the information regarding administration of the drug can
include a name of the drug, the concentration of the drug, the NDC
number of the drug, the drug lot number of the drug, and/or the
identity of the person that transferred the drug.
[0012] In various embodiments, information regarding drug
utilization documentation can be used to track one or more of the
utilization and waste of the drug by clinicians.
[0013] In another aspect, the invention also features methods for
enabling the transfer of a drug from a first drug container to a
second drug container. These methods include retrieving drug
identifying data for a drug in a first drug container; retrieving
from a storage medium that stores a site-specific database one or
more attributes and associated values for the identified drug;
based on the drug identifying data and the attributes and
associated values for the drug, producing, by a processor,
information about the drug; applying, by a processor, one or more
rules to the information about the drug to generate drug handling
information; and producing markings including the drug handling
information in human-readable or machine-readable form, or both, to
be associated with the second container.
[0014] In another aspect, the invention features a computer program
product stored on a computer readable storage device for enabling
transfer of a drug from a first drug container to a second drug
container, the computer program product including instructions to
cause a computer to retrieve drug identifying data for a drug in a
first container; retrieve from a storage medium that stores a
site-specific database one or more attributes and associated values
for the drug; obtain the drug identifying data and the attributes
and associated values for the drug and produce information about
the drug using the drug identifying data and the attributes and
associated values; apply one or more rules to the information about
the drug to generate drug handling information; and output markings
including the drug handling information in human-readable or
machine-readable form, or both, to be associated with the second
container.
[0015] The invention provides several advantages. For example, the
invention helps ensure patient safety by enabling clinicians to
automatically produce labels for e.g., drug syringes having human
readable information, and optionally machine-readable information,
conforming to a hospital's safe practices and/or regulatory
requirements, thus reducing the likelihood of administration
errors.
[0016] Unless otherwise defined, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
methods and materials similar or equivalent to those described
herein can be used in the practice or testing of the present
invention, suitable methods and materials are described below. All
publications, patent applications, patents, and other references
mentioned herein are incorporated by reference in their entirety.
In case of conflict, the present specification, including
definitions, will control. In addition, the materials, methods, and
examples are illustrative only and not intended to be limiting.
[0017] Other features and advantages of the invention will be
apparent from the following detailed description, and from the
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a schematic block diagram of a drug labeling
system.
[0019] FIG. 1B is a schematic block diagram of a database
builder.
[0020] FIG. 1C is a representation of a screenshot from the
database builder.
[0021] FIGS. 2 and 3 are schematic diagrams of additional
implementations of the drug labeling system.
[0022] FIGS. 4 and 5A-B are schematic diagrams of different drug
labels.
[0023] FIG. 6 is a flowchart showing a drug labeling process.
[0024] FIG. 7 is a flowchart showing a drug dilution
subroutine.
[0025] FIG. 8 is a flowchart showing a drug mixing subroutine.
[0026] FIG. 9A is a representation of a drug labeling system.
[0027] FIGS. 9B-G are representations of screenshots from a drug
labeling system.
DETAILED DESCRIPTION
[0028] Disclosed are automated labeling systems and methods that
can assist in accurately, quickly, and safely transferring drugs
from a first drug container, e.g., a large, multi-dose container,
to a second drug container, e.g., a single-dose syringe or IV bag,
in, for example, a health care institution. In one implementation,
the new labeling systems can obtain drug identifying data, e.g., an
identity of the drug in the first container, and bind or connect,
e.g., physically or electronically link, the drug identifying data
with other information about the drug (referred to herein as "drug
attributes"), including information about recalls of specific
drugs, allergic reactions associated with particular drugs or
typical diluents used with those drugs, the transfer of the drug,
e.g., identity of the person performing the transfer, time of the
transfer, whether the drug was diluted or mixed with one or more
diluents, and an expiration date and/or time. In some examples, the
labeling system can, based on the drug identifying data, retrieve
the drug attributes from a local or remotely connected
site-specific database.
[0029] In certain implementations, the systems can apply rules
and/or guidance based on specific values of the drug attributes
and/or on other contextual information, such as information about
the class or category of the patient, e.g., adult, adolescent,
child, or male or female, or information about the specific
patient, e.g., weight, age, other health issues, or allergies.
These rules can be defined by an authorized user, e.g., a clinician
on behalf of the health care institution. The system can
automatically produce markings on, for example, a data carrier such
as a colored label, with human-readable information and/or
machine-readable information that includes some or all of the
appropriate information described above. In some examples, the
system can produce markings with the human-readable information
and/or machine-readable information that are directly printed or
etched on the second drug container.
[0030] Sometimes drugs need to be diluted before they are
administered. Accordingly, the labeling system can implement a drug
dilution process for including information regarding the drug
dilution on the labels. In some cases two or more drugs may need to
be mixed in a second drug container. As such, the labeling system
can implement a drug mixing process or protocol including
information regarding the drug mixture on the label 136. In some
implementations, the labeling system can also track the
administration of the drug to a specific patient, and record the
information in, e.g., a drug tracking system.
Drug Labeling
[0031] During the course of caring for a patient in a hospital it
is common that a drug needs to be given to the patient. For
example, a drug may need to be injected, e.g., intravenously or
intramuscularly, using a syringe. In some cases, the syringe is
prepackaged in a single-dose, ready-to-use, syringe
configuration--in these cases the drug may not need to be
transferred from a source drug container to the syringe by a
clinician or at the hospital. However, in some cases, the drug may
need to be transferred, mixed, reconstituted, diluted, or otherwise
prepared for a patient, e.g., at the point of care. Such drug
preparation is particularly common during surgery and other
invasive procedures, where the anesthesiologist or nurse is
constantly administering precise amounts of various drugs to ensure
the patient is properly anesthetized or sedated yet not
physiologically compromised.
[0032] The drug preparation can also occur in the Post-anesthesia
Care Unit (PACU), the Intensive Care Unit (ICU), procedural
sedation area and/or other areas of the hospital where patients
need specialized drugs. Finally, in less urgent situations, an
order can be written for a certain drug for a specific patient and
a similar drug preparation process can also occur in a pharmacy
(e.g., inside or outside a hospital), using, e.g., sophisticated
labeling systems that are already part of the pharmacy
infrastructure. The patient-specific drug can then be transported
to the patient for administration.
[0033] Due to rigorous procedures executed by a relatively small
number of highly trained technicians, most hospital and pharmacies
abide by safe practices and regulatory requirements that provide
for relevant information regarding a drug to be accurately and
completely documented on a label affixed on a drug container. For
example, if a drug is to be prepared and/or diluted and then
administered to a patient via a syringe, at least the following
information can be captured on a label to be affixed to the
syringe: drug name, concentration, dose units, time and date of
preparation and/or dilution, who prepared it, and expiration date
and time. Other drug attributes may also be captured, including,
but not limited to, the drug's lot number, warnings, and
manufacturer or a color code to rapidly identify the classification
of drug. In some examples, the minimum information that is required
on a drug label may be prescribed by an industry regulatory body
such as, The Joint Commission (TJC), an independent, not-for-profit
organization that accredits and certifies health care organizations
and programs in the United States. The Joint Commission's 2010
National Patient Safety Goals (NPSG) 03.04.01, the contents of
which are incorporated by reference herein in its entirety,
prescribe that in perioperative and other procedural settings both
on and off the sterile field, medication or solution labels should
include the following: medication name, strength, quantity, diluent
and volume (if not apparent from the container), preparation date,
expiration date when not used within 24 hours, and expiration time
when expiration occurs in less than 24 hours.
[0034] At present, the information is typically hand-written on a
blank label that is then affixed on the second container, e.g., a
syringe, by the clinician who prepares the drug. In some examples,
a colored label can be used to rapidly identify the classification
of drug. The American Society of Anesthesiologists (ASA) standards
specify twelve different classes of drugs and with corresponding
color labels. For example, ASA standards require drugs that cause
neuromuscular blockade to have a red label. In addition, health
care settings are generally required by law to have complex
requirements for tracking the disposition of narcotics and other
drugs with high addiction potential.
[0035] In some cases, compliance with the safe practices and
regulatory requirements outlined above can be sporadic. For
example, the information on the label may be handwritten and thus
prone to, for example, poor legibility and/or ink smudging. In
addition, human-created handwritten labels are prone to errors.
Further, the label may have only a portion of the information
required by the standards, e.g., only a name of a drug and/or a
concentration of the drug. Also, because the diameter of syringes
can vary from being very small (e.g., 0.25'') to very large (e.g.,
1.25''), the labels can correspondingly vary in size. Consequently,
the format of the information contained on the labels for the
different may not be consistent. Further, syringes may include
markings or graduations that are helpful in measuring an amount of
the drug being administered. These markings or graduations
generally cannot be obscured by affixing a label.
[0036] Moreover, as described above, a label can include several,
e.g., twelve, different color options used for identifying drugs.
Accordingly, there can be at least twelve different types of blank
labels that must be kept in stock. These label stocks can takes up
a lot of room on a drug cart. Electronic documentation of medicinal
drug administration can be done using e.g., a bar code scanner
accessory, an anesthesia information management system, an
electronic medical record or other documentation system. In such
systems, rolls of labels can be inconvenient as they generally
cannot easily be each provided with a unique barcode with all data
elements that can be useful to capture during the electronic
documentation.
Automated Drug Labeling System
[0037] FIG. 1 shows one example of a drug labeling system 100,
which includes a drug identifying component 104, a processor 108 in
communication with a memory 112 and a database 116, a rules engine
120, and an output unit, e.g., a data carrier generator 124. In one
implementation, an industrial design of the labeling system 100 can
be aimed at minimizing overall size for easy placement on or near a
medication cart in an operating room of a hospital. For example,
the design can provide for easy cleaning and disinfection between
operating room procedures as required in many hospital
environments. The labeling system 100 can be implemented through
the use of, for example, a workflow aware connectivity (WAC) system
described in PCT Application No. PCT/US2008/079487 to Nathaniel M.
Sims et. al., the content of which is incorporated herein by
reference in its entirety.
[0038] In one implementation, the drug identifying component 104,
e.g., a bar code laser scanner, scans or images a machine-readable
identifier 128, e.g., a barcode, an RFID tag, or an image of or on,
e.g., a first container 132 of a medicinal drug to retrieve, e.g.,
obtain, drug identifying data. The drug identifying component 104
implements a process for recognizing (e.g., identifying, scanning,
and/or imaging) the first container 132 to retrieve the drug
identifying data. For example, the drug container 132 can be a drug
vial in, for example, an operating room. The processor 108
processes the drug identifying data to identify the drug and/or
look-up other information, e.g., attributes, regarding the drug in
a database, e.g., a site-specific database, 116. In this manner,
the processor 108 uses the drug identifying data to retrieve other
information regarding the drug from one or more local and/or remote
databases 116-118.
[0039] In one implementation, the database 116 is an annotated,
site-specific database that includes one or more attributes and
corresponding values for a set of drugs selected from a master
database 118 and/or from a reduced database 117 by a healthcare
institution (e.g., via database builder 119a). The site-specific
database 116 is so named, because each site (e.g., hospital or
other healthcare office or institution) that uses one of the
systems described herein will have its own database that is
annotated specifically for that site. The set of drugs within the
annotated site-specific database 116 can be selected to be
representative of the range of drugs that physicians within the
health care institution might wish to prescribe in their practices,
and/or drugs are typically used by on-site pharmacies. The
attributes are generated by the specific institution, and include
safety issues and warnings (e.g., recall notices, potential
allergen notices, and minimum and maximum permissible dosages and
rates of administration for infusions and/or bolus amounts) as well
as policy issues (e.g., use of particular types or brands of drugs
compared to others or based on current inventory). In addition,
some or all of the attributes in such an annotated site-specific
database 116 can be updateable or customizable annotations, e.g.,
additional attributes and corresponding values for the selected set
of drugs, such as, one or more data elements, drug policies, drug
handling guidance, and/or drug status information.
[0040] The master database 118, from which the site-specific
database 116 is directly or indirectly derived, can be a formulary
database hosted by, for example, a third party entity such a
governmental agency or industry-standard body. For example, the
master database 118 can be one or more databases provided by
Lexi-Comp of Hudson, Ohio or FirstDataBank of San Bruno, Calif. An
example of a governmental agency database is the U.S. Food and Drug
Administration (FDA)'s National Drug Code Directory.
[0041] In one implementation, a reduced database 117 can be
implemented for storing a customized drug list based on some or all
of the information about the drugs retrieved from the master
database 118. The reduced database 117 can be located locally,
e.g., physically located at the healthcare institution, or located
remotely, e.g., physically located remote from the healthcare
institution. The customized drug list may include some or all of
the attributes from the master database 118. In such an
implementation, the annotated, site-specific database 116 can be
implemented based the customized drug list in the reduced database
117, along with the customizable annotations as described
above.
[0042] The annotated database 116 and/or the reduced database 117
can be stored on disk storage media as files, or secured files,
e.g. encrypted files, or in a memory within the system. In some
examples, the files can include one or more annotated drug lists
and/or customized drug lists that are stored as separate files on
the disk storage media
[0043] Once the processor 108 produces the information about the
drug, the rules engine 120 can apply one or more rules to the
information as described in detail below to generate drug handling
information such as, e.g., guidance to a user of the drug,
including, checking for recalls, information about allergies and/or
interactions with other drugs, dosage information, warnings and
other information of interest regarding the drug.
[0044] In general, the rules implemented by the rules engine 120
specify how the system 100 interacts with a user (e.g., a doctor,
physician's assistant, or nurse) after the drug container 132 has
been scanned. In one implementation, the rules act on the values
assigned to attributes in a database, for example, the annotated
database 116, by the healthcare institution. In this regard, the
attributes are predetermined attributes and the healthcare
institution may select values for one or more of the attributes in
specifying the behavior of the system 100 through the rules. In
some implementations, the attributes can be further configured by
creating one or more new attributes and/or editing the existing
attributes.
[0045] The rules engine 120 can be implemented as a software module
executed by the processor 108. In some examples, the rules engine
120 can be implemented by a computer system that is separate from
the processor 108. A drug-specific data carrier, e.g., label 136,
can be produced that includes markings conforming to current
best-practices and regulatory guidelines and includes at a minimum,
e.g., the drug name, dose, concentration, lot number, preparation
date and time, dilution date and time (if diluted), expiration date
and time, clinician, pharmacist, technician or other personnel who
prepared and/or transferred or mixed the drug(s), drug pedigree,
color markings, drug classification indications, and/or other
information such as warnings and other indications. Drug pedigree
information can include, for example, a statement of origin that
identifies one or more of each prior sale, purchase, or trade of a
drug, including date of transactions and names and addresses of
parties to the transactions. The label 136 can include human-
and/or machine-readable markings. In some scenarios, e.g., during
surgery, the drug is removed from a first drug container 132 and
transferred to a second drug container 140, e.g., a syringe, a
medicinal bowl or basin, or an IV bag. The label 136 described
above can be applied to the second container 140 after information
about the drug is identified and the drug is removed from the first
container 132 and transferred to the second container 140.
[0046] Further, in some examples, the machine-readable portion of
the label 136 can be read back into the patient's record when the
drug is actually given. For example, during surgery, the drugs can
be mixed before the surgery begins and administered to the patient
in small amounts as the surgery progresses. In this regard, the
labels' 136 machine readable markings can be scanned by, e.g., an
anesthesia information management system (AIMS) or other
documentation system to be recorded in e.g., the patient's medical
record even as the drug is administered. This allows for an
accurate and timely documentation of a drug's administration.
Further, such practices can improve regulatory compliance and
medication safety, and reduce drug administration errors.
Configuration Module
[0047] The drug labeling system 100 can include a configuration
module 119 having a database builder 119a and a rules editor 119b.
In one implementation, the configuration module 119 can be
implemented as a software application program executed by the
processor 108. In some examples, the configuration module 119 can
be implemented by a computer system that is separate the processor
108. Further, it should be recognized that, in some examples, the
database builder 119a can be implemented by a first computer
system, and the rules editor 119b can be implemented by another
computer system.
[0048] The database builder 119a can provide a user interface (for
example, FIG. 1C) for enabling an authorized individual 99 (e.g., a
user with an authorized password and access level) to, for example,
retrieve information about one or more drugs from the master
database 118, and specify additional attributes, such as, fields
(columns) having values to be stored in the annotated database
116.
[0049] In one implementation, using the database builder 119a, the
authorized individual 99 can process the information retrieved from
the master database 118 into a smaller and customized drug list
having one or more predetermined attributes (described in further
detail below). This customized drug list can be stored in the
reduced database 117. Further, the authorized individual 99 can
annotate the customized drug list with additional information about
the drugs and store the annotated list in the annotated database
116. The database builder 119a enables the authorized individual 99
to easily construct entries for the annotated database 116 and/or
the reduced database 117 both by selecting particular drug entries
from the master database 118 and/or by creating custom drug
entries. Once the annotated database 116 and/or the customizable
reduced database 117 has been constructed, the database builder
119a can enable the authorized individual 99 to download the
annotated database 116 and/or the reduced database 117 into one or
more handheld devices (e.g., handheld device 1 in FIG. 2 below) for
use in identifying and processing drugs in the drug containers
132.
[0050] In one implementation, the media on which the annotated
database 116 and/or the reduced database 117 is stored can also
include a user file that contains, for example, a full name, a
password and an authorized access level for one or more authorized
individuals 99 that are authorized to access the functionality of
the configuration module 119. Further, in one implementation, for
tracing and accountability purposes, the configuration module 119
can include a track log for storing information about changes made
to the annotated database 116 and/or the reduced database 117 along
with identifying information of the authorized individual 99 who
made the changes.
[0051] FIG. 1B shows an example schematic for extracting drug
information from a master database 118, e.g., Lexi-Comp of Hudson,
Ohio. In one implementation, the master database 118 can be
implemented in Microsoft Access format. Accordingly, an
import/export tool 1100 can be used to convert the database format
into a native format, for example, SQL Server database format. The
import/export tool 1100 can access the master database 118 using
any transfer protocol, for example, file transfer protocol (FTP).
The database builder 119a can then be used to view tables that have
been automatically populated based on attributes and values
contained in the tables of the master database 118 (e.g., Drug
table 1200). Using the database builder 119a, an authorized
individual 99 can specify a new "dataset" that includes, for
example, the Drug table 1200 and one or more new tables and
attributes and associated values (e.g., Drug Preferences table 1300
and Dose Form table 1400). These new tables along with the
attributes and associated values can be stored in, for example, the
annotated database 116 (FIG. 7).
[0052] The annotated database 116 can be changed to a format that
is acceptable to the destination environment where the database 116
would be uploaded, e.g., a computer system or a personal digital
assistant (PDA). For example, in the format conversion module 1500,
the information in the annotated database 116 can be converted into
a format supported by Microsoft Excel, which can then be converted
into a file having comma separated values. In one implementation,
the annotated database 116 can be directly converted into the file
having comma separated values. In an update database module 1600,
the database builder 119a can check to see if the changes that have
been made to the tables corresponding to the annotated database 116
call for replacing the tables in an old annotated database with a
new annotated database. In such an implementation, when the old
database is replaced with the new database, a change report can be
generated that documents the changes. Finally, a distribution
module 1700 can assist in uploading the changed annotated database
1700 to the computer system or the PDA.
[0053] FIG. 1C shows an example user interface 2000 implemented by
the database builder 119a. Field "Database update?" 2100 is used to
indicate whether a database update is expected. If the old database
is to be replaced by a new database, the radio button "Yes" is
checked. Fields "Current database" and "Data Set name" 2200 can be
used to specify a location of the current database and a data set
within the database that is to be updated. If the current database
is to be replaced by a new database, fields "New Database" and
"Data Set name" 2300 can be used to specify the location and name
of the new database and data set within the new database. If the
new data set name matches an existing data set name, the existing
data set is overwritten by the new data set. Once the information
in fields 2100-2300 is provided, the "start" button 2400 can be
activated to begin the update process described above, and dose
forms information 2500-2600 is displayed.
[0054] In one implementation, dose forms corresponding to the drugs
in the database can be provided through item "Dose Forms" 2500 on
the user interface 2000. If an existing database is being updated,
then dose forms from the existing database can be used. If a new
database is replacing the existing database, then check items 2600
can present the dose forms to be associated with the drugs in the
new database.
[0055] When the "Save" button 2700 is activated, the new database
having the new tables (e.g., Drug table, Drug preferences table,
Dose Forms table corresponding to FIG. 1B) are created. In an
update of an existing database, the new database is updated with
information and preferences from the existing database. If the
existing database is not being updated, then information about the
new drugs is added to the existing tables. For example, National
Drug Code (NDC) values corresponding to the new drugs can be added
to the existing tables. Subsequently, a tool, for example, a
Database Verify tool (not shown) can produce a change report
documenting all the differences between the current dataset and the
new dataset. This report can be used to identify to the clinician
101 what drugs are new in comparison to the current dataset and any
changes made to the dataset.
Rules Engine
[0056] In one implementation, the configuration module 119 includes
a rules editor 119b having a user interface for enabling the
authorized individual 99 to create and/or edit one or more rules to
be applied to the information about the drug produced by the
processor 108. The rules are implemented by the rules engine 120.
The rules may be based on one or more national, regional, hospital,
departmental, or patient specific rules to be applied to a drug in
question. For example, if the drug Propofol at a concentration of
1000 mg/mL is identified, but the maximum concentration allowed by
a hospital is 10 mg/mL, an alert can immediately be generated. The
rules engine 120 can also cause the system 100 to generate a
warning label having an appropriate warning message such as: "DO
NOT USE--OVERDOSE HAZARD." In this scenario, other than the warning
label, another option is that the system would produce no drug
label 136 at all. In some examples, if the drug is identified as
being on a recall list, the clinician can be alerted and a label
can be produced which says: "DO NOT USE--RECALLED DRUG--RETURN TO
PHARMACY." In some examples, the rules may also include one or more
dilution and/or mixing rules.
[0057] The rules engine 120 can also apply rules for proper
identification of drugs. For example, the American Society of
Anesthesiologists specifies that, in an operating room, muscle
relaxants must be labeled with a red label. Accordingly, once the
rules engine 120 determines that the drug is a muscle relaxant, the
rules engine 120 can instruct the data carrier generator 124 (FIG.
1) to, e.g., produce a red label.
[0058] In some examples, user-defined rules can be agreed upon by,
for example, a therapeutics committee authorized by the healthcare
institution to create rules on behalf of the institution. The rules
can then be entered into the rules editor 119b by the authorized
individual 99 e.g., system administrator.
[0059] The institution (or the therapeutics committee acting on
behalf of the institution) may authorize a master set of drugs for
use in a specific site (e.g., operating room) within the
institution. Optionally, the institution may further authorize one
or more subsets of drugs that are derived from the master set of
drugs for specific applications (e.g. drugs for one or more of
pediatric, cardiac, and/or pregnancy applications).
[0060] In some examples, the master set of drugs can be organized
into a hierarchy having multiple levels. As such, the institution
can create a classification of the site-specific drugs. Each
classification can define one or more of the following associated
attributes. The authorized individual 99 can create rules for drugs
by assigning values to these attributes.
[0061] 1) Text Attributes, i.e., Text that is to be Associated with
a Drug.
[0062] The text attribute includes text that is associated with
naming a drug. For example, the text "Propofol" may be used to
refer to a drug. However, the drug may also be marketed as
"Diprivan" by AstraZeneca Pharmaceuticals LP, Wilmington, Del.
Other examples of text attributes may include, for example, a name
that is to appear on user interface screens for verification, and a
name that is to be printed on the label 136. The text attribute can
also indicate whether the name should appear in "tall man"
lettering, and/or whether any additional text should accompany the
name. For example, the text "Paralyzing Agent" may accompany the
name of the drug to indicate that the drug is a paralyzing
agent.
[0063] 2) Multimedia Attributes
[0064] For example, one or more sound files can be associated with
the drug to produce audible identification and warnings. Also, one
or more graphics files and/or video files can be associated with
the drug for visual identification and warnings.
[0065] 3) Label Template Attributes
[0066] For example, one or more label attributes may be specified
for the drug, such as, a color, a pattern, a style, a size, a
graphic (e.g., a logo), a barcode type, and/or an indication of
where information is to be printed on the label 136.
[0067] In some examples, the institution can also specify a set of
one or more of the following attributes to be associated with each
drug.
[0068] 1) All subsets to which the drug belongs.
[0069] 2) Classification of the drug.
[0070] 3) Status attribute (e.g., an indication of whether the drug
can be used. This attribute can also be used to specify whether the
drug has a status of "recalled," "for adult-use only,"
"not-recommended," and/or "restricted").
[0071] 4) Text attributes overrides (e.g., an indication of whether
the text attribute associated with the drug as specified by, for
example, the master database 118 can be overridden to indicate a
new text attribute. For example, "Diprivan" can be labeled as
"Propofol" for appearance on a user interface screen within the
institution or for appearance on the label 136).
[0072] 5) Multimedia attribute override (e.g., an indication of
whether the multimedia attribute associated with the drug as
specified by, for example, the master database 118 can be
overridden to indicate a new multimedia attribute).
[0073] 6) Label template attribute overrides (e.g., an indication
of whether the Label template attribute associated with the drug as
specified by, for example, the master database 118 can be
overridden to indicate a new label template attribute).
[0074] 7) Diluent attributes (an indication of whether a dilutent
is allowed, preferred, and/or required for the drug, e.g. distilled
water, normal saline).
[0075] 8) Expiration attributes (e.g., an amount of time after
preparation that the drug in drug container expires).
[0076] 9) Barcode attributes (e.g., information about the barcode,
e.g., types of barcodes, such as, PDF-417, Datamatrix, and/or
encoding standards. Also, the barcode attributes may include
content of the barcodes such as a unique tracking code, and/or NDC,
and/or one or more other user-defined drug attributes).
[0077] In some examples, the authorized individual 99 can use the
rules editor 119b to specify one or more features for label 136. In
one implementation, a bar code component that is distinct from the
rules editor 119b (and located inside or outside the configuration
module 119) can be used to specify the features for the bar code on
label 136. For example, the rules editor 119b can allow the
authorized individual to customize one or more bar code elements
(e.g., 45, 55, and 55' of FIGS. 4 and 5A-B) on the label 136. The
authorized individual 99 can specify the type of bar code elements
(e.g., bar code symbologies) and set preferences for the type of
information contained in the bar code elements (as described in
detail below).
[0078] In some examples, the authorized individual 99 can use the
rules editor 119b to apply rules to sections of the annotated
database 116 and/or the reduced database 117. For example, the
authorized user 99 can specify that all of the entries in the
databases 116, 117 corresponding to a class of drugs called muscle
relaxants print a red label and a warning message. As such, the
authorized individual 99 can save the time of having to apply rules
for each entry in the databases 116, 117, and further assure
reasonably safely. In one implementation, the authorized individual
99 can use the rules editor 119b to apply rules to one or more drug
entries corresponding to individual NDCs. For example, a rule can
be implemented to generate a recall message for a particular drug
from one specific source.
[0079] In one implementation, the rules editor 119b can produce
change reports for audit checks. In some examples, the change
reports can be produced by a component separate from the rules
editor 119b, but take directions from the rules editor 119b. For
example, a process can be implemented for comparing the reduced
database 117 at a particular site to a latest monthly download from
the master database 118. As described above, the site
administrators (e.g., authorized individual 99), can then make
updates and apply site specific rules to the reduced database 117
or the annotated database 116. In such an implementation, an
additional change report can be generated for quality checks and
tracking purposes. Further, the change report can be used for
version control of the individual devices and compare the content
of old and new databases.
[0080] Drug Scanning and Look-Up
[0081] Referring to FIG. 2, in some implementations, the drug
identifying component 104 (FIG. 1) can include a handheld computer
1 having a display 2 and a keyboard 3 for recognizing one or more
drugs in drug containers 132. In some examples, the display 2 can
include an audio-visual unit, e.g., a touch screen and/or a
microphone and speaker 58 for data input. For example, the display
2 can include a back-lit, flat panel display with a touch screen.
In some examples, the handheld computer 1 can be implemented within
a smart phone or a personal digital assistant (PDA) that includes
either circuitry in hardware or software application modules for
carrying out the features of the labeling system 100. In one
implementation, the handheld computer 1 can be the MC70 Handheld
Mobile Computer from Motorola, Holtsville, N.Y.
[0082] The handheld computer 1 can include a built in
camera/optical scanner 5 that can scan a variety of types of
barcodes. The handheld computer 1 can also include a variety of
radio links, e.g., a short range IEEE 802.15.1 (Bluetooth) link 4,
and a longer range IEEE 802.11 (WiFi) link 6.
[0083] In some implementations, the handheld computer 1 can include
a port (not shown) for accepting software updates. The software
updates can be transferred to the handheld computer 1 through a
wired or wireless connection. The updates can ensure update
integrity and provide for reverting to a previous version manually
or automatically if an error is detected during an upgrade. In some
examples, multiple update package deliverable scenarios can be
supported. For example, in an example, update packages can be
applied individually in an appropriate order for items such as
firmware updates, software application updates and/or database
updates. Various methods known to those skilled in the art can be
used to deliver application update packages.
[0084] A clinician 101 can use the handheld's 1 imager/scanner 5
to, e.g., scan or image the container 132 to identify the drug in
the container 132. In some examples, the clinician can scan a
barcode on the identifier 128, or scan an RFID tag 60 on the
container 132 (or on the identifier 128), or image the container
132 and/or the identifier 128 and compare the image of the
container 132 or the identifier 128 to known images in a, e.g.,
first database 61 located in the handheld computer 1. In some
implementations, a server 210 on, e.g., a hospital computer network
14 (e.g., local area network) can include the database of known
images, e.g., database 225. In such implementations, the handheld
computer 1 can communicate with the database 225 on the server 210
through, e.g., long range WiFi link 6.
[0085] In one implementation, the processor 108 (FIG. 1) can be
implemented in the handheld computer 1. The processor 108 in the
handheld computer 1 can communicate with a memory 112, e.g., also
located in the handheld computer 1. In some examples, the memory
112 can be a removable memory unit. The handheld computer 1 can
include a variety of wireless and wired communications links that
allow the handheld computer 1 to communicate with e.g., the server
210 over the network 14. For example, the handheld computer 1 can
transmit the drug identifying data based on, e.g., the barcode on
the identifier 128, to the server 210. The server 210 can look up
information about the drug based on the drug identifying data in a
variety of proprietary databases, e.g., database 220. The database
220 can be local to the server 210, or the server 210 can remotely
connect to one or more databases at remote locations. For example,
the database 220 can be local to the server 210 and be, for
example, the annotated database 116 and/or the reduced database 117
(FIG. 1). In some examples, the server 210 can directly connect to
one or more remote databases that may be government agency and/or
industry-standard databases, for example, the master database 118
(FIG. 1). In this regard, the drug identifying data based on the
barcode on the identifier 128 can be converted into an NDC number
and looked up directly in the master database 118. In some
examples, if the barcode on the identifier 128 includes a hospital
generated number, or a manufacturer's unique number that has been
previously entered into the local database 220, then the drug
information can be looked up in the database 220 with no need to
connect to another remotely located database.
[0086] In some implementations, the handheld computer 1 can include
a second database 62 having information about drugs that are
uploaded as needed from the server 210. In one implementation, the
second database 62 can be the annotated database 116 (FIG. 1). In
some implementations, the database 62 on the handheld computer 1
can include information about drugs that are frequently looked up.
By locating the database 62 on the handheld computer 1, the
labeling system 100 may achieve higher look-up speeds, and further,
the handheld computer 1 will not need to always be connected to the
network 14. In this manner, the handheld computer 1 can provide
improved reliability during a drug transfer process.
[0087] In some implementations, the server 210 can also include a
utilization database 235 for storing drug information such as, drug
name, pedigree and final concentration administered to a patient.
In some examples, the utilization database 235 can be located in
the handheld computer 1 and stores, for example, the last several
drug administrations. The utilization database 235 can be used to
produce reports describing actual drug utilization as described in
the section on drug administration below.
[0088] The handheld databases 61 and 62 can be synchronized and
updated with the server databases 220 and 225 through the network
14 in a variety of ways known to those skilled in the art. Once the
first drug container 132 is identified, the handheld computer 1 can
be configured to display a name of the drug and/or other
information about the drug on the display 2. In some examples, the
handheld computer 1 can announce the name of the drug and/or the
other information about the drug through the speaker 58.
[0089] FIG. 3 illustrates a labeling system 300 that can include a
desktop or laptop computer 310 in communication with an
imager/scanner 320 for scanning and/or imaging drug containers 132
and/or identifiers 128 on the drug containers 132. In scenarios
where a hospital is already equipped with a computer system and
network, such a system 300 can be cost effective. For example, the
computer 310 may already be part of an Anesthesia Information
Management system (AIMS). Since computers 310 are available in most
hospitals, the system 300 can be easy to setup and maintain. The
computer 310 is connected via a wired or wireless link 24 to the
imager/scanner 320 (having similar functionality as, e.g., the
imager/scanner 5 of FIG. 1) In some implementations, the computer
310 can include short range radio links 330 and/or long range radio
links 340 for connecting to e.g., server 210 on the network 14. In
some examples, the computer 310 can also connect to the network 14
through e.g., wire 350. The computer 310 can include a keyboard 360
and/or one or more other input devices, and a display 370. For
example, the computer 310 can be a portable computer such as the C5
provided by Motion Computing of Austin, Tex.
[0090] As described above, once the drug in the first drug
container 132 is identified, the system 100, 300 can display the
name of the drug and "read back" the name by, e.g., producing
audible and visual feedback. The "read back" can assist e.g., a
busy clinician by providing way to confirm to identify of the drug
and thus reduce potential for errors. If the clinician hears or
sees the wrong drug name, he or she can stop drawing up the drug
before it is administer to a patient.
Label Generation
[0091] FIGS. 1-3 show that the system 100, 300 can include an
output unit for producing markings including drug handling
information on the label 136 and/or directly on the drug container
140. For example, the output unit can be the data carrier generator
124. In one implementation, the data carrier generator 124 can be a
label printer. The data carrier generator 124 can produce a variety
of types of labels 136. In some examples, the data carrier
generator 124 can be configured to produce labels 136 in color. In
some examples, the data carrier generator 124 can be configured to
produce labels 136 in grayscale. In some implementations, the
labels 136 include only machine-readable markings. Further, in some
examples, as described above, the label 136 can include both human-
and machine-readable markings. The data carrier generator 124 can
be connected to the network 14 through a hardwired connection
(e.g., wired connection to local area network 14, or a local
serial, USB, or parallel port connection). In some examples, the
data carrier generator 124 can be connected to the network 14
through e.g., a short range wireless connection (such as IEEE
802.15.1 Bluetooth) 8 or a long range wireless connection (such as
IEEE 802.11 WiFi) 9. The network 14 may include wired connections
18a or 18b to access points 7a and 7b to enable the connection of
the 802.11 links into the wired network 14. In some examples, the
data carrier generator 124 may be connected to the network 14
through a, e.g., wire or cable 19. The data carrier generator 124
may also connect directly to the handheld computer 1 through a
short range radio link 4. Alternatively the handheld computer 1 may
communicate over its long range radio link 6, through, e.g.,
network access points 7a, 7b, to the data carrier generator
124.
[0092] Through one or more data transfer mechanisms described
above, the handheld computer 1, the desktop computer 310, and/or
the server 210 can send the drug-specific information (e.g., drug
name, concentration, dose units, time and date of preparation
and/or dilution, who prepared the drug, and expiration date and
time) for inclusion on the label 136. For example, the desktop
computer 310 can communicate to a local printer serving as the data
carrier generator 124 to print the label 136. In this manner, the
handheld computer 1, the desktop computer 310, and/or the server
210 can cause the data carrier generator 124 to print a label 136
to be applied on the drug container 140, e.g., a syringe.
[0093] The system 100, 300 can allow for other specialty
"compliance" labels to be printed, such as, intravenous insertion
times and expirations as well as labels to mark invasive monitoring
devices on a patient or on patient monitoring systems, e.g.,
central venous lines, arterial lines, and/or intracranial pressure
lines.
[0094] While the new systems described herein are typically
designed to generate a paper or plastic label that can be affixed
to the second drug container, in some embodiments, the new systems
include a device the prints, inscribes, etches, embosses, or
otherwise applies the human-readable and/or machine-readable drug
handling information directly onto the second container.
Label Features
[0095] FIG. 4 illustrates an example of a label 136A for a drug
that has not been diluted. The label 136A includes the name of the
drug, e.g., "Propofol" 39, the concentration of the drug, e.g., "10
mg/mL" 44, the lot number corresponding to the drug, e.g., "1234"
40, the identity of the clinician 101 who transferred the drug,
e.g., "Kim Donovan" 41, time/date stamp that the drug was
transferred, e.g., "07/09/08 18:17" 42, and time/date the drug
expires, e.g., "07/09/08 21:17" 43. The label 136 can also include
warnings and/or other information 63.
[0096] In some examples, as described above, the background 47 of
the label 136A can be colored, where the color can indicate e.g.,
drug classification. In other words, the label 136A itself can be
colored, and the label printer adds information to the colored
label 136A, or the label printer can print the colored background
as well as add additional information. For example, the background
47 can be yellow to indicate that Propofol is an induction agent.
The label 136A can also include a linear barcode 45 and/or one or
more two-dimensional barcodes 46a-f that can be read by, e.g., an
external information system and/or other medical devices. In other
embodiments, the unprinted label includes various fields of all
potentially required colors, and the printer is directed to print
black (or white) ink to obscure all but the particular color field
required for a specific drug. In this way, a single type of label
can be used for any type of drug that requires a color designation,
without the need for multiple different colored labels, and without
the need for a color printer.
[0097] One or more small two-dimensional barcodes 46a-f can be
advantageous on small syringes. Since the label 136 must wrap
around the syringe, the curvature of the syringe (and hence the
label 136) can cause barcodes printed on the label 136A to also
have a slight curvature. As such, the barcodes are distorted making
it difficult for the imager/scanner 5 to read the label 136A. By
using smaller barcodes 46a-f, the effective curvature on any one
barcode 46a-f is smaller and hence easier for the imager/scanner 5
to read the label 136A. In some examples, multiple barcodes 46a-f
can include duplicate information or can include concatenated
information and simply provide more "targets" for the imager
scanner 5. This can be useful as it would allow the clinician 101
to find a barcode 46a-f easily without having to rotate the
syringe.
[0098] FIG. 5A shows an example of a label 136B for a drug that has
been reconstituted from a powder. As shown, a cautionary message 49
can be included on a portion of the label 136B. Similar to the
label 136A of FIG. 4, the label 136B can include a name of the
drug, e.g., "Remifentanil" 50, and information that the drug is
administered in a reconstituted concentration, e.g., "50 mcg/ml"
58. The label 136B can also include lot number, e.g., "3678" 51,
identity of the clinician 101 who prepared the drug, e.g., "Bill
Driscoll" 52, time/date stamp that the drug was
transferred/prepared, e.g., "07/09/08 18:06" 53, and time/date the
drug expires, e.g., "07/10/08 18:06" 54. The label 136B can also
include information about the diluent and volume of the diluent,
e.g., "Normal Saline 20 cc" 59, and information about the total
final volume of the reconstituted drug, e.g., "20 cc" 59A. The
label 136B can also include warnings and/or other information 64.
The label 136B also has linear barcodes 55 and/or one or more
two-dimensional barcodes 56a-g. In this label 136B, the background
57 may be blue for, e.g., identifying that the drug is a
narcotic.
[0099] FIG. 5B shows an example of a label 136C for a drug that has
been diluted from a concentrated liquid drug. A cautionary message
49' can be included on the label 136B. Similar to the label 136A of
FIG. 4, the label 136C can include information about the name of
the drug, e.g., "Morphine" 50', and information that the drug is
administered in a diluted concentration, e.g., "1 mg/ml" 58'. The
label 136C can also include information about lot number, e.g.,
"6789" 51', identity of the clinician 101 who prepared the drug,
e.g., "Wilton Levine" 52', time/date stamp that the drug was
transferred/prepared, e.g., "07/09/08 18:06" 53', and time/date the
drug expires, e.g., "07/10/08 18:06" 54'. The label 136C can also
include information about the diluent and volume of the diluent,
e.g., "Normal Saline 9 cc" 59', and information about the total
final volume of the reconstituted drug, e.g., "10 cc" 59A'. The
label 136C can also include warnings and/or other information 64'.
The label 136C also has linear barcodes 55' and/or one or more
two-dimensional barcodes 56'a-f. In this label 136C, the background
57' may be blue for, e.g., identifying that the drug is a
narcotic.
[0100] In one implementation, the labels 136A-C produced by the
data carrier generator 124 and applied to syringes into which drugs
are drawn are legible and water proof, and thus comply with
prescribed standards. Further, clean clear labels 136A-C can
enhance patient safety by reducing a likelihood of a "syringe
swap."
[0101] In some examples, the information contained in the linear
barcodes 45, 55, and 55', and/or the two-dimensional barcodes,
46a-f, 56a-f, and 56'a-f of FIGS. 4 and 5A-B can be decoded to a
unique identifier (e.g., a string of characters) that functions as
a pointer to additional information. In one implementation, the
additional information can be sourced via, e.g., a networked
look-up. An advantage of such a scheme is that the information
object that the identifier points to can be a large object.
[0102] In some examples, the information contained in the barcodes
can be based on government and/or industry prescribed standards,
e.g., standards prescribed in "Positive Identification for Patient
Medication Safety, ANSI/HIBC 3.0-2008," made available by the
Health Industry Business Communications Council (HIBCC). The scheme
for encoding the information in the bar code can be modified by an
authorized individual (e.g., a system administrator) as needed for
particular situations. In one implementation, the information
contained in such barcodes can be decoded to the following
exemplary string: "DIC/SYR/Drug
name/NDC/user/exp/serialnumber/\DIC"
[0103] A destination system, e.g., an anesthesia information
management system, may need to "know" certain information about the
drug before the drug is administered to a patient. In this regard,
the string above can provide the necessary information. As
described above, an authorized individual 99 can use a software
interface (e.g., rules editor 119b of FIG. 1) to specify the
information in the string and thus in the bar code elements. In one
implementation, the string can include the following
information:
[0104] 1) an identifier that identifies the item as a syringe;
[0105] 2) an identifier that identifies the name of the drug (e.g.,
if the destination system can only use that particular drug);
[0106] 3) an identifier that identifies the NDC (e.g., if the
destination system can use the true source); and/or
[0107] 4) an identifier that includes the identity of the clinician
101 and expiration information in a unique code format, e.g., Hex
format, base 64 encoding. The identifier can be, e.g., a unique
serial number that forms a portion of the string.
[0108] Using the information contained in the string above, one or
more administration rules (e.g., "has this syringe been used before
on a different patient?") can be run on the destination system
before documenting the administration of the drug.
[0109] In one implementation, the information contained in the bar
code can be parsed locally, i.e., the decoding of the bar code can
be performed within the computer system (e.g., the drug identifying
component 104) and/or the personal digital assistant (e.g.,
handheld computer 1) that scans the drug container 132 and/or the
identifier 128 on the drug container 132. An advantage of such a
scheme is that the information can be instantly obtained without
delays or failure-modes that may be inherent in networked
lookups.
Example Process for Drug Labeling
[0110] FIG. 6 shows a flowchart for an example of a drug labeling
method 600. The clinician 101 first scans and or images a barcode
on the label 136 and/or on the first drug container 132 (Step 605).
The drug and possibly other information, e.g., drug concentration,
is identified as drug identifying data (Step 610). Based on the
drug identifying data, a local or remote database, e.g., database
62 and/or database 220 is looked-up to produce information about
the drug (Step 615). In some examples, the drug name can be
displayed to the clinician 101 (Step 620). In some examples, the
drug concentration and/or other information regarding the drug can
be displayed to the clinician 101. Subsequently, one or more rules,
e.g., user-generated rules 503, that are based on compliance and
safety standards are applied (Step 625). For example, if there is a
"hard stop," such as when a recalled drug is identified (Step 630),
the clinician may not be able to continue the process of producing
a drug label 136, and may instead be directed to producing a label
136 having only warning messages (Steps 635). Otherwise, in some
implementations, the drug name or other information can be
announced over a speaker 58 (Step 640). In some examples, the
warning messages can also be played over the speaker 58.
[0111] In some examples, a drug may need to be diluted as described
in further detail below (Step 645). If there is no need for
dilution, in some examples, a drug may need to be mixed as also
described in detail below (Step 650). In some examples, the
clinician 101 can be prompted to input whether each or either of
the diluting or mixing processes are needed. If each of these
processes is not needed, i.e., the drug need not be diluted or
mixed, complete information about, e.g., the drug's pedigree can be
looked-up on e.g., the databases 62 and/or 220 (Step 655). In some
examples, the information can include, e.g., a manufacturer of the
drug, information about when and how the drug was shipped or
received, and information about how the drug was processed by an in
house pharmacy. In some examples, the utilization of the drug can
be recorded in e.g., a utilization database 235 (FIGS. 2-3) (Step
660). One or more steps of the method 600 described above can be
implemented by the drug labeling system 100, 300 (FIGS. 1-3).
Drug Dilution
[0112] Sometimes drugs need to be diluted before they are
administered. For example, the manufacturer supplied dosage may be
too strong. In these cases the final concentration of the drug is
dependent upon how much diluent is added. In many cases after the
drug is identified, the rules engine 120 can apply rules that
require that the drug never be diluted, so that the system 100, 300
can proceed to printing the label 136. In cases where the drug
needs to be diluted, the system 100, 300 may prompt the clinician
101 to provide guidance. If the clinician 101 selects "yes" to
suggest that the drug needs to be diluted, the clinician 101 can
then select the desired final concentration (from e.g.,
user-defined rules, which can include a list of approved choices
that are clinically appropriate) A prompt screen on the display
can, based on the rules, remind the clinician 101 how much (and
what type of) diluent can be added to the original drug. The rules
can also check to see if the proposed drug concentration is too
strong or too weak. In some implementations, the dilution
information is also printed on the label 136. In some cases, the
drugs can be in the form of powders or emulsions, and need to be
reconstituted into an injectable form. In such cases, the feature
of system 100, 300 for dilution described above can be used to
reconstitute the drug.
[0113] FIG. 7 illustrates an exemplary flowchart of a drug dilution
subroutine 700 that can be used in a drug labeling process as
described herein. In the drug labeling process (e.g., process 600
of FIG. 6), the clinician 101 can be prompted to indicate whether
the drug needs to be diluted. In some examples, rules can be used
to verify whether dilution may be permitted. If the rules permit
the dilution and/or if the clinician 101 selects "yes" (Step 710),
then the clinician 101 may be prompted for dilution criteria, i.e.,
the clinician 101 may be prompted to enter his or her desired
dilution amount (Step 720). The prompting can also include "asking"
the clinician 101 to add a specific amount of diluent to produce a
desired end concentration. In some examples, rules are applied
again to verify whether a proposed final concentration is within
the prescribed guidelines (Step 740). After the final concentration
of the drug is confirmed, the subroutine 700 can terminate 750 and
return control to the labeling method 600 (FIG. 6). One or more
steps of the subroutine 700 described above can be implemented by
the drug labeling system 100, 300 (FIGS. 1-3).
Drug Mixing
[0114] In some cases two or more drugs may need to be mixed in the
same syringe. For example, neostigmine and glycopyrrolate may be
combined in the same syringe. Glycopyrrolate is used in conjunction
with neostigmine, a neuromuscular blocking reversal agent, to
prevent neostigmine's muscarinic effects such as bradycardia.
[0115] FIG. 8 shows a flowchart of an exemplary drug mixing
subroutine 800 that can be used in a drug labeling process as
described herein. If the clinician 101 selects "yes" in the drug
labeling method 600 to indicate that drug mixing is desired,
subroutine 800 is called (Step 810). The clinician 101 is prompted
for the drug mixture (Step 820). After the first drug is scanned,
the clinician 101 can select a "mix drugs" button on the screen.
The clinician 101 can then be prompted to scan in a second drug
(Step 830) and, after that drug is identified, will be asked if
there are more drugs to be mixed (Step 840). If there are more
drugs to be mixed, the process above is repeated. If there are no
additional drugs to be mixed, the mixing rules are verified (Step
850). If a violation of the rules is detected, an alert can be
immediately generated and display to the clinician 101. In some
implementations, the drug mixture may now have a new name. One or
more databases can be consulted to provide the name for printing on
the label 136 (Step 860). In some examples, the subroutine 800 can
then terminate and return control to the labeling method 600 (FIG.
6). One or more steps of the subroutine 800 described above can be
implemented by the drug labeling system 100, 300 (FIGS. 1-3).
[0116] In an example scenario, the drugs glycopyrrolate and
neostigmine may be mixed, but only in certain ratios. Therefore,
glycopyrrolate would be scanned first, then the "mix button" can be
pushed. Then, neostigmine may be scanned. The rules would be
applied to ensure that the drugs are mixed in an acceptable ratio
before and the final mixture information is presented on the
label.
Drug Administration
[0117] As described above, in some implementations, the system 100,
300 allows drug utilization to be recorded. While the pharmacy
knows what drugs are purchased, it is sometimes not well understood
what drugs are actually used and in what clinical context. It is
generally assumed that if prepackaged drugs (drugs that are
manufactured and used as a single, sterile package) need to be
restocked, they were used. However, when drugs are transferred from
one container to another, this may not be the case. For example, a
vial may contain 50 mL of a drug but the clinician only draws up 10
mL--in this case only 20% of the drug is used. Since the labeling
system 100, 300 has information regarding the drug and its final
concentration, the system 100, 300 has substantially all of the
information regarding the actual utilization of drugs. With respect
to the tracking and reconciliation of drugs, e.g., controlled
substances, the system 100, 300 can provide information about a
drug's transfer, including, documentation of the chain of custody,
administration, disposition, and reconciliation of controlled
substances such as the opioid narcotic drugs which are essential to
anesthetic care.
[0118] In some implementations, the rules engine 120 (FIG. 1) can
allow for data from the identifier 128 on the first drug container
132 to be included in the information in the label 136. One
advantage of this feature is that when the label 136 is later
scanned by a system, e.g., a documentation system (such as AIMS),
the original information on the identifier 128 can also be entered
into the documentation system. In some examples, the data may be
presented either in its native format or after being manipulated by
the rules engine 120 to ensure compliance with the particular
documentation system.
[0119] As described above, referring again to FIGS. 2 and 3, the
system 100, 300 can record the drug name, pedigree, and final
concentration in a database 235. In one scenario of drug
utilization, use and waste of narcotics or other controlled
substances can be tracked based on reports generated from the
information in the database 235. For example, an initial amount of
the drugs can be documented, and any unused portion of the drug
(e.g., waste portion) can also be recorded. An advantage of this
feature is that abuse of the drugs by e.g., clinicians 101 can be
avoided.
Example System
[0120] FIG. 9A illustrates an exemplary system 900 having one or
more of the features of the labeling system 100, 300 described
above. The system 900 includes a user interface 910, e.g., a touch
screen, for allowing a clinician 101 to provide input to the system
900 and also view information about, e.g., drugs and the transfer
of the drugs. The system 900 also includes an output 920 for
ejecting prepared data carriers, e.g., labels 136.
[0121] At start-up, the system 900 can perform a startup
initialization and self check. The time to system 900 availability
from power-on can be, e.g., less than 2 minutes. Upon startup, the
system 900 can alert the clinician 101 to one or more inconvenient,
unsafe or potential system operation issues. The system 900 can
also prompt the clinician 101 to correct any of one or more
serviceable conditions, including, conditions concerning the system
900 being off-line, out of paper, and/or out of ink. In one
implementation, the system 900 can verify whether the conditions
have been corrected prior to entering an operational state. The
system 900 can also check for required devices such as, whether the
display having the user interface 910 is connected to the system
900 and/or the existence of one or more required databases or
configuration data. In one implementation, the initialization
process described above can be made available to the clinician 101
from a menu, e.g., an administrative menu.
[0122] The system 900 can perform one or more test prints as a part
of the initialization process to verify operation of the data
carrier generator 124, e.g., the printer. The test prints can
verify whether, for example, the color accuracy and/or the text or
barcode printing on the label 136 is of acceptable quality. In some
examples, while certain elements of accurate label printing, e.g.,
color and text, can be determined through the use of software
components, human verification may be required to avoid compromised
label quality due to other issues, including, nozzle clogs, media
upside-down, and/or incorrect media. Upon the first login after
start-up, the system 900 can print a test label to verify all
colors can be accurately reproduced. The verification check may
culminate in the presentation of a verification message to the
clinician 101 requiring that the clinician 101 affirmatively
acknowledge the message before the system 900 can be used to print
labels 136. The acknowledgement can be logged and recorded in log
files, e.g., local system log files. In some examples, on
subsequent logins, if the test print operation had not been
performed within the last 24 hours, the operation can be performed
again. In one implementation, labels 136 may not be printed if a
test print acknowledgement has not been performed in over 24
hours.
[0123] In one implementation, user identification in the form of a
user login can be required to use the system 900. To facilitate
easier login, the system 900 can be configured to recognize a user
badge having markings, e.g., machine-readable markings, which
identify the clinician 101. In some examples, the system 900 can
include a "Make User Badge" function to allow for the production of
user badges for identifying clinicians 101. The user badges can be
encoded to be automatically recognized by the system 900 as badges
assigned to clinician 101. In some examples, the user badges can
include certain information, e.g., the name of the clinician 101,
three letter initials for the clinician 101, an employee number for
the clinician 101 and date/time the user badge was created. The
"Make User Badge" function can be logged in an application log. The
logged information can include, for example, the identity of the
user making the badges as well as the information about the badges
that were created.
[0124] FIGS. 9B-C show example screenshots 930-980 from the user
interface 910. FIG. 9B illustrates an example of a screenshot 930
that shows a prompt 935 for requesting that a clinician 101
identify himself or herself to the system 900. The clinician 101
can either scan his or her badge or enter an identification number
to initialize the system 900. Once the clinician 101 has identified
himself or herself to the system 900, the system 900 is ready for
use. The initials of the clinician 101 creating syringe or other
medical labels 136 can be logged and printed on the labels 136 for
proper accountability. The system 900 can also allow user
identification by methods such as, reading an RFID tag, swiping a
magnetic stripe (magstripe), a user identification card and/or
manual login using the touch screen interface on the system 900. In
one implementation, once a valid user login barcode is scanned, the
login screen can display the clinician's 101 user name as "logged
in" and enabled to produce the labels 136 for the syringes. In
certain implementations, some or all user login activity, including
failed attempts and login method (scan or manual entry) can be
logged to an audit log.
[0125] In some examples, audit logging includes logging of one or
more of user, function, device specific identification information
in addition to date/time of the logged actions. System logging can
include similar information as well as one or more of error codes,
module/class/function line number, limited tracing and/or messages
produced by external interfaces.
[0126] Once logged in, the system 900 can allow for the clinician
101 to log off at any time. Additionally, the system 900 can
include a configurable setting that can automatically log
clinicians 101 off after a predetermined inactive time (e.g., one
hour). In some examples, automatic logouts can be preceded by a
warning or indication of sufficient time to allow the clinician 101
to continue by e.g., resetting the logout timeout. In some
examples, the system 900 can permit one clinician 101 to exit the
system 900, and allow one or more other clinicians 101 to use the
system 900. Automatic logout can help insure that the clinician 900
is the true operator of the system (as recorded on labels 136 and
in the audits logs). The process of logging off the system 900 can
return the system 900 to the original login screen (e.g.,
screenshot 930).
[0127] FIG. 9C shows a screenshot 937 of an exemplary menu 938 for
presenting one or more options to the clinician 101. In general,
the operation of the menu 938 can be designed to be intuitive and
easy even for novice and first time users. In one implementation,
once logged in, the system 900 can be in, e.g., drug vial scanning
mode, and can present the menu 938 on the touch screen display,
including options such as, "Syringe," "Blank," "I.V.," "Lines," and
"Custom" corresponding to the type of labels 136 and/or operations
the clinician 101 wishes to perform. The clinician 101 can select
the "Syringe" option to begin the process of scanning drug
containers 132 to prepare labels 136 for syringes. In some
implementations, a default option can be automatically initiated
upon merely scanning the drug containers 132 without actual
selection of the corresponding option. For example, once on the
screen 937, the clinician 101 can simply begin scanning the drug
containers 132 to produce labels 136 for syringes without needing
to select the "Syringe" option. In this manner, a streamlined
workflow can be implemented for producing syringe labels 136 in
which much of the time is spent merely scanning drug containers 132
without any additional steps. Upon scanning, the drug container
132's barcode can be decoded and parsed to obtain the drug's NDC.
As described above, the NDC can be used to lookup drug information
required by the system 900. In one implementation, one or more
meaningful sounds and displays can be provided to ensure that the
workflow is proceeding correctly and safely. For example, if the
drug's NDC is not found, the system 900 can emits a sound having a
predetermined characteristic (e.g., a high frequency sound).
[0128] In one implementation, an option "Blank" can be presented to
clinicians 101 for selecting preconfigured labels using graphic
label representations of the drug labels 136. This option can be
provided for some labeling applications that do not conform to
standard drug container 132 scanning, or when the barcode on the
drug container 132 is unreadable.
[0129] In certain implementations, an option "IV Label" can be
presented to clinicians 101 for producing an identical pair of
predetermined labels for intravenous applications having date, time
and expiration information.
[0130] In one implementation, an option "Lines" can be presented to
clinicians 101 for providing access to a menu (not shown) for
selecting a type of "line" that is being prepared for a patient.
Each option in the menu can produce a predefined label for a
corresponding line. For example, an option on the menu can produce
labels to identify each one of several identical-looking lines
representing fluid-filled tubings that conduct body cavity or fluid
pressure measurements from, e.g., an invasive catheter in a
patient, to a physiological monitoring system transducer (e.g.,
"Arterial Line", "Pulmonary Artery Line", "Central Venous Pressure
Line")
[0131] It is understood that the system described herein can be
modified or extended, through, e.g., an appropriate user interface,
to provide predetermined labels for other purposes, such as
pathology tissue specimens or fluid samples (i.e., blood or other
bodily fluids) that may be created in a medical setting, and need
to be transported to a different location for analysis, together
with proper identifying information about the patient, the
preparer, and the identify of the specimen or fluid.
[0132] In some examples, the system 900 can provide a "Lockout"
feature (not shown) that allows certain personnel, e.g., system
administrators, to lock the system 900 from both authorized and
unauthorized use. For example, the label printer may need servicing
or have a data-set/configuration issue and consequently the system
900 may need to be locked out. An administrative function can lock
the system 900 and provide for a message to be displayed on the
user interface 910 while the system 900 is locked out. A
configurable administrative password to unlock can be provided.
[0133] System 900 can provide internationalization of literals,
local time, date and number conventions and representations.
Literals can be stored in resource files that are employed based on
a clinician 101's language preference. System 900 can allow
configuring a system default for presenting the log in screen, but
the log in screen can also provide e.g., an icon, to change the
language preference. If a language preference is not set for a
clinician 101, a system default will be used. If a system default
is not set explicitly, US English can be set to be the default
language. Resource files can be end-user accessible and provide for
an override of literals protected during application updates.
Resource names can be in the English language. If a resource is not
set, the name of the resource preceded by an "@" symbol and all
underscores converted to spaces can be displayed on the user
interface 910. Common resources can be grouped to a single resource
for use on different screens.
[0134] FIG. 9D shows a screenshot 940 of exemplary information that
is displayed to the clinician 101. Accordingly, on scanning a drug
container 132 or an identifier 128 on the drug container 132, the
user interface 910 displays drug identifying data 945, e.g., the
name and concentration of the drug, to the clinician 101.
[0135] FIG. 9E shows a screenshot 960 for displaying an warning
message to the clinician 101. For example, if the rules engine 120
requires that a drug, e.g., menthohexital, not be administered to a
patient, the user interface 910 can display a warning message
965.
[0136] FIGS. 9F-G show screenshots 970-980 for facilitating an
example drug dilution process. In screenshot 970, the clinician 101
can enter, in the text window 975, the name of a drug, e.g.,
propofol, to mix with menthohexital. In screenshot 980, the user
interface 910 displays a prompt 985 indicating that the drug
propofol needs to be diluted. Further, in some examples, the user
interface 010 can also provide the clinician 101 with one or more
dilution concentration options 990.
Implementation
[0137] The techniques and components of the labeling systems,
processes, and computer program products described above can be
implemented in digital electronic circuitry, or in computer
hardware, firmware, software, or in combinations thereof. The
techniques can be implemented as a computer program product, i.e.,
a computer program tangibly embodied in a data carrier, e.g., in a
machine-readable storage device or in a propagated signal, for
execution by, or to control the operation of, data processing
apparatus, e.g., a programmable processor, a computer, or multiple
computers. A computer program can be written in any form of
programming language, including compiled or interpreted languages,
and it can be deployed in any form, including as a stand-alone
program or as a module, component, subroutine, or other unit
suitable for use in a computing environment. A computer program can
be deployed to be executed on one computer or on multiple computers
at one site or distributed across multiple sites and interconnected
by a communication network.
[0138] Method steps of the techniques described herein can be
performed by one or more programmable processors or computers
executing a computer program to perform functions described herein
by operating on input data and generating output. Method steps can
also be performed by, and apparatus of the invention can be
implemented as, special purpose logic circuitry, e.g., an FPGA
(field programmable gate array) or an ASIC (application-specific
integrated circuit). Modules can refer to portions of the computer
program and/or the processor/special circuitry that implements that
functionality.
[0139] Processors suitable for the execution of a computer program
include, by way of example, both general and special purpose
microprocessors, and any one or more processors of any kind of
digital computer. Generally, a processor will receive instructions
and data from a read-only memory or a random access memory or both.
The essential elements of a computer are a processor for executing
instructions and one or more memory devices for storing
instructions and data. Generally, a computer will also include, or
be operatively coupled to receive data from or transfer data to, or
both, one or more mass storage devices for storing data, e.g.,
magnetic, magneto-optical disks, or optical disks. Machine-readable
storage devices suitable for embodying computer program
instructions and data include all forms of non-volatile memory,
including by way of example semiconductor memory devices, e.g.,
EPROM, EEPROM, and flash memory devices; magnetic disks, e.g.,
internal hard disks or removable disks; magneto-optical disks; and
CD-ROM and DVD-ROM disks. The processor and the memory can be
supplemented by, or incorporated in special purpose logic
circuitry. The computing system can include clients and servers. A
client and server are generally remote from each other and
typically interact over a communication network. The relationship
of client and server arises by virtue of computer programs running
on the respective computers and having a client-server relationship
to each other.
Other Embodiments
[0140] It is to be understood that while the invention has been
described in conjunction with the detailed description thereof, the
foregoing description is intended to illustrate and not limit the
scope of the invention, which is defined by the scope of the
appended claims. Other aspects, advantages, and modifications are
within the scope of the following claims.
* * * * *