U.S. patent application number 13/399092 was filed with the patent office on 2012-07-19 for centralized sterile drug products distribution and automated management of sterile compounding stations.
This patent application is currently assigned to ForHealth Technologies, Inc.. Invention is credited to Abdul Wahid Khan, Joel A. Osbrone, Bhavesh Padmani, Dennis Tribble, Matthew Valentine.
Application Number | 20120185277 13/399092 |
Document ID | / |
Family ID | 39686558 |
Filed Date | 2012-07-19 |
United States Patent
Application |
20120185277 |
Kind Code |
A1 |
Tribble; Dennis ; et
al. |
July 19, 2012 |
CENTRALIZED STERILE DRUG PRODUCTS DISTRIBUTION AND AUTOMATED
MANAGEMENT OF STERILE COMPOUNDING STATIONS
Abstract
Central management of dose order preparation retrieves an
unprocessed dose order record, selects a workstation from a set of
workstations, forwards the order for conversion into a drug dosage
form, and repeats the process for additional unprocessed dose order
records. Depending on the operation type of the selected
workstation (manual, automatic), protocol information concerning
preparation of the dose order is selectively provided to the
selected workstation. Interrogatable elements enable tracking of
dose orders and dosage forms throughout preparation, storage and
distribution cycles. Further methods enable rapid fulfillment by
utilizing inventory ahead of drug order processing if suitable
dosage forms exist in inventory records.
Inventors: |
Tribble; Dennis; (Ormond
Beach, FL) ; Osbrone; Joel A.; (Port Orange, FL)
; Khan; Abdul Wahid; (Lindenhurst, IL) ;
Valentine; Matthew; (Ormond Beach, FL) ; Padmani;
Bhavesh; (Port Orange, FL) |
Assignee: |
ForHealth Technologies,
Inc.
Daytona Beach
FL
|
Family ID: |
39686558 |
Appl. No.: |
13/399092 |
Filed: |
February 17, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11752769 |
May 23, 2007 |
8140351 |
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13399092 |
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60888832 |
Feb 8, 2007 |
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Current U.S.
Class: |
705/3 |
Current CPC
Class: |
G16H 20/10 20180101;
G06Q 10/10 20130101 |
Class at
Publication: |
705/3 |
International
Class: |
G06Q 50/24 20120101
G06Q050/24 |
Claims
1. A method for centrally managing dose order preparation,
comprising the steps of: retrieving at a monitoring computer a dose
order record having an unprocessed status; selecting a workstation
from among a set of workstations, at least one being an automated
workstation, to handle the unprocessed dose order; forwarding the
unprocessed dose order to the automated workstation for conversion
into a drug dosage form; and repeating the steps of retrieving,
selecting, and forwarding.
2. The method of claim 1, further comprising the steps of:
determining an operation type of the selected workstation; and
selectively providing a protocol concerning preparation of the
unprocessed dose order to the selected workstation based on the
operation type of the selected workstation.
3. The method of claim 2, wherein the selected workstation has a
manual operation type and wherein the protocol is provided in
response to the operation type being the manual operation type.
4. The method of claim 3, further comprising the steps of:
prompting an operator of the selected workstation to provide
information input regarding the protocol; receiving the information
input; analyzing the information input to verify preparation in
conformance with the protocol.
5. The method of claim 2, wherein the selected workstation has an
automated operation type and wherein the test resulting in
selectively providing the protocol fails in view of the operation
type being the automated operation type.
6. The method of claim 1, including the additional steps of:
receiving at the monitoring computer from the selected workstation
a processed-order status indication; and updating the dose order
record to the processed-order status.
7. The method of claim 6, including the additional step of
responding from the monitoring computer to any status inquiry
concerning the dose order with the processed order status.
8. The method of claim 6, wherein the updating step includes
updating a location of the drug dosage form to be that of the
selected workstation.
9. The method of claim 8, including the additional step of
responding from the monitoring computer to any status inquiry
concerning the dose order with the processed order status and the
location.
10. The method of claim 6, including the additional steps of:
supporting a first interrogatable tag on the drug dosage form; and
linking the first interrogatable tag to the dose order record.
11. The method of claim 10, including the additional step of
associating a current location of the drug dosage form with a
location.
12. The method of claim 11, wherein the location has a second
interrogatable tag and wherein the associating step comprises
interrogating the first and second interrogatable tags and storing
information associated with each response in the dose order
record.
13. The method of claim 1, wherein the retrieving step retrieves
the unprocessed dose order record from either a memory or a file or
a database.
14. The method of claim 1, wherein the selecting step updates the
dose order record to associate the dose order with the selected
workstation.
15. The method of claim 1, wherein the retrieving step receives a
plurality of dose order records, and wherein the method includes
the additional step of arranging the plural dose order records in
accordance with a rule.
16. The method of claim 15, wherein the arranging step comprises
grouping the plural dose order records by either type or
medication, wherein the dose order records in the group are all
forwarded to the selected workstation.
17. The method of claim 15, including the additional step of
identifying an urgency associated with one of the plural dose order
records, wherein the identified dose order is forwarded to the
selected workstation for conversion into a drug dosage form with a
higher priority for handling than any unprocessed dose order that
has been forwarded to the selected workstation.
18. The method of claim 15, further comprising the steps of:
generating a supply-list identifying a plurality of supplies
required to fulfill the plurality of orders; comparing the
supply-list with an inventory of supplies; and ordering one or more
of the plurality of supplies not in the supply-list.
19. (canceled)
20. (canceled)
21. (canceled)
22. (canceled)
23. (canceled)
24. A method for centrally managing logistics of a dose order
fulfillment, comprising the steps of: receiving the dose order at a
first station, the dose order having a first priority for
completion; comparing the dose order against an inventory record of
prepared drug doses for a match; in the event of the match:
directing a person to a location associated with the matched,
prepared drug dose; registering the retrieval of the prepared drug
dose from the location for delivery to another location; updating
the inventory record; and instructing the preparation of the dose
order at a second station for completion at a priority which is not
greater than the first priority.
25. (canceled)
26. (canceled)
27. (canceled)
28. (canceled)
29. A method for centrally managing dose order preparation,
comprising the steps of: receiving at a monitoring computer a
medication order containing one or more dose order records;
assigning an unprocessed status to each dose order record among the
received dose order records; retrieving a dose order record having
an unprocessed status; selecting a workstation from among a set of
workstations to handle the unprocessed dose order; forwarding the
unprocessed dose order to the selected workstation for conversion
into a drug dosage form; and providing to the workstation a
standard order process protocol suitable for confirming any dose
preparation steps.
30. (canceled)
31. (canceled)
Description
FIELD OF THE INVENTION
[0001] The present invention relates to the management of
medication dose orders and the environment within which the
preparation of sterile doses occurs, and more particularly to some
or all of the systems and steps taken in connection with the
receipt, processing, filling, management, and distribution of
medication dose orders and in connection with the management of
medication preparation workstations.
BACKGROUND OF THE INVENTION
[0002] 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.
[0003] 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. Additionally, there are inefficiencies associated
with the present process and management of medication orders from
the point of origination or to the point of consumption.
[0004] Physicians and other care providers order medications for
hospitalized patients by generating medication orders in their
patient record. When a pharmacy receives such an order, a
pharmacist performs a variety of operational and clinical functions
to ensure that the order is safe and appropriate and issues a
medication dose order for the release of medications for
administration to the patient. Current pharmacy practice limits the
amount of that medication to that which is immediately needed both
for reasons of patient safety and economics. Pharmacy computer
systems regularly review the currently active medication orders,
and generate additional medication dose orders as needed to
maintain the patient supply. However, pharmacy computer systems do
not provide preparation instructions to the sterile products
compounding technician.
[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-worker, 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 disclosure
of which is hereby incorporated by reference, as though set forth
in its entirety. 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] Finally, delivery of medication dose orders to patient care
areas in a hospital is not well-controlled, sometimes resulting in
care-givers in patient care areas in a hospital being unaware that
medication they require for care of a given patient has been
delivered to the medication storage area where they are rendering
care. This can result in lost productivity in the pharmacy and in
the patient care areas while the pharmacist and the care giver
attempt to sort out whether or not a medication dose order of
interest has been completed.
[0012] The present invention addresses one or more of these and
other problems to provide a 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. As work is completed at and returned from these
workstations, it is valuable to know that the medication dose
orders are ready for distribution and to prompt pharmacy personnel
to get them delivered to the patient care areas.
SUMMARY OF THE INVENTION
[0013] In accordance with one aspect of the invention, a method for
centrally managing dose order preparation comprises the steps of
retrieving a dose order record having an unprocessed status,
selecting a workstation and forwarding the order for conversion
into a drug dosage form, and repeating the steps for additional
dose order records.
[0014] In accordance with a further aspect of the present
invention, the operation type of the selected workstation is
determined, and a protocol concerning preparation of the
unprocessed dose order is selectively provided to the selected
workstation based on the operation type of the selected
workstation.
[0015] In further aspects in accordance with the foregoing method,
the dosage form can support an interrogatable tag which can be
scanned in order to link the dosage form, and optionally also its
current location, to the dose order record. Also, the foregoing
method can include the additional step of arranging a plurality of
dose order records in accordance with a rule such as urgency, type
(solid, oral, intravenous), or medication.
[0016] In accordance with another aspect of the invention, a method
for centrally managing logistics of a dose order fulfillment
comprises the steps of receiving a dose order having a first
priority for completion, comparing the dose order against an
inventory record of prepared drug doses for a match, and, in the
event of the match, directing a person to a location associated
with the matched, prepared drug dose, registering the retrieval of
the prepared drug dose from the location for delivery to another
location, updating the inventory record, and instructing the
preparation of the dose order at a second station for completion at
a priority which is not greater than the first priority.
[0017] A database of interactive Standard Operating Procedures can
be utilized for each drug that might be anticipated as needing
preparation. Such database can perform dose calculations and
manipulations of final volume and dose of the drug in accordance
with unique aspects of the specific dose being prepared.
[0018] In accordance with yet a further aspect of this invention,
confirmations can be performed to ensure that a proper preparation
procedure was followed.
[0019] The invention can further log the steps of preparation and
confirmation to provide a way to review or audit a prepared dose to
ensure that the preparation was performed properly and that the
expected values were achieved. Additionally, the current status of
a medication dose order can be queried and retrieved at any time
from an associated workstation.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0020] The foregoing and other features of the present invention
will be more readily apparent from the following detailed
description and drawings of the illustrative embodiments of the
invention wherein like reference numbers refer to similar elements
throughout the views and in which:
[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; and
[0022] FIG. 2 illustrates a process for managing and distributing
prepared medication doses in accordance with an embodiment of the
present invention.
DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS
[0023] The present invention relates to the capture, processing,
tracking, and distribution of medications. More particularly, the
invention relates to an automated fulfillment system and method for
receiving incoming medication dose orders, 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, and tracking
the prepared medication dose through to its predetermined
destination.
[0024] By way of overview and example, a doctor can enter one or
more medication orders ("medication order") at a terminal in a
hospital. The terminal can be connected via a network or to a
computer system in the pharmacy. When the order is processed by the
pharmacy computer system and labels for medication doses are
generated, the data contained in the order and on the labels is
captured, processed, and parsed by a computer implemented system to
create individual medication dose orders ("dose order") and
associated database records. The software managing the medication
dose order processing distributes the orders to various compounding
workstations (e.g., automated sterile compounding stations or
manual processing stations) preferably in an optimized manner, as
described below. At each stage of the order processing, the
database record associated with the dose order is updated to
reflect its status and location. Once the medication order is
fulfilled, the resulting dose order is labeled preferably so as to
associate it with a patient care location, represented in the
pharmacy as a delivery container, such as a bin.
[0025] 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 the 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" and "scanning" 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."
[0026] As the dose is transported through the hospital to its final
location, the bin is scanned and any new location is scanned at
various points to track its progress through the hospital. If the
dose is removed from the bin and placed into another bin, the new
bin and the dose are scanned and associated in the database to
correctly track the dose as it travels in the new bin. Once the
dose reaches the point of consumption (e.g., the patient), the dose
is removed from the bin and scanned so that its status can be
updated as "delivered." Anyone with access to the system can track
the progress of an order and determine its current location by
inputting an identifier of the order. Furthermore, the fulfillment
system provides complete oversight of the process from end to end
for auditing and compliance purposes.
[0027] 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. Order streams can be
received through various methods. For example, a medication order
can be entered into a computer terminal in communication with the
pharmacy over a network. Alternatively, the medication data can be
captured by a monitor device, such as a serial data monitor, a
network monitor, or a software application monitor. Typically these
order streams represent data intended to be printed on labels on a
printer.
[0028] 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
prescription.
[0029] 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.
[0030] 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.
[0031] At step 106, the fulfillment system determines 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).
[0032] 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.
[0033] 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.
[0034] 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.
[0035] 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.
[0036] 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.
[0037] Referring now to FIG. 1A, order fulfillment processing
commences at step 130 at which the fulfillment system determines
whether there are any unfulfilled medication doses in the database.
If no unfulfilled orders exist, the fulfillment system 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
system will retrieve an unfulfilled order at step 140. At decision
141, the system can determine whether a dose was previously
prepared and stored which would satisfy the dose order. If no such
dose exists, the dose order can be assigned to a medication
preparation workstation at step 142.
[0038] Dose order records stored in the database can be ordered or
arranged in accordance with one or more rules. For example, the
rule can be to optimize fulfillment of the orders. For example,
dose orders can be processed faster if the same medication is
required 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.
Alternatively, dose order records can be prioritized by urgency.
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, an urgent order can be moved near the front of
the queue, or identified as urgent and therefore receive immediate
or expedited fulfillment. Through this or a similar mechanism, the
next unfulfilled dose order retrieved at step 140 can be ordered to
optimize throughput or to satisfy priorities.
[0039] 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.
[0040] 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 drag 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 to
assign the dose order 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
prepared dosage form is being stored, based on the contents of an
inventory record, which can be matched to the dose order so as 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.
[0041] It would be understood by one of skill in the art, that
workstations can be located either centrally or in a distributed
environment. Dose orders can be retrieved 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.
[0042] 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 or other setting associated with the
workstation such as availability and setup. If the dose order
record is not appropriate for automated fulfillment, the order can
be queued at a manual workstation and processed at step 170.
However, before the dose order record is dispatched to a manual
work station, additional information to facilitate the manual
fulfillment of the dose is preferably provided to 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 additional
information can be associated 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, can guide the technician 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 technician's input and
process logging at critical stages of the dose preparation process
(e.g., requiring the technician to scan information related to the
source drug containers).
[0043] The additional information (i.e., protocol) can be
associated with the dose order record at step 162. 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.
[0044] 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 deceive the
system.
[0045] Quality control can 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.
[0046] 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 a work station
that is known to be processing the same medication, or at a
workstation at which a dose order involving the same medication was
just queued. 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.
[0047] 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.
[0048] 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 of drug dosage forms 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, as indicated at step
190, enables the complete tracking of the order and prepared dose
from its entry as data to the pharmacy to its delivery to the
patient.
[0049] The foregoing discussion details the process by which a data
stream containing medication dose order information enters the
pharmacy and is fulfilled to produce the associated 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 the
patient), as discussed next with reference to FIG. 2.
[0050] The workstation identifies the dose as completed at step
200, and the database is updated with completion information at
step 202, providing a status change 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.
[0051] It can be beneficial, for example, to test randomly selected
or specific prepared doses for correct preparation. At step 210 a
determination is made as to whether the prepared dose should be
tested for correctness. Some prepared doses (e.g., manually
prepared doses) require verification. Procedurally, it can also be
beneficial--or even required--to select a prepared dose and verify
its proper preparation. Verification can be performed on a random
sample or for each prepared dose.
[0052] If it is determined at step 210 that the prepared dose
should be tested, the database record associated with that dose
(e.g., as may be identified using the doses' unique identifier) is
retrieved at step 220. The record can be retrieved by scanning a
barcode or other machine readable indicia included on the dose's
container. The barcode preferably codes the unique identifier
associated with dose, and the database record associated therewith
is accessed. Alternatively, other information sufficient to
uniquely identify the dose can be entered, manually or by machine.
Optionally, if a particular sample is identified as a test
candidate, a duplicate dose order can be introduced into the dosage
queue, or it can be re-queued as though never prepared, so that a
replacement is prepared.
[0053] Preferably, barcode scanners, reconstitution stations, label
printers and other devices can be connected to the network to
facilitate tracking and processing of dose orders. If, for example,
a barcode scanner is connected to the network via a wireless
communication link (e.g., an IEEE 802.11 variant) or as a
peripheral to a network connected computer, database records can be
updated in real-time as doses are scanned. Alternatively, an
offline barcode reader can cache the scanned information along with
a timestamp of the scan to upload and synchronize data once it is
connected to the network, for example via a dock.
[0054] The dose record is displayed at step 222 so that the
pharmacist, or other qualified clinician, can compare the database
record against the physical prepared dose. If, at step 230, the
pharmacist does not approve the dose, for example because the
quantity does not match the quantity indicated by the database
record, the disapproval is preferably confirmed at step 240. The
pharmacist can further confirm that the dose is to be reassigned
for preparation by a workstation, and, at step 242, the dose order
record associated with the prepared dose is re-queued in the
database, so that the fulfillment system will process it at step
140.
[0055] In addition to re-queuing an order record for any reason,
the fulfillment system can update the status of the order to
"incomplete" or "unprocessed." Alternatively, it may be desirable
to track the number of prepared orders that are disapproved and the
data associated with those orders (e.g., the workstation assigned,
the pharmacist assigned, the medications and other lab equipment
used during preparation, etc.) In such a scenario, the database
record can be marked as disapproved or rejected and stored for
auditing at some future date. If the database record is marked as
rejected and stored, a duplicate dose order that is marked as
unfulfilled can be generated and re-queued in the fulfillment
system for processing. Preferably, the duplicate dose order
indicates that it is a re-order of a previously processed order,
contains a link or way to identify the original database record,
and includes the original parsed data including an association with
the original data stream.
[0056] If the pharmacist approves the prepared dose after testing
it at step 230, the database record is preferably updated to
reflect that it was approved, as indicated at step 232. If the
prepared dose was not tested or was tested and approved, that dose
is associated with a location at step 250. Preferably, the
association of the prepared dose and the location is accomplished
by scanning the barcode included on the prepared dose and a barcode
associated with the location where the dose is being stored, with
that location being recorded in the database as indicated at step
252. By associating the dose with a location soon after the dose is
prepared, the dose can be fully tracked by its location as it moves
through the hospital or facility until it reaches its final
destination, in the event that a status inquiry is received or the
system polls for that information in connection with the processing
or management of other tasks, such as by assigning additional
orders to the workstation at which that dose was just
completed.
[0057] The location to which the dose is scanned can be a
distribution location or a storage location. Distribution locations
can include bins, racks, carts, trays, or any storage mechanism
that is used to transport doses to patients or remote locations. A
storage location can include a refrigerator or cabinet in which
commonly used medication doses that are prepared in anticipation of
use are stored for quick access and distribution. At step 260, the
fulfillment system determines whether the dose was associated with
a storage location or a distribution location.
[0058] If the dose is staged for storage, the dose order record is
updated at step 262 to reflect its status as "stored" and its
storage location. Preferably the database maintains the stored
doses and the associated dose record to track the inventory
available without requiring dose preparation. Additionally, the
dose record can include an expiration date, whereby if an urgent
order that is received for a particular medication, the database
can be searched for stored doses that have not expired. Thus, the
dose can be delivered to the patient or doctor quickly by
retrieving the stored dose and bypassing the preparation and
filling stage. When the stored dose is retrieved for distribution
(e.g., to fulfill a particular order) and removed from storage, its
location is scanned again and marked in the database, by again
performing steps analogous or the same as steps 250 and 252, for
tracking of the dose through its delivery.
[0059] On the other hand, if the dose is staged for distribution,
the dose order record is preferably updated to "ready." The "ready"
status indicates to a delivery person or other staff person that
the medication is ready to be delivered and administered to the
patient. Thus, if a nurse or doctor checks on the status of a
particular dose order, the user will be notified that the dose is
ready and delivery can be expedited if necessary. Likewise, the
system can access and use that status information in connection
with the processing or management of other tasks.
[0060] When a staff member retrieves the bin in which the dose is
stored, and thus begins the dose's journey to its final
destination, the bin is scanned at step 272 and the status of the
dose, and any other doses known to the system as being held in the
bin, is updated to "in delivery" at step 274. The bin can be used
to update the location of all doses contained therein. Thus, if the
bin is moved to a centralized distribution center on another floor,
when the bin arrives at the distribution center, the bin can be
scanned again and its location updated to indicate the distribution
center. Therefore, the last known location of every dose can be
tracked.
[0061] Preferably, the last known person to control the location of
the dose is also recorded. Tracking the person can be performed by
assigning individuals their own scanner on a temporary or permanent
basis or requiring a user to input a personal identifier whenever
an item is scanned.
[0062] The bin, and all doses stored within the bin, travel through
the facility and are preferably scanned at each location, until it
reaches its final destination, and is scanned at step 280. Scanning
can be performed manually or automatically. For example, if the
item being tracked is bar-coded or includes a computer readable
identifier, scanners, which can be located throughout the facility,
can be used to scan the item as it travels. After being scanned,
the location of the item associated with the bar-code can be
automatically updated in the database. Alternatively, passive or
active RFID tags can be used to track the items by locating
throughout the facility automated sensors which can detect each
item when it comes within range of one of the sensors. Upon
detecting the item, the item's identification can be read (e.g.,
passively or actively) from the tag and its associated location
updated in the database.
[0063] When the individual dose is removed from the bin so that it
can be administered to the patient, it is scanned at step 282 and
its status is update to "delivered." In a further aspect of
tracking and accounting for medication doses, the dose can be
scanned once it has been administered, or once administration has
begun (e.g., in the case of an intra-venous drip in which
administration occurs over a period of time.) Additionally, the
patient to whom the dose is administered can be recorded to ensure
the correct patient received the prescribed mediation. Preferably,
the patient's record includes a barcode or other indicia that can
be scanned and associated with the administration of the dose.
[0064] Information concerning the dose can also be gathered from
virtual checkpoints during transport and even after being
administered. For example, the dose can be scanned and associated
with a particular infusion pump. Thereafter, data from the infusion
pump can be transmitted to the system and associated with the
dose.
[0065] Thus, the fulfillment system described above tracks a
medication order from its point of origin to its point of
consumption. The data collected as it progresses through the system
enables very thorough auditing and monitoring of the system.
Furthermore, the pharmacy can be operated more efficiently by
managing multiple orders and multiple workstations so as to
optimize order priority and physical preparation.
[0066] 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.
* * * * *