U.S. patent application number 16/112395 was filed with the patent office on 2018-12-20 for management, reporting and benchmarking of medication preparation.
The applicant listed for this patent is BAXTER CORPORATION ENGLEWOOD. Invention is credited to Jayson Lee Bender, Abdul Wahid Khan, Gregory T. Olsen, Bhavesh S. Padmani, Dennis Schneider, Dennis TRIBBLE, Matthew A. Valentine.
Application Number | 20180366215 16/112395 |
Document ID | / |
Family ID | 42099713 |
Filed Date | 2018-12-20 |
United States Patent
Application |
20180366215 |
Kind Code |
A1 |
TRIBBLE; Dennis ; et
al. |
December 20, 2018 |
MANAGEMENT, REPORTING AND BENCHMARKING OF MEDICATION
PREPARATION
Abstract
A system for preparing and managing patient-specific dose orders
includes an order processing server configured to receive the
patient-specific dose orders, define a queue of dose orders and
distribute the dose orders to at least one dose preparation
station. The dose preparation station is in bi-directional
communication with the order processing server and has an interface
for providing an operator with a protocol associated with each
received drug order and specifying a set of steps to fill the drug
order. Steps to fill the drug order are captured at the station and
a display, positionable independent of the station outputs the dose
order queue and metrics concerning activity at the dose preparation
station. Systems for preparing patient-specific doses and a method
for telepharmacy in which data captured while following the
protocol are provided to a remote site for review and approval by a
pharmacist.
Inventors: |
TRIBBLE; Dennis; (Ormond
Beach, FL) ; Khan; Abdul Wahid; (Lindenhurst, IL)
; Schneider; Dennis; (Nashua, NH) ; Olsen; Gregory
T.; (DeLand, FL) ; Bender; Jayson Lee; (Ormond
Beach, FL) ; Padmani; Bhavesh S.; (Port Orange,
FL) ; Valentine; Matthew A.; (Ormond Beach,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BAXTER CORPORATION ENGLEWOOD |
Englewood |
CO |
US |
|
|
Family ID: |
42099713 |
Appl. No.: |
16/112395 |
Filed: |
August 24, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14022415 |
Sep 10, 2013 |
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16112395 |
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12358574 |
Jan 23, 2009 |
8554579 |
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14022415 |
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61104954 |
Oct 13, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G06F 19/3456 20130101;
G16H 20/17 20180101; G06F 19/326 20130101; G06F 19/00 20130101;
G16H 20/10 20180101; G06Q 50/22 20130101; G16H 40/67 20180101; G06F
19/3462 20130101; G16H 70/40 20180101; G16H 40/63 20180101; G06Q
10/08 20130101; G06Q 50/24 20130101; G16H 20/13 20180101; G16H
10/60 20180101 |
International
Class: |
G16H 20/10 20180101
G16H020/10; G06Q 50/22 20180101 G06Q050/22; G06Q 10/08 20120101
G06Q010/08; G16H 20/17 20180101 G16H020/17; G16H 20/13 20180101
G16H020/13; G16H 10/60 20180101 G16H010/60; G06F 19/00 20180101
G06F019/00 |
Claims
1. A medication preparation system for preparing and managing dose
orders for compounded doses that have been entered into a first
system, comprising: an order processing server executing software
on a processor thereof and connected by a network to the first
system and configured to receive the dose orders for compounded
doses from the first system, the order processing server including
a database configured to store the dose orders and information that
relates to the dose orders in a dose record, the order processing
server being configured to generate a dose order queue listing all
dose orders received by the order processing server; a dose
preparation station for manual preparation of a plurality of
compounded doses by a human operator based on received dose orders,
the dose preparation station being in bi-directional communication
with the order processing server and having an interface comprising
a display for providing a human operator with a protocol associated
with each received dose order in a human perceivable manner and
specifying a set of steps to prepare the compounded dose
corresponding to the dose order; the dose preparation station being
configured to present the protocol using the display to the human
operator in the human perceivable manner for use by the human
operator for manual preparation of a compounded dose corresponding
to the dose order and having one or more data input devices
operable by the human operator to capture dose preparation
information that relates to at least one step of the protocol to
prepare the compounded dose to fill the dose order in accordance
with the protocol and communicate the dose preparation information
to the order processing server for association with the dose
record, wherein the dose preparation information includes
confirmation data entered by the operator to confirm that the at
least one step of the protocol was successfully completed and
further includes indicia associated with the compounded dose that
permits the contents of the compounded dose to be confirmed, and
wherein the dose preparation information must be received prior to
advancing to a subsequent step of the protocol; and a portal that
is accessible remotely from the dose preparation station and in
communication with the database that is configured to access the
dose preparation information from the dose record of the database
for presentation of the dose preparation information on a display
to a remote user for inspection of the prepared compounded dose by
review of the dose preparation information in order to verify
whether the compounded dose has been prepared in accordance with
the protocol, wherein the portal is configured to receive an
approval of the release of the compounded dose if the remote user
confirms that the dose has been prepared in accordance with the
protocol.
2. The system of claim 1, further comprising a plurality of dose
preparation stations.
3. The system of claim 1, wherein the dose preparation station has
a printer for printing dose labels of only those dose orders that
are received from the order processing server.
4. The system of claim 1, wherein the protocol is based at least in
part on information obtained from a National Drug Code (NDC)
associated with each drug that is used to fulfill the drug
order.
5. The system of claim 1, wherein the dose preparation station
includes and interactive screen that includes prompts that can be
highlighted by an operator to receive additional information
relative to one particular step of the protocol and includes areas
for entering an input.
6. The system of claim 1, wherein the one or more data input
devices comprises a camera to capture images of a plurality of a
set of drug preparation steps that are part of the protocol and are
followed to prepare the compounded dose to fill the dose order,
wherein each image associate with the drug preparation steps of the
protocol is stored together in a data record of the database.
7. The system of claim 6, wherein at least one captured image is
captured at, corresponds to, and confirms a performance of one
discrete drug preparation step in which the compounded dose is not
completely prepared and ready for delivery to a patient and the
captured image displays a result of a discrete isolated event
performed in accordance with one drug preparation step.
8. The system of claim 6, wherein each of the steps must be
confirmed as completed before the operator can continue with the
other steps of the protocol.
9. The system of claim 1, wherein the protocol is at least
partially based on the dose order.
10. The system of claim 9, wherein the protocol is at least
partially based on the input information.
11. The system of claim 10, wherein the protocol comprises an
interactive protocol determined during the manual preparation at
least in part based on the dose order and the input information.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/022,415, filed Sep. 10, 2013, which is a
continuation of U.S. patent application Ser. No. 12/358,574, filed
Jan. 23, 2009, now U.S. Pat. No. 8,554,579, which claims the
benefit of U.S. patent application Ser. No. 61/104,954, filed Oct.
13, 2008, which are hereby incorporated by reference in their
entirety.
TECHNICAL FIELD
[0002] The present invention relates to the management of
medication dose orders and medication dose preparation, and more
particularly to some or all of the systems and steps taken in
connection with the receipt, processing, filling on-demand `and in
anticipation of use, management, and distribution of medication
dose orders, as well as remote dose inspection for facilitating the
practice of telepharmacy.
BACKGROUND
[0003] In many medical facilities, medication orders are
transmitted to a pharmacy from various locations throughout the
hospital and by various means of communication. The process by
which these medication orders are managed involves many discrete
steps. Orders must be entered, transmitted and received by the
pharmacy, validated, and filled according to manufacturer's
specifications or established institutional guidelines. The filling
process involves the selection and, where required, preparation of
drug products for administration to patients in compliance with the
validated order. Once filled, the resulting drug products (i.e.,
doses) must be delivered to the patient that requires them. One
environment, by way of example, in which such transmissions and
processes occur, is a hospital.
[0004] There are points in the process that are susceptible to
miscommunication or loss of information. This can be problematic in
terms of logging and auditing the processing and preparation of
medications, which is often mandated by insurance and regulatory
requirements.
[0005] The pharmacy operationally receives these medication dose
orders in the form of printed labels, typically generated by a
hospital pharmacy computer system, one for each medication dose
order to be dispensed. In many cases, a separate label is printed
for each dose to be dispensed. Pharmacists and technicians use
these labels as work documents to identify the medications to make
and properly prepare and issue the desired medication. The labels
are then used as address labels to ensure that the medications are
routed to the correct patient for use. These labels lack detailed
preparation steps, causing the technician to rely on his or her
memory of the preparation procedures and guidelines, seek input
from a co-operator, or find a manufacturer's package insert or a
written institutional guideline.
[0006] One hazard of this method is that the label represents the
only record of the work needing to be performed with the result
that, if the label is lost or damaged, the work may not be
performed (that is, the medication dose order may not be fulfilled)
and the omission does not become known until a caregiver complains
because they cannot locate the medication, or because a patient
experiences an adverse event because of omitted medication.
[0007] U.S. Pat. No. 7,096,212 for "Serial Data Capture and
Processing" and U.S. Patent Application No. 2003/0097368 for "Data
Transmission Capture in Support of Medication Preparation" describe
technology for automating the preparation of medication dose orders
in response to the printing of such labels, the entire disclosures
of which are hereby incorporated by reference, as though set forth
in their respective entireties. However, these systems do not
manage the distribution of medication dose orders to the various
pharmacy workstations at which they are to be prepared, nor do they
track the distribution of the completed dose orders to the patient
for whom they are intended.
[0008] While many medications can be prepared by automated systems
containing "built in" knowledge of correct preparation procedures,
there are still large numbers of medication dose orders that
require manual preparation, or institutions whose size precludes
the incorporation of automation technology. The information and
knowledge regarding how to prepare the medication is typically
transferred verbally from one person to another. Thus, if a
clinician receives an order for which he is unaware of the correct
procedure for fulfillment, the clinician would have to request
assistance, and thereby acknowledge a lack of training for that
particular task. However, seeking training can be a source of
embarrassment or be perceived as an undesired delay, either
scenario providing a potential basis for the clinician to
potentially use an improper procedure for the preparation of a
particular medication, significantly increasing the possibility of
a serious medication error due to flawed preparation procedures.
Repeated conduct in this regard can result in "self trained"
experience in a manner which is inconsistent with published
procedures for handling that medication. Typically, the correct
procedures are defined and written in a manual or other
documentation. However, there is currently no efficient way to
present the relevant excerpt of the manual to the clinician in
relation to the particular medication order to be processed.
[0009] Furthermore, after a doctor or nurse enters a medication
order, determining the status of the order requires manual
intervention. The progress of the order can not easily be
determined. The order must be located, determined if it has been
filled, then possibly located somewhere throughout a facility, such
as a hospital, which can be complicated further as the medication
dose is being transferred to the patient or as patients are moved
from one location to another (e.g., from the patient's room to
physical therapy or a lab).
[0010] Workload management systems for hospitals and sterile
products preparation are unsophisticated and incapable of properly
managing the process, causing conflicts between the level of
staffing provided and the level of work to be performed.
[0011] Centralized preparation of medication dose orders within a
hospital or pharmacy creates a further set of logistical problems.
A large number of medication dose received within the same general
time frame can quickly outpace the production capabilities of the
hospital. Further, hospital pharmacies generally have no way of
separating medication dose orders that are needed immediately from
those dose orders that are less urgent.
[0012] For example, IV rooms currently operate via manual
distribution of labels and this type of system can lead to a number
of problems, including the following problems. Currently, a
pharmacy that "kits" work for transmission to the IV room obtains
one or more labels from a label printer, mentally determines what
products and supplies are needed to prepare the requested doses,
assembles those items, places the items and the labels in a bin and
passes that bin into the IV room. There is no verification of
correct drugs. In addition, doses are not tracked; doses become
acknowledged as "lost" when a nurse indicates that an expected dose
was not received at the patient care area. Some doses are very
difficult to track because they cannot be prepared as soon as the
label is received. Manual tracking methods often result in those
doses being overlooked. There are currently no tracking metrics can
definitively state what amount of work is to be done, or where the
IV room is in the completion of that work.
[0013] In addition, a pharmacist by law has to approve each drug
order before it can be released and delivered to a patient. Since
this is a state regulated activity, there are a number of different
rules and regulations imposed by the state on pharmacists in terms
of the level of supervision required by a pharmacist in monitoring
and approving drugs prepared by others. For example, a pharmacist
may be able to approve a drug order and release it even if the
pharmacist is in a different room of the same building; however, it
is clear, that the pharmacist cannot approve a drug order from a
remote location outside the building, such as, the home of the
pharmacist or some other location. These rules and regulations can
potentially limit the efficiency of the pharmacy since an order can
not be released until approved by a pharmacist and therefore, if
the pharmacist is temporarily unavailable, etc., the order will be
delayed.
[0014] The present invention addresses one or more of these and
other problems to provide a centralized medication order
management, fulfillment, and tracking system. As more and more
automated dispensing devices are developed, there is additional
value in a mechanism in accordance with the present invention for
automatically routing medication dose orders generated by the
hospital pharmacy computer system to the most appropriate automated
or manual workstations in the pharmacy and then tracking them to
ensure that they are completed and distributed to their intended
recipients.
SUMMARY
[0015] One aspect of the present invention concerns a method for
performing telepharmacy in which a dose order is received and
processed at a machine executing code that forwards the processed
dose order to a medication preparation station. The dose is
prepared at the medication preparation station, based on the dose
order, and the preparation includes following a recipe provided by
the machine to the medication preparation station. Information that
relates to actions taken to follow the recipe are captured and then
stored at a database. The captured information is accessed from a
remote site using a portal in communication with the database. The
prepared does is inspected through the portal, and the captured
information is reviewed in order to verify whether the dose has
been prepared in accordance with the recipe. If the reviewer
confirms that that the dose has been prepared in accordance with
the recipe, then he or she approves the release of the dose to the
patient.
[0016] In another aspect of the present invention, a centralized
system for preparing and managing patient-specific dose orders
entered into a system comprises an order processing server, a dose
preparation station, and a display. The order processing server
executes software on a processor thereof and is connected by a
network to the first system. The order processing server is
configured to receive the patient-specific dose orders from the
first system and includes a database configured to store the dose
orders and information that relates to the dose orders. The order
processing server is further configured to generate a dose order
queue listing all dose orders received by the order processing
server. The dose preparation station is adapted for the preparation
of a plurality of doses based on received dose orders. The dose
preparation station is in bi-directional communication with the
order processing server and has an interface for providing an
operator with a protocol associated with each received drug order
and specifying a set of steps to fill the drug order. The dose
preparation station is further configured to present the protocol
and has one or more data input devices to capture information that
relates to the set of steps to fill the drug order. The display is
communicatively coupled to the order processing server to output
the dose order queue and metrics concerning activity at the dose
preparation station. The display is positionable independently of
the dose preparation station.
[0017] In a further aspect of the present invention, a system for
preparing patient-specific drug doses includes a dose preparation
station having a work area adapted for the preparation of a
plurality of drug doses corresponding to at least a portion of
patient-specific dose orders that originate from another system. An
interface at the station has a display and one or more input
devices. A computer associated with the station executes code that
is operative to receive a protocol associated with the preparation
of each of the drug doses, to display the protocol for a given one
of the drug doses, and to capture information that relates to
completion of steps defined by the protocol to prepare that drug
dose using the one or more input devices.
[0018] In still a further aspect of the invention, a system is
provided that is configured, among other things, to provide drug
order preparation benchmarks to an administrator. Such a system
cooperates with a plurality of local servers each associated with a
hospital or pharmacy and comprises a central server, a dose metrics
module, and an output module. The central server has a selective
communication link to the plurality of local servers and is
configured to receive drug order preparation data from each local
server. The dose metrics module has access to the drug order
preparation data and is operative to process the drug order
preparation data of at least one local server in accordance with a
rule so as to output a performance metric. The output module is
operative to compare the performance metric of the at least one
local server to the performance metric associated with one or more
of the plurality of local servers.
[0019] The system as described in the foregoing paragraphs
optionally can have a database connected so as to maintain the data
received from each local server, such as drug order preparation
data. A tabulation module can be operative to process such data
from each local server and to generate billing data as a function
of said processing. The processing can comprise a tally of records
uploaded to the central server by each local server. A
communications module can be operative to forward the billing data
to a prescribed destination, including to one of the local servers.
The billing data can be forwarded by the communications module in
the form of an invoice.
[0020] In yet another aspect of the invention, a system for
preparing patient-specific drug doses based upon drug orders that
have been entered into a first system comprises an order processing
server, a plurality of dose-preparation stations, and a display.
The order processing server of such a system executes software on a
processor thereof and is connected by a network to the first system
and configured to receive the patient-specific dose orders from the
first system. In addition, the order processing server includes a
database configured to store the dose orders and information that
relates to the dose orders and is further configured to generate a
dose order queue listing all dose orders received by the order
processing server and has a first mode of operation in which drug
orders are parsed and sent to a select dose preparation station
based on at least one optimization criteria and a second mode of
operation in which individual drug preparation stations select drug
orders to fulfill at which time the drug order is assigned to the
drug preparation station. The dose-preparation stations are for
preparing a plurality of doses based on received dose orders. Each
dose preparation station is in bi-directional communication with
the order processing server and has an interface for providing an
operator with information relating to drug preparation and also to
allow the operator to input information in furtherance of a
protocol having a drug-identification integrity-check process. The
display is communicatively coupled to the order processing server
and is positionable independent of the dose preparation station.
The display outputs the dose order queue and metrics concerning
activity at each dose preparation station. Dose labels for
placement of completed drug orders are only printed at the dose
preparation station that was responsible for preparation of the
drug. These and other aspects, features and advantages of the
present invention can be appreciated further from the description
of certain embodiments and the accompanying drawing figures.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0021] FIGS. 1 and 1A illustrate a process for receiving,
processing, and preparing medication dose orders in accordance with
one embodiment of the present invention;
[0022] FIG. 2 illustrates a process for managing, approving and
distributing prepared medication doses in accordance with an
embodiment of the present invention;
[0023] FIG. 3 illustrates an operating environment in accordance
with an embodiment of the present invention;
[0024] FIG. 4 illustrates a database and server arrangement for the
preparation and management of medications in accordance with an
embodiment of the present invention;
[0025] FIG. 5 is an exemplary display of a situation board that is
part of the operating environment for displaying overall status
summary information about current operations within the
pharmacy;
[0026] FIG. 6 is a dialog box showing an incoming, processed drug
order that needs filling;
[0027] FIG. 7 is a dialog box showing details concerning a
preselected drug order;
[0028] FIG. 8 is an exemplary display of a dose verification screen
for verifying that the prepared dose is the proper, intended dose
of medication;
[0029] FIG. 9 is an exemplary display of a dose preparation screen
and procedure;
[0030] FIG. 10 is an exemplary display of a product preparation
screen and procedure;
[0031] FIG. 11 is a schematic overview of management and reporting
of medication preparations in accordance with a broad aspect of the
invention; and
[0032] FIG. 12 is an exemplary display of a product information
screen.
DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS OF THE INVENTION
[0033] The present invention relates to the capture, processing,
tracking, approval and distribution of medications. More
particularly, the invention relates to an at least partially
automated fulfillment system and method for receiving incoming
medication dose orders, and processing those orders, preferably in
an efficient and optimized manner, through the selective use of
either an automated medication preparation fulfillment system or a
manual medication preparation system. Optionally, each prepared
medication dose can be tracked through to its predetermined
destination. In addition, the present invention relates to a system
and process by which individual processing steps that are taken in
preparing a dose of medication are captured and stored for later
verification that the dose was properly prepared. In addition, the
present invention relates to software-based systems that operate to
provide a portal for dose inspection that facilitates the practice
of telepharmacy.
[0034] By way of overview and example, a doctor or another person
can enter one or more medication orders ("medication order") at a
terminal in a hospital or a pharmacy 310, such as through a
conventional pharmacy information system 320 as shown in FIG. 3. In
addition, one or more medication orders can be entered through a
terminal that is at a remote location and these orders can be
delivered though a network (e.g., Internet), as described below, to
a local server 310 (discussed below) where they are processed in
the same manner as any orders entered directly into a terminal
within the hospital or pharmacy.
[0035] When the order is processed by the pharmacy information
system 320 and labels for the medication doses are generated, the
data contained in the order and on the labels is captured,
processed, and parsed by the computer implemented system to create
individual medication dose orders ("dose orders") and associated
database records. The software that operates in the local server
330 manages the dose-order processing and generates a dose order
queue that can be sorted and/or filtered in any number of different
ways as described below. The dose orders can be distributed to
various compounding workstations such as workstations 500, 510, 520
in FIG. 3 (e.g., automated sterile compounding stations or manual
processing stations) preferably in an optimized manner, as
described below. At each stage of the dose-order processing, the
database record associated with the dose order can be updated to
reflect its status and location. Once the medication order is
fulfilled, the resulting dose order is labeled, preferably at the
dose preparation station so that the label is in close proximity to
the prepared dose (as opposed to the conventional practice of
centralized printing of all of the labels for dose-orders that
enter the pharmacy), and more preferably is labeled so as to
associate it with a patient care location. As described below, in
one aspect of the present invention, a situation board 400 provides
a view to all personnel in the pharmacy as to the status of each
dose order record using metrics that have been established for
display on the situation board.
[0036] In accordance with one aspect of the present invention, the
dose orders that are received internally through terminals onsite
or externally through remote terminals are all delivered and
processed at a local server 330 that includes a label processing
module, a local database, web services, and software for managing
the status of the doses through the entire system. For example, the
local database 330 can be hosted locally at a site, such as a
hospital, and this local server stores a rolling cache of the
current in-process work as well as a history of past orders (e.g.,
30-45 day history). A situation board 400 is in communication with
the local server and is configured to maintain a high-level view of
the work that immediately instructs an observer regarding
incomplete work and further allows identification of work that is
pending, under preparation or prepared but not yet reviewed by a
pharmacist. The situation board 400 can also maintain alarms for
doses that are past due, as well as tracking doses whose
preparation must be delayed because of limited stability in
solution.
[0037] As mentioned, each dose order has an associated data record
and the association in the data record can be a result of linking
the interrogation of a scanable element to the dose order record. A
code supported by or secured to the dose itself and a code
associated with a bin at the dosage form's current location can
both be interrogated and then that information uploaded to a
database. For example, the codes can be bar codes and can be sensed
using a bar code scanner. The particular "scanner" used and the
manner of "scanning" can be varied within the context of the
invention to suit the requirements of a given implementation. Thus,
for example, the code can be an optically scannable bar code or an
interrogatable code such as an RFID tag that is supported in lieu
of or in addition to bar codes, plain text, or other codes. The
terms "scanner," "scanning," and "scanable" are intended to include
wireless interrogation or passive data reception whether they are
based on an optical read, a radio frequency interrogation or an
interrogation in some other frequency band, or a form of passive
wireless data reception. More generally, the codes in scanable form
are referred to as "tags."
[0038] As the dose is transported through the hospital to its final
location, the bin can be scanned and any new location is scanned at
various points to track its progress through the hospital.
[0039] With reference now to FIG. 1, a process is illustrated by
which orders are received, processed, and distributed within the
pharmacy or medication preparation center. At step 100, medication
order streams are received by the pharmacy and are processed by a
label processing module that comprises code that executes in a
machine such as the local server 330 to perform the processes in
FIG. 1. Order streams can be received through various methods. For
example, a medication order can be entered into a computer terminal
within the pharmacy itself, at a computer terminal in communication
with the pharmacy over a local network, or at a device that is
communicatively connected to the pharmacy from a remote location.
Alternatively, the medication data can be captured by a monitoring
module comprising computer code executing in the pharmacy for
monitoring of, say, a port normally connected to a pharmacy
printer, network monitoring for medication order information, or
software application monitoring for events related to the input of
medication orders. Traditionally these order streams represent data
intended to be printed on labels on a printer, and oftentimes
comprise serial data streams.
[0040] Medication order streams can contain a list of medication
doses to prepare. Each dose order and dose is preferably associated
with additional related data such as the patient for whom the
medication is intended, by when it should be delivered, and to
where it should be delivered. Further details can be associated
with the medication including the prescribing doctor, the time and
date the prescription was entered, the reason for medication, and
other relevant information frequently recorded and associated with
a prescription.
[0041] Data streams containing medication dose data are preferably
logged at step 102 by a monitoring computer. Preferably, streams
are logged in a database or other computer accessible medium.
Logging data streams enables extensive auditing and monitoring of
the pharmacy--or hospital--dispensed medication. Because all data
is logged, preferably in its raw form when it is first received by
the pharmacy, no information is lost, corrupted, or disassociated
during the processing or distribution of the medication. If
necessary, an audit can be performed manually, off-line, or by a
separate software program to reconstruct the data stream and all
processing that should have or did occur after the pharmacy
received the data stream. Furthermore, the logged data can be
analyzed with respect to dose order demand. The average volume,
peak volume, and standard deviation of dose orders can be
determined for various historical time periods (e.g., day of the
week, month, last week, last month, etc.). Based on this analysis,
decisions regarding the required staffing to fulfill the expected
volume of dose orders can be made.
[0042] Preferably, the data stream has an identifiable source. The
source can be explicitly identified within the stream of data, or
it can be determinable by the fulfillment system. Source
determination can include, for example, examining TCP/IP packet or
its header/footer information, examining cryptographic signatures
of the stream, or data retrieved through additional network
communication requesting the source. The source is identified at
step 104.
[0043] At step 106, the fulfillment system can be configured to
determine whether the data stream originated from one of a set of
valid sources. This can include identifying the source of the data
stream and testing that it is one of the sources among those in the
set. Validating the source ensures each medication dose prepared by
the fulfillment system is legitimate and originating from an
authorized prescribing entity. Alternatively, the validation can
ensure that the prescribing entity is presently entitled to have
its prescriptions filled by the pharmacy. If the source is not
valid, the fulfillment system returns to step 100 to receive
additional streams. Optionally, notifications can be sent to the
source to inform it that there were validation issues or that the
window for continued validation has one or more constraints (e.g.,
will expire in so-many days due to an overdue invoice).
[0044] In one embodiment of the fulfillment system, the software
executes in a multi-threaded or multi-process environment. Thus,
multiple streams can be processed simultaneously, by including
necessary memory and database locks to ensure consistency. While
the fulfillment system is described above as returning to step 100
to receive additional streams, persons of skill in the art
appreciate that streams can be received by a server thread and
dispatched for processing to other threads within a thread-pool.
Other multi-threaded or multi-process mechanisms can be used to
control the processing of data streams received by the fulfillment
system.
[0045] After determining that the source is valid, the stream is
parsed to extract relevant information at step 110. The fulfillment
system can parse various message and data formats. Moreover, the
parser can be extensible, such that as new formats are implemented
or included within the networked environment, a parser extension
can be included in the fulfillment system to parse the new format.
For example, if the data stream is a serial printer data stream,
the fulfillment system can determine the format of the data and
pass the stream to the appropriate serial printer data parser. The
printer data parser is configured to extract the dose medication
contained within the stream. Preferably, the parser extracts all
relevant data contained within the stream and maintains a record of
the extracted data. The parsing methodology is preferably
encapsulated in a library or set of modules that are called upon,
as necessary, to parse a stream of any determined format. Each
library entry or module operates as a "parser," as that term is
used herein.
[0046] The data stream can contain one or more dose orders. For
example, the stream may contain a single prescription dose request
by a doctor for a single patient. Alternatively, the stream can
include multiple dose orders for batch processing. The parser is
preferably configured to recognize and discriminate between
individual dose orders within a stream. The discrimination of
individual dose orders can be accomplished by recognizing an order
delimiter, or alternatively can be defined by the format of the
data stream.
[0047] The data extracted by the parser at step 110 is used to
create a dose order record at step 120. A dose order record is
preferably created for each individual dose order encoded by the
data stream, and contains the information extracted from the
stream. At step 122 each dose order record can be stored in a
database or other data storage system such as a suitable
data-structure. Additionally, each dose order is preferably
assigned a unique dose identifier that can be used to track the
dose order and resulting dose through the fulfillment system.
[0048] A dose order monitoring application or module is operative
at the local server 330 to track dose orders in the database and
provide monitoring services such as to provide data that is
displayed by the situation board 400. As such, at this stage, the
dose order can be included in the presentation output on the
situation board 400 to apprise persons in the pharmacy that another
dose is in the queue for processing, and to apprise a supervisor or
pharmacist of the change to the queue without requiring them to be
in the pharmacy, as will be described further below.
[0049] The above description outlines the steps by which medication
data streams enter the pharmacy and are pre-processed in
anticipation of being filled by the pharmacy. Once the data streams
have been processed, parsed into individual medication doses, and
stored as dose records within the fulfillment system, the pharmacy
can prepare the medication doses identified by each dose record at
one or more workstations configured to permit preparation of
medications, such as workstations 500, 510, 520.
[0050] In accordance with an aspect of the present invention the
medication data streams can enter pharmacy through data entry at a
local station or by being entered over a network at a remote
location (see FIG. 3). The local server 330 includes a label
processing module and a local database, for example, an Ensemble
database). The local server receives dose-orders and performs the
processing described above with reference to and illustrated in
FIG. 1.
[0051] All dose orders are initially stored in the local database,
such as the Ensemble database that is hosted locally at each site.
A queue is generated for all received dose orders and, as described
below, in accordance with one aspect of the present invention, the
work order queue can be displayed on a touch screen display at one
or more workstations.
[0052] With reference briefly to FIG. 11, an overview of the dose
management process is outlined in broad terms. At block 1110, a
dose order received from a pharmacy or hospital information system
310 is processed substantially as described in connection with FIG.
1. Those dose orders define respective records in the local server
330 that are forwarded to applications executing at one or more
workstations located within the pharmacy, hospital, or elsewhere.
This workstation application or the technician responsible for
operating the workstation has access to a dose queue and can
prioritize and manage does order processing, as indicated at block
1120. The workstation application or technician can manage the
various open tasks (orders to fill) by interacting with the
workstation in order to follow the protocol or "recipe" mandated
for a particular dose order or batch of orders, as indicated at
block 1140. The dose orders are prepared as final doses at the
workstation with the benefit of documentation support, as indicated
at block 1130. The document support is provided to the technician
to guide preparation and better ensure that doses are prepared in
accordance with established protocols and policies. As described
further below, the intermediate steps in the preparation of each
dose order are subject to data capture to permit post-preparation
review of the steps taken to prepare each dose. Thus, as can be
appreciated, blocks 1120, 1130, and 1140 are contemplated as being
performed at one or more dose-preparation workstations. In the
meantime, as schematically illustrated along the left and right
margins of FIG. 11, the situation board 400 can present progress
information and other metrics to assist in the orderly management
of the pharmacy, while management modules can provide queries and
report results of the progress as well as other metrics that
concern the facility 310 as well as other facilities through an
interface to the local server 330. At block 1150, the local server
330 receives through a connection such as a web service portal or
other communicative link an approval or a denied message from a
pharmacist upon his or her post-preparation review of the
intermediate steps in the preparation of each dose order. At block
1160, sorting and distribution of the prepared medication doses to
the intended recipient or for storage in anticipation of use
completes the process.
[0053] Referring now to FIG. 1A, order fulfillment processing
commences at step 130 at which a fulfillment module determines
whether there are any unfulfilled medication doses in the database.
The fulfillment module comprises code executing in a machine, and,
more preferably, within the local server 330, and the label
processing module can be part of the fulfillment module or the two
modules can communicate with one another in the processing of dose
orders. If no unfulfilled orders exist, the fulfillment module can
redirect its resources to processing incoming data streams at step
100, or completing or processing any active thread, as indicated
schematically by the "end" terminator in the flow chart. However,
if unfulfilled dose orders are in the database, the fulfillment
module will retrieve an unfulfilled order at step 140. At decision
141, the fulfillment module can determine whether a dose was
previously prepared and stored which would satisfy the dose order.
For disclosure of a system that prepares dose orders in
anticipation of need for such orders, see U.S. application Ser. No.
11/844,135, filed Aug. 23, 2007, entitled "Automated Centralized
Preparation Of Medications In Anticipation Of Use," which is hereby
incorporated by reference as if set forth in its entirety herein.
If no such dose exists, the dose order can be posted to the work
order queue at each workstation and is posted to the situation
board 400 (sometimes referred to in the art as a "dashboard") at
step 142. Optionally, the requirements for filling the dose order
are retrieved and used to post the dose order to the work order
queues of only those workstations that are suitable for handling
such a dose order. In this way, individual workstations can have a
tailored queue of pending dose orders. In another arrangement, such
tailored queues are provided to the individual workstations but the
operator of such workstation can expand the presentation to see
other dose orders in the queue even if not suitable for handling at
the operator's workstation.
[0054] Referring briefly to FIG. 6, as previously mentioned, the
dose orders are stored in the local database and are displayed on a
display (touch screen) at one or more workstations. For example,
each workstation can include a touch screen display that lists all
received work orders and can include identifying information or
icons or other indicia that indicate which workstations are capable
of fulfilling the dose order. An operator at a given workstation
can thus view a running tally of received dose orders and can
select the orders to be processed at his/her workstation. For
example, the posted drug orders can be color coded or otherwise
coded to indicate which workstation(s) is currently capable of
fulfilling the order (assuming that all orders are displayed). As
another example, there may be two workstations that are similarly
equipped and one operator is principally responsible for filling
certain medications unless the order queue for other medications
becomes too large. An operator (technician) at any given
workstation can thus look at the work order queue and select
certain dose orders to process and fulfill. Once the workstation
operator selects the work orders, as by highlighting them on the
touch screen, the work orders are assigned to this workstation and
the selected work orders can be eliminated from the work order
queue or otherwise indicated as being selected and not pending and
available for selection by another operator at a different
workstation.
[0055] In addition, if a workstation is off-line for maintenance or
the like, the dose order processor will not indicate that this
workstation is capable of fulfilling the order and will not assign
dose orders to this workstation until it is back on-line and is
fully operational.
[0056] The work order queue can sort and display the dose orders in
any number of different ways. For example, the work orders can be
sorted and displayed by drug type and can be further sorted by
dosage amount as shown in FIG. 6. The total amount of work orders
for each drug can be displayed next to the drug name in a main
banner 301 and then underneath the main banner, the various drug
dosage amounts are listed along with the quantity of each that is
currently needed (lines 303). For example, as shown in FIG. 6, the
main banner shows that there are 34 orders for the drug Cefazolin
and underneath, the various drug dosage amounts, such as Cefazolin
1000 mg; Cefazolin 100 mg; Cefazolin 200 mg, are listed along with
the quantity that is needed for each.
[0057] Each dose order listing can be displayed in a different
manner to indicate information that is intended and helpful to the
operators at the one or more workstations that process and fulfill
the dose orders. For example, on the left column of the screen that
is shown in FIG. 6, a box 305 labeled "DC" stands for discontinued
dose orders which are orders that have been discontinued for some
various reason and therefore, do not need to be processed and
fulfilled. The box can have an associated color, such as purple,
that allows individual dose orders to be indicated as being
discontinued and therefore, should not be selected for processing
and fulfillment. For example, the Cefazolin 500 mg (Qty: 8) dose
order line can be displayed in purple, thereby indicating that this
dose order is discontinued and should not be processed. Also along
the left column are other status indicators, such as "STAT" 307,
"First Dose" 309, "Unknown Drug" 311, "Make Now" 313 and "Wait"
315. These indicators can dictate a preferred order of selecting
and fulfilling the dose orders. For example, "First Dose" can
indicate the highest priority dose orders which should be selected
first before another dose order, including those dose orders that
are labeled "STAT". Meanwhile, the situation board (FIG. 5)
provides an overview of the queue for all drug orders that are
being handled.
[0058] In addition, other options available for selection by the
operator at a station can be displayed, such as along the left
column. For example, one or more filters 317 can be employed by the
operator to filter the dose orders that are listed in the work
order queue. The filter 317 can be selected among standard ones,
such as a filter that lists only those dose orders that can
selected and fulfilled by the operator at a given workstation or
the filter can be designed to only show only those dose orders that
are classified as STAT orders and/or those that are classified as
First Dose orders. Alternatively, the filter can be a custom filter
that is created and defined by the workstation operator.
[0059] Referring now to FIG. 5, the situation board 400 can be
located at more than one location, such as at each workstation, as
well as centrally within the pharmacy, and can be in the form of a
browser-displayable "dashboard" that displays the overall status
summary information about the current operations within the
pharmacy (e.g., in the pharmacy IV room) through a conventional
web-browser application such as Internet Explorer by Microsoft
Corporation, Redmond, Wash. The situation board 400 can be
displayed in the pharmacy on a large size, widescreen, flat panel
display for high visibility and includes the count and percentage
of doses awaiting preparation, in-process, or waiting verification.
The situation board 400 thus lists all of the dose orders and
permits operators at the various workstations to view all open
orders and select orders as described below.
[0060] Dose order records stored in the local database can be
ordered or arranged and displayed in the work order queue and/or at
the situation board in accordance with a rule base that operates on
the database with one or more rules. For example, one rule can be
to optimize fulfillment of the orders. Thus, like dose orders can
be processed at the same workstation one after another and hence
faster because there is less cross-contamination and medication
changes (i.e., retrieval and storage). Thus, dose orders can be
grouped by type or medication, such that dose records requiring the
same medication or with no risk of cross-contamination can be
processed in order by the same machine, or set of machines. In this
regard, the rules are configured to sort the dose-orders by type or
medication. Alternatively, dose order records can be prioritized by
urgency (e.g., "First Doses" or "STAT"). For example, if a doctor
urgently needs a specific medication, the data stream identifying
the dose can include information indicating its urgency, and the
dose order record can include such urgency information. Thus, the
rule in this instance operates to re-sort an urgent order to near
the front of the queue, or have that order identified (e.g.,
flagged) as urgent for immediate or expedited fulfillment. Through
this or a similar mechanism, the next unfulfilled dose order
retrieved at step 140 can be arranged in the queue to optimize
throughput or to satisfy other rule-based priorities. Alternatively
and as described above, urgent orders can simply be highlighted
and/or labeled as such in the drug order queue presented at the
workstation.
[0061] At step 142, the drug order queue is generated and
optionally one or more dose orders can be assigned to a particular
workstation based on one or more rules that govern the distribution
of dose orders to a particular workstation. The present invention
can be configured so that the server receives, stores, and parses
the incoming dose orders (e.g., by using the label processing
module and other software) and generates the work order queue that
can then be posted at each workstation as well as at the situation
board. The system can be designed so that the dose orders must be
"pulled" from the work order queue, in other words, an affirmative
step can be required for the dose order to be assigned to a
particular workstation. For example, as discussed above, an
operator at a given workstation reviews the dose order queue and
then selects those dose orders that he or she will fulfill, e.g.,
by using the touch screen display, at which time, these orders are
effectively assigned to the workstation and are removed from the
work order queue.
[0062] In some instances the workstation is in the form of an
automated device and therefore, the processor of the automated
device has a selection module comprising code that causes a
selection of those dose orders in the queue that can be fulfilled
by the workstation. As discussed above, this selection can take
into account a number of different rules including the number of
pending dose orders at this workstation, the availability of
different drugs, etc. The automated device communicates with the
local server 330 and selects and pulls dose orders for filling.
[0063] However, even when the system is configured to operate in
"pull" mode, the individual dose orders can be pre-assigned in the
event that a dose order can only be fulfilled by a specific
workstation, in which case the system recognizes this fact and
identifies that this particular drug order is intended for delivery
to that particular workstation. For example, if the dose order that
is received and processed at step 141 is of a type that can only be
fulfilled by a specific workstation (e.g., an automated
chemotherapy workstation), the dose order will be identified as
such on the work order queue and the workstation type that is
qualified for receiving and fulfilling the dose order can be
notified. Similarly, the type of dose order can be identified as a
manual fill dose order on the situation board and one or more
manual workstations can be alerted or can simply include the dose
order on its screen.
[0064] Alternatively, the dose orders can be "pushed" to the
individual workstations in that the local server selects which
workstation is best capable of handling the incoming dose order and
then assigns the dose order to the workstation. The dose order is
then sent to the workstation for fulfillment of the order.
[0065] Furthermore, as dose orders are received and parsed 110 or
processed 140, the system can analyze the supplies necessary to
fulfill the order. The list of required supplies can be compared to
an inventory of supplies and their availability, optionally broken
down by hospital, pharmacy location, or workstation. If there are
insufficient supplies, additional supplies can be automatically
ordered or the relocation of supplies from one workstation to
another can be ordered such that at least one workstation will have
the necessary supplies to fulfill the dose order.
[0066] Each dose order record initially has an unprocessed status
and is operated upon by a particular workstation that is selected
to convert the dose order into a particular drug dosage form in
fulfillment of the order. A workstation can be adapted for a
particular purpose, such as to include automated pill counters,
automated syringe preparation, automated intravenous compounding
stations, or be configured for manual preparation. By examining the
dose order record, the fulfillment system can determine the
appropriate workstation among available resources to which the dose
order can be assigned at step 142, in view of the dosage order
itself or its urgency, that is, its priority requirement for
completion. The workstation assignment can further consider the
supplies required to fulfill the dose order and the supplies
available at each workstation. Also, at step 141, by examining the
dose order record, the fulfillment system can determine whether a
matching dosage form has previously been prepared and stored, based
on the contents of an inventory record, and used to fulfill that
order, as indicated at step 144. In the event that a match is
located, the further steps of FIG. 1A do not need to be performed
in order to provide the source of the order with the requested
dosage form; however, to prevent inventory depletion, the order can
be processed at a priority (that is, in a time frame) that is less
urgent than indicated in the order itself since the preparation of
a drug dosage form based on the dose order is for the purpose of
restocking the inventory. Also, in the event of a match, a person
can be directed to a particular location associated with the drug
dosage form so as to retrieve it from inventory, and the retrieval
can be registered so that the inventory record can be updated to
reflect that event. This is described in the aforementioned U.S.
application Ser. No. 11/844,135.
[0067] It would be understood by one of skilled in the art that the
dose-preparation workstations can be located either centrally or in
a distributed environment. Dose orders can be retrieved by or sent
to workstations via standard data messaging techniques. A
centralized environment allows for the pooling of resources.
However a distributed environment allows fulfillment to be
completed closer to the end user and can reduce some of the
inefficiencies of centralization.
[0068] At step 150 each dose order record can be examined to
determine if it is appropriate for an automated workstation, or an
operation type of a selected workstation can be determined, for
example, based on a flag, profile or other information associated
with the workstation and interrogatable by the management module,
such as workstation availability and its present set-up. If the
dose order record is appropriate for automated fulfillment, the
order can be queued at an automated workstation and processed at
step 170.
[0069] On the other hand, and in accordance with a salient aspect
of the present invention, if the dose-order is one determined to be
suited for manual preparation, then the process flow branches to
block 160. At block 160, protocol information is retrieved. This is
because, before the dose order record is dispatched to a manual
workstation for action by the operator, additional information is
provided to facilitate the manual fulfillment of the dose order at
the selected workstation. This can be based on the determination
that manual preparation is required and the assumption that
providing additional information can improve safety, efficiency,
and precision during fulfillment of the dose order. The management
module can associate the additional information with the dose order
record. For example, at step 160 the medication and form of dose
(e.g., syringe, IV, etc.) specified by the dose order record can be
examined so as to determine the protocol by which the dose of that
medication should be prepared. The protocol can specify the steps
(e.g., sanitization and documentation) that must be taken during
preparation to comply with Food and Drug Administration regulations
or any other governing procedures regarding the conduct of the
pharmacy. Furthermore, the protocol associated with the dose order
at steps 160 and 162, preferably is interactive in guiding the
operator through the fulfillment process to achieve the same level
of accuracy and dose safety which is typically associated with the
automation. For example, the protocol can require the operator's
input including logging of events at critical stages of the dose
preparation process (e.g., requiring the operator to scan
information related to the source drug containers).
[0070] The additional information (i.e., protocol) can be
associated with the dose order record at step 162 for presentation
to the operator. The association can be accomplished by attaching
the protocol file to the dose order record, or otherwise
communicating it electronically to the workstation selected for
handling that dose order, or by printing a copy of the protocol to
include with a printed order for the dose. In a paperless
environment, the protocol is preferably displayed along with the
display of the order or can appear as a hyperlink or call-up dialog
box from within the order display at the workstation.
[0071] The workstation can include various tools and monitoring
equipment to assist and perform quality control during the manual
preparation of the dose order. Such tools and monitoring equipment
can include barcode scanners, digital cameras, scales, hydrometers,
spectrometers, and other tools that can be used to verify the
properties of a substance. For example, a computer monitor at the
workstation can prompt the operator to take certain measurements of
the dose order being prepared and input the results of those
measurements. Failure to input a measurement within an acceptable
range can result in the system automatically rejecting the
preparation. Furthermore, to prevent operator fraud, the system can
prompt the operator to place the preparation on a scale, or within
another instrument, that automates the measurement, thereby
reducing the opportunity for the operator to intentionally or
unintentionally deceive the system. In this regard, it should be
appreciated that the protocol presented to the used at block 162 is
preferably coded to capture the progress made toward dose
fulfillment. Thus, steps taken in completing the protocol or recipe
are preferably coupled with specific operator input such as
photographing a drug vial, weighing a syringe, and the like, with
the inputs being captured and included in a data record that can be
forwarded to the pharmacist for review and approval. The data
record can be a record storable in the Ensemble database that is
used in a preferred embodiment of the invention.
[0072] As noted, one form of data capture during order preparation
can be the capture of images of the medication source(s) used to
prepare a particular dose. That is, a digital camera can record an
image of each medication source, individually or together, that is
used to prepare the dose. The image preferably displays the
identification of the type of medication, its lot number,
expiration date, and other quality control information that went
into the final dose that is later submitted for pharmacist
approval. The image(s) can be stored in the database or otherwise
associated with the data record for the prepared inventory dose,
and by accessing the dose order and the images associated with the
prepared dose, from either a local or remove terminal/computer, a
pharmacist or other authorized and qualified individual can verify
that the correct medication sources were used to prepare the
inventory dose.
[0073] Quality control can also include the recordation and logging
of any technician or operator involved in the preparation of a dose
order. The identity of the technician or operator can be recorded
by fingerprint, key-card, username, password, or other known
methods of identification. Additionally, quality control tasks can
be assigned to specific workstations or operators, such as
supervisors or quality control specialists. All of this information
can be stored in the same data record as the medication dose, or in
a different record that includes a link or information that permits
association with the medication dose.
[0074] In one embodiment of the present invention, step 162
involves presenting the protocol to the operator in the form of a
number of steps that must be performed in order to prepare the
dose. As the operator performs each step or selected steps,
verification that such step was performed must be entered by the
operator or otherwise be confirmed by equipment that captures
certain information presented by the operator. If during any step,
a verification error arises and there is a question as to whether
the step was properly performed, the dose order processing is
prevented from continuing to the next step until the step is
verified as being properly performed or until the dose order is
flagged as being not completed due to an error. If this occurs, the
operator can then receive the next dose order in the work order
queue for that particular workstation and start the dose
preparation process for this new dose order. Thus, step 162 is akin
to presenting the operator with a recipe except that several if not
all steps that are performed have the operator interrogated to
provide information that better ensures that each step was
performed in accordance with the protocol. As discussed below,
certain steps can be recorded by using one or more cameras or other
equipment and thus, a record is compiled and saved for each dose
order in case there is every any question as to the integrity of
the dose order and whether an error was made in processing the dose
order.
[0075] Referring briefly to FIG. 10, one exemplary screen 600 is
illustrated that lists a number of steps generally indicated at 610
that are required to be performed to successfully prepare a
medication product that is used to prepare a dose that is part of a
dose order. On the left side of the screen, the drug to be prepared
is clearly identified at 620, in this case Cefazolin 1 g (Apoth).
This screen is an interactive screen in that the user can simply
highlight different areas either to receive more information or to
enter information. For example, there is a Detail button 622 near
the drug identification and if additional information is needed
concerning this particular drug order, the user can simply
highlight this particular button (as by "clicking" the box).
[0076] On the right side of the screen are processing steps 610
that must be undertaken in order to prepare the requested dose. For
example, a banner 612 indicates again the drug being produced is
Cefazolin 1 g (Apoth) and below this banner there are a number of
steps 610 that must be performed in order to produce the correct
dose (drug product). The illustrated screen shows a first step 614
of printing and applying a product label. The label is printed by
simply pressing the button 616 that is labeled "Print Label". As
soon as the label is printed, the user is prompted to move on to
the next step 618 which is a step of scanning the product to verify
that the proper product is present at the workstation.
Conventionally scanning equipment can be used to scan (e.g., a
barcode) the product and then the user is prompted to enter the
Product Lot Number in a box 620 that is provided and the user then
enters the Product Expiration Date in another box 622. All this
inputted information is used to confirm that the correct product
(drug) is present and is being used in the preparation of the
Cefazolin 1 g dose.
[0077] In another aspect of the present invention, other
identifying information can be used to assist in determining that
the correct drug is present at the workstation and is suitable for
use in fulfilling a pending drug order. More specifically, the Drug
Listing Act of 1972 requires registered drug establishments to
provide the Food and Drug Administration (FDA) with a current list
of all drugs manufactured, prepared, propagated, compounded, or
processed by it for commercial distribution. The National Drug Code
(NDC) is a universal product identifier used in the United States
for drugs intended for human use. The FDA inputs the full NDC
number and the information submitted as part of the listing process
into a database known as the Drug Registration and Listing System
(DRLS). The information submitted as part of the listing process,
the NDC number, DRLS, and the NDC Directory are used in the
implementation and enforcement of the Act.
[0078] The National Drug Code is a unique 10-digit, 3-segment
number assigned to each medication listed under Section 510 of the
Food, Drug, and Cosmetic Act. The number identifies the labeler or
vendor, product, and trade package size. The first segment (the
labeler code) is assigned by the Food and Drug Administration. A
labeler is any firm that manufactures, repacks, or distributes a
drug product. The second segment (the product code) identifies a
specific strength, dosage form, and formulation of a particular
firm. The third segment (the package code) identifies package
sizes.
[0079] The official format of the NDC code is a 10-digit number
that can be presented in one of three formats: [0080] 1)
4-4-2=1234-5678-90 [0081] 2) 5-4-1=12345-6789-0 [0082] 3)
5-3-2=12345-678-90
[0083] When presented electronically, the NDC number is presented
as a 10-digit, unformatted number (such as in a bar code). The
10-digit, unformatted number can be accessed and used as part of an
automated drug preparation system in that this number can be used
to locate drugs that are stored at a storage location. However,
when presented in print, the NDC number is presented as a 10-digit
formatted number as shown above. Consequently, a drug label on the
chug container will typically have the formatted NDC number.
[0084] Recently, the format of the NDC has been revised and changed
so that it includes 11 digits as opposed to 10 digits. The new 11
digit NDC number has a 5-4-2 format. More specifically, database
vendors, CMS (Centers for Medicare & Medicaid Services), and
recently, the FDA are now using an 11-digit unformatted number that
is intended to remove ambiguity between the three formats that were
previously used for 10 digit NDC numbers. Since many drug
preparation systems, including the present one, purchase formulary
data from a vendor (e.g., Multum), the 11 digit unformatted form of
the NDC data is automatically provided in the formulary when the
formulary is loaded into the drug preparation system. Conversion
from the 10 digit code to the 11 digit code results from the proper
placement of a zero. More particularly, the 11-digit code is
created by adding a leading zero (0) to the field (in the 10 digit
code) that has too few digits. The table below shows the
transformation.
TABLE-US-00001 10-digit 10-digit 11-digit 11-digit formatted Format
unformatted formatted unformatted 1234-5678-90 4-4-2 1234567890
01234-5678-90 01234567890 12345-678-90 5-3-2 1234567890
12345-0678-90 12345067890 12345-6789-0 5-4-1 1234567890
12345-6789-00 12345678900
[0085] The conversion between the 10 digit unformatted NDC number
to the corresponding 11 digit unformatted NDC number or vice versa
is complicated and there is no reliable conversion method since
there is no way in positively telling where to add a zero (0) or
which zero (0) is to be either deleted. The only reliable manner to
transform between a 10 digit format and an 11 digit format is to
start with the 10 digit formatted number.
[0086] In accordance with the present invention and as shown in
FIG. 12, an interface of the present system can include areas where
NDC information is inputted, For example, a product information
screen 800 is shown in FIG. 12 and includes a number of input
fields (input boxes with or without pull down type menus) where a
user can input certain product information.
[0087] It will also be appreciated that some of this information
can be inputted using a reader devices, such as a barcode reader,
etc. Part of the product input information includes NDC related
information. For example, in FIG. 12, the product information
screen 800 includes a product name field 810; an NDC code field 820
that contains the unformatted 11 digit NDC number; an NDC code
field 830 that contains the unformatted 10 digit NDC code, and an
NDC format field 840 that contains the 10-digit format (i.e.,
4-4-2, 5-4-1, or 5-3-2). By storing the 10 digit unformatted NDC
code, conversion to the 11 digit format is possible. In addition,
by storing, the NDC format at field 840, the integrity of the
conversion process is ensured.
[0088] By inputting and storing the above information, the present
system is capable of handling requests and requirements from
entities, such as CMS, that require 11 digit NDC codes. In
addition, by storing the 10 digit NDC code, the present system and
the formulary stored therein, can process and communicate with
third party systems that require the 10 digit NDC codes. As new
CSP/drugs are added to the formulary (e.g., by loading formulary
updates), both the 10 digit and 11 digit NDC codes are updated.
[0089] In accordance with the present invention and as previously
mentioned, the present system includes means, such as readers and
the like, which allow a particular drug to be identified at step
618 and compared to a database to ensure that the identified drug
is the drug which is being requested is the same drug which has
been identified at a particular location (station) of the present
system. Since the NDC includes product code information, such as
the specific strength, dosage form and formulation, it can be used
in drug identification step 618 of the present system. It will also
be appreciated that the NDC number can provide a means for
redundantly confirming the identification of the drug being used at
the work station to prepare the requested drug order. In other
words, other identifying information that is printed or otherwise
present on the drug product can be read and then the NDC number can
be read and the two compared as part of an integrity check to
ensure that the correct drug product is present at the
workstation.
[0090] The next step 624 involves scanning the diluent that is used
in the reconstitution process. Once again, conventional scanning or
imaging techniques can be used to identify and confirm whether the
correct diluent is being used in the reconstitution process. The
step 626 involves acquiring the diluent for the reconstitution and
then confirming its proper identity and the user can indicate that
the step has been completed by pressing the button labeled "Done".
The next step 628 can involve capturing the image of the diluent
using conventionally techniques (e.g., a camera) and additional
steps that can be performed are capturing the image of the
completed vial 630 and scanning a dose to begin preparation of the
individual dose 632. All of the information that is gathered in
each of the steps is stored in the local database, preferably in
the same record as or in association with the particular drug order
being filled.
[0091] At any point, if a task performed in one of the steps is not
verified as being correct, the operator is prevented from going
onto the next step and the dose is not prepared.
[0092] Also, with brief reference to FIG. 9, a sample screen 700
shows exemplary steps that are displayed to the operator to assist
the operator in preparing a specific dose of medication. On the
left side of the screen, a "Selected Products Information" section
710 is provided and lists the drug product that is being prepared.
In this example, the drug product is Cefazolin 1 g (Apoth). On the
right side of the screen is information 720 that relates to the
current dose that is being prepared for a specific patient. For
example, the patient's name (e.g., Karen Mirabelli) is clearly
identified along with any identifying patient information (a
patient number). The dose information also includes a final volume
of the dose (e.g., 1 ml) and administration information is
provided, such as a date and time (e.g., 8/7/08 17:04) when the
dose is to be administered. The type of dose (e.g., STAT) can also
be listed to alert the operator to any special processing
information (e.g., the dose should be processed in an urgent
manner).
[0093] The screen of FIG. 9 lists a number of steps 730 that are to
be performed by the user to prepare the dose and fulfill the dose
order. For example, one step may be the step of applying a label to
the dose and once this task is performed, the user can indicate so
by pressing a button that is labeled "Done". Another step can be to
acquire the dose volume from the product and once this task is
performed, the user can indicate so by pressing a button that is
labeled "Done". Other steps that are to be performed and verified
are capturing the image of the product dose transfer; capturing the
image of the completed dose; and scanning the barcode label on the
completed dose. Each of these steps must be verified as being
properly completed before the user can continue with the other
steps of the dose preparation process.
[0094] The NDC information also contains formulary information and
this can be used at the workstation as the drug is being prepared
in accordance with the steps shown and described with reference to
FIG. 9. In particular, this information can be used as part of an
integrity check (drug verification process) to ensure that the drug
is being prepared properly.
[0095] Referring again to FIG. 1A, the steps presented to an
operator at a workstation generally include a number of steps. At
step 163, a counter is started to make sure all N steps are
performed. The value (i) is equated to 1 at step 163 and in step
164, the operator is stepped through the recipe (protocol) where
the recipe includes steps 1 to N. In step 165, the operator is
presented with a step to perform (namely, step i). At step 166, the
operator must present some type of feedback (e.g., capture an image
or scan a barcode) or confirm that the action requested at block
165 has been performed. If the feedback confirms that the step 165
was properly performed, then at block 168, a comparison is made
between the value of i and N and if i=N, then the order has been
filled and the flow proceeds to step 180, as described below. On
the other hand, if i does not equal N, the process flow proceeds to
block 167, where the value of i is incremented (e.g., by 1 as shown
(i=i+1), and then the process flow loops back to step 164 so that
the operator can be presented with the next step of the recipe. The
steps 164 to 168 are performed until i=N which indicates that all
steps have been completed.
[0096] As mentioned above, if it is determined at step 150 that the
dose order record is suitable for automated handling, it will be
queued at an appropriate automated workstation. Queuing the dose
order record at a workstation presents a further opportunity to
optimize the distribution of orders within the pharmacy. For
example, it may not be feasible to determine at step 140 an optimal
organization of dose order records to ensure that dose order
records requiring similar medications are queued at the same
workstation. Thus, at step 170, a particular dose order can be
queued at an automated workstation that is known to be processing
the same medication, or to any workstation at which a dose order
involving the same medication was just queued (e.g., a workstation
to which the dose order and protocol are provided at block 160.
Re-ordering and queuing of dose orders can be very flexible if the
urgency of the dose order is very low. For example, the dose orders
can be queued in a less than optimal order with respect to time,
but more efficient with respect to medication changes and cleanings
to prevent cross-contamination. Optionally, the current workload
and/or work distribution of dose orders to workstations can be
tracked or monitored and presented to a user (e.g., presented on a
centralized display) for management and performance monitoring.
[0097] Moreover, various quality assurance activities can be
assigned to workstations. These activities can include mandatory
cleaning, training sessions, or inventory procedures. They can be
scheduled at a workstation based on necessity (e.g., if the
workstation is determined to be "dirty"), passage of time (e.g.,
protocol can call for cleaning or training every two hours or two
days), or by need (e.g., monitoring procedures determine that
certain equipment is "dirty" or that a particular operator is
making mistakes and requires additional training). As used herein,
"dirty" refers to a station being in a queue for a cleaning.
[0098] Once the workstation fulfills the dose order, the status of
the dose order record can be changed to indicate that it has been
processed at step 180. The status change can be received by the
fulfillment system as an acknowledgement that the drug dosage form
has been prepared, or as a "processed-order" status, and this can
further result in an update to the dose order record, the inventory
record, or both concerning any drug dosage forms that have been
prepared but not yet delivered. Additionally, data concerning the
assignment of the dose order to the selected workstation and the
completion of the dose order can be logged in the database. Logging
information concerning which workstation processed the dose order
into the database (e.g., an Ensemble database), as indicated at
step 190, enables complete tracking of both the dose-order
processing steps and tracking of the prepared dose itself from its
entry as data into the pharmacy system to its delivery to the
patient. Accordingly, at step 190, the information can be logged
into the Ensemble local database and the situation board updated to
show completion of the drug order. The situation board thus
provides an updated tally on current drug orders being processed
and historical information on processed drug orders, thereby
affording the pharmacy and workstation operators hands-on access to
performance data and other relevant information concerning the dose
orders that are being requested for fulfillment.
[0099] The foregoing discussion details the process by which a data
stream containing medication dose order information enters the
pharmacy and is processed by the local server 330 (which includes a
label processing module, a database such as the Ensemble database
mentioned above, and web services) and filled so as to produce the
requested pharmaceutical dose. The fulfillment system is further
capable of responding to any status inquiries concerning a given
dose order with order status (e.g., "unprocessed," "in-progress at
{selected workstation}," "processed" and the like) and optionally a
location (e.g., in bin A, on cart B, in pediatric ward, etc.). The
fulfillment system is also capable of monitoring and tracking the
prepared dose through to its delivery with additional status
information (e.g., dispensation to patient {X} s), as discussed
next with reference to FIG. 2.
[0100] Referring now to FIG. 2, a process flow is illustrated that
commences when a workstation identifies a particular dose as having
been completed, as indicated at terminator 200. The local database
is updated with completion information at step 205, and this
provides status information that can be referenced by persons
outside of the pharmacy in response to a status inquiry and by the
system in managing the distribution of subsequent dose orders. The
identification preferably associates a unique identifier with the
dose. The database record associated with the identified dose can
be marked as completed. Alternatively, various other subsystems can
be notified of the completion of the dose. For example, a storage
subsystem that tracks medication that is "on-hand" can be updated
with the prepared dose's record. Additionally, a delivery subsystem
can be notified that the prepared dose is completed and ready for
delivery to its destination. At a later time, for instance,
according to a schedule, the information in the local database can
be uploaded to a central server 390 that can be configured to
communicate with the respective local databases of multiple
pharmacy systems.
[0101] At step 210, the completed dose order is sent to a
pharmacist for approval to allow the dose order to be released if
it is verified. At step 220, the pharmacist is presented with the
information necessary to decide whether the dose order should be
approved. If the pharmacist is on-site, the pharmacist can visually
inspect the dose order and if the dose order was manually prepared,
the pharmacist can interview the clerk who filled the dose order in
order to verify that protocol was properly followed. If the drug
order was prepared by an automated system, the pharmacist can
review the associated records of the dose order that were generated
by the automated drug preparation system during the processing of
the dose order.
[0102] Another aspect of the present invention is that it provides
a portal for remote inspection of prepared doses and thus
facilitates the practice of telepharmacy, by which a pharmacist can
inspect the dose preparation from any location inside the hospital
or elsewhere so that doses are released more quickly and
efficiently. Accordingly, dose inspection/verification can be
performed by a pharmacist from any location using the portal of the
present invention. Dose information such as can be collected and
stored as the recipe or protocol for order fulfillment is
performed, and any images that have been captured (see FIGS. 7 and
8) are presented to the pharmacist for inspection and approval.
Images, such as those in FIGS. 7 and 8, can be presented through a
conventional browser, optionally with the use of a plug-in or other
active code that provides magnification, rotation, contrast, and
other adjustments for closer inspection.
[0103] The pharmacist can thus look not only at images of the final
product, including the product label, and other related product
information, such as barcode information, but also, the pharmacist
can review information and images that are obtained at particular
steps in the overall drug preparation process. For example, during
a drug reconstitution process, the operator is stepped through the
drug preparation as described above and must confirm that each step
was successfully completed. One of the steps is the selection of a
particular drug vial and this event can be captured using a camera
to produce an image that can later be reviewed by the pharmacist or
a scanning event by which the operator identifies the drug vial
being used. The pharmacist can view each or many of the steps that
was taken in order to confirm that the step was properly completed
and thus, the dose was properly prepared. Many times in a pharmacy,
a clerk is working under the supervision of a pharmacist and it is
the clerk that actually processes the dose order. Thus, in the
event of any questions about an order, the pharmacist is limited to
speaking with the clerk. This aspect of the present invention
offers a superior and more complete way of inspecting and verifying
the drug order in order to release it to the patient since the
pharmacist can visually inspect the different, multiple images
and/or data obtained during the various steps of preparing of the
drug to confirm that the steps where carried out properly and thus,
ultimately conclude whether the dose order was properly prepared
and should be released to the patient. This can be important in
many circumstances, including when the constituent components of
the final dose include more than one clear fluid such that a visual
inspection of the final dose cannot provide a basis for the
pharmacist to confirm the accuracy of the dose. Thus, a benefit
results from the capture and review steps described above,
regardless of whether the pharmacist is on-site or remotely
situated.
[0104] FIGS. 7 and 8 show the various images that can be selected
by the pharmacist in order to view the final dose order, in this
case a syringe filled with medication, Different angles and
different views are available to the pharmacist, as well as
information that has been captured in other ways such as by
scanning or weighing steps, if called for in the recipe at the
workstation that prepared the final dose being inspected.
[0105] Preferably, the local server 330 includes web services or a
communication module that enables the data records associated with
the dose order and its production to be viewed through a
conventional web-browser program. As such, the pharmacist no longer
has to be physically within the pharmacy to inspect and verify dose
orders and ultimately either approve and release the dose order or
reject the dose order. The opportunities that this system presents
are varied and great. For example, a number of pharmacies can
subscribe to a service where pharmacists inspect and verify dose
orders from a remote location, either all the time or after the
close of normal business hours. In addition, when the drug orders
are prepared by automated drug preparation devices as opposed to
pharmacy clerks, the inspection and verification process can be
outsourced to one or more pharmacists who review and verify the
dose orders.
[0106] In addition, a panel of pharmacists can, at one or more
remote locations, review the dose orders that have been prepared by
a number of different workstations (both automated and manual),
regardless of the location of such workstations. Each pharmacist
can review all of the digital records and stored information as
described above as part of the inspection process and then can
approve the dose order for release if the pharmacist concludes that
the dose order was properly prepared. The approval process can
comprise messages communicated through the portal, e.g., a
web-browswer application such that the pharmacist simply logs into
the system and approves particular orders by mouse-clicks,
keystrokes, and other conventional inputs that are forwarded to the
local server that was the source of that particular dose order. A
conventional login process with password and optionally further
user-authentication ensures that the pharmacist's identity is
verified before providing access to the pharmacist to any dose
order information. The system can be designed so that for each dose
order, the pharmacist must enter a unique identifier, such as a
password, in order to release the drug. The date and time of the
inspection and release or rejection of the dose order is also
logged. Optionally, this information can be associated with the
dose order record so that the approval stage is saved together with
the processing steps to fill the dose order. In this manner, a
record of which pharmacist has approved a particular dose order can
be saved.
[0107] It will be appreciated that an entity can be formed in which
pharmacist-members span the world in different time zones so as to
have a pharmacist available regardless of the time of day to
inspect and release or reject a particular dose order. The
pharmacists can thus be part of an organization or a corporation
that offers this service to different pharmacies across the globe.
To accommodate different languages, the software can be configured
to offer the dose order information in different languages, which
can be selected in a pull down menu on a screen, such as a login
screen.
[0108] With continued reference to FIG. 2, in step 230, if the
pharmacist approves the dose order, then the dose order is released
in step 240. The determination as to whether to approve the dose
order is not managed by the present system. Rather, that
determination is made by the pharmacist with the system providing
detailed tracking of the recipe followed to prepare a particular
dose order so that the pharmacist can make the approval decision
using "over-the-shoulder" information, that is, information
captured during the course of dose preparation as though he were
looking over the shoulder of the operator of the workstation where
the dose was prepared. On the other hand, if at step 230 the
pharmacist does not approve the dose order based on the information
presented to the pharmacist, then the dose order is rejected and
the original order is added back the dose order queue at step 250
for preparation anew. At step 260, the local database and the
situation board are updated to reflect whether the dose order was
released or not. At a later time, the local database can
communicate the completed dose information including any
dose-approvals and dose-rejections from the local server 330 to the
central server 390.
[0109] The above discussion is generally directed to the
preparation and fulfillment of medication dose orders and the
tracking of the dose order from origination to delivery. However,
the present invention also applies to a method and system for the
centralized preparation and delivery of medications in anticipation
of use (i.e., at times before a patient-specific dose order has
been prescribed or presented for fulfillment), such as described in
the aforementioned U.S. application Ser. No. 11/844,135, by having
workstation operators at manual workstations and automated
workstations capture information at steps in the dose-order
preparation process for approval as previously described.
[0110] With reference now to FIG. 3, topology 300 illustrates an
environment in which a central server 390 communicates with local
servers of each of potentially numerous pharmacies, hospitals, or
other healthcare providers, each of which is generally identified
at 310. These entities 310 can communicate with a respective local
server 330 configured to implement the processes described herein
(such as shown in FIGS. 1, 1A and 2) from a conventional pharmacy
information system 320. The pharmacy information system 320 is the
location where drug orders are initially entered for processing.
The system 320 can thus include one or more stations where a doctor
or other person can enter individual drug orders, such as orders
for IV admixtures. The pharmacy information system 320 communicates
with the local server 330 which preferably includes the
functionality described above, including at least the label
processing module that extracts drug order information from the
pharmacy information system messages or data streams (and
optionally a fulfillment module that determines whether new
medication preparations are required or are already available in
inventory), a database and a database query module that supports
read and write operations to the database, and a communications
module such as a web services module that supports communication
with servers and other machines at remote locations. Optionally,
the local server 330 comprises plural, dedicated servers. The
pharmacy information system 320 and the local server 330 can be
connected across various types of communication links or network
segments. For example, communications can be transported over the
Internet, a private network, or across a virtual private network
(VPN). Further, the server 330 can communicate using a variety of
communication interfaces such as IEEE 1284 (parallel port), USB or
USB 2.0 port, IEEE 1394 ("Firewire"), IEEE 802.11 transceiver
variants, Bluetooth transceiver, infrared port, or 10 Base-T and
100 Base-T Ethernet, or one of a variety of emerging interfaces. A
variety of protocols can be employed for communication with the
pharmacy information system 320 and with other workstation,
databases, and servers and devices, including, for instance, TCP/IP
and WAP. Communications between the entities 310 and the server 330
are preferably secure (e.g., utilize HTTPS, SSH, VPN, DES
encryption or RSA encryption) so as to prevent the interception or
snooping of potentially sensitive medical information such as
patient history and medication orders.
[0111] As illustrated in FIG. 4, the local server 330 within each
hospital or pharmacy 310 is in communication with a number of
devices and is in exclusive communication with the central server
390. The pharmacy information system provides label information to
the database and that data is received at the local server 330 and
processed by the label processing module as described above.
Likewise, various workstations receive data from the local server
and guide technicians in the preparation of medication doses while
also providing captured images and other data to the database
through communications with the local server. A pharmacist provides
verification through a portal connection to the local server, such
as a secure connection through the Internet, using a browser and/or
an application that provides tools to aid in the review process
(e.g., to magnify, rotate or otherwise manipulate the captured data
associated with a given preparation). Finished doses are noted,
sorted, and checked-out of the preparation queue or inventory as a
function of the completion of process flows such as described above
in connection with FIGS. 1, 1A and 2. All the while, the situation
board 400 presents metrics relating to the in-progress,
yet-to-be-started, and completed doses using data provided by the
local server, and more preferably from a dose status module
operating on the local server or a machine connected thereto.
Similarly, devices such as terminals can communicate with the local
server 330 to query the status of dose preparation or gather
reports on productivity, errors, workstation throughput, or other
operational parameters (including parameters of interest to an
information technology professional).
[0112] Beyond each of the pharmacies and hospitals that have a
respective local server 330, there is a central server 390 that
communicates only with the local servers. Each local server
preferably runs a number of other services that assist in the
management of information and periodic communication with the
central server 390. In an implementation of the present invention,
an Ensemble server includes a number of services in the form of
code (e.g., software modules) that support system operation. For
instance, a data backup and purge service has a rule base that
defines the time period for the local server to maintain data. The
time period is set so as to balance machine efficiency with the
desirability of having data stored locally. This service operates
to send data to the central server 390 at intervals or in response
to events. Thus, for instance, data can be provided to the central
server every minute and the local copy of any captured image data
can be purged after 45 days. A system status service monitors the
performance of the local server 330 and provides an administrator
with information relating to the success or failure of data backup
operations, system slowdowns, and the like. A dose order monitor
service generates the data shown on the situation board 400, and
the rules and parameters used for generating this data can be
established in a profile that the service refers to. In addition,
the dose order monitor service can advise of any doses that are not
being made by any of the workstations at that particular location
310. A notification service operates to send messages such as
emails by SMTP or instant messages using an IM protocol.
[0113] In one embodiment, the pharmacy information system 320 sends
a label print stream to the server 330. The entity 310, whether it
is a hospital, pharmacy, healthcare provider or the like
communicates with the server 330 which, in turn, coordinates and
manages the medication ordering and fulfillment process.
Optionally, communication can be handled at the server 330 by a
communication module. In addition, if the healthcare providers 310
communicate with the server 330 via a world-wide-web interface, the
communications module can comprise a web server, such as Microsoft
Internet Information Service (ITS) or Apache Web Server. The
communications module, regardless of its form, preferably manages
certain administrative and communication tasks so as to offload the
processing demands placed on the server 330. For example, the
communication module can authorize healthcare providers 310 access
to data maintained by the server 330 through secure key or password
protection. Further, the communications module can encrypt outgoing
traffic and decrypt incoming traffic.
[0114] In the illustrated embodiment, the server 330 includes a
label processing module and optionally an attached printer that can
generate labels for medications prepared in anticipation of use as
well as any medication doses that have been matched with a
patient-specific dose order. Labels can be printed in standard
fonts or typeface as well as be printed with bar-codes or otherwise
encoded in a machine readable format. Furthermore, label printing
can include electronically writing data to an RFID tag or similar
device, if desired.
[0115] The label processing module can comprise code executing in
the server so as to capture the printed label feeds, parse the
labels, and post the dose order information into a database
communicatively coupled to the server 330. The label processing
module can be of the type described in commonly assigned U.S. Pat.
No. 7,096,212, which is hereby incorporated by reference in its
entirety. The label processing module supports a variety of methods
for receiving label stream input including TCP, LPD, and any file
transfer protocol. Preferably, the module includes language
interpreters for a number of commonly used label-printer languages
including Zebra, DataMax, SATO and Intermac.
[0116] Preferably, the server is able to receive and post to the
database drug orders that are already in a format for posting, in
other words, that do not require processing by the label processing
module. Properly formatted drug orders can be posted using suitable
database commands, such as commands in MySql, when a sequel
database is used. Preferably, however, all drug orders from
pharmacy information systems 310 pass through a processing module,
even if not in the form of a "label" for data verification.
[0117] The server 330 also includes a local database (cache) server
that is hosted locally at each site, such as a hospital or
pharmacy, etc. The local database can be in the form of an Ensemble
database, commercially available from InterSystems. The database
stores a rolling "cache" of the current in-process work, as well as
the works from a predefined number of previous days, such as the
past 30-45 days, thereby creating a work order history that can be
later accessed and reviewed even in if there is a temporary
disruption of communication lines to a primary server at a
different location. As described further below, the central server
390 preferably maintains an archive of data from each installation
310 and provides reporting functionality to thereby free the
individual hospitals and pharmacies from maintaining all of the
gathered data for an indefinite period of time. Data of various
kinds including images (such as JPEG images), are captured during
the dose preparation process and this data is stored in the local
Ensemble database. Thus, the incoming print stream that is
received, parsed and interpreted by the label processing module can
be placed into the local Ensemble database and that record
augmented as the dose order is being filled with data collected
during each or selected ones of the steps in the recipe for
producing the drug in the drug order.
[0118] Unlike conventional messaging products, the Ensemble
database has a high performance, highly scalable and SQL-compliant
object database at its core. This database leverages technology
found in a Cache product offered by InterSystems, and scales easily
to handle thousands of simultaneous users and terabytes of data.
All elements of Ensemble itself are modeled as object classes in
its database. This object model is extended, during solution
development, by Ensemble's advanced abstraction facility to all of
the applications, services, data sources, business rules, and other
components of an integrated solution.
[0119] Data is synchronized to a hosted central server 390,
described below, via a network 301 (e.g., via SOAP web service
process over HTTPS) and is eventually purged from the local server.
The label processing module can run on the same physical machine as
the local database (e.g., Ensemble local database). The central
server 390 can securely manage data received from numerous entities
310, including entities that are not associated with one
another.
[0120] The server 330 also includes management software, such as
the Ensemble production module, that manages the status of doses
through the system, and is configured to monitor and compute
metrics that are to be displayed on the Situation Board 400. In
addition, the Ensemble production module sends email notifications
and manages communications with external systems, including the
backup/synchronization process to the central server 390. The
Ensemble production module runs on the local database.
[0121] The database and web server utilized by the server 330
should be provided locally by facilities at the entity 310.
[0122] The Situation Board 400 shown in FIG. 5 is a browser-based
"dashboard" application that displays the overall status summary
information about the current operations within the pharmacy IV
room or another site. The Situation Board is displayed in the
pharmacy on a large size, widescreen, flat panel display for high
visibility and can include the following metrics: (1) count and
percentage of doses awaiting preparation, in-process, or awaiting
verification; (2) current productivity compared to a 30 day average
(or some other average); (3) state of each workstation in all
pharmacy locations in the hospital or the like; (4) wait time for
preparation and verification for selected doses, such as STAT and
"First Dose" orders.
[0123] The Situation Board 400 of FIG. 5 includes a number of
different sections that present useful information to personnel.
For example, the upper left hand corner includes a dose order
summary 510 in the form of a bar graph that includes the types of
doses (e.g., STAT, FIRST, WAIT, HAZMAT) along one axis and a
percentage value along another axis. A color code is provided so
that the operator can easily determine the percentage of each type
of dose (as well as the total doses) that are pending, in-process
and waiting for verification. In this example, 100% of the WAIT and
HAZMAT type doses are pending. In a top center section, a dose
order productivity reading 512 is presented to the operator and
maps out the total count over a period of time and allows the
operator to compare the current productivity reading compared to an
average productivity reading. The bottom area of the screen (bottom
left, center and right) 520 shows the wait time of various types of
various doses. For example, the average wait time for the
completion of the dose preparation is listed, as well as the
average wait time for dose verification. Available workstations and
the number of dose orders being handled by each workstation are
identified by icons in the upper right corner of the screen.
[0124] The Situation Board 400 can be hosted on a machine running a
conventional web browser application, including the server 330. To
achieve ease of deployment and support for a broad base of client
platforms, the majority of the present system can be presented
through a web-browser interface. The main advantage of a web-based
interface is to allow remote access from any location without the
need to install any client applications on the end user's PC. Cache
provides two avenues for developing web-based applications, namely,
Cache Server Pages and Zen and additionally, ASP.NET can also be
used to access data that resides in the local database 330. The
Situation Board 400 is one example of the web-based interface of
the present system and is a highly-visible dashboard application
for obtaining at-a-glance status information about pending and
in-process dose orders.
[0125] As previously mentioned, the server 330 and in particular,
the local database thereof, periodically sends the set of completed
work (and other data changes) back to the central server 390 for
backup. Data transfers to the central server 390 can be quite
frequent such as in response to each write operation to the
database of the local server 330 or infrequent such as on the order
of minutes or hours apart. A backup of all "log" data (i.e.,
completed doses, captured data including images, and action logs),
as well as "static" data, such as formulary and procedure
information, are stored on the central server 390. After a period
of time has elapsed, such as 30 to 45 days, some of the data (e.g.,
captured images) or all of the data can be purged from the database
of the local server 330 if the transfer to the central server 390
has been verified. Data can be segregated in the same database by
customer ID (and other security "keys" as needed) to prevent
customers from accessing any data but their own. This enables a
central server to securely host a number of installations each
having their own server 330. Moreover, multi-site hospital networks
can also access data across a subset of customer IDs for all
hospitals in their network, while maintaining those sites as
separate and distinct entities.
[0126] A principal chore for the central server 390 is to manage
the backup process that runs from each local site in response to
their respective data uploads. Once the central server 390 has
verified to the local server that it has received the dose order
and dose preparation data records intact, the local server is then
free to purge information in accordance with the data retention
polices at that facility. Meanwhile, the central server 390 can
retain all of the information in archive, or can maintain only dose
related information such as which dose, what hospital, how many
generated each day, who approved, and the like. Customers can also
access the site periodically for query and reporting purposes. An
ancillary benefit of having the central server 390 manage a
plurality of entities 310 is that it is uniquely positioned to
track actual dose dispensing in terms of which medications are
dispensed and when within multiple geographic territories,
providing a wealth of patient-independent information that can be
mined, if desired.
[0127] In accordance with another aspect of the invention, the
central server 390 can leverage the data-transfer relationship and
support the data archiving functionality through a method of
charging entities 310 on the basis of the number of doses prepared.
Because each of the hospitals and pharmacies communicates regularly
with the central server, and because the central server is
maintaining information on prior dose-preparations, a tabulation
module can operate to associate each data upload session with a
particular installation and tally the number of records uploaded to
the central server. At a prescribed interval, such as monthly or
quarterly, an invoice can be generated in an amount that is a
function of the quantity of information uploaded. Thus, the invoice
can reflect a charge for each record uploaded, or a tiered-charge
structure in which there is a fee for each of one or more bands of
uploads (e.g., for the first 1000 uploads, the next 4000 uploads,
etc.), or for the size of the upload (e.g, a charge calibrated to
Gigabits of storage associated with that installation), as a few
examples.
[0128] In yet a further aspect of the invention, the central server
390 can have a dose metrics module that processes incoming data
from each particular hospital or pharmacy, and provides reports to
administrators regarding the data from such hospital or pharmacy,
or with respect to a group of hospitals or pharmacies that are
commonly owned or that are in competing geographic, academic, or
specialty areas. The dose metrics can be programmed to identify,
among other parameters, how many different drugs a hospital,
pharmacy or set of installations are using, the average time to
produce a given dose, the number of errors in producing a given
dose, the number of re-dos for a given dose.
[0129] As well, the dose metrics module can be programmed to
benchmark the performance of a given hospital or pharmacy against
that of another hospital or pharmacy. In this regard, a hospital
system with multiple pharmacies can identify the most efficient or
accurate pharmacies in its group, and can identify
medication-preparation protocols that optimize processing through a
comparative report across installations. Optimizations can be had
at the operation level, as just described, and also with regard to
resource allocation, such as by distributing drug orders that is
statistically more likely to have fewer errors or faster handling
of a given drug order (assuming there is more than one suitable
pharmacy to select). Similarly, there can be new optimization
capabilities at the purchasing level by comparing the handling of
different drugs that are suitable for treating the same illness.
For instance, if drugs A and B both are suitable for treating a
given ailment, the drug metrics module might identify that drug A,
although more costly, is more accurately prepared with fewer errors
and re-dos and therefore is the better choice for filling the
prescription, when substitutions are permitted. More generally,
benchmarking includes an application of a rule base (algorithm) to
the data collected from the various entities 310 to output a report
or recommendation concerning future drug preparation, and that
recommendation can concern training of pharmacists and their staff,
workstation selection and quantity, hours of operation, material
stocking, and the like.
[0130] The connection between the local server and the central
server is over a network such as the Internet. The frequency of
this backup can be hourly, daily, or at some other interval
selected in view of the bandwidth available at the local site or
other constraints or preferences. To provide additional safety, a
secondary central site 392 can be provided and serve as an offsite
disaster recovery site where critical data can be stored. The data
can be sent (backed up) from the primary central server 390 to the
secondary central site 392 in a conventional manner.
[0131] The server 330 is in bi-directional communication with a
number of workstations to allow the workstations 500, 510, 520,
etc., to receive the drug order queue and details concerning the
individual drug orders. In addition, confirmatory acts that are
performed at the workstations (e.g., capturing images and scanning
barcodes) are transmitted to the server 330 for storing in the
local database. Any number of different workstations can be a part
of the present system. For example, FIG. 3 shows a FlowHood
Workstation A 500; a FlowHood Workstation B 510 and a Chemo
Workstation 520. However, other workstations can be part of the
system including manual drug preparation workstations, automated
workstations, and workstations that are specifically used to
prepare a certain type of drug order can be connected to the server
330 to receive drug orders and report drug order processing.
[0132] A client application is provided at each workstation. The
workstation can include a touch screen, one or more bar code
scanners, label printers and a camera. Additional hardware that can
be present at the workstation can include a scale, a reconstitution
module (mixing station) and/or a security ID badge reader. The
client application is preferably a web-based application and
therefore, the specific location of the workstation relative to the
server 330 is not critical since communication between the two is
over a network, and so data and business logic of the server 330
can be communicated in a conventional manner, such as via a
web-service using SSL http protocol (https) over the standard web
port (80) that is typically available for web access through
network firewalls. This architecture allows the server to be hosted
locally, at the customer site, or at an ISP on the internet, with
no changes to the application itself.
[0133] The drug order queue that is assembled in the server 330 is
preferably displayed on the situation board 400 as well as at each
of the various workstations. The display at the workstations can
comprise a touch screen device to permit inputs via direct contact
with the display. The touch screen can be provided at each location
where doses are prepared, e.g., inside the pharmacy IV cleanroom. A
camera is used to capture JPEG images or other images of dose
preparation activities for later inspection (images are stored
directly in the database). A foot-pedal, barcode scanner, and
audible cues are used to keep the application hands-free during the
preparation process. Unlike conventional systems where a single
pharmacy printer prints all of the drug order labels prior to
actually preparing the drug orders, the printing of the drug order
labels preferably takes place only at the specific workstation that
is fulfilling the drug order. Since the dose labels are printed at
their point of use, the need to sort large batches of labels is
eliminated, and therefore, they are prevented from getting lost in
the pharmacy or being matched with the incorrect dose are minimized
if not eliminated. Dose preparation instructions are presented to
the technician as described herein. Detailed instructions and
reference materials, such as PDF documents or web sites, can be
referenced at the workstation.
[0134] The workstation communicates with the local database at the
server 330 via a web service (e.g., SOAP web service) using the
built-in web services capabilities of the server 330. Various
reports can be generated via a connection to the database.
[0135] It will also be appreciated that the touch screen
workstation can include voice recognition software to allow the
operator to use voice commands to navigate. For example, the
operator can navigate through a menu and review the drug order
queue and even make a selection from the drug order queue using
voice commands. By using the foot-pedal and voice commands, the
operator can also capture images of the product and other objects
as well as scanning the product, etc.
[0136] The work flow process described herein includes a "kitting"
function that organizes work into appropriate kits, prints picking
documents to assist the technician in locating and securing the
appropriate drugs and supplies. Bar codes or the like can be used
to verify the selected drugs and the work flow process includes
issuing a kit report that tracks the work into and through the IV
room or other room.
[0137] Dose tracking takes a number of forms. The situation board
provides one manner of dose tracking because it maintains a high
level view of the work being performed in the pharmacy and because
is configured to immediately instruct an observer regarding any
incomplete work. Moreover, color coding on the situation board can
immediately identify the amount of work that is pending
preparation, under preparation or prepared but not yet checked out
by a pharmacist (i.e., orders not yet approved for release. Dose
tracking is also provided at each step in the dose preparation
process, including without limitation, the selection and
preparation of the ingredients, pharmacist checking, removal from
the IV room for delivery to a patient, and the actual delivery of
the dose to the floor. Each of these steps is part of the work flow
process that is tracked in the system managed by the server 330. As
well, there is a dose query function that permits any authorized
user to probe the database to discover the current status of any
particular dose or group of doses. Also, the situation board
maintains alarms for doses that are due and also tracks doses whose
preparation must be delayed because of limited stability in
solution.
[0138] Because the information is being stored in a database over
long periods of time, the system develops metrics that demonstrate
workload vs. staffing patterns; when the workload deviates from a
"normal" condition, and when the workload is out of control;
thereby permitting managers to adjust staffing for work load needs.
Furthermore, the central server 390 can develop metrics that cover
greater regions than gathered at any given server 330.
[0139] In yet another aspect of the present invention, the NDC
number can be used when the system is configured to "push" the dose
orders to the individual workstations. Incoming drug orders can be
identified by their NDC numbers and the local server selects which
workstation is best capable of handling the incoming dose order
based, at least in part, by their NDC numbers and then assigns the
dose order to the workstation. The dose order is then sent to the
workstation for fulfillment of the order. For example, chemo drugs
can be identified as such by their NDC number and the local server
will select a workstation that is intended to handle chemodrugs. To
implement this earmarked type routing, a database at the local
server can include the NDC numbers to assist in routing certain
medications to specific station or otherwise assist in ordering the
drug orders on the situation board.
[0140] The present system therefore provides a composite workflow
application that can layer on top of a hospital's existing pharmacy
information system 320, without requiring any changes to that
system, in order to manage the production of IV doses (and other
doses) in the pharmacy, track dose delivery from the pharmacy,
prevent medication errors caused by incorrect dose preparation,
capture detailed history of dose preparation (including images),
and serve as a gateway to automation systems throughout the
pharmacy, such as carousels, compounders, and IV robots.
[0141] It will be appreciated that the present system eliminates
the stacks of paper labels used by the current entirely manual
process and the system provides greater visibility into the entire
process, uses bar code verification to prevent the possibility of
adverse drug events causes by dispensing errors, and improves the
overall quality of life for the IV room or other department.
[0142] The present system combines a macro-level workflow manager
that tracks the status of dose production in the pharmacy IV room
from the receipt of the dose order, through preparation at a
workstation that can include a laminar flow hood or chemotherapy
bio-hazard cabinet, or distribution to an automated system for
preparation, dose verification by a pharmacist, and finally to
sorting and distribution from the pharmacy. Additionally, a
micro-level workflow manager is provided at the dose preparation
station. Using a combination of a touch screen, base code imager,
camera, printer, foot pedal input and other equipment, the system
ensures proper and complete preparation of each dose and provides
full traceability to the products used during preparation.
[0143] In order to overcome the liabilities associated with a pure
ASP mode, the workflow management system of the present invention
is architected with a two-stage data process in which immediate
operations are managed using a local server (also called a data
cache) and such operations are continuously backed up to a network
(Internet). The system therefore looks like an ASP to a user
performing long term data retrieval and analysis, but on the other
hand looks like a local application to the persons performing the
mission-critical work. This ensures availability of critical data
at all times for the entity 310 using the system.
[0144] The architecture is further divided into workstation
applications that are deployed as thick clients to workstations
located at each drug preparation area. The workstation applications
are localized to the IV room and drive printers and other
equipment, and so are more suitably deployed as thick clients. All
other functions can be performed at any workstation at which the
pharmacist finds him or herself, and so are mediated as thin
clients using ubiquitous Internet browsers, which eliminates the
need to physically deploy the software to those locations. This
permits scalability and ready-access by a pharmacist that may be
performing a drug dose inspection from a remote location.
[0145] In yet another aspect, the architecture and arrangement of
the systems of the present invention provides the ability of
multiple sites (local or remote) to place orders to a central
filling site in a manner as described above. The central filling
site processes each dose in accordance with the received
instructions to generate a medication dose for delivery to a
patient. As the medication dose is prepared, associated dose
preparation data is generated at the central filling station and
can be stored. The central filling site can then transfer the
associated dose preparation data back to the ordering site using
electronic means when the physical medication dose is sent back and
received at the ordering site. Thus, the receipt of the medication
dose along with the associated dose preparation data at the
ordering site permits confirmation of the process, approval and
release of the medication dose. For example, comparison between the
dose preparation data and the medication dose (e.g., indentifying
information thereon (e.g., bar code, etc.) ensures the integrity of
the dose preparation process. In addition, by having the dose
preparation data, which can outline all the steps that were taken
to prepare the dose, a person can more easily confirm and approve
the dose preparation, thereby allowing the dose to be released to
the patient. For example, as described above, each dose preparation
can have a documented protocol (steps) that the person or machine
follows to prepare the dose.
[0146] The present system provides a number of advantages
including: (1) elimination of non-productive workload associated
with label tracking and management; (2) elimination of
non-productive time spent by pharmacists entering and leaving clean
facilities used to prepare IVs for checking purposes; (3) provision
of complete record-keeping on an activity that is now fundamentally
impossible to document; (4) transfer of workload from scarce
pharmacists to relatively abundant technicians; (5) entry of orders
for IV admixtures into a hospital pharmacy information system that
produces labels in a just-in-time manner for those doses that are
actually being prepared and hence that are currently required for
placement on the final drug dose; (6) transfer of label data to a
server where they are electronically read and placed into a
database; (7) configuration of computer workstations at each
preparation location with knowledge of what doses on the list of
pending doses their respective operators can prepare; (8) selection
of doses by the user (typically, a pharmacy technician or operator)
to be prepared, with labels printing only after that selection at a
printer located at that workstation, with concomitant settings of
that dose order as being "unavailable" to other workstations (this
grouping of doses, all of which have the same medication(s) at the
same dose(s), is called a "micro-batch").
[0147] While the invention has been described in connection with a
certain embodiment thereof, the invention is not limited to the
described embodiments but rather is more broadly defined by the
recitations in the claims below and equivalents thereof.
* * * * *