CA2201311A1 - Prescription management system - Google Patents

Abstract

A wirelessly deployable, condition-oriented, electronic prescription management system (figure 16) for physician use which provides for patient record assembly (10) with privacy controls (39) for patient and doctor, adverse indication review (42), online access to comprehensive drug information (50) including scientific literature, extensions to novel multi-drug packages and dispensing devices, and an "intelligent network" remote data retrieval architecture (figure 16). Onscreen physician-to-physician e-mail is also provided.

Description

3 ~ ~

PRESCRIPTION MANAGEMENT SYSTEM

TECHNICAL FIELD
This invention relates to professional data management systems useful in the production of product specification documents such as prescriptions, service or parts orders, insurance contracts and the like that require detailed product and history information from multiple extensive information sources, especially remote 5 heterogenous sources. More particularly, the invention relates to systems that assist professionals pclrol~n their everyday work in specifying customized technical products. A particularly preferred embodiment relates to a computer-implemented prescription management svstem to assist physiciaIls in prescribing and reviewing drugs.

~ 2 û 11 3 ~ ~

BACICGROUND
An important professional activity undertaken by most physicians during the course of their day is the prescribing of drugs. Many physicians prescribe a great number of drugs every day. Studies show that over two thirds of all doctor-patient encounters 5 were completed with the writing of a prescription. In 1993 typical prescribers were prescribing in excess of two hundred thousand dollars-worth of drugs annually.
While most physicians exercise the utmost of professional slcill and caution in prescribing, there are inherent difficulties and uncertainties in the process. Most physicians will probably agree that they do not have access to adequate, reliable drug 10 information and relevant patient information at the time and point of prescription.
In particular, information regarding relevant new drugs, comparative efficacy, and importantly, relative costs, may not be readily and conveniently available to a physician creating a new prescription, as well as relevant patient information such as current conditions being treated, current treatments, and preferred medications for 15 conditions, pursuant to requirements of the patient's drug formulary.

Nevertheless, while ~crto.~sing it is impractical for the typical practitioner, such information is available to any physician willing to take the time and make the effort to obtain it. ~~
~- -In contrast, integrated patient-specific information which is directly relevant to treatment management for the subject patient is frequently both unavailable to, and unobtainable by, a prescribing physician unless that physician's institution or organization has been exhaustively responsible for the subject patient's prior care and 25 maintains sophisticated computerized records. Information as to allergies, current prescriptions and currently active conditions is clearly desirable or essential for intelligent prescribing. In 1994, few prescribing sessions are conducted with the benefits of integrated patient-specific information and fewer still have the benefit of specific drug forrnulary recommendations on the subject patient.

2 2 ~ 1 9 WO 9Grl3790 3 PCT/US95114118 Typically, drug formularies comprise lists of preferred drugs whose costs will be borne by a drugs benefit house. Drug formulary information is usually determinative of the cost-effectiveness of a prescription. Unwitting failure by a prescriber to follow formulary guidelines can impose unnecessary or unexpected cost burdens on the 5 patient, or their benefits provider, and lead to poor patient compliance and aggravating and time-consuming disputes. The cost in dollars of non-compliance with drug formulary guidelines to benefit-providing corporations, insurers, health maintenance organizations and government providers, for example MEDICAID and MEDICARE, can be enormous. The cost of poor patient compliance may ultimately 10 increase the total cost of care by generating a more serious, expensive adverse health outcome ( emergeny room visit, or hospital admission or death).

A difficulty in malcing integrated patient-specific information readily available to prescribing professionals is that the needed information components are not 15 centralized but are widely distributed geographically and even when their geographic or electronic locations are Icnown, are hard to access because of proprietary and liability and patient-confidentiality concerns and because of system, file or protocol incompatibilities.

20 Even in the computer-abundant United States, m the mid-90's, prescription writing is generally a manual process. After consulting with a patient to determine their problems and diagnosing, or attempting to diagnose their condition or disease, aphysician selects a drug and a dosage and an amount to prescribe based upon their own personal Icnowledge and experience, if necessary using available reference 25 materials which may or may not include promotional materials from drug manllf~ctllrers. A prescription is then written up under the physician's signature and bears a patient identification, a drug name, dosage amount and timing, refillability information and the physician's signature, the date, possibly an advisory regarding contraindications, and little other information. While a prescription may be typed, 30 lceyed or otherwise "generated" on a computer most prescriptions are still manually 2~0~31 ~

_ written.

Prescribing activity should be a good field for cornputerization, but one difficulty is the lack of apparent benefits to many physicians. Paper prescription pads are small 5 and easily carried around by a physician. Manuallv writing a prescription will often be quiclcer and easier than using a computer, however good the system. The benefits of automated information systems often come not from greater data entry efficiency, but from the increased eff1ciency of the entire process, from the value of the transaction records generated and also from the control of the transaction entry10 process which may ensue. Physicians who are not computer-literate or who are even "computer-phobic" will require a most compelling reason to adopt a computerized prescription management system.

To be fully effective, a prescription management system must be readily usable by a 15 wide range of physicians, preferably for all tl-eir prescribing activity must provide compelling value to patient care and increase overall treatment management efficiency. Providing an attractive computer-based system to physicians is fraught with unexpected difficulties.

20 Physicians and other health care professionals, especially those with prescribing authority, are re~leselltative of certain groups of professionals whose unique characteristics raise obstacles to the computerization of their day-to-day professional activities. Desirably, a computerized professional management system should be capable of flexible integration into their personalized and varied worlc flows.
Contrary to many perceptions and assumptions in conventional data-management systems intended for use by physicians, clinical physicians are not deslcbound worlcers and do not usually have continuous access to a personal deslctop computer during the course of their normal daily routine. To the contrary most physicians are 30 ambulatory or even highly mobile, moving from room to room, from off1ce to office, 2~0q~ ~

from hospital to hospital and to and from their car and home. While some physicians may spend the majority of their healt}l care patient encounter activities at or near a deslctop in their own office, such physicians are probably the exception. In clinics and hospitals physicians are often continually on the move between 5 examination rooms, reception areas, adlministrative centers, hospital wards, specialist facilities such as radiology rooms and so on and so forth. In addition many physicians have more than one practice or more than one professional activity which talces them between an office or clinic and a hospital or other facility on a regular basis. Accordingly, it is a significant technical challenge to provide such mobile 10 physicians with access to a computer-implemented management system that is readily available at the point of care.

Portable computers are a possible solution to the access problem now that powerful and compact notebook computers are widelv available. Altho~lgl- currently available 15 portable computers offer some advantages particularly to physicians moving between one work place and another, they also suffer certain drawbaclcs. One drawback isthat external communication is difficult beillg commonly effected by moving diskettes7 a valuable but limited n-ethod, or by modem connection to a telephone line which inconveniently requires plugging into a wall jack. Though possibly adequate 20 for a physician having multiple offices, neither the communication means nor the portability of such systems is satisfactory for a ward physician moving from patient bed to patient bed. The weights and form factors of traditional portable computers are severe impediments to their assimilation into many clinical physicians daily lives as dependable assistants to their professional work.
More recently, small handheld or palm computers lcnown as personal digital assistants or personal information communicators have become available. An example is the Apple NEWTON trademark). As of summer 1994, these are rather rudimentary devices as compared with deslctop or full-powered portable systems, 30 having modest permanen-t and RAM storage capacities and lim~ted processing and communications abilities. Attractive to busy mobile professionals for their small size, such handheld computers can also embody highly desirable radio wave or infrared wireless communications abilities enabling them to exchange data with host systems without the cost or inconvenience of hard wiring.
uch portable hand held radio communicating computing devices are attractive for computerizing mobile professionais such as physicians, but their processing and storage limitations r-~ies~l~t a real problem in providing a sophisticated, capable and attractive system for physicians.
A broad objective of this invention is to provide a prescription management system that can be used by physicians on such mobile computing devices.

imply delivering a system on a convenient portable computer will not be enough to 15 assure its regular use by a majority of physicians. Though highly educated and technically slcilled, many physicians are not computer literate and are averse to confronting a computer screen. ome may even be intimidated by computers. Nor do their busy schedules permit time to learn complex or difficult systems. Even for `an experienced user adoption of computer use into their daily routines requires time 20 change and adaptation. With tremendous competition for their time, physicians will only be willing to talce these steps if they are enticed by powerful system features that provides them with compelling value to patient care and overall practice management efficiency.

25 Nevertheless, the greatest of system features will be worthless if the system hinders the professional in executing routine functions. Even at sophisticated computer products companies with access to, and experience with, state-of-the-art systems, telephone sales staff often talce down orders with pen and pad rather than using an on-line sales order systems.

~2~93~ ~

An experienced professional practicing their specialty for example a pediatrician treating infants knows from experience exactly what to prescribe, in many instances.
They will have neither the time nor the patience to work their way through conventional software selection and data entry procedures. Accordingly, a further 5 object of this invention is to provide a prescription management system which personalizes itself to the prescribing patterns of experienced users.

SUMMARY OF THE INVENTION
This invention solves a problem. It solves the prol~lem of providing a computerized, 10 prescription management system that an average prescribing physician can use and will want to use and which malces possible significant improvements in the quality of prescriptions written. In preferred embodiments, the invention also solves the problem of significantly reducing prescription costs to patients and to their drugs benefit management company or government agency.
15 The invention solves these problems for physicians by providing a prescnptionmanagement system for electronic prescription creation by a prescriber at a point of patient care, said prescription being usable l)v a pharmacist to dispense drugs7 said prescription management system comprising:
a) electronic posting means to select and capture in said prescription:
i) a patient identifier;
_ ii) a prescribed drug;
iii) a dosage for said prescribed drug; and b) a patient-condition treatment specification procedure;
whereby in creating said prescription said prescriber specifies a patient condition for 25 treatment by said prescribed drug.

More generally, the invention provides a computer-based professional product specification system for use by other professionals, in addition to physicians, which can deliver substantial benefits to mobile, users who may be computer-inexperienced.

~ 2 ~ ~ 3 ~ ~

By associating a patient condition or problem with each drug prescribed, a treatment objective is both ex~ressed and recorded,...physician intent... and deliver for physicians the problem is solved by providing a user- friendly prescription management system, requiring minimal data entrv enabling prescriptions to be created with an overall efficiency unobtainable by any lcnown automated system and which can helpfully supplement the slcills of the best of practitioners.

Pursuant to one preferred embodiment of the invention, the drugs in the drug list are classified according to a patient condition for which the drugs are effective and the onscreen drug selection procedure lists multiple drugs for treating each patientproblem. In an alternative embodiment, the user makes a drug selection by generic or brand name or some other drug identifier~ and the svstem supplies, suggests or requires, entry of an appropriate treatment condition so that the patient record is completed with the condition or conditions for which the selected drug is prescribed.
The invention also provides a user-adaptive prescription management system for electronic prescription creati~n by a prescriber at a point of patient care, said prescription being usable by a pharmacist to dispense drugs, said prescription management system comprising:
20 a) electronic posting means to select and capture in said prescription:
i) a patient identifier;
ii) a prescribed drug;
iii) a dosage for said prescribed drug;
b) a patient-condition treatment specification procedure whereby in creating said prescription said prescriber specifies a patient condition for treatment by saidprescribed drug;
c) an onscreen drug selection procedure having a patient condition list specifying multiple possible patient conditions, having a drug list specifying multiple possible prescribable drugs and having drug specification means to select and post a desired drug to said prescription; and

3 ~1 ~

d) traclcing means to track preferred data usage bv a user and to adapt data displays to favor such ~reft:lled usage, wherebv the system learns and adapts to a user's habits;
wherein drugs in said drug list are classified according to a patient condition for 5 which said drugs have efficacy and said onscreen drug selection procedure lists multiple drugs for treating each said patient problem.

Drug lists or individual drug selections or suggestions may be presented to prescriber-users in any of a variety of ways for example by frequency of prescription for a10 selected condition, based upon either the user's historical prescription activity or a --- wider base of historical prescribing activity, which could be nationally or regionally defined or derived from a drugs benefit house, health maintenance organization, hospital or other appropriate institution.

15 ystem suggestions for condition-related drug selection may be further refined into categories such as relative cost, generic or brand name and so on. Where many drugs are available for treating a patient's active condition, one particularly usefulpresentation is by multiple lines of therapeutic preference according to drug formulary guidelines. Thus, within the patient's particular formulary there may be 20 suggested firs~, second and third lines of therapy. Different suggestions may be made for different patients according to the ~refelellces of the patient's particular drugs benefit management company.

Pl~fe~bly the system includes a comprehensive database of approved drugs classified 25 by conditions for which they are lcnown to have therapeutic effect and this database need not be maintained in the users station but should be accessible in real time to the user. Many valuable professional benefits are obtained by delivering a selective listing of drugs by condition to a physician. For example in treating a particular chronic condition such as gastro-intestinal disease, a physician rnay find that 30 common medicaments such as antacids are ineffective, that a particular brand name 3 ~ 9 drug such as TAGAMET (trademark) has, witll prolonged use, undesired side effects so that the physician may at this point be interested in gaining information about alternative drugs with which thev are less familiar. If the physician does not have the information at their finger tips, this could be a time consuming process in their office reviewing files and other archival information systems they have. Alternatively on-line electronic services may be used but this can also be a time consuming process.
By offering a comprehensive selec~ion of drugs lcno~vn to be effective for a particular condition, this problem is easily solved for the physician. The preferred embodiments include baclc-up prescribing information on each drug, along with details of literature references supporting its manufacturer's therapeutic claims or with means enabling the physician promptlv to obtain such references.

The invention is not limited to providing a prescription management svstem. It can provide, in the medical field alone, systems for clinical laboratory management, for medical record management for radiology management and the like. In addition theinvention can provide novel professional data management systems that can createnew products and yield comparable benefits in other professional spheres where professionals are responsible for specifving more or less complex technical products to solve client or customer problems.
In this wider aspect the invention provides a professional product specificationsystem for electronically creating a technical specification usable bv a professional to specify technical products said product specification system comprising:
a) electronic posting means to select and capture in said technical specif1cation:
i) a customer identifier;
ii) a specifled product; and b) an onscreen product selection procedure having a product benefit list specifying multiple possible customer benefits having a product list specifying multiple possible specifiable products and having product specification means to select and post a desired product to said specification;

3 ~ ~

wherein products in said product list are classified according to a customer benefit which said products can provide and said onscreen product selection procedure lists multiple products for providing each said customer benefit.

S BRIEF DESCRIP~IC)N OF THE DRAWINGS
By way of example, some preferred embodiments of the invention are described in detail below with reference to the acconnpanving dra~,vings in which:-Figure 1 shows a system entl~ screen of a prescription management system embodimen~ of the invention which system incorporates the screens of Figures 2-1 1;
Figure 2 is a patient selection screen;
Figure 3 shows a prescription creation screen;
Figure 4 is a condition list selection screen;
Figure 5 is a condition selection screen;
Figure 6 is a drug selection screen, condition specified;
Figure 7 is a nonformulary drug selection screen;
Fig~lre 8 is an alternative condition-specification and drug selection screen;Figure 9 is an alternative direct drug specification screen;
Figure 10 is a condition selection screen, drug specified;
Figure 11 is a drug selection evaluation screen;
Figure 12 is a single prescription history screen.
Figure 13 is a patient problem historv information screen; and Figure 14 is a manually updatable problem list maintenance screen;
Figure 15 illustrates a scheduled dosage drug paclcage; and Figure 16 is a schematic diagram of one way of connecting users of the prescription management system of Figures 1-14 with remote source databases across network to provide data and processing resources needed duling operation of the prescription management svstem and useful inter alia for creation of a virtual 2~0~3~ ~

patient record.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Overview 5 The prescription management system illustrated in Figures l-14 can be provided in software for single-user operation ~n a stand-alone personal computer for use, for e~cample, by a sole practitioner or for multi-user operation on a local area network for use, for example, by physicians and other prescribers within a single facility, hospital, group practice, or the lilce prescribing organization, and the invention can bring 10 substantial benefits to such users and their patients.

However, more significant benefits can accrue to patients, phvsicians, drug beneflt providers and the public at large bv implementatioIl of the described prescription management system on a regional or nation-wide basis. To this end, a preferred 15 embodiment of prescription management system comprises a host computer facility supporting wired or wireless network deliverv of user-relevant components of said prescription management svstem to multiple remote user interface devices.

The host computer facility provides data, or access to data, data processing and20 communications resources for users to draw upon via the user interface devices. The host computer &cility can be a server or cluster of servers with associated datastorage volumes, and at least one intelligent client providing access to the server or servers. As will be explained in more detail hereinafter, especiallv with reference to Figure 16, the host computer facilitv can call upon a varietv of external resources and 25 functions as a marshalling and processing center for organizing resources into useful and manageable pieces for utilization bv limited capacity user-interface devices. In a e~ll~d embodiment it is a co-ordination point on a network for a number of user-device clients. Pl~fel~bly the network accesses or includes a number of remote ~l~t~h~ce sources providing useful information elements to the system.

.

2 ~ 3 ~ ~

eferring to Figures 1 to 14 of the drawings, the screens shown emplov user-friendly data selection and data entry devices such as are familiar to manv computer users in Apple Corporation's Macintosh~ (trademark) and Microsoft Corporation's Windows operating systems, for example activatable buttons, pointers, scroll bars, icons, arrow 5 lcey, drop-down menus7 windows and other screen svmbols designed for ~ctll~tion by a pointing device, for example, a mouse or traclcball. More preferably, for compact "pocket-boolc" computer applications, the pointing device is a pen or stvlus.

The prescription management system shown in this embodiment of the invention has10 been designed for implementation on phvsicallv compact, portable, user-interface devices such as small portable personal computers, especiallv hand held devices Icnown as personal digital assistants. Those slcilled in the art ~vill understand that the system can readily be used on or adapted to other hardware platforms, for example, a physician's deslctop computer and can be expressed in different software interfaces 15 from that shown, especiallv ones that use different input devices such as Iceyboards, touch pads or touch screens and the like.

Pursuant to certain user-adaptive aspects of this invention, the screens automatically personalize themselves, with use, to adopt the patterns and habits of a regular user of 20 a particular device platform for the svstem, offering the user their most frequently used information, drugs, conditions, patients or patient groups, and so on as first line . .
choices. This adaptive characteristic is a valuable benefit endearing the system to experienced users who may become impatient with hierarchically accessed data.

25 Ease of use and suitability of the system to keyless or minimally keyed platforms, especially PDA's is promoted by minimizing the need for actual text or data entry by the user and by emphasizing instead data selection from extensive, preferably comprehensive, data lists. r~cfcLled embodiments of the invention allo~v quiclc pen selection of data items through columnar pick lists.

~2~3~ ~

The data lists, categories, groups7 addresses or routes, can be organized in multiple hierarchies for rapid and flexible access to multiple large, remote databases, via multiple access routes to retrieve multiple relate~ data elements and assemble them into a single data file, for example, a patient history file compiled from the data 5 resources of a patient's historical health providers.

A desirable goal is to provide the physician-user with intelligent data lists that are, where possible, exhaustive and list, for example, all prescribable drugs, all conditions, all formularies or all patients and present the physician with helpful first-line choices 10 or defaults selected intelligentlv on the basis of historical data Icnown to the system.
Preferably, the selection means is fullv svstem embodied, or automatic, operating transparentlv to the user and requiring a minimum of configurational or setup operations by the user.

lS Virtual P~tient Record An ability to compile ~vhat may be tenmed a "virtual" patient record from multiple remote databases of primary source infonnation is a valuable novel feature of preferred aspects of this invention. uch a virtual patient record can be created in a chronologically cunrent version bv online intenrogation of all possible primary sources 20 of electronically recorded patient history elements, by retrieving those elements and assembling them into a complete record. Yet the record need neither be drawn from, nor committed to, permanent storage, obviating storage requirements for accumulations of patient records.

25 The record can be assembled dynamically, on an as-needed basis, consulted by an authorized system user, and then dissolved, ~vithout ever having been saved, giving the record a virtual character.

ecord element retrieval and record assemblv are conducted under the auspices of 30 the host computer facility emploving a novel patient data directorv service providing - 2~0~3~ ~
!~ WO96/13790 5 PCT/US95114118 routing inforrnation to each patient's record elements. For each patient, the patient data directo~y service lists all institutions, including independent physicians,hospitals, HMO's, insurance companies, and so on, Icnown to have source historical records on that patient, against a unique patient identifier, such as described 5 hereinbelow. Also listed are routing or address data enabling the host facility to access institutional databases to retrieve record elements. Access protocols ~let~iling, for example, what data can be accessed, when it may be accessed, by whom or by what organization or department it may be accessed, can be kept in a patient-specified directory, or elsewhere.
Patients not listed in the directorv service can be searched at the remote source databases and, optionally, at other, host computer facilities supporting the inventive system for other groups of users 15 The complete, assembled patient history, or record, need never be stored, unless the patient requests or consents to such storage, and it serves some useful administrative or care-related function. torage or archivillg of a record that is potentially updatable from multiple uncoordinated locations has tlle dra~vback of dating it. To becorne current, the record must be refreshed from any database containing a new data 20 element for that patient.

By using a dynamicallv assembled virtual record, and never storing it, potentialproblems of maintaining patient confidentiality and preventing unauthorized access to highly sensitive personal information can be mitigated or avoided. This aspect of 25 the invention avoids proliferation of a patient's confidential histo~y and permits primary source data proprietors to act as exclusive ~ardens of their individual confidential data elements.

I~io-pattern recognition 30 Bio-pattern recognition of personal user characteristics including, for example, handwriting, signatures7 voice patterns and fingerprints is an attractive medium for accepting user inputs, but in the present state of development of the technology, suffers drawbaclcs which disfavor use of bio-pattern recognition in ~lef~llcd embodiments of the invention. Future developments such as greater processing 5 capabilities in small user-interface devices, and more accurate and efficient bio-pattern recognition techniques may change this picture and favor adoption of one or more forms of bio-pattern recognition.

Thus, handwriting recognition, is eschewed in preferred embodiments of the 10 invention, at the present time7 because writing is more tiresome to the user than pointing, pressing or cliclcing and adds complexitv and processing overhead to the svstem. Additionally, handwriting recognition7 although presentlv available in pioneer svstems, adds ~Incertainties, mav require significant user effort or adaptation and may threaten data accuracv or promote user error.
ignature recognition may be desirable. if permitted by regulatorv agencies, for remote electronic authorization of ful~lllment at the pharmacy especiallv for mail order prescription fulfillment and the pharrnacy-prescriber link can, if desired, add additional levels of security bv transmitting or exchanging supplemental electronic 20 identifiers.

. . .
However, better security, in terms of ensuring that the filled prescription is released to the intended patient, or their agent, may by provided, by treating an electronic prescription transmission to a pharmacy as an advisorv against which fulfillment may 25 be initiated, while the prescription is released onlv in exchange for a manually signed hard (paper) copy. ignature recognition or transmission as an individual graphicelement, insofar as it may be useful or required in the prescribing process, canaccordingly be incorporated in systems according to the invention. Processin~
demands on the user's device can be minimized by con~lning the device's capabilities 30 to recognition of the signatures of onlv those users authorized to use that particular ~2al~3~ 9 devlce.

Adding higher perforrnance llardware to support the processing needs of handwriting recognition may be impossible with available technology if a ~lcfc~l.d lightweight, 5 compact forrn factor is to be retained for the user's device. An aim of the invention is to provide a qualified prescribing professional with a valuable tool that imposes no significant burdens of weight or volume on the user, that demands little of their time and yet can respond rapidly, delivering valuable drug and patient inforrnation to the user from remotely located, disparate sources. In other words, an aim of the 10 invention is to provide an intelligent, Icnowledgeable computerized prescription pad.

This aim could be compromised bv adoption of handwriting recognition technology at the date of this application. imilar problems applv to voice recognition as asignificant data input medium. Either or both handwriting and voice recognition 15 may be valuable enhancements of future embodiments of the inventive svstems especially if future technology malces these capabilities available on smaller user devices. In particular, limited voice recognition mav be valuable as a user identifier for pass~ord access or as an authorizing signature.

20 Securitv _ ecurity may be provided by password protection operating hierarchicallv on one or more levels, to provide varying degrees of access according to the user's level of authorization, as desired. Additional password or numeric code control may protect sensitive sys~em-accessed information, for example, patient records, or parts thereof, 25 or physician user data, including personal lists and prescribing profiles.

Patient record access codes can, in selected instances, be patient provided, or granted by intelligent security control cards, having been furnished to the patient by a system administrator, or agent, prior to the phvsician encounter. Physician or other user 30 access to a patient's record, or to sensitive details thereof, can thereby be restricted to . .

.

2 ~

a need-to-lcnow basis. Access bv third parties to phvsician-related data can be similarly protected.

Provision for override of such security features should be available, for example for an 5 emergency room doctor, and is allowed on a special case exception basis, is auditable, and traceable to the overriding user.

Password-controlled access to manv computer networlcs is often worlcstation dependent with each worlcstation using a unique password to access the network.
10 Although user passwords may also be employed7 these are often worlcstation-dependent, for example7 being incorporated in the worlcstation's login scripts. In contrast thereto the present inventioll prefers that user access to the host computer facility be device-independent so that a given user can access the svstem via any of numerous devices, provided they have the right password or passwords. By this 15 means, users are not dependent upon a single device that may be lost or misplaced.

A still more preferred feature is to have user passwords wllicll link each user with an individual profile or style sheet on the host cormputer facilitv representillg the user's patterns of ~cfclc.lces so that the user-customization features of the svstem, which 20 will be described more fully hereinafter, are readilv available to the user independently of the particular interface device that happens to be emploved foraccessing the system.

These and other device-independent features can permit the prescription 25 management system to be fully operative without committing useful data to storage on the user device. This is a valuable security feature. In the event of theft or attempts at unauthorized use, even by slcilled third parties, a user device will be worthless as a means to access sensitive data on the system or to use the systemillegally.
30 Optionally, lost or stolen-devices can be deactivated bv the application or bv system 2 2 ~

software, after user notification, bv erasing or otherwise rendering device-resident application procedures inoperable, ~ithout loss of device-resident data. Use of a virtual patient record, as described herein, ~vhich need not be stored locally, is a valuable safeguard against unauthorized access of confidential data on lost, stolen or 5 "borrowed" user devices.

Host computer facilit~
Currently contemplated preferred embodiments further control the processing and storage demands placed on the user's device by intelligentlv delegating data-10 processing and storage activities to a linlced remote, host computer facility, aslefelenced above, to the extent warranted bv the capabilities of the user device.
Thus, for example, a comprehensive dIug database mav be stored and maintained onsuch a host computer facilitv with selected data, for a particular dnlg list or an individual drug's formulation characteristics, being forwarded to the user's device on 15 an as-needed basis, then being eliminated from the user device when no longerrequired. Other activities may advantageouslv be perfor~ned locallv on the device, such as dynamic assembly of records from elements retrieved across the network from remote storage, and storage of the user's personal or most frequentlv referenced data and data lists, where the device's capabilities permit.
Where the user device is more powerful than present-day PDA's, for example a present-day deslctop computer or perhaps the PDA's of the future, more processing and data storage functions can be retained at the user device rather than delegated to the network. Although permanent (disk, dislcette or flasll memory) storage may have 25 uses, security concerns can be better managed on the network than on the userdevice, so that it is preferred that minimal data be permanently stored on the user device. Accordingly physical storage resources of limited user devices are ~.efc,ably allocated to AM rather than permanent storage.

30 Advantageously, a user profile can also be stored on the host computer facility so that 3 ~ ~

if the user device is lost, broken or stolen7 a new device can be automatically reconfigured across the network linlcing the user to the host facility, so that the application behaves the same.

5 Preferably such a host computer facility also provides customized services to each user device, pelro~ ing "user-adaptive" functions for that device, as described herein7 to adapt it to its authorized user or user's prescribing behavior and improve the level of assistance provided to the user. Employing such off-loading techniques, permanent storage capabilities of the device can be minimized in favor of faster AM
10 storage capabilities.

The screens are designed to be non-intimidating to computer-inexpelienced professionals and to present familiar informatioIl and terminology to them whileavoiding specialist computer jargon. Individually7 they are easy-to-use for novices yet lS rapid enough for experienced users. Collectivelv7 they provide an appealing system interface whicll can Qexibly integrate into a physician's personal work flow.

In addition7 the screens are laid out in the manner of appealing logical forms that echo familiar data formats encountered by a physician in-their dav-to-dav work. An 20 important objective is to make the screens self explanatorv within the professional's normal terms of reference so as to avoid any need for access to heip7 although of course, HELP buttons can be provided if desired and extensive help documentationcan also be provided. ystem utilities such as indexing7 setup and purging are either concealed from the user or removed for execution on a remote host computer facility.
25 Data integrity and availability responsibilities are also delegated to the host computer facility, or its remote data suppliers. Thus data saving7 archival7 baclcup and data-replication functions are host facility responsibilities7 not concerns of the user.

The system is designed to require a minimum of actual text or data entry. o far as 30 possible, item entry is effected bv selection from lists of items7 for example bv 2 ~

highlighting an item, then cliclcing a mouse, or more preferably penning, to activate an item.

The prescription management system is made as user-friendly to physicians as 5 possible, for example, by using familiar professional terminology and abbreviations.
Thus terms such as "Patient" or "Pt", "Drug" or "Rx", "Condition" or "Dx" and "Treatment" or "Tx" are used rather than confusing generalities such as "subject" and "item" that often appear in generic soft~ are. The Prescription Management ystemshown in this embodiment of the invention has been designed for use with small 10 portable personal computers, especiallv hand held devices lcnown as personal digital assistants. Those slcilled in the art will understand that the system can readily be used on or adapted to other hardware platfonns, for example, a phvsician's desk top computer and can be expressed in different software interfaces from that shown.

15 eferring now to Figure 1 the system entrv screen illustrated has a user-customizable button bar 10 which has been set with a conventional Quit button 12 and a Help button 14, along with a Mail button 1 6 for accessing an electronic mail ("E-Mail") system, a Prescribing button 1 S for accessing tlle prescription management system embodiment of the invention, an Encounter button 20 for accessing a patient 20 encounter management system (not further described herein). Ans Svc button 22cP~S.5~ an answering service screen (not shown), which as a convenience functionean be~m.~lly linl~ed ~via the host cor..puter faci!ity to log inco~PIing r~!!s .~or the user. The answering service is preferablv intelligent and prioritizes, bv flagging or displaying, patient- or treatment-related calls, for example tllose from a pharmacy, 25 while screening out or de-prioritizes less relevant calls.
. .

- History-cognitive drug and condition listing A Doctor's Lists button 24 accesses a more or less complex display of patient condition and therapeutic dnlg lists. Preferably, the dnlg and condition lists are 30 linlced together to associate a dnlg with one or more conditions for whicll it might be 2 ~ o ~

prescribed and, in most cases to provide the phvsician user with a conveniently displayed, concise selection of drugs for treating any particular condition. In a ~rcfe~cd feature of this invention, the system has a user-adaptive character andadapts itself to the user's habits and prescribing patterns so as to seni~ice the user 5 more efficiently. To this end, the drug lists or the condition lists, or both, are system-modified with use to reflect the prescribing frequency of particular drugs or the frequency of occurrence of particular conditions. Thus, more frequently prescribed drugs or more frequentlv encountered conditions can be presented to the user physician in a more prominent manner or more immediate manner than ones 10 found by the system to be historically less common in the particular user prescribing -~ environment. In this way the system becomes more valuable with use as the drug and condition lists develop into personalized lists featuring the user's preferences.

With such cognitive features the inventive system is effectivelv cognizant of ongoing 15 prescribing activity. It comes to Icnow its user's environment and preferences, can adapt itself to any number of specialist situations, and can, if suitablv equipped7 subtly prompt the user, online with original, relevant, but elusive information derived from the user's computer-memorialized practice experience. For example the system may prompt the user that the last time Drug X was prescribed for Condition Y, 20 Patient Q reported adverse reaction Z. Where the host computer facilitv documents a catalog of l<nown adverse reactions to system-listed drugs, a system enhancement can report new adverse reactions to the user or centrally, to the host computer facility, by traclcing logged patient conditions and relating them, where a~ liate, to a previous prescription. In similar manner the system may log drug-drug 25 interactions, which interactions can also be associated with a target condition or conditions. Many other valuable retrospective statistical studies and analyses are made possible by deployment of the invention, as will be apparent to those slcilled in the art. While such studies are potentially of immense public value if widely implemented, careful controls will be required to avoid reporting unrelated 30 conditions as adverse drug reactions.

2 ~
~ WO 96/13790 -23- PCT/US95114118 With time, as it adopts appropriate specialist prescribing patterns, the user-adaptive prescription management svstem of the invention can be just as relevant and useful to, for example, a specialist in tropical medicine as it is to a pediatrician. This desirable result can be achieved without encumbering either specialist with the needs 5 of the other.

Those slcilled in the art will appreciate that the invention's cognitive, user-adaptive features employ significant programming routines and procedures and are quite different from common, user-responsive soft~are defaults which merely offer defaults 10 pre-set by the user or simply show the last used item, file or the like as a default.

If desired, the user's prescription management svstem can have built-in, online,statistical reporting functions enabling a phvsician user to review their, or others~
historical experience with a particular drug or condition and providing online 15 historical review of any other activities or data entrusted to the system.

Of scientific note is that the system is priw to and operates at the confluence of three powerful emergent data streams: encvclopedic data on therapeutic agents intended to moderate particular conditions or patient problems; data on individual 20 prescriber activity using slcill and judgment to diagnose conditions or problems and malce prescribing decisions selecting and applying therapeutic agents to diminish dlagnosed conditions; ~nd patient histol v da~ recording not oldy presclibing decisions but also the results of those decisions (see the description of Figure 12, below). Thus, the system captures not only prescribing activity but also the 25 pres~iber's intent, the problem or condition targeted by the prescriber in specifying a particular drug, and can track the success of that intent. The linlcage of treatment with condition treated captures the reason why the doctor took the prescribing action .
that was talcen. This intent may, and can legally, be different from approved FDA
therapeutic indications for a drug.
--~ ~ 0 ~ 3 1 ~1`

Of commercial note is that the foregoing data may be aggregated for multiple users, for example by the host computing facility, for marlcet research purposes. Also, an individual user's prescribing pattenns mav be reviewed by the user or by others. For example, drug benefits companies, can revie v the user's prescribing pattenns for 5 formulary compliance and respond by encouraging better compliance, where a~,u~liate. elease of such data to third parties can be controlled to safeguard the privay of the prescriber, or other health care provider, by prescriber-determined data access protocols specifying who, or what organization, department or group, may access what data, when they may access it and what they can do with it. For 10 example, one physician may penmit academic use for research studies and prohibit commercial use while another may permit either.

As will be described in more detail subsequentlv, a range of optional features, for example the answering service and e-mail features mentioned above, or other 15 communications features, can be made available from button bar 10 providing the user with user-configurable means to custolllize the system to their personal needs and tastes.

Intelligent drug-selection procedure 20 lceptical prescribers are encouraged to adopt the prescription management system of the invention, by its ability to bring to the point-of-care, in readily utilizable form, a battery of relevant drug-specification infonnation and important patient-relatedinformation, much of which is not readily accessible at the point-of-care by conventional means.
Pl~fel~cd embodiments of the invention achieve this desirable result by providing an intelligent drug-selection procedure which is supported by transparent connectivity to multiple remote proprietary infonmation systems at the point of care, enabling aphysician to draw upon the following categories of data:
i) physician-user prescribing-frequencv data;

22~3~ ~
-ii) patient drug formularv information as to a drug's status with a patient's drug benefits provider;
iii) drug dosage characteristics7 for example, form7 size7 route of administration, amount, frequencv and the like;
iv) drug-specific treatment information as to condition-related efficacy, and preferably as to contraindications and adverse reactions;
v) relevant patient history information as to current and previous prescriptions, and preferably also, pursuant to the teaching of the present invention, problem-history inforrnation; and vi) laboratory and other diagnostic test information related to the patient's indications, to dosing, to therapeutic choices or to specific drug selections.

Preferably, this data is brought to the point-of-care by relying upon retrieval from 15 remote source ~l~t~h~ces at remote facilities responsible for capturing original update data, and not by relying upon redundant non-source data requiring constant synchronization with source data to remain current.
Diagnostic tests I~ms i)-v) above, will be described in considerable detail hereinafter. With regard to 20 diagnostic tests and procedures, for example radiology, the invention contemplates electronically bringing relevant information to the point of care to assist health care providers malce informed decisions. uch diagnostic information may comprise recommendations for clarifying a tentative diagnosis, or choice of diagnoses, or may comprise diagnostic results that can be used to malce more informed therapy 25 decisions and, in particular, to malce better therapeutic drug selections. Body system function tests" for example renal or liver function tests are clearly valuable to a drug selection process, since renal and liver condition are important in determining dosages of some medications. Other therapy-relevant diagnostic determinations can usefully be presented at the point of care, by means of the present invention, for 30 example, drug-level determinations can enhance dosing decisions.

WO 96/13790 ;~ 26- PCTIUS95114118 ~tient encounter program A useful, prescription management system-compatible patient encounter program can begin u~ith a patient selection screen such as that of Figure 2. The patient selection screen of Figure 2 can be activated by any one of multiple programs which may, for 5 example, be initiated via the system entry screen of Figure 1, but could be independent, free-standing programs or any other program for which the ability to create, update and modify a patient-specific record or a patient history is valuable.

P~efe~,ed embodiments of software procedures (or programs) associated ~vith the 10 novel patient record selection procedure illustrated in Figure 2 can access multiple remote databases to retrieve patient records, for example, bv using the host computer facility, and can also post new patient records, and updates, created locally by the physician-user, to the multiple remote databases in real time, or in batch mode.

15 Patient record source data ource data for a typical patient record may l~e distributed across multiple, geographically dispersed, electronically incompatible, remote databases maintained for example by drug benefit companies, insurers, laboratories, medical facilities, diagnostic testing facilities and health maintenance organizations, including 20 government agencies (MEDICAID, MEDICA E, etc.) and health care providers themselves, that have serviced the patient in the past. ICnown automated patient . . .
record systems either ignore such remote data and ~vork only with data created at the maintaining facility or vertically integrated health care organization, or create and maintain duplicates of the remote data.
till more ~c:fe~led embodiments of the invention provide substantial savings of resources, time and effort by using only source data for patient records, minimizing creation of multiple redundant local ~l~t~ ces that require constant synchronization with remote sources if they are to remain accurate and up to date.

220~3~ ~

The invention also provides novel data-retrieval network systems to retrieve relevant patient data elements from multiple remote heterogenous primary source databases.
Preferably, every time a host computer facility receives a call from a user device for a patient history or patient record, relevant data elements, for that record, or a record 5 component (e.g. the most recent six-month or t~velve-month portion), are retrieved from remote source databases, dynamically assembled, or integrated, into a virtual patient record, as described above, and delivered to the user device as an integral system data set. Alternatively, record assembly, which does not require undue hardware resources, can be performed on board the user device.
--- The record is viewed and may be printed out bv the user, ~ith patient authorization, but does not need to be permanently stored.

The host computer facility responsible for dynamic assembly of the virtual record 15 logs the time, date and calling user to provide an audit trail of access to the patient's record, but does not commit the record to permanent storage. After use, the virtual patient record disappears, although it can be reconstructed archivallv.

If the record is required again, it is assembled anew, thereby incorporating any20 updates that may have occurred in the interim, for example changes in drug benefit status, insurance coverage or the lilce, newly generated laboratory, radiology or other diagnostic results, or other, e.g. emergency, prescriptions dispensed. The act of assembling a record externally of its sources immediately dates the record: it is cut off from any updates, and therefore liable to become incomplete, obsolete or dated.
25 Virtual patient record assembly, as described herein, avoids this problem maldng local storage of patient records unnecessary.

Transactions are archived by the host system to provide a complete transaction history, so that past activity can be reconstructed. uch a data-réconstruction 30 capability to provide clear hind vision of the patient's record at any given time is an 2 2 0 ~1 3 ~ ~

important medicolegal capability. That historical version is preferably reconstructed from a transaction log and assembly of timed and dated record elements, or segments, in a manner not unlike that used bv version control software.

5 Creating a virtual patient record permits optimal data currency and accuracy and, by avoiding unnecessary redundant copies of patient data minimizes liability for misuse or unauthorized access. Patient confidentiality can be maximized and is verifiable by the system-generated audit trail.

10 Preferably for individual record elements to be admitted to the system, they are required to be at least dated and preferablv also to be timed at source, such timing and dating relating to whatever event created the record. In addition to its value as an integral record characteristic, chronological data is useful for retrospective archival reconstruction of a record as it existed (in its elements) at any given point in time.
15 This can be achieved by retrieving record elements, as described above, using a suitable date filter and if appropriate, a time filter, to include only those (or selected ones of those) record elements that existed at the desired given point in time.

uch an archival retrospective record reconstruction capability is a highly desirable 20 adjunct to the virtual patient record described l-erein permitting full creation and examination of any desired historical records, such as may be required for review or legal purposes.

Using the above-described method of dynamic retrieval from remote databases across 25 a data-retrieval, record-integrating network, source database proprietors can remain wardens of the only copy of that data and obtain patient authorization to be the sole repository of that data. Laboratories can lceep laboratory records; insurance companies can lceep insurance records; hospitals can lceep hospital records; andhealth maintenance organizations can Iceep their own records; without ever having to 30 release copies of these records into external electronic storage bv third parties, with ~ WO96/13790 29 PCTIUS9~114118 the security hazards attendant upon such releases. Any electronic release made externally using the data access control features described herein can be assured of always being authorized by whatever entitv, be thev patient, phvsician or organization, that has proprietary rights in the data.
Figure 2: Patient selection screen Upon selecting Prescribing button 18 bv cliclcing or pen contact, a patient selection screen, for example as shown in Figure 2, is displaved as a preliminary to prescription management functions. eferring to the patient selection screen of Figure 2, the 10 name, age, gender, and social security numbers of patients who have authorized the user physician to treat them, or to access the svstem on their behalf, are listed under respective column header buttons, namelv, Name button 26, A~e button 28, Gender button 30 and Social Security # button 32.

15 Lists can be scanned, or text entries made in a blank search box 34 at the top of the screen, using string or full name searches to locate the desired patient or to review the patient list. Column headers 26-32 can be clicked or touched to sort the patient list on any of those fields and activate search box 34. earch box 34 is linlced to the sort fields so that, for example, if the listing is sorted bv social securitv number then 20 alphabetical entry attempts are rejected from search box 34 and numeric entries are used as social security number }ocators. Tl~e characters can be keyed or system provided from pop-up screens, or voice or handwriting recognition may be emp}oyed.

New Pt button 36 activates a new patient entry bar, while the Ok button 39 accepts 25 a highlighted patient selection and advances to the prescription management screen of Figure 3. Cancel button 38 returns to the system entry screen of Figure l.

If desired, preliminary selection of groups of patients can be made by providingvarious patient lists, for examp}e "Todav's Patients", "In-Patients", "Out-Patients", 30 "Private Patients" and the lilce. uch patient lists are preferablv svstem-maintained, W096,l3790 2 ~ ~ ~ 3 1 ~ PCT/US95/14118 ~

on an ongoing basis, using the latest data available to the system and preferably enable the user to select a convenient group of patients that has a high probability of including the next patient or patients to be encountered, thereby speeding access and retrieval of a desired patient record. Where tlle user typically encounters patients in 5 groups, for example one group in an out-patient clinic and another group in an in-patient clinic, such grouping of patient records into lists also facilitates organization by a host computer facility of display data into small batches that can more rapidly be communicated via limited capacity copper wires and modems and are of a size that can conveniently be held in AM on a small, portable user device.
Patient Data Security Critical to public confidence in the prescription management svstem of the invention are issues of security, since the system requires access to personal records. Many people will fear unauthorized access to or use of their personal information.
15 Preferably, the invention provides careful controls to alleviate such fears and to prevent unauthorized access to a patient's data or to their physician's prescribing profiles.

Preferably also, the system, or an associated support network, provides data access 20 controls such that the only accesses that can occur are those that have been authorized or pre~uthorized, at a point of care or elsewhere, in accordance withsecurity profiles on the network established Oll behalf of data-proprietor entities such as patients, physicians or organizations. It is further preferred that the entity's security profile, or filter, details what data can be accessed, when it may be accessed, 25 where it may be accessed and by wholm it mav be accessed.

Various suitable data access control measures will be lcnown to those slcilled in the art and considerable security can be obtained bv using more or less complex identifiers for patients or for physician-users of the svstem or for both.

22~3~1 ~
~ WO 96/13790 -31- PCTIUS9~/14118 Patient records should use a standard identifier to be clearly and distinctly identified with a confidence level a~ yliate to the expected patient population in the lifetime of the system so that the records of patients with similar or identical names are not confused. If desired, a coded alphanumeric patient identifier (not shown) may be5 used. Alternatively, or in addition, other unique patient identifiers such as social security numbers may be used alone or as secondary references in conjunction with patient names and the lilce.

More relevant to security is proper identification of a user to whom patient data is 10 released or from whom new data is received by the host computer facility. While numeric or alphanumeric user identification codes provide some level of security, higher levels are provided bv using graphic7 photographic or fingerprint recognition to identify a system user.

15 More preferred embodiments of the invention can ensure a still higher level of confidentiality by automatically maintaining a complete audit trail of access topatient data. Preferably the audit trail details, for every access, who or what organization accessed the record, wllat part of the record was accessed, when it was accessed (both date and time) and what was the purpose of viewing the record.
20 Thus, associated with every patient record is a timed and dated log of every physician user, organization or health care professional accessing that record. If desired, the log can be reported, or made available to a patient, on request, for example throughonline access (with careful security controls), via print or fax, and so on.

25 Patient-directed control of the flow of their own data, a novel concept in medical or health care information systems, can be achieved by centrally inputting at the, or a, host computer facility patient-generated record-access specifications to determine which users, or user organizations or departments (for example clinics), can access what data during what period and what uses can be made of the data. Clearly, such 30 specifications must not deleteriouslv restrict physicians in the execution of their 2 ~ 0 ~

professional missions. uch record-access specifications or profiles could be maintained at a remote database rather than the host computer facility. Thus, access to their records is controlled by patients and individuals and organizations can be given patient-defined, selective access or access based on a need to Icnow, or a patient 5 may block access to all data flow, if they wish. In emergencies, physicians may be able to override a patient security block, but such events are recorded so that any abuse can be monitored and action can be talcen to discourage abusers.

MD-Related Data Security 10 Many similar data security considerations apply to prescriber-related data. Used comprehensively, as it is intended to be, the system is privy to full particulars of a physician user's professional prescribing behavior, dav in, dav out, potentiallythroughout their career. ystem resources may be used to compile any desired historical record of a user's prescribing activities. Patient-confidentiality aspects of 15 this data have been addressed above and can be satisfactorily managed by controlling access to patient-related data in accordance ~ith a patient's previously, or currently ~,csscd wishes, as described herein. In addressing physician-oriented prescribing issues, the historical record may be rendered patient-allonymo-ls by stripping the data of recognizable patient identifiers, or aggregating the data. The resultant20 historical prescribing data can communicate significant information about the prescriber, is personal and proprietary to the prescriber.

Pursuant to this invention, the prescriber's rights in their historical prescribing data are protectable in a manner similar to the protection affordable to patients, by25 providing prescriber-determined access control specifications detailing permissible levels of third-party access to prescriber data. uch prescriber data access control specifications can be stored in individual files on the network and can comprise as to who or what organization, or type of organization may access what data, for whatpurpose and for what period of time such access right may be effective. Clearly,30 multiple levels of access control may be described to any desired degree of complexitv. User preferences mav include user authorization for data access byvarious third parties for example health maintenance organizations (HMO's), hospitals, government agencies, managed care organizations and so on.

5 A particular group to whom a prescriber may wish to yield access rights comprises collective bargaining associations, for example independent practitioner associations, ~-efc,lc;l provider organizations and physician hospital organizations. Preferably, all accesses to a prescriber's data are system stamped with a date, time and accessor ID, to create an audit trail of such accesses, similar to the audit trail left by accesses to 10 patient data.

ystem-determined access control can be invoked, whenever a prescriber data access request is received, by referencing the prescriber's access control file and permitting or denying access in accordance ~ith the file's speci~lcations.
Prescription creation screen 39 eferring to Figure 3, prescription creation screen 39 has a full a;ray of user-activatable buttons enabling a phvsiciall to dra~v Oll powerful resources ~ithin the prescription management svstem and supportillg it in the host computer facility and 20 associated data-retrieval net~vork, as will shortlv be described. Near the top of screen 39 is a patient features bar 40 belo~v ~vhic}l a prescription features bar 42 coordinates all features necessary to review currellt therapv and order changes in treatment, or order new treatment, for the selected patient. A prescription history zone 43 extends across the middle of the screen, the lower screen portion contains a prescribing zone 25 44, and a screen title 45 appears at the top of the screen.

Patient features bar 40 comprises a Select Patient button 467 a selected patientindicator 48, in this case Mary Harrington, a patient Problems button 50 and a patient Allergies button 52. Beneath Problems button 50 are displayed Mary 30 Harrington's currently active problems 51 or conditions, shown here as pharvngitis 3 ~ ~

and bronchitis. Beneath Allergies button 52 are displayed Marv Harrington's lcnown allergies. Pressing or otherwise activating Problems button 50 or Allergies button 52, opens a window or screen listing problems or allergies from which a physician, or other professional user, can select new problems or allergies to add to Mary 5 Harrington's record, or delete ones that are no longer active. Optionally, system-provided problem or allergy libraries mav be organized into multiple lists with button 50 or 52, respectivelv, opening a list selection box as a preliminary to displaying a selected problem or allergy list.

10 Problems or conditions 51 and allergies 53 are here displaved as a helpful notation for the prescriber and do not become prescription elements as a result of being selected for display in this part of the screen. However, selections made here are functional in that selected problems 51 (conditions) will become defaults or preferred choices in a subsequent condition specification procedure and the system will review 15 any drugs prescribed for relevance to allergies 53.

Prescription features bar 42 comprises an R~c History button 54, an Rx Options button 56, an Updating indicator 58, an Rx Info button 60 and a l~enew R~c button 62.
Prescription history zone 43 displays those historical prescription details that may be relevant to a current prescription and has a Condition field 64, a Drug field 66, a Size field 68 a Dosing field 70, a generic flag 72, an ~xpires field 74 and a Mine field 76, in which the various characteristics of patient Mary Harrington's previous 25 prescriptions are listed.

Prescribing zone 44 comprises three active buttons, New R~c button 78, Send Rx button 80 and Close button 82, below which extends a prescribing header bar 84 which contains field identifiers for data entry of a full complement of prescription 30 details. Available prescription detail fields comprise a Condition field 86, a Drug 3 ~ ~
~ WO 96/13790 35 PCT/US95/14118 field 88, a Generic field 90, a Form field 92, a Size field 94, a Route field 96, an Amt (Amoun~) field 98, a Refill field 100, a Dosing field 102 and an Expires field - 104.

5 Multiple lines of the selected patient's prescription history are listed in patient history zone 43 in the middle of the screen for convenient review by the physician-user, and possible renewal, with scrolling or paging of extensive histories. Depending upon the patient's previous whereabouts and service providers, individual lines may come from multiple remote sources. uch histories are preferablv compiled by the 10 host computer facility in response to a call from the user device (see the description of Figure 16).

Prescribing zone 44, lower down prescription creation screen 39, allows a physician user to select and prescribe drugs and dosages, for the selected patient, in this case 15 Mary Harrington, and to transmit the created prescription externally across a data network to other interested and authorized parties for prescription fulfillment,patient record updating and the lil~e.

Select Patierlt button 46 returns to the patient selectio*~screen of Figure 2 for 20 selecting a different patient from one or more lists. Preferably7 Select Patient button 46 draws up a "Toda~s Patients" list or whichever patient list the user last selected from, or a default, user-selected patient list, and provides the options of selecting a new patient from alternative patient lists.

25 P!roblems button 50 brings up a patient problem history information screen such as that shown in Figure 12 (to be described) in which a historical record of the patient's individual symptoms and diagnoses is listed and to which new problem reports canbe posted. To maintain data integrity, and as a legal safeguard, historical information is not editable but mav be supplemented, for example by reporting the 30 subsequent status of a problem as (still) active or inactive Preferablv, anv such 3 ~ ~
WO 96/13790 -36- PCT/US95/14118 ~l additions to the record are stamped with the identitv of the reporting physician, providing valuable elements of a treatment decision-malcing audit trail.

The patient's drug-related allergies, or drug reactions, are brought up in possibly 5 editable form (screen not shown) by activating an Allergies button 48 and may be automatically system updated, if desired by adding newly reported drug reactions and allergies. Desired personal or drug records relevant to possible allergies of this patient may be summoned from the host computer facility, which may in turn call on the remote ~l~t~h~ce data-retrieval network for records or record elements.

Rx History button 54, scrolls, drops do~m, or otherwise accesses any additional patient history lines beyond what will fit in prescription history zone 43 and may introduce vertical or horizontal scroll bars, or both, into zone 43, enabling the user to 15 display any desired section of a patient's prescription history in zone 43 with the top line of the history highlighted. Any desired prior prescription line displayed in zone 43, can be highlighted by cliclcing or pressing on it.

A highlighted prior prescription can be automatically renewed by cliclcing or pushing 20 an Renew Rx button 62. Typically, prescription creation screen 39 opens with the most recent prescription highlighted for possible renewal. Activating Renew R~
button 62 posts a highlighted prior prescription into prescribing zone 44 for automatic renewal, after editing, if desired. enewal of any prior prescription can thus be effected in as few, as two user steps by pressing Renew I~x 62 to post a25 highlighted previous prescription to prescri~ing zone 44 and a single further action to complete a prescription from there. If desired option buttons such as Renew and Send Last Prescription or Renew All Active Prescriptions can be added.

Pressing header buttons Condition 64, Drug 66, or Expires 74 causes the drug 30 history display to be sorted bv the selected header enabling the prescription historv ~20~3~ ~

to be evaluated according to a particular parameter. This feature is of particular value for patients with long and complex treatment histories.
-An important novel feature of the inventive prescription management svstem is the 5 ability to associate a specific patient condition with each drug prescribed. Bycapturing detailed information on every prescription the system automatically builds a novel patient medical record having new uses in evaluating individual patient treatment and in enabling powerful ne~7 multi-center outcome studies for evaluating therapies in various populations of patients.
-- By deploying the inventive system regionally, nationally or in some other population area, and employing the preferred methods for retrieving patient data from remote sources, as described herein, a complete patient record of all activitv within a region can be built. Preferably this is a virtual patient record dynamically assembled only 15 from original source data, which7 as described above7 is maintained in component form at multiple distributed source databases7 is retrieved therefrom across a data-retrieval network from which the source databases can be accessed, and is compiled or assembled into a single virtual or transient record that appears to the user as an integral system data resource.
Outcome studies. prescription cost savings and drug alerts Patient histories generated by the inventive system can show not only the drugs prescribed, but also the conditions for which they were prescribed, allergies, den~ographics, insurance coverage, treating health care providers, and so on. lCnown 25 medical management systems do not provide listings associating each prescribed drug with a patient condition or problem, as reported to, or diagnosed by their physician.

Careful review of a patient's record for relationships between amelioration of problems and prescription of particular drugs can provide important information 30 about the efficacy of a drug for a particular problem in a given patient. eview of a ~ 2 0 il 3 ~1 ~

physician's prescribing record, detailing the various drugs selected to treat the different conditions exhibited by the patients encountered in the physician's daily practice, can reveal valuable information about the physician's prescribing practices and the degree to which they follow formulary guidelines.
This information is clearly of value to the individual physician and can, if desired, be enhanced by including in the problem record a condition severity rating7 enabling declines (or increases) in severity to be reported. The resultant patient prescription history, replete with dated information as to patient problems, what drugs were 10 prescribed to treat those problems, what forms, routes of administration and dosages were used and, by implication from the timing and nature of subsequent problems7what the outcome of tllat prescription was, provides a very attractive treatmentevaluation tool to a physician, and a powerful inducement to any professionally conscientious physician to use the prescription management system of the invention.
Implementing the invention on a wider scale, valuable new outcome studies and clinical trials are easily, or even automatically, performed. One of many problems in successfully implementing the herein described prescription management system on a large scale is one of funding the system. Medical cost structures, with their 20 reimbursement systems leave little scope for expenditure on aids to overall practice improvements which may have to be squeezed out of tight overhead budgets.
Accordingly, significant cost to the phvsician user, or user's medical facility will be a - major deterrent to system adoption. Preferably the system is provided to prescribing users on a low-cost or no-cost basis with funding from outside sources.
Implementation of the invention is expected dramatically to reduce the overall cost of prescriptions and this saving has been estimated to be from 20 to 40 percent of total prescription costs. avings will accrue initially to the drug benefit management companies who reimburse the direct costs of most prescriptions, but can be expected 30 eventuallv to be passed to corporations and consumers by wav of lower drug benefit 3 ~ ~

rates. uch sa~ings r~li7e~1 on a national scale would amount to many billions ofdollars and provide an avenue of reimbursement for system proprietors. In the early 1 990's, the cost of prescription drug benefits is one of the fastest rising components of all health care costs.
Outcome studies produced by the system may have substantial value to various parties, and their sale can support svstem costs, as may formulary compliance savings. For example7 drug efficacv data is of value to pharmaceutical companies, as is early warning data from reliable specialists regarding adverse reactions. ubject to 10 confidentiality and other relevant controls, such data can be automatically compiled and readily supplied by system management, requiring only approval, not active participation by involved physician prescribers. Equally, the system mav facilitate clinical trials by identifying health care providers or prescribers who would be lilcely participants in trials, based upon their having frequently diagnosed relevant 15 conditions, or specified relevant drugs7 as shown by their historical prescribing profiles, or relevant patient histories. uitable patient pools can be identifiedsimilarly.

Organizations participating in outcome studies, for example health maintenance 20 organizations, insurance companies, hospitals, physician alliances and the like, and may pool their data but may not wish to reveal certain proprietary data. By employing data access control methods for accessing such organizational data, such as the methods described in detail herein for controlling access to patient's rights, the system of this invention can enable organizations to control what data they release.
To implement such clinical trials, additional information required for collection can be obtained by flagging selected prescribers' profiles to trigger additional on-screen routines so that whenever a trial-related drug or condition is selected by the prescriber, they will be aslced to supply necessary additional information. For 30 example, whenever a prescriber participates in a trial relating to treatments for wo 96/13790 ~ 2 ~ ~1 3 ~ 9 PCT/US95/14118 gastritis, the system can request information as to whether certain tests were p~lrolllled, and what were the results of those tests. Thus, the test drug might be a~ liate for, or be in trials relating to, gastritis testing positive to H. pylorz, whereas a different drug would be indicated for H. pylori-negative gastritis.
The system can also provide, preferàbly from source ~t~h~ces, complete prescription drug disclosure requirements as set forth by the FDA, including full cautionary information, for example as is now set forth in the Physicians' Desk eference (Medical Economics) and Physician's Gen x (Denniston Publishing) lcnowledge of l O which by the prescriber may be necessary to avoid malpractice liability, and-- dissemination of which may limit a drug manufacturer's liability. Efficient promulgation of drug disclosure information to system users is tantamount to publication, yet can be more current than any printed document, and may be accepted as an alternative to hard copy publication or supersede it.
In addition, the system provides a valuable means for government agencies and others to communicate important messages, such as drug warnings and alerts, quiclcly and directly to physician users. Electronic mail accessed via Mail button 16 can be used for this purpose, and may include prioritv flags triggering screen alerts, but a 20 much mQre powerful route for communicating warnings relating to particular drugs is to associate the alert with system information on the drug so that when a user calls up the drug in question, they receive the warning or alert, or other special message.

In the extreme case of withdrawal of a drug from the marlcet, that fact can 25 immediately be communicated to system users. Thus a drug can be withdrawn from the marlcet the same day by malcing a system entry preventing completion of a prescription for the withdrawn drug. Alternatively, a warning can be posted directly to the prescription. Current users of the medication can be identified from-prescription history records, referencing not only drugs prescribed, but also 30 prescription expiration dates. Both the patient and their doctor can be notified 2 ~

~ WO 96/13790 -41- PCTIUS95114118 immediately. In this case, electronic mail is a preferred route for notifving the physician.

elative cost-to-benefit data can also readily be prepared in outcome studies when 5 individual drug costs are factored into the data, and such cost:benefit data can~ in some circumstances have very substantial dollar value to drug benefits management companies whose objectives are to maximize the quality of care while minimizing the cost of that care.

10 Pharmaceutical and managed care companies can gain marlceting benefits from use of the system to introduce new drugs or new uses of old drugs to phvsicians, in a relevant manner, at a moment of peak interest.

Other benefits can be derived from outcome studies using the novel drug-prescribed 15 and condition-treated data records provided bv the prescription management system of the invention. For example, the appearance of a new patient problem may be insignificant when associated ~ith prior prescription of a particular drug for one patient, but may gain significance when repeated for a number of patients.

20 Optional system enhancements may enable post-introduction marlcet surveillance of new drugs to be con~ ctetl for adverse outcomes to the treatment of a specified . . .
condition or conditions. For example the svstem may monitor patients reporting new problems after having been prescribed the new drug in question, refer such new problems to ~he physician user to qualify them for medical relevance and then 25 statistically compare a collection of similar reports with data on a pool of similarly treated patients for significance.

Contin~lous post-marl~et-introduction monitoring of a drug in relation to the treatment of conditions is possible, and an end-to-end solution to the problem of 30 managing unanticipated problems arising with new drugs can be provided: the system ~ ~ n ~ 3 ~ ~

provides a vehicle data collecting relevant data; parameters and a means for analysis of that data; and a means for disseminating alerts and advisories regarding newly discovered problems. The same vehicle is used for all three steps.

S With such a system enhancement, one specialist pioneering a new drug for a particular condition may provide an early warning of adverse reactions not identified in clinical trials in a manner not heretofore obtainable7 because of the difficulty of coordinating prescription and diagnostic data.
Quicldy and conveniently presented at the point of care, as an integral part of the 10 prescribing process, in the manner achieved by the system of tl-e invention, this information can be of immense value to a phvsician when treating a patient, widening the physicians' choices bevond their o~vn field of lcnowledge (by suggesting new drug information) and helping the physicians optimize the prescribing process.

15 Another advantage of the invention is tllat each physician user inherently and easily supplies critical enabling data for outcome studies as part of the prescribing process.
No extra effort is required by the physician to malce the data available for studies.
One potential difficulty in malcing such studies is the existence of legal barriers to aggregating patient data into studies without specific patient permission. While this 20 might be obtained on a piecemeal basis or by the prescribing phvsician, a much better solution is provided by centrally maintaining patient directed patient-record-access specifications, as described above. The system can then include only those records of patients agreeable to becoming study participants in such outcome studies.

25 The historical drug-prescribed and condition-treated records obtainable by using the invention can provide a basis for condition-based treatment guidelines developed by drug formularies. This novel data provides a new vehicle for outcome research for managed care, leading to new approaches to cost-effective prescription treatments.

30 Compilation of an extensive or national database of (patient-anonvmous) records ~ 2 0 ~ 3 ~ il providing a statistical historical listing of drugs prescribed versus associatedconditions for which they were prescribed would be in the public interest and ofconsiderable value, so long as patient-confidentiality were maintained. Widespread adoption of the present invention can help achieve this desirable goal. It is relevant S to note that FDA regulations only permit a drug to be promoted for approved7 speafic therapeutic purposes but physicians are professionally free to prescribe an approved drug for any condition for which they believe the drug to be effective or useful so that, failing specific point-of-care diagnostic information, no assumptions can be made as to the treatment objectives of any particular prescription.
10 Accordingly, prior to the present invention, statistical prescribing data have generally laclced lcnowledge of why a physician prescribed a particular drug, and such data is, in most ~es, not useful for outcome studies and cannot be related back to other patient-specific variables present in the patient's medical record.

15 Prescription history record eferring to the prescription history zone 43 of the Figure 3 screen, under the Condition field 64 is listed a condition reported as active when the drug was prescribed. Drug f1eld 66 may be a generic name or a brand name. The Size field 68 is the dosage size. Dosing field 70 shows the dosing frequency. The "G" flag 72 is 20 for generic and is a simple yes/no indicator. An Expires field 74 displavs anexpiration date system calctll~tell from the prescription quantity (not sl-own), the size and the dosing rate and indicates tlle day on which the prescription will run out.

The last colu~n, Mine field 76, is a yes/no toggle flag indicating whether the 25 prescribing physician was the current system-designated physician user ("~' = my prescription) or some other physician ("N"). Another prescribing physician's details and other da~a relevant to a previous prescription can be obtained by pressing R~c Info button 60, or double-pressing or -cliclcing on the a~ro~liate prescription history line, l:o draw down a prescription information screen, for example, as shown 30 in Figure 12. Additional available options, if any, can be accessed through the Rx 1 3 ~1 ~

Options button 56.

Update button 58 can be a simple blinlcing indicator alerting the user that their device is communicating with the host computer facility and actively processing a 5 local update. To indicate additional time taken accessing remote ~t~h~ces, themessage can change to " emote etrieval", if desired. Additionally, Update button58 can activate various update options, selectable from a menu, if desired. For example, Update button 58 may offer a selection of different sources from which to update the patient's prescription history. While a preferred objective of the 10 invention is that the prescription management system obtain a comprehensive, nationwide update of any previous prescribing activity regarding this selected patient, considerations of system speed, system development or marlceting considerations may make it desirable to offer patient prescription histories drawn from all prescribing activity in a more limited geographical region, for example, local or 15 regional updates local network updates or capability to update from the physician's institutional or office practice information systems.

New prescriptions Activating the New R~c button 78 highlights the first available blank iine in the lower 20 portion of the prescription management screen for creation of a new prescription by a physician-user. During the prescription creation process, the user receives intelligent decision support from the system of the invention. Preferably, the system proffers the prescribing physician comprehensive relevant prescribing data to enable creation of a new prescription intelligently, in an informed, manner with routine loolc-up 25 functions being fully automated so that professional time spent on routine chores is mirumized or eliminated. To this end, data entries available via both Condition button 86 and Drug button 88 are selectable from extensive lists, as will be described hereinafter.

30 As described above, the system provides the user through their interface device and a WO 96/13790 45 PCTlUS9~i/14118 linlced host computer facility, transparently connectivity to multiple remote proprietary rl~t~h~ces for retrieving necessary data such as drug and condition lists.

Pressing (or clicking on) highlighted fields beneath the headers in prescribing header 5 bar 84, in most cases, activates pull-down menus, or data entry scrolls. Generic field 90 is merely a toggled flag while Expires field l 04 is a system-calc~ te-l field.
Although provision can be made for a physician to malce original entries, the ~lef~lled embodiment provides a comprehensive selection of system-generated drugprescribing data from which the user may malce selections.
If the user lcnows the drug they wish to prescribe, the drug name may be lceyed in or, ~lerel~bly selected by highlighting and cliclcing from one or more intelligentlymaintained lists presented in drop-down menus to post it to the respective highlighted field under Drug header 88. Alternatively, the user can select a 15 condition from a condition list and malce a drug selection appropriate to that condition from a drug selection screen such as those shown in Figures 4 through 11 as will shortly be described in more detail.

Generic flag 90 is a simple yes/no indicator which is linlced to each drug selection to 20 approve generic drug substitution for brand name drugs by the pharmacist, if such substitution is perrnitted by state regulation.

Prescription quantification The Form, ~ize, Route and Amounts headers 92-98 are linlced to the drug selected25 and bring system resources to bear to enable a prescriber rapidly to quantify the prescription with a~ iate dosages that can be filled at a pharmacy, without undue difficulty. Activating any one of the fields under headers 92-98 drops down a menu, which menus together offer a selection of all lcnown formulations of the drug .
selected, as provided by the manufacturer, using comprehensive drug inventory data 30 accessed via the host computer facilitv or its supporting data-retrieval networlcs.

22~3~ ~
WO 96/13790 -46- PCT/US95/14118 ~1 The entry for Form field 92 may be selected from choices such as capsule, caplet, tablet, and liquid. That for Size field 94 might be a selection of 50 mg, 100 mg, and 200 mg and the Route field 96 selections might be "PO" for per oral, by mouth, "P "
per rectum, "I~" for intravenous, and so on. The displays are related and intelligently 5 slolec~e~l to display relevant options. Thus, for example, if "PO" is selected as the route of administration, only PO dosage forms are displayed. On the other hand, if PO oral forms are selected, "PO" appears as the route of administration.

The AInt field 98 iS the amount or quantity of drug to be dispensed in the 10 ~les~ ion, for example 30, 50 or 100 capsules or 50, 55, or 100 ml of liquid.
Refill field 100 shows the number of times refilling is permitted and Dosing field 102 has two columns, one being a numeric designation of a number of tablets, caplets or liquid dosages to be talcen at any one time and the other being an alpha indication of the dosing frequency such as QD for daily.
In an optional, modified embodiment of the invention (not shown), the system cancalculate or suggest effective dosages for a selected drug, or a narrow range ofeffective dosages, according to dosage-relevant patient characteristics, for example7 height, weight, age, sex, pregnancy and the lilce, talcing into account the physical 20 formulations in which the drug is lcnown to be available. While these characteristics might be entered or selected from lists during the prescription quantification procedure, greater power is obtained by including them on the patient's record and having the system lefclc,lce these characteristics each time a new drug is prescribed for that patient and malce dosage recommendations according to the lcnown behavior 25 of the selected drug as it applies to the current patient.

eferring to the embodiment illustrated in the drawings, Expires field 104 can besystem-calc~ te(l field from the entries in Amount field 98 and Dosing field 102, to 30 indicate the day on which the last dose will be talcen. Alternatively, the physician-q ~ WO 96/13790 47 PCItUS95/14118 user can select, or enter, an expiration date in Expires field 104 for example to coincide with a desired duration of treatment, or next visit, the system can baclc-calculate refills or the amount dispensed.

5 Baclc-calculating prescription quantifiers is useful to coordinate multiple prescriptions to expire on the same day, for the patient's convenience and to reduce potentialerrors or abuses. Another valuable application of an expiration-controlled prescription is to beneflt plan managers, enabling the physician, where a~ro~liate, readily to coordinate prescription amounts to l-lef ll~d schedules and programs of 10 drug benefit plan managers~ for example a ninetv-dav plan. uch preferred schedules can be system-offered or defaulted, if desired.

Alternatively, if desired, means can be provided for the phvsician themselves to write or lcey in the appropriate dosage entries for a selected drug.
In this ~refel,ed embodiment of prescription management system according to the invention, the Drug and Condition fields 88 and 86 are linlced together to CX~leSS
the therapeutic objective of the user's prescribing decisions, or the pres~ribing intent of the prescription, as will be described in more detail with reference to Figures 4 20 through I 1.

As stated above, a ~l~fe~,ed objective of the invention is to minimize need for Iceyed data entry, to minirnize information loolc-up, or ~lere~ably to avoid all need for keying, by providing a comprehensive system interfacing with the user through easily 25 operated data entry devices such as employed in pen-based computer devices. To achieve this end, the prescription management screen of Figure 3, is preferably supported by comprehensive, fully adequate, up-to-date databases of drug information that, in a particularly ~le~.ied embodiment of the invention, provide a physician user with substantially all available relevant prescribing information on 30 drugs, especially on those drugs they write most frequently, which mav be favored ~0~3~ ~

with preferential device storage on the user's interface device, for rapid retrieval.
elevant prescribing information on other drugs, written less frequently, or not at all by that user is available on the network.

5 Prescription fulfillment When drug specification is completed to the physician's satisfaction, Send Rx button 80 is pressed to output the newly created electronic prescription in any desired form such as to print, to local or remote storage or to remote file transfer as an electronic prescription. The electronic prescription can be transmitted across a network for 10 fulfillment by any specified pharmacy, for example, the patient's preferred pharmacy or a pharmacy preferred by the patient's drug benefit companv for the particularpatient's locality. Preferred routing options can be provided for the patient or the drug benefit plan, or both, and the system can default to appropriate options for the patient's benefit plan. outing may be more or less complex and may for example 15 split say a one-month prescription to provide a bridge prescription giving the patient an immediate one- or two-week supply from a local pharmay, and sending the balance of the prescription for fulfillment by a lower cost mail order house. Ifdesired, a Bridge R~c button (not S}lOWIl) may be added to prescription creationscreen 39 to perform such a prescription-splitting function-.-20Patient compliance and prescription drug abuse Ensuring that a patient complies with the terms of a prescribed treatment, neither neglecting nor overindulging in a prescribed drug therapy, is a serious problem in health care management. It is difficult to ensure that out-patients actually ingest the 25 prescribed amounts of medication at the prescribed intervals. ~lany mistalces and abuses occur. The problem is exacerbated when a patient is prescribed a confusing multiplicity of drugs that may have to be ingested in different amounts at different times of the day. The present invention enables, and includes, unique solutions to this problem that greatly facilitate a patient's ability to comply with a simple or 30 complex regimen of dosages, ~vithout costlv slcilled supervision. In addition, manv 3 ~ ~

~-- WO 96/13790 49 PCTIUS9511~118 types of intentional abuse can be monitored and possibly prevented.
One approach to enhancing patient co npliance, according to the invention, employs a novel dose-scheduling drug paclcage that is readily adaptable to accommodating and scheduling single or multiple prescription dosages to help a patient talce the right 5 dose of the right drug at the right time, and will be described in detail hereinbelow.

Another approach is, to some extent, inherent in features of the prescription management svstem described herein. Where multiple physicians accessed by a patient utilize the system described herein, with common online access to, and 10 assembly of, a patient's prescription history record whereby that record provides a current record of new prescriptions, then a common abuse can be controlled wherein a patient presents a problem or condition to more than one physician to obtain multiple prescriptions with a view to indulgillg in abusive ingestion or illicit resale.
This problem is especially prevalent with analgesics. Where a physician, or perhaps 15 pharmacist, if the patient's prescription history is available to the pharmacist, sees a similar current prior prescription has been issued, they can refuse to duplicate it.

Clearly, regulatory authorities Vis}liIlg to control such abuses can further that goal by encouraging widespread, or universal, deployment of the prescription management 20 system of the invention. Where the system also provides, for example in the patient's history record, notification from a pharmacy, or from a drug benefit plan linlced to the pharmacy, of fulfillment of a prescription, and that information is available to the prescriber, for example from the patients' history record, another common abuse wherein a patient pleads loss of a prescription to obtain a duplicate, can also be 25 prevented.

Bringing fulfillment information from the pharmacy to the point of care via the patient's record or other convenient reporting medium, with or without the intermediary of a drug benefit company linked as a remote source ~l~t~h~cP, can 30 provide not onlv a valuable prescription abuse monitoring parameter but can also be 2~3~ ~
WO 9G/13790 50 PCr/US95/14118 ~

used to enhance compliance with the prescribed treatment, especially if coupled with an alerting system.

For example, the system may alert a prescriber that the intended expiration date of a 5 critical prescription has passed without the prescription having been filled. The prescriber thus becomes aware that the patient has gone off the medication and can talce steps to contact the patient and alert them to the dangers or problems that may arise. Alternatively, routine alerts can be passed to administrative personnel associated with the prescribing health care provider, notif~ing them of any unfilled 10 prescription after a prespecified period of say two weelcs or a month, or prescription --- expiration, or a shorter period for more critical medications.

Scheduled dosage drug pack A particular benefit the system provides when a patient has multiple simultaneous 15 prescriptions is an ability to print out a dosing schedule or better still, to generate a scheduled dosage multi-drug paclcage from tlle electronic prescription, for example as shown in Figure 15. Because the system Icnows dosage, dosage frequency and the duration of all prescriptions, it can report out what pills should be talcen at different times of the day to comply with the requirements of multiple medications. The 20 information used for such a further report can drive the dispensing of the drugs of a multi-drug prescription into a novel paclcage which has multiple labeled or coded compartments for each of a number of dosing intervals.

Figure 15 shows a scheduled dosage drug pack 182 configured as a daily pack with25 the day of the week prominent and the date, patient and doctor identified. Across pack 182 run three multi-compartment drug bays 184 each of which can accommodate up to four different solid drug formulations 184, pills, capsules, tablets, caplets, or the lilce and is sealed by a tear strip having an opening tab 186 F.~r'n bay is clearly labeled with a time of day at which the dosage in each bay 184 should be 30 talcen. Vertical zones 188 are dedicated to an individual drug and comprise a header .

3 ~ ~

with a drug name and special instructions (take with water, after food, and so on) and a compartment in each bay 184 for each dosage time. To demonstrate the flexibilitv and dose-organizing power of this novel, pacl~-based svstem a first drug is shown schematically in lefthand zone 188 with thrice-daily dosing, a second in left 5 central zone 188 with twice-daily dosing and a third in right central zone 188 with once-a-day dosing. ighthand zone 188 is not used, but could be occupied by a fourth drug, the individual dosages of which are loaded into those individual compartments of ighthand zone 188 that correspond with desired dosage times or intervals.
Clearly, modi~led drug paclcs 182 embodving the principles of that shown in -Figure 15 could be configured for more (or fevver) doses or drugs or for different calendar periods, for example weelcly or monthly paclcs rather than daily. Nor is the card configuration essential, for example, a multi-dmg container could be in strip or roll or 15 book form, or metal foil sheets, ~ith tear or press-out compartments. Dosing errors are common with patients with multiple prescriptions, especially the elderly. There can for example be difficultv in Icnowing wllether a dose has been talcen or not. Drug pack 182 solves these problems in a simple inexpensive manner that is prescription controlled to organize multiple doses correctlv and can be easily followed by most 20 patients. Individual sealing of doses is hygienic and child- or overdose-resistant.
Daily or weeldy cards could be connected together by hinges to make compact concertina or boolc-lilce paclcs supplving a week or a month's prescribed drug requirements.

25 Variations on the theme of a scheduled dosage paclcage will be apparent to those slcilled in the art. If desired, the paclcage could be standardized as to the number of dosage compartments, providing for example, a compartment for every hour, v~,iththose compaltments Iying betweel- desired dosage times being obviously blank or never filled. A valuable feature of such paclcaging, which could be embodied in a 30 single prescription paclcage, is that by giVillg the phvsician-prescriber some physical wo 96/13790 ~ 3 ~ ~ -52- PCT/US9!i/14118 control over the circumstances that exist wheIl a patient is supplied with drug therapy for remote administration, the prescriber gains the freedom to adopt time-related dosage variations during the course of therapy, without confusing the patient. In a simple example, scheduled paclcaging might provide one pill in the morning, one at 5 lunch time, and two at night, in an attempt to maintain blood drug levels through the night.

Other regimens could provide higher initial dosages to build up blood drug levels, followed by lower maintenance dosages. In anv such case, the patient simply talces, 10 or is administered, at any given time, whatever dosage or dosages have been paclcaged into the bay 184 that is appropriatelv identified b~ patient, time and date. More subtle or more complex regimens will be apparent to those slcilled in the art, for example one drug might be discontinued, and possiblv resumed after a suitable interval, ~hile another continues. Another useful technique to be able to administer 15 via the dosage-scheduling paclcage described herein is to taper down one drug while beginning to administer another, to provide a graduated switchover. Changing anticonvulsant therapies from one dnlg to another is an example of where this technique may be useful.

20 Prescriber-controlled dosage scheduling can be included in the system via an additional window or screen, offering the prescriber selection of the relevant variables, such as time-related dosages, with defaults or preferred selections for what can be system-determined as the most probable or most beneficial choices for thepatient being treated, or accord with the patient's formular~s preferences or with the 25 particular prescriber's preferences, pursuant to the principles described herein.
pecific tapering or starting protocols can easily be implemented for outpatientsdecreasing the requirement for costly slcilled supervision.

Dosing Indicator Device 30 For more needy patients, the time- and date-scheduled drug packaging described 2 ~
WO 96/13790 53 PCT/US9!i/14118 herein can be rendered electronicallv or electro-optically readable, for example with bar-coding or by using transparent compartments, to cooperate with a novel dosing indicator device that a patient could take w ith them to their home or on their travels.
uch a novel dosing indicator device, as contemplated herein, includes a time-and-5 date clock and is designed to receive at least one scheduled dosage paclcage, asdescribed herein, and to inspect that paclcage to determine what drug pills, capsules or the like have been removed. In the event that a pill or the like is ~letecte~ in any bay stamped with a date and time prior to the date and time clocked by the device, an audible or visual or remote alert, or a combined alert, is triggered. Inspection 10 sensing is l~lc~e~ably electro-optical and targets individual compartments with a light beam that is reflected or diffused by an individual pill or associated light-modulating tag, or by a bar code stamp or label which is required to be removed with each dosage of any drug. Tlle device can include a movable scanner that advances in relation to a paclcage from one bav 184 15 to the next, scanning relevant compartments in the bay, as time passes, or it can comprise an array of photoelectric sensors registering with individual compartments of the paclcage, which are electronically controlled and read in turn, as tlme passes.
Equivalent sensing systems will be apparent to those slcilled in the art.

20 A preferred embodiment of dosing indicator device accommodates, within an aesthetically pleasing housing, a multi-bay sdleduled dosage paclcage7 a time-and-date dock, a time-related sensor to detect the presence of a drug dosage in the bays one or more alerting systems, associated electronics whic}l may include a microprocessor, and a power supply, for example, a batterv, ac connector or remote drawdown source, 25 or the lilce.

uch a dosing indicator device can be embodied as a motor-driven single- or multi-drug dosage dispenser which, for example, can house a tape, or strip-like and ~f~lably rolled, scheduled dosage paclcage, having a time line along the roll, and 30 advances individual bays 1 S4 containing one or more dosages for a given dosage ~0~311 ~

time, and presents a single bav 1~4 (containing one or more dosages) for external delivery and removal (for example bv tearing) bv the patient, or patient's aid, in timed relationship to the dosage time (a half hour before, perhaps) and triggers one or more alerts if the bay 184 is not removed (a half hour after, perhaps).
Preferably, each bay is accompanied by written information as to the patient, time and date, each drug, and any relevant dosing instructions. The individual compartments of such a removable bay cannot readily be sensed for the presence of individual pills. Clearly a sensor is required for the presence of an externally exposed 10 bay. The system assumes that the pills in a removed bay will be ingested, but this assumption may be wrong on occasion. More rigorous patient compliance may be exacted by including in, or in association with the device, a receptacle for an emptied bay 184 and triggering alert means if such emptied bav is not received within a specified time interval. Emptied bavs can be retained within the receptacle. To deter 15 deceit of the receptacle it can read a time and date stamp, or other ullique identifier on bay 184.

A multipatient version of the drug dosage dispenser described hereill can also be provided for inpatient use in medical or healtll care facilities, especiallv hospitals and 20 clinics. uch a multipatient version could comprise a central dispensing station, located for example at a nurse's station. The dispensing station can have multiple . .
ports, preferably identified with bed locations and bed-occupants' names, whereby scheduled drug dosages for each bed-occupant patient are dispensed at scheduled dosage intervals, if desired ~vith appropriate alerts or indicators. Nursing or other 25 staff can readily remove and administer the correct drug dosages for multiple patients, possibly on a single round, or at specific times of the day.

Drug contraindications A further valuable feature of tlle novel prescription management svstem described 30 herein is an abilitv to review a completed prescription for contraindications~ or 2~3~ ~

relative contraindications, such as patient allergies to the prescribed drug and such as possible drug-to-drug interactions with other drugs the patient has previously been prescribed. Contraindications may be clear-cut, for example, penicillin must not be selected for penicillin-allergic patients, whereas relative contraindications are less 5 decisive and may be overridden by the prescriber in a~u~liate circumstances, for example an N AID (non-steroidal anti-inflammatory drug) mav be a preferred choice, in the prescriber's judgment for a patient with peptic ulcer disease, in spite of the attendant risk of ??

10 The system can also screen or revie~.~ for other possible unintended adverse outcomes to the prescribed therapy, or for special precautions regarding a prescribed drug's use.

Preferably, the system alerts the physician-user at the point-of-care if they prescribe an offending agent, and provides an alert and an opportunity to amend the 15 prescription before dispatching it for ful~lllment. Processing to screen for interactions may occur on the user's point-of-care device or on the host computer facility orremote compu~cer system, or may be delegated elsewhere by the host computer facility, and reported back to the physiciaIl7 o~ le as an integral function of the prescription process. Alternatively, interaction screening mav be run on pharmacy-20 related systems, and notification of problems can be sent immediately to the user'spoint-of-care device using e-mail or using procedures within the prescription management application of the invention.

An allergies review can be conducted by checlcing system-stored lcnown allergies of 25 patient Mary Harrington against Icnown pharmacolcinetics and pharmacodynamics of the newly prescribed drug, entered in prescribing zone 44, for any of those allerg,ies. Mary Harrington's allergy information is preferablv an adjunct to her patient record and is downloaded to the user device from host computer facility when Mary Harrington is selected from the patient selection screen of Figure 2. Drug 30 allergenic proclivities are also downloaded from one or another remote database W096,l3790 2 ~ O ~ 3 1 ~ -56- PCT/US9S114118 employing the host computer facilitv, under supervision of the inventive prescription management system, but preferablv at a later point in the procedure, such as when a particular drug is selected for posting to prescribing zone 44.

5 Alternatively, the requisite information can be downloaded when the allergy review is conducted. uch allergy screening can alternatively be effected when a new drug is posted to Drug field 88. Either way, a positive system finding, indicating a risk of allergic reaction to the newly selected drug can activate a visual indicator or warning, for example, Allergies button 52 may blink and, if desired, an audible warning may 10 sound alerting the physician to reconsider their selection. Alternatively, oradditionally, an alert screen can tell the phvsician of an allergy if an attempt is made to prescribe an offending drug. UCll alerts can be used to notifv the physician of drug interactions, treatment warnings or can alert them to non-compliance with formulary recommendations, for example to the use of an unnecessarilv expensive 15 drug, and may be accompanied bv suggestions for more appropriate alternative therapies.

Equivalent procedures can alert to possible dnlg interactions and contraindications, referring to the patient's prescription historv for possible active or recentlv expired 20 prescriptions that may interact with a newly prescribed drug, and for other patient data relevant to the drug's behavior in that patient. Alternatively, the such a review for possible undesired aspects of the drug's performance on the patient is made upon activating Send R~c button 80.

25 Electronic prescription transmission Activation of Send R~c button ~0 can provide a drop-down menu of choices including " end this l~r~s~ ion" and "Add prescriptions prior to sending in a batch".

A preferred embodiment of the invention includes a capabilitv wherebv a completed 30 prescription is transmitted across one or more data networlcs for fulfillment and 3 ~ ~

record updating in a wired or more conveniently, for mobile professionals, a wireless broadcast. Preferably, where ne~,v information is generated in the prescription creation process, relevant remote source databases (which may be proprietary) are updated with a~o~liate components of the new information and such updates are 5 effected with proper controls to ensure data integrity, confidentiality and authenticity. Using the system as described herein, all transactions generate an audit trail and are authorized or preauthorized by the patient.

Because of the currently substantial cost of air time, batch transmission is highly 10 desirable. Accordingly, system defaults encourage the physician to elect batch transmission of multiple prescriptions for an individual patient, although in Iceeping with the principle of not imposing constraints on a phvsician, the system does not mandate such batch transmission. Executing a " end Prescription" function outputs the prescription for fulfillment in any desired form7 posts the completed new 15 prescription to the prescription History zone 43 in the center of the screen, and outputs the new prescription from the user's station to update a control system or remote database, as desired. Prescriptions call be electronically transmitted to a pharmacy or pharmacy-management system for fulfillment, or printed on paper for paper-based fulfillment by hand deliverv or fax.
The inventive prescription management system embodiment disclosed herein is designed flexibly to facilitate a physician's prescribing activities, to place helpful information at their fingertips and reduce manual loolc-up chores, while avoiding any authoritarian direction, mandate or constraint upon a physiclan's professional 25 activities or judgement. Thus, while the system may attempt to provide intelligent options and exhaustive selection lists, options such as "other" are always available to permit the prescriber complete freedom of choice, whether or not their choice isIcnown to system-available databases.

30 Optional system enhancements provide for enrichrment of external communications, ~2~3~ ~
WO 96113790 58 PCT/US95/14118 J~
for example prescriptions and e-mail with what mav be termed "electronic ink"
messages generated at the user device. "Electronic inlc" refers to notes or messages appended to external communications, or transactions in the form of free text orvoice annotations for non-structured instructions, and the like. Voice annotation is S particularly convenient, as well as possibly constituting unique user-identification and some currently available low form factor user devices incorporate a microphone, facilitating voice annotation.

Toward the end of prescribing flexibility, to avoid being second-guessed by physician 10 users, and to command their respect and loyalty, the system should have access to, and provide to its users fully comprehensive drug and patient information so far as this is available. Comprehensive, accurate and complete drug and patient information are equallv important for effective prescribing. It follows that the drug and patient information source databases from which the prescription management 15 system draws, must be maintained up to date, by appropriate net~vork services.

It is the normal, challenging nature of highly qualified professionals that those with the latest news, such as new drug releases and approvals, will want immediately to test the system for currency with the news. ---20The unique sourçe-oriented information retrieval and updating system describedherein provides ~lcfell~d means for supporting the prescription management system of this invention with an adequate infra-structure of data-retrieval networlcs supplying a comprehensive array of up-to-date prescribing information and patient-25 related data to the point-of-care. Other suitable information data retrieval and updating systems will be apparent to those slcilled in the art and can be linlced to the system of the present invention to provide allergy and interaction alerts, formulary changes, new drug approvals, and to lock out or warn against, the prescribing ofina~ro~liate or recalled drugs.

. .

2~3~ ~
~ WO 96113790 59 PCTIIJS9S/14118 I~)rug and condition selection Novel drug selection methods pursuant to the invention will now be described with rcfelence to Figures 4 to 11. The condition list selection screen shown in Figure 4 appears upon activation of Condition field 86 in the prescription management 5 screen of Figure 3, to enable a prescriber to approach selection of a treatment drug by first specifying a diagnosed condition. Alternatively7 a drug mav be directly specified by drug name by activating Drug field 88, as will be described in connection with Figure 9, after which the prescriber selects a condition to specify the purpose of the therapy. uch condition or drug selection screens can be opened by similar 10 condition or drug buttons in any other relevant screen or application, for instance in a patient encounter screen where tlle drug selection routines now to be described with ~efelcllce to Figures 4 to 11 can be used to assist a phvsician to select or review treatment objectives in a computer-assisted patient encounter.

15 Condition li~t selection The condition list-selection screen of Figure 4, provides a preliminary selection of a suitable condition list from ~,vhich a phvsicial- user can work to select a drug. As shown, the screen comprises a Select Condition List title 1 10 and a Condition List display header 1 12 beneath which the names of Condition Lists 1 14 are grouped in 20 a left-hand column. A right-hand column beneath header 1 12 displays the conditions 1 16 of whichever condition list 1 14 is hignlighted, or otherwise selected.
In this case the user's personal condition list 1 14 has been highlighted and may be seen to comprise a short list of commonly occurring problems that, for example, a general practiffoner might encounter.
Multiple different Condition Lists 1 14 are available in this embodiment to provide a range of choices to physicians, and si~c are shown, by way of example. Three of these lists 1 14 classify conditions broadly by diagnosis (Dx) and comprise a system-maintained Dx-Personal list 1 14, an alphabetically organized Dx-Alphabetic list30 1 14 of a!l conditions in the system and a Dx-Category list 1 14. Dx-Category list 22~3~ ~
WO 96/13790 -60- PCT/US9~i/14118 1 14 lists conditions by broad therapeutic categorv such as cardiovascular, GI or dermatology. A fourth condition, problem or diagnosis list, Dx-Patient list 114 lists previously exhibited conditions or problems of the selected patient, in this case, Mary Harrington. Dx-Patient list 1 14 is system maintained (and manually 5 supplementable) and changes according to the patient selected in the patient-selection screen of Figure 2. Dx-Personal list 1 14 is also system maintained (and manually supplementable) and changes according to which prescriber signs on.

Preferably, the system includes frequencv counters to traclc the conditions the user 10 encounters with time, and the counts obtained are used automatically to maintain or generate a Dx-Personal list 1 14 for the user, whicll more closely portravs patterns of conditions encountered in the user's practice as time goes bv. Base periods for reporting usage may be varied, or user selected, to list conditions encountered by frequency in, for example, the last year, the last five years, or perhaps, the last three 15 months. Also, a default can be included to l-ighlight a selected patient's last active condition or conditions as a first-line choice.

Preferably, any time a new diagnosis is made, the new condition encountered is placed in the user's Dx-Personal list 1 14 and anv time a drug is chosen it is placed in 20 a personal drug list for the user. Tlle first time either a condition or a drug is selected, it is added to a user profile stored on the network, for example, at the host computer facility.

In addition, a physician-user can manuallv maintain one or more custom lists, Dx-25 Custom 1 list 1 14 and Dx-Custom 2 list 1 14, for their own preferred short lists of conditions being, for example, conditions appropriate to their specialty that the individual physician frequently encounters for treatment. Alternatively, libraries of specialty lists may be made available from which the user selects one or t~vo lists for their personal use. uch custom lists 1 14 mav be associated with different user 30 activities, for example, Dx-Custom 1 could be used at a hospital where the user is an 2~0~3~ ~
~ WO 96113790 -61- PCT/US95/14118 attending physician7 while Dx-Custom 2 is used at a pain clinic where the user is a visiting physician. The-various condition lists 1 14 provide alternative pathways to drug selection that a physician mav use as an aid to deciding upon a course of treatment. Different pathwavs may suit different clinical circumstances or S prescribers. Availability of alternative routes to relevant drugs mav enable aphysician to f~nd improved treatments, and increase their range of choices, and may lead to new solutions to difficult prescribing situations.

The condition list selection screen sllo~vn in Figure 4 is a gatewav to other condition 10 and drug selection screens. As an altemative for quiclcer selection, a preferred condition list (typically a Dx-Personal list 1 14) could be set as a default with other condition lists 1 14 being reached via a Change Condition List button (not shown).

Any or all condition lists 1 14 can be automatically supplemented or maintained by 15 the system as it receives data in the course of processing numerous prescriptions for one or more physician users. In addition to supplementation with user-originating data, ~ d embodiments maintain ~Iser profiles on a host computer facility which continually refreshes the data at the user's device so that the user can use any device or share a device with other users.
Condition selection In the Select Condition screen of Figure 5, the patient condition 1 16 in the DxPersonal category shown comprise generalized groups of disease, some serious lilce diabetes and pneumonia, and others less so, for example rhinitis or sinusitis. More 25 comple~c embodiments than the one shown here may categorize conditions into as many as four or five different columns of subcategories of condition according to disease pathology, therapy, personal lcnowledge and so on. uch condition categorization, as a preliminary to drug listing, provides a vely powerful tool for physicians to view their prescribing options on screen and to organize them.
30 Organization of drugs bv lists of effectivelv treated patient conditions enables a user ~2~3~ ~1 WO 96/13790 -62- PCT/US95/14118 /~

intelligentlv to access a large body of drug data selections. This approach provides multiple mapping so that the user can find a s--itable drug or selection of drugs via different pathways according to their preferred work methods.

5 Different pathways to a drug via conditions organized in other ways, notably by body system, are illustrated in Figure 8, described hereinbelow. Direct pathways of drug selection using drug lists are illustrated with reference to Figures 9 and 10, described hereinbelow.

10 In the example shown in Figure ~, tlle user-physician has highlighted and selected a patient condition 1 16, namely, peptic ulcer disease (PUD)/gastritis, displaying, in the next right-hand column (see Figure 6), a short, system-generated list of drugs lcnown to be therapeutically indicated for PUD/Gastritis and which may be suitable for pr~scFip~ion ~r i(:r ~ave been prescri'~d il~ ~e pas~ h~ user ~or ~a~ngtnese15 conditions. The presence of the user's previously prescribed drugs, which may not necessarily appear on third parties' lists,-helps personalize the list to the user.

eferring to Figure 6, now that a condition, Pl JD/Gastritis, has been selected, a new ~ screen title, Select Drug 111, appears and selection of a drug to treat this condition 20 proceeds. To aid the selection, a condition-specif~c, formuiary drug list l 18 is displayed in the next right-hand column of the Select Condition screen of Figure 6 under Formulary Drug header 120. Alternatively, a physician's personal list of drugs may be displayed with formularv drugs higlllighted. If desired, relative cost information can be included or alternative drugs may be ranlced by ~lefel-ellce of the 25 formulary manager.

Formulary Drugs are those listed by a drug formulary specified by, or relevant to, the patient, in this case, Mary Harrington. The drug formulary may be generated by a~r~.~i~ion benefits management company and is a lcey ingredient in a system for 30 reducing overall prescription costs bv using volume purchasing to get preferred ~q~ ~

pricing on selected drugs.

A major problem in fulfilling the cost-control objectives of a managed care organization is that of informing a prescribing phvsician as to which drugs are in the 5 formulary for a given patient. Noting that there are many different forrnularies it is quite impractical for the average physician to keep referencing different formularies for every patient every time they write a prescription. The aspect of the invention shown in Figures 6 through 11 helps solve this problem by providing computer access of remote databases containing the information and by presenting available 10 formulary drugs in a form which is easy for a physician to use, lefe~ ce and prescribe without enforcing phvsician compliance with a formular~s treatment guidelines and attempting to restrict a physician's exercise of their professional judgment.

To the contrary7 the system of this invention is designed to empower a physician to 15 malce informed choices at tlle point of care. T~le system fosters quality, cost-effective prescribing. Physicians do not have to attempt to remember drug formularies and formularies may be changed with instant effect on all users without having physicians relearn the formularv. Where formularv information is called across a data-retrieval network, each time it is required, in accordance witll preferred embodiments of the 20 invention, from a remote source database, updates are automatically posted across the networl~ ~~~

Nonformulary drugs may be substantially more expensive than formulary drugs, or may not be covered by the patient's dmg benefits plan, and may require out-of-25 poclcet payrnents by the patient which circumstance may cause administrativeproblems to the physician and be a burden to the patient. Worse still, the patient may not have the prescription filled.

By including pharrnacy-derived prescription fulfillment information, a patient 30 prescription history can indicate whether a patient actually received a medication.

3 ~ ~

The physician can be alerted (by e-mail) if a patient has not filled a prescription for a critical medication, for example ~A IX (Hoecl-st), prescribed for hypertension, enabling a follow-up with the patient to be initiated.

5 Where formulary drugs are professionally acceptable to the physician and of equivalent therapeutic effect to non-formulary drugs, failure to use them is clearly undesirable. This problem is overcome by tl-e present invention. If the physician is satisfied with the formulary drugs offered by the prescription management system of this embodiment, anyone may be selected and automatically posted to the novel 10 prescription described herein as will be described.

Prescribing non-formulary drugs hould the physician Icnow, for example, tllat cimetidine and ranitidine, drugs in a similar class, have been tried and found ineffective and that the condition is well 15 beyond these first line treatments, so that none of the formulary drugs is suitable, then the physician can select Other, which selection displays a nonformulary drug list 122, under nonformulating dmg header 124, as shown in Figure 7. In this case, the physician selects Sucralfate as being a noll-formulary drug in a different chemical category and having somewhat different therapeutic properties from those previously 20 applied to treatment of this patient's symptoms.

Having made the decision to select ucralfate, the physician is informed by the system display shown in Figure 7 that sucralfate is a nonformulary drug not on patient Mary Harrington's prescription benefit management company's schedule.
25 With this timely notification in hand, the doctor can, if appropriate, consult with a patient, explain the reasons for his or her drug selection and gain the patient's agreement to assuming the cost of the prescription, or obtain authorization from the plan to cover the cost of this prescription for this exceptional case. Physicians manifesting increasing compliance flowing from use of a prescription management 30 system according to thIs invention can expect readv approval of a non-formularv drug 3 ~ ~
~ WO 96113790 65 PCT/US9S/14118 on a justified exceptional basis.

By tying a diagnosed condition to a prescribed drug and requiring a condition to be recorded as a treatment objective before a prescription is fulfilled, new drug S formularies can be created where prescribing of a drug is qualified according to the condition treated. For example, an expensive drug like captopril may be a first-line formulary choice for an acute condition such as congestive heart failure, but not a first-line choice, or may even be excluded as non-formulary, if prescribed for achronic condition such as hypertension.
In practice, after the system learns the user's preferences, most condition and drug selections will be quicldy made from the user's preferred or custom lists or from historically derived patient lists of previouslv encountered conditions, or previously prescribed drugs. The system adapts to the prescribing user to enable rapid creation 15 of routine prescriptions. A minority of situations may call for less obvious therapies or therapies with which the physician has little or no experience. Physicians tend to be most reluctant to prescribe new drugs. esponsible physicians will usually scrutinize a great deal of relevant information before prescribing a drug for the first time. This effôrt is captured by the system wllich enables a prescriber to have quick 20 access to their prior experience and confine their drug selections to drugs they have used previously and which were satisfactorv. (A physician can of course edit their personal list to remove drugs that proved unsatisfactory for some reason or another, whether therapeutic or not, or they can be removed automaticallv based on decreasing frequency of use.) In other circumstances a physician will need to select a drug with which they have little or no experience. Here, when it is most needed, the system provides majorsupport and reassurance, presenting several different pathways to appropriate solutions enabling online access to the latest available scientific, clinical and 30 commercial information about a new drug as ~vell as screening for complications.

~n~3~ ~
WO 96113790 -66- PCTIUS95/14118 ~

The ability to offer drug detailing at the point of need for new drug information can be used to attract revenue from pharmaceutical companies, managed care companiesor others, and is especially useful in decreasing the barriers to switching to first-time use of a drug. The system-provided prescribing information resources that are 5 brought to the point of care are also valuable in enabling a physician to malce quick therapeutic substitutions.
., The drug selection screen shown in Figure 8 offers, by way of example, one route to selecting a new drug not on the prescriber's short lists. Here, selection is condition 10 driven and proceeds with the selection of a condition list l 14, Dx by Body System or Dx by Therapeutic Class, and then locating a drug to treat that condition; oralternatively, by directly selecting a drug via d;ug lists 1 15 Rx by Therapeutic Class or ~c by Alpha. Displayed in Fig lre 8, reading across the columns from left to right, are a list of body systems 1 17 from which the prescriber has selected Musculo-15 skeletal. In the next right column the system displays a list of conditions 1 16 thatmight be displayed by the musculo-slceletal system, of which nine are listed by way of illustration. From these nine the prescriber has selected Osteoarthritis.
Osteoarthritis is posted to Condition field ~6 in prescribing zone aA of prescription creation screen 39 (Figure 3).
With a condition specified, selection proceeds to the choosing of a drug to treat the condition of osteoarthritis. Drug selection proceeds throug'h a preliminary selection of drug category, from a list of drug categories 1 19 in the next column to the right, enabling the prescriber to choose their therapeutic approach, in this case, as between 25 employing an analgesic, a narcotic, a N AID (non-steroidal anti-inflammatory drug) or a salicylate. A NSAID is chosen, generating an extensive list of drugs 121 in the right most column in Figure 8, from which the prescriber can make their final selection which will be posted to Drug field 88 in the prescription creation screen 39 (Fig. 3).

3 ~ ~

The complexity of the prescribing process is graphically illustrated in Figure 8. Even after narrowing the field down to a specific class of drugs, N AID, for treating a particular symptom, osteoarthritis, there are still of the order of fifty drugs from which the prescriber malces a final selection.

Direct drug selection Prescribers often Icnow what drug they want to prescribe and will wish to access it very quicldy, and may not use the svstem if they are unable to do so. This goal can 10 be reached with user-adaptive personal drug lists organized to default to a prescriber's f~ d choices, as described herein.

One ~lefelled user-adaptive approach to providing a quiclc-prescribing pathway to a prescription is for the system to process the user's personal drug list7 to highlight, or 15 short-list or otherwise present those drugs on the personal list that are a~lu~liate therapy for any of the patient's active conditions, and preferably also, that are on the patient's formulary.

eferring to Figure 9, an alternative direct dn~g-specification pathway commences, 20 reading from left to right, with selection of drug list 1 15 R~c by Therapeutic Class.
From a list of perhaps fifty to one hundred drug categories 1 19 which appears in the next right hand column, the prescriber has picked Diuretics, generating an even longer list of diuretic drugs 121 from which the prescriber has piclced Dya~ide (trademark, nnith ICline Beecham). The system now calls for entry of a condition, in 25 this case "hypertension". The extent of the lists of drug categories 1 19 and diuretics ~ -- . .
121, again illustrates the bewildering arrav of drug selections with which a prescriber is confronted. An otherwise uncertain or overly conservative decision-malcing process can be rendered efficient, reliable and manageable by a prescription management system according to the invention.

~2~3~ ~ `

The selection program illustrated in Figure 10 provides a varietv of pathways for direct drug selection via five drug lists 1 15, a personal, an alphabetic, a category list and two custom lists, analogous to condition lists 1 14. Here the user has selected ~ Alphabetic list 1 15 and the system has displayed a portion of a long, scrollable 5 list of drugs 121 in the next column. This approach can quiclcly locate a target drug when the physician lcnows it by name. Here Cefixime has been selected and the system calls for, and requires, the prescriber to enter a condition before proceeding to quantification of the prescription. In the next column the system lists conditions that the user has previously treated with Cefixime, highlighting the most recent10 condition so treated, or the system may display a previous condition of this patient -- that was treated with cefLxime, not necessarily by the current user. If the physician wishes to attack some other condition with cefixime, such other condition may beselected from the last righthand column, activated by "other".
The diversity of conditions treatable with cefixime illustrates the potential for 15 outcome studies based upon widespread use of systems according to the invention to refine definitions of the therapeutic scope of individual therapeutic agents by collecting data on effective new applications and Ol- precautions, interactions and side effects.

20 Some advantages of condition-specified drug prescribing Being abundantly served at the point of care with relevant prescribing information at the critical moment of decision, the physician can eliminate many subsequent problems or difficulties which may lead to unnecessary paperwork, or surprised, ann~yed or non-compliant patients, and to unnecessary phone calls between 25 pharmacist and physician when a patient learns only at the pharmacy that their prescription is non-formulary. The system can eliminate much unnecessary "phone tag" beL~ n pharmacies and physicians. Improved physician and patient compliancewith preferred guidelines will reduce the cost of care and increase the quality of care.

30 The availability, bv means of the invention, of vital drug selection information, 3 ~ ~

categorized by therapeutic condition and denoted as formulary or not,for the patient in ques*on, rapidly assembled, ~lefelablv from remote source data, and conveniently presented to a physician for flexible use in their own personal work flow, greatly enhances prescribing practices7 fosters cost containment and eases the administrative 5 burdens that fall on heavily prescribing physicians. It enables informed choice at the point of care leading to a decrease in adverse outcomes of therapeutic choices.

Naturally the prescription management system of the invention can provide a variety of printed reports and other data outputs of any facet of the described operations. In 10 some cases, these reports can be enhanced to provide entirely new products for example a dosing schedule such as that described with lcfelcllce to Figure 15, and shipping schedules or split prescriptions divided according to suppliers requirements.

Current and historical reports can, subject to the access controls described herein, be 15 patient-specific, prescriber-specific or organization-specific and can be aggregated across various groups, pools, geographical regions, conditions, drugs, or time periods or combinations of any of the foregoing to provide a valuable data resource to health care providers, patients, managed care organizations, govermnent agencies and others.
Further to enhance the prescribing decision process, additional features can be .
included on screens such as Figure 7, for example drug pricing information, employing actual wholesale or retail pricing, or comparative pricing or on another manner of drug pricing or grouping, such as a comparative scale or price rating 25 system, or relative pricing based on actual prescription benefit management company contracts. uch pricing information can greatly influence M.D. decision-malcing, improving formulary compliance and reducing overall drug costs, without restricting a physician's choices.

30 A powerful optional feature of the invention is shown in exemplarv fashion by the _ .

~1131 ~

drug evaluation screen depicted in Figure 11. After a physician selects a drug from one of the screens of Figures 7 to 10, the system can optionally scan a drug ~ler~ ce database of preferred drug treatments for an evaluation of the merits of the selected drug in treating the condition. The drug preference database may be5 remote and may be maintained, for example, by a managed care organization, HMO, or prescription benefits management companv. As the Figure 11 example shows (which example employs different condition and drug selections from those used in Figures 6 and 7) one possible result of the database scan may be an on-screen report with an alert message, in header 126 advising the physician that the selected drug is 10 "Not a first line drug" for treating the selected condition. As a helpful suggestion to the physician the system can also offer alternative drugs, from listings in the drug ~.~f~.cllce database, as being more meritorious for t'he treatment of the condition in question (pursuant to the maintaining benefit companv's standards or, preferably, to objective literature reports).
To this end, the drug selection evaluation screen of Figure 11 comprises an explanatory box 128 elucidating header 126; an alternative drug selection menu 130;
and at the bottom of the screen, three action buttons; for example, Tx Guidelines 132 to access treatment information about the alternative drug highlighted in menu 20 130; a confirm button 134 to post the physician's original drug selection, in this case "~lofixime" and to return to prescription creation screen 39; and a cancel button 136 which returns the user to the drug-selection of Figure 7.

The treatment information available via Tx Guidelines button 132 may indude a 25 literature r fe.ellce supporting the system's finding that Cefixime is not a ~lefc.,ed first line agent for treatment of the selected condition, otitis media. Optionally there may be a selection on a drop-down menu from the Tx Guidelines button 132 enabling a physician, without further effort to have a copy of such a study sent to them. In a further optional embodiment, Tx Guidelines button 132 can provide the30 user with an access point to full disclosure and prescribing information on the drug.

3 ~ ~

Available treatment guidelines information can include details of the particularconditions for which a system suggested alternative drug has been found effective, adverse conditions, ~rcfc~l~d dosages and administration routes, literature sources and so on. This aspect of the inventive system provides a simple, nonintrusive 5 technique for bringing new drug information to physicians at a critical moment of need, when creating a prescription.

Although described as a self-contained system, it will be appreciated that functions such as the identification and listing of drugs via conditions treated, and patient 10 prescription histories will have value in other systems, for example, patient encounter management systems, and mav be accessed directlv from such svstems via a prescribing information button.

As well as compensating for error or lack of information on the physician-user's part, 15 the prescription review system exemplified in Figure 1 1 has great value as an educational tool. Physicians can be subtly trained to improve their drug selection behavior. By using the system ag~,les~,ivelv and exploring its information resources, as they are encouraged to do bv the system's prompts and alerts, physiciall prescribers effectively receive education and training at tlle point of care. Improvements in drug 20 therapy are subtle and complex and it is often difficult, even for the most conscientious of physicians, to be abreast of developments in any more than one narrow field of medicine. It is just as difficult for purvevors of new drugs to break in to a physician's paclced work schedule to educate them as to the merits of a valuable new drlg.
More than one alternative drug may be offered. Also in an optional embodiment not shown, the physician user may choose to display a screen of drug information regarding the alternative drug or any other drug. After confirming a drug selection the system can review the patient's history in relation to the selected drug and alert 30 the physician to anv relevant allergies, one-on-one drug interactions or, if ~2~3~ ~

a~lo~liate, multiple drug interactions.

Often, when new drug information is presented, a physician is unable to consider it, yet when the information is needed, or could be used, for example at the point-of-5 care, when creating a prescription, valuable new drug information may be unavailableor forgotten. This invention solves that problem by presenting new drug information in a timely manner at the moment when it is most needed and a physician is most interested in considering it, namely at the time of writing a prescription. It gives a benefit management companv the opportunity to influence a phvsician's choice at 10 the most influential moment, during the prescribing decision.

~Iser-adaptive drug formularv compliance Conventional formulary guidelines specifv one or more substantial lists of preferred drug therapies. Many of these drugs will be unfamiliar to most prescribers who will 15 the~efole be reluctant to prescribe them. Natural professional prudence malces most physicians extremely cautious about specifving powerful agents for therapeutic goals when they have little or no prior experience with the agents but will be responsible for the outcome of the treatment.

20 The system of the invention can provide a novel approach to drug formulary management whereby prescriber-centric formularies can be established. By means of .
the system, drug formulary guidelines effectively adapt to the user's prescribing patterns or can be followed effortlessly by the prescriber. This desirable prescriber-centricity can be obtained by giving priority to the prescriber's personal or custom 25 lists or, better still if they are a subset of these, to the patient's history lists, and system-identifying patient-forrnulary preferences on those lists for easy final piclcing by the prescriber. Where the prescriber is selecting a drug providing effective therapy for a just-specified condition, the above procedure may often clearly identify a single drug meeting all requirements or may result in a short list of a very small number of 30 drugs for final selection. Where no drug is listed as meeting all requirements, the 3 ~ ~

~ WO 96/13790 _73_ PCTIUS95/14118 system may so alert the user and suggest formularv drugs not on the doctor-specific lists or ask the user whether thev wish to revie~v appropriate non-formulary drugs from their personal or custom lists.

Patient's prescription history Figure 12 shows a prior prescription information screen which can be displayed by double cliclcing the prescription display line or activating RX History button 54 in a screen zone such as prescription llistory zone 43 of prescription creation screen 39 10 shown in Figure 3. The embodiment of screen shown in Figure 12 provides a simple passive inforrnation display, comprising an information box 138, a close button 140 and a scroll bar 142 for scrolling or browsing a library of prescription histories. The displayed prior prescription information in box 13~ comprises, for the selected prescription, the condition for which tlle dmg was prescribed, the drug name, date of 15 prescription, dates of any renewals and the name, phone number and any other a~,u~liate identification of the prescribing physician, in this case it is the user physician, and any other useful details that mav not be strictly prescribing information, including appended free text, voice annotations or other electronic ink.
Where an "N" indication appears in the Mine column 76 on the prescription history 20 line in Figure 3, the name of another physician who authored the relevant prescription will appear in Figure 12.~

In addition to conveniently presenting useful historical prescription-related fle~ilc7 powerful optional features,~ for example, direct E-Mail communication with the 25 physician whose name is displayed (or with some other physician) can be activated from the prescription information screen of Figure 12 or other suitable screen, can be induded in the prescription management system of the invention. uch options enable physicians to send an inquiry to, and perhaps retrieve relevant records directly from another physician such as a previous prescriber to the patient, or a referring 30 physidan. The invention facilitates the execution of such information transports . .

=

22n~3~ ~
WO 96/13790 _74 PCT/US95/14118 during the user-physician's encounter with tl~eir patient. The screen of Figure 12 could additionally have an Auto Dial button and be linlced to other modes of communication to facilitate a direct connection to the physician of interest.
Additional options include a displav of historical dosage information and an ability to 5 page through all prior prescriptions or all prescriptions for a given patient, a given prescriber, a given condition, a given therapeutic clas~" and s~ on, recapping some of the functionality of the Figure 3 prescription creation screen 39.

A further optional feature of the invention is sl~own in the patient problem or 10 condition screen of Figure 13, openable, for example, from Problem button 50,Figure 3, which traclcs, as indicated by the field headers 144-156 extending across the screen, a history of the patient's problems and records diagnostic determinations regarding individual problems. in particular, tlle system captures information regarding the date wllen a new problem first becomes active and when it is 15 "deactivated". These dates are associated with the name of a physician user, and thence with a patient encounter and can be regarded as authentic diagnostic determinations capable of being substantiated from the physician's office records.
Additional information screens, detailing, for example laboratory or other diagnostic data, or relevant personal patient characteristics, for example height and weigllt, can 20 be linlced to problems as they are with drugs.

By processing such reliable base data, combined with historical prescription data associating a patient problem, or treatment category, or treatment objective, with a prescribed drug routine, valuable new information and outcome studies can be 25 generated. For example, the duration of problems in relation to particular treatments can easilv be calc~ te~l Using the Figure 13 screen the system user, or the system, labels a problem or condition as new in New field 144; describes the nature of the problem in Problem 30 field 146 from a condition list (not shown) such as condition list 1 14 shown in ~2~q3~ ~
~ WO96113790 75 PCT/IJS95/14118 Figure 4; selects a "~' or "N" flag in Act field 14~ to show the status of the condition as active or not; inserts the name of the physician adding the problem to the list in Diagnosing Physician field 150 (which the system will default to the current user);
inserts the date the problem was added in Date field 152; inserts the name of the 5 physician deterrnining the problem is resolved or no longer active in Resolving Physician field 154; and inserts the date of resolution in Date field 156. Thus changes to the patient record are stamped with the name and date of the responsible physician to provide an audit trail. A physician identifier can be added if desired.

10 Problems that no longer manifest themselves to the patient or physician can be indicated as not active in Act f1eld 148. The problem list can be sorted by header selection and preferably presents active problems at the top of the list bv default.

uch a system-maintained problem list provides an easy and convenient rcfciellce to 15 the patient's history of conditions or problems and of the duration and currency of such problems and constitutes a valuable case management tool for physicians. The problem list is automatically supplemented during the prescribing process with the latest prescriber's latest observations and diagnoses, as indicated by selection of one or more conditions for posting to a ne w prescription.
20 Where a patient complains of an old problem a quick prescription creation routine comprises selecting the problem from the Dx-Patient list 1 14, then selecting a drug from a system-generated pick list of drugs providing a~lo~liate therapy for thatcondition. The pick list is ~lcf~ably drawn from the doctor's personal list and is either compliant with the patient's formulary guidelines, or indicates those guidelines, 25 for example by inverse video, highlighting or the lilce, and also includes a selection of "other" to access drugs not on the prescriber's personal list. uch a quick prescription routine enables the most routine situations to be promptly handled, yet permits the physician to expand their prescribing horizons and does not merely require selection of the same drug as was used previously. Quick treatment substitutions are made 30 possible by the system's presentation of available alternative therapies enabling the 3 ~ ~

~rt~ n~er easily to see ~vhat alternatives are available and to explore those with which they are unfamiliar.

Also the problems or conditions on this list can be automatically posted to a patient 5 problem list 1 14 to appear as an additional "Dx" list in screens such as those shown in Figures 4-10, to provide quick selection or review of a patient's historical conditions. Preferably, such a Dx-Patient list 1 14 changes automaticallv when another patient is selected.

10 As various system-using physicians, laboratories and the like encounter the patient or provide services to the patient, they become original sources for new record elements memorializing their encounter with tlle patient or the patient's attributes. Thepatient's history accumulates, and tlle svstem compiles, on demand, a cumulativevirtual patient record including all ne~vly created record elements. This current 15 patient history record is promptly available to any autllorized physician user on the networlc. In an ideal world, all relevant encounters are captured so that tlle patient's record is comprehensive or complete.

The value to a patient's care givers, of an instantly available~ comprehensive patient 20 record cumulatively reflecting all current and recent medications and conditions, is immense. Its availability to emergen~ypersonnel may be life saving.

The problem list screen of Figure 13 is accessed from prescription creation screen 39 (Figure 3) by pressing button 50. electing an OIC button 158 or Cancel button 25 160, the problem list returns to prescription creation screen 39 (Figure 3). Change Status button toggles the highlighted Act entry between "~' and "N", and records a date and physician name with any status change. Add button 164 enables a physician user to add a new condition to the list, using condition selection pick lists, as previously described. This routine may be used to note problems for which there 30 is no specific prescription given, e.g. obesitv or senile dementia.

2 2 ~

WO 96/137~0 77 PCT/US95/14118 Where the inventive prescription management svstem is applied to statistical data collection for outcome studies, it is preferable to supplement the patient record with a range of relevant personnel data7 to the extent that this is available, for example drug abuse behavior, smolcing and habitual eating or drinl~ing behavior, dietaryS habits, marital and family status, pregnancies, ethnicity, environmental factors, and so on. The system provides an excellent means for traclcing these factors and their changes as they may pertain to an individual's health. For example, dat~ fields could be added to record any of the foregoing data and the data could be updated by medical or administrative personnel in preparation for a patient-physician encounter.
Of particular significance to outcome studies will be death certificate information, and preferably this information is added to the patient problem record of Figure 13, as appropriate.
, 15 More complex embodiments of the invention can integrate applications for prescription management with equivalent applications for diagnostic tests, laboratory analyses, and radiological studies to provide a more comprehensive patient history viewable in multiple screens. Of particular value in such an integrated presentation - - are laboratory results providing drug dosing levels, renal and liver function tests that 20 provide important indications as to appropriate dosing, and so on.

Figure 14 shows a manually maintainable problem record maintenance screen, for physician use, which can be accessed for example from the Doctor's lists button 24 in the system entry screen of Figure 1. This screen enables a doctor or physician 25 manually to maintain their own personal customized prescription, diagnosis, allergy or other useful lists, to supplement the automatically maintained system lists. If desired, problems the doctor's patients have experienced previously can be system-added to the list, for example when a patient is selected. These personalized lists or profiles are posted to the network where the system can retrieve them to any user 30 interface device via a host computer facility, subject to appropriate password ~2~3~ ~
WO96113790 -78- PCT~S95114118 protection or the lilce. elying upon such centrallv stored personalized profile files, the system can present a customized, personal appearance, with familiar configurations, attuned to the user's work habits, at any geographical location from which the network can be accessed.
The problem record maintenance s`creen of Figure 14 comprises a Problem List box166, a List Type box 168 and a Problems box 170 displaying a comprehensive, or ~refelably exhaustive list of problems which can be selected and transferred to the network and the physician's problem list by pressing update button 172. Highlighted 10 entries can be removed from the Problem List 166 by pressing delete button 174.
~-- ave button 176 and Exit button 178 perform the usual functions, and ~lefelably provide options to cancel changes, and the like. Data entry box 180 permits an unlisted condition to be keyed in, or other~vise entered character-by-character and paging buttons 142 move between lists.
A~rchiving Given the medical, commercial and legal significance of the transactions executed and the data generated by use of the system of the invention described herein, as well as the value of that information to the patient, the physician and many other 20 organizations, maintenance of accurate historical records, or archiving, is desirable, or essential, and ~lefe~l~d embodiments of the invention provide archiving at a host computer facility 106.

Da-ta storage burdens attendant upon long-term archiving are substantially relieved 25 by using virtual patient records, as described herein. Pursuant to the principles relating to the use of virtual patient records dynamically created from source data record elements, the invention prefers to archive such data as will enable a full and accurate record of the past to be regenerated from diverse sources, rather than recording the past verbaum. Date and time stamped record elements allow 30 recreation of a virtual patient record at any point in time.

1 3 ~ ~
.~
~ WO 96113790 79 PCT/US95114118 Preferably, the data logged into archives comprise all data relevant to a patient's diagnosis and therapies, data relevant to the user's prescribing activities, including the prescriber's relevant electronic communications ("e-mail") with third parties (pharmacies, laboratories, other health care providers, or potential providers, to the 5 patient, and so on) and access audit data as to parties ~cct csing the patient's or prescriber's personal data.

System-support infrastructure eferring to Figure 16, the lefthand side of the diagram shows an arrangement of 10 services and devices that provide a downstream flow of data and communications resources to users of the prescription management7 or other system described herein.
The righthand side shows sources from wllicll desired data and data elements may be drawn and pathwavs for those data to reach the user, the flow being marshalled by a centrally depicted host computer.
hown schematically in Figure 16, are a number of user interface devices 200 and a deslctop computer 201 communicating via any of a variety of communication services 202, through a gateway-router 204 with a host computer facility 206. The drawingdepicts schematically how a group or pool of users worlcing with interface devices 200 or computers 201, running the prescription management software of this invention, can be se~viced by host computer facility 206. Those slcilled in the art will appreciate that the schematic layout shown in Figure 16is described in terms of its logicalarchitecture and that the actual physical disposition of elements may be quite different.
2~
In addition to coordinating system-related communications7 especially retrieval of source data from remote databases, ga~eway-router 204 can manage supplementary services such for example as a paging service 208 or any other relevant desired function.

~nt3~ ~

Interface devices 200 are depicted as small form factor, handheld devices, or PDA's, communicating wirelessly over a WAN, a proprietarv wireless service, or a cellular digital packet data service, or the lilce. Deslctop computer 201, which may be aportable, notebook or other higher form factor computer, connected to 5 communications gateway-router 204 via a local area network labeled LAN, which connection could equally well be via modem, infra-red, wireless or the lilce, depending upon the circumstances. Any suitable network may be used, depending upon the user's equipment and the location of desired resources. Wired or wireless, local or wide area networlcs, or mixed networlcs, are suitable.
outing to the appropriate service and other communications technicalities are coordinated by communications gateway-router 204 which is networlced or otherwise connected with host computer facilitv 206.

15 Other prescribers (or other professionals in different environments) may use different methods to communicate with host computer facility 206 using a two-way digital data communication system across a network.

` ~ till other users may be supported bv other host computer facilities communicating 20 in their turn with host computer facility 206 using ay~lu~liate network services and providing communication linlcs or pathways between such other users and physician users supported by host computer facility 206. uch organizations employing one or more each of both users and host computer facilities are intended by r~felellcesherein to "neLw~lk" or the "networlc".
Communication services 202 can be any service providing effective two-way data transfer between users 200 and host computer facility 206. As labeled, some possible communication services 202 are wired local area networlcs ''LANI...LAN.l''~ wireless local area networlcs ''WLAN~...WLAN,l'' and proprietary radio frequency paclcet data 30 networlcs, such as A DI and AM (trademarlcs of their respective proprietors), 2~3~ ~

cellular digital paclcet data networlcs "CDPD,...CDPD,~" and so on.

Not shown is a wire telephone connection between a user device 200 and communieations gateway-router 204. This is of course a possible embodiment of the S invention and it is also, to be understood, local area networlcs LAN,~, could eomprise a single deslctop eomputer or a faeility-based networlced system of multiple desktop, or other eomputers.

Communications gateway-router 204 manages communications through these 10 various media serviees and provides consistent interfaees to users at deviees 200 and to host eomputer faeility 206, regardless of whieh eommunication serviee 202 is used.

As refereneed hereinabove, host computer facility 206 ean comprise a client-server 15 system in which a file server or database management server, or cluster of such servers, manage data storage and traffic functions, providing high volume data availability to multiple intelligent clients linlced, typically over a local area network, to the server or servers.

20 Exehanging data, programs and processing services across this system, user interface deviees 200 and host computer facility 206 support applications such as the prescription management system of the invention, E-Mail services and any other desired applications, for example patient encounter management programs, diagnostic proeedure management programs, and the lilce, in an analogous manner to 25 conventional client-server supported operation of such applieations.

Host eomputer facility 206 provides intelligent network services to user devices 200 and 201 and may support aneillary serviees, espeeially for example, as deseribedhereinbefore, patient-directed data access control software. Prescriber-directed data 30 aceess eontrol software or organization-directed data access control software could 2~311 ~
WO 96/13790 g2 PCT/US9S/14118 ~

also run in an application separated from the prescription management svstem7 but is preferably integrated therewith as a component of a user initi~li7~tion routine.
Conveniently, patient interface components of the patient-directed data access S control software are run at separate stations from the point-of-care locations used by prescribers and are located, for example7 in administrative or reception areas of health care facilities or managed care organizations. Here, data access rights may be read off a patient's data access control card, and such cards may be issued, under control of software supplied by, and in communication with host computer facility 206.
The level of software and data resident on interfaces devices 200 can be varied according to their phvsical capabilities and user or svstem administrator ~ref~lc.lces.
At a minimum, and for device redundancy, interface devices 200 need have resident neither files nor software, beyond what is supplied with the device off the shelf.
o long as the user interface device has an operating system and is communications-equipped, they may establish communication with host computer facility 206, using a separately supplied electronic address for that facilitv and may ~Ipload necessar,v program components and data files, including such personalized user profiles as have 20 been established by the user's prior experience with the system and which have been stored at the host computer facility 206, are called from a remote host computer .. ..
facility supporting other users.

Neither such program components, nor data, need be stored on the interface device 25 200 but, where the device 200 has adequate storage capacity, it will be more convenient and faster-loading for a user to maintain configuration and user profile files, along with limited amounts of relevant drug, and possibly patient data, on the user's local interface device 200. Preferablv, however basic system access software is required to be installed on the user device before system resources can be accessed.
30 uch basic system access software can be activatable after reported loss or theft to 3 ~ ~
~ WO96/13790 -83- PCT/US95tl4118 disable system access capabilities and to render anv stored proprietary data r~Pccihle to unauthorized users.
.

Host computer facilitv 5 ~Iost computer facility 206 provides full software support for user interface devices 200 and maintains complete program files for the prescription management system along with e-mail services and any other non-personal applications that may be needed by users of devices 200 beyond the basic operating systems and utilities, and the lilce, with which the devices are originally equipped.
--- Host computer facility 206 maintains databases of patient information for patients encountered or whose records have previouslv been viewed by users of devices 200 in response to calls sent via host computer facility 206, (and logged bv it for audit purposes) but, in lceeping with the preferred practice of the present invention, host 15 computer fadlity 206 does not maintain patient records in permanent storage. It could however be used to maintain patient record components that are source components to users of devices 200 for WhiCIl this particular host facility 206 is, at it were, their "home" facility.

20 Important functions maintained by the host computer facility 206 are information locator ~l~t~h~ces and advanced directorv and routing services, including the following:
i) a user device and system registrv enabling communications to be routed -- to the target user;
ii) 2 patient information directo~y service enabling access the system to access remote databases to retrieve patient record components for compilation of virtual patient records as described above;
iii) archiving of transaction logs and records, and of audit logs; - --iv) patient drug formularies and formulary guidelines or locators to access same;

~2~311 ~

v) libraries of alerts and other system displayed messages; and vi) access control software and related data files for patients, care providers and organizations.

5 Drug and condition lists and some drug information are also maintained on the host computer facility 206, but these are preferably either synchronized or refreshed at intervals (e.g. overnight) from source databases of such drug information. More detailed drug information (e.g. U. . Pharmacopeia information) can be retrieved from remote databases by host computer facility 206. Host computer facility 206 10 also maintains directory services for ~rrtocsing such drug related information, formularies, guidelines alert messages and the like and updates this data remotely from source databases maintained by the proprietors of the information.

Also in addition, host computer facility 206 can off-load data-processing functions 15 from interface devices 200, or conduct such functions in baclcground to provide support for the relatively limited processing capabilities of devices 200.

A further important function of host computer facility 206 is to retrieve multiple elements of a single patient record from multiple heterogenous remote ~ h~ces and 20 to deliver them to users for assembly into a virtual patient record by an interface device 200 or 201, in response to the user's call for that record.

Host facility 206 can reach out nationally, or internationally, for example across the INTE NET (trademarlc) to multiple remote databases such as remote databases 210 25 shown on the right hand side of Figure 16, to provide to users of interface devices 200 data resources beyond (and potentially more current than) those available from direct storage in the device or at the host facility.

Csmmunications 30 Communication between host computer facility 206 and remote databases 210 will 3 ~ ~

WO 96113790 g5 PCT/US95/14118 usually be via vvire lines such as telephone, or local or wide area network communication via copper line, or optical fiber, or any other suitable communication medium. Clearly, host computer facility 206 can access any remote third party database vvith which appropriate arrangements have been made, or can be made on 5 line, and some possible source databases for patient records components are labeled as "HMO's, Hospitals Insurance, Drug lBenefit Cos, Pharmacies, Labs and Independent Ll'hysicians". Drug information may be additionally sourced from pharmaceutical companies' research centers, reference libraries, or publishers and the lilce.
One or more pools of users of devices 200 and computers 201 constitute a valuable professional audience and the svstem provides a valuable means enabling such third party database proprietors to become data publishers and electronically publish or post their databases or on the network to reach that audience.
Using recognizable common record element identifiers, for example patient identification numbers or drug identifiers, host computer facility 206 forages across available networlcs for similarly identified record elements to retrieve. Employing its information directory services as locators, host computer facility can retrieve a variety 20 of data including patient-specific data, application-specific data (users ~ref~ ces and the lil~e), organization-specific data (formulary guidelines, for example) and general drug or prescribing data, e.g. from MEDLINE.

To assist vvith compatibility problems vvith the legacy systems operating at remote 25 databases 210 and to avoid heavy volurnes of user calls, via the systems of the present inven~ion, interfering with or slowing dovvn the daily operations at theproprietary facilities supporting the remote data bases 210, this embodiment of the invention provides, at each of a limited number of remote ~l~t~h~es 210 lcnovvn to be a significant source of patient recordL elements, a dedicated data warehouse 212.
30 Data warehouses 212 can be real or functional, depicting either actual physical 1 3 ~ ~
WO 96/13790 -~6 PCT~S95/14118 embodiments of system-dedicated services located at the facilities of remote databases 210, or logical functions executed at the host computer facility 206.

Data warehouses 212, host computer facility 206, communications router-gateway S 204 and communications services 204 are components of a conceptual integratingnetwork 214 which brings users of devices 200 and 201 transparent access together with the resources available at remote databases 210, and preferably gives those users a seamless appearance, as though data stored piecemeal at multiple remote databases 212 were directly available from a single file across a local area network.
To facilitate connection Witll heterogenous databases, and to give their proprietors fluent access across the network, it is preferred that the svstem provides uniform application programming interfaces, remote API's 216 for use bv third party deve}opers. Compatible user API's 218 OIl the do~lstream side provide similar 15 standardized connectivity with user devices 200 and 201.

Integrating network 214 and API's 216 and 218 permit easy system integration, al}ow third parties to deve}op end-to-end communications solutions with standardized third party communication across the network and a data "firewal}" for 20 security.

Data Warehouses 212 Each data warehouse 212 maintains rep}icated copies of re}evant data sets obtained by read-on}y access of remote databases 210, which data sets are maintained 25 synchronously with updated source data at remote databases 210, or are periodica}}y refreshed ther~r~ efe.~b}y at frequent intervals. Data warehouses 212 can also provide search and retrieval facilities and, in particular, provide protocol interchange and reformatting capabilities to reformat or othertvise standardize data and communications across net~rork 214, for any application to use. Preferablv, to 30 facilitate compliance with the desired auditabilitv of the transactions and data 2 ~ ~ ~ 3 ~1 ~
WO 96/13790 ~37 PCT/US95/14118 accesses of preferred embodiments of the invention, data warehouses 212 screen data incoming from associated data warehouses 210 for date-stamping, and ~lef~,dbly, also time-stamping, of individual received data or record elements, and reject those that lack such stamps. Preferably also, the date stamp indicates origination, creation 5 or updating of the data element, rather than being merely a date of entry of the data element into data warehouse 212.

ource data generated by point-of-care or other transactions at user interface devices 200 or computers 201, can be directly posted to remote databases 210 across 10 network 214 which bears two-way traffic. As will be apparent from the disclosure herein, remote databases also include data from other places, for example pharmacies, laboratories and testing facilities.

Communications gateway-router 204 also maintains a physician-device directory 15 providing routing or access information needed to establish communication protocols with each individual physician. This device directorv service can maintain an electronic address, a device identifier or device configuration, operating system information and user device commullications protocols for each user device supported by l:he gateway-router. User ID's can be listed separately and in preferred 20 embodiments are accompanied by a prioritized listing of one or more device addle,,scs where the user may be accessed.
.

Other temporary or permanent update means are provided to enable a user to access the host computer facility from more than one device, preferably using an address 25 that is device-independent.

It will be understood that an individual host computer facility 206 can serve one group of users that may, for example, be defined geographically and may number from, for example, as low as 10 or 20 users in the earlv davs of establishment of the 30 facilit,v to hundreds and thousands as the facilitv matures. To service more users or to service users in other geographical areas, additional host computer facilities 206 can be established as centralized or regionally distributed hubs. uch additional host computer facilities 206 will, in all lil~elihood, access many of the same remotedatabases 210. Preferably, switching or rerouting means are provided to optimize5 data traffic loads between multiple host computer facilities 206.

It will also be understood that a national or international network can be created by establishing a sufficient number of host computer facilities 206 in strategic locations, each serving a local client base of, for example campus or regional users, with 10 interface devices 200.

Summary The foregoing description has emphasized an approach to therapy prescribing which records an association between a therapeutic agent (dmg) and a condition or problem 15 targeted for resolution or amelioration by the prescribed therapeutic agent.
ignificant benefits derive from organizing l<nowll therapeutic agents according to conditions for which they are lcnown to be effective, and emphasis has been placed herein on a drug selection and specification which begins with selection of a problem or condition to be treated, because this is be an appealing and beneficial approach in 20 many circumstances. Frequently however, the physician may lcnow exactly what drug they wish to prescribe, in which ~e they can proceed to a direct drug entry screen, and then specify the condition targeted by the prescribed treatment.

While emphasis has also been placed in the principle examples on the prescription of 25 drugs, it will be appre~i~te~ that the invention can be beneficially applied to the specification of other therapies and technical remedies for example to the specification of surgical procedures, physical therapies and diagnostic testing.

rlcfc~l~d embodiments of the invention include quick and easy routines for directly 30 posting a drug to a prescription, without prior condition selection, such routines ~ WO96/13790 89 PCT/US9S/14118 ~refelably being by-passed. In order to gaiIl the subsequent historical review and outcome study benefits described herein, it is preferred to provide for inclusion of a treatment objective of the prescribed drug in the prescription record before completion of the prescription. The treatment objective can be rapidly selected from 5 a system-supplied list of a patient's existing or historical conditions, or through powerful system-aided selection of a new condition. While a default patient condition or problem may be suggested by the svstem for a particular prescribed drug, it is l.r~fcl,~d that such default be actively confirmed by the prescribing user before being accepted by the system.
To accommodate direct prescribing by dn~g name, Drug field ~ of the prescriptioncreation screen of Figure 3, can open a personalized or customized user-activatable drug list, or proceed to compreheIlsive svstem drug lists to enable rapid specification of familiar or unfamiliar drugs prior to conditioll selection. Drug dosage selection 15 then proceeds as described above. Before leaving prescribing zone 44 of the prescription creation screen 39 the system caIl require an appropriate entry to be made in Condition field 86.

Other ~iefellcd embodiments enable the patient, the prescribing phvsician and the 20 relevant organization to control the flow of their own data by predetermining access rights to that data. Every transaction can be stamped with a patient identifier, a prescriber identifier and, if appropriate, an organization identifier, as well as with the date and time of day.

25 Emphasis on ~lefcll~d, historical or custoInized sllort lists of drugs and conditions enables an attractive worldng environment to be provided even on relatively low power PDA's. hort list data may be maintained on the user device providing rapidresponses in the user's most common prescribing situations. Less common situations entail calls to the host computer facility, in which circumstances delays of a few 30 seconds wl~ile data is retrieved from the network are quite acceptable.

3 ~

System requirements User software components of a currently preferred embodiment of prescription management system described herein are designed to run under an operating systemthat plcfe~bly supports a full or modified version of M -DO ~ (trademark, 5 Microsoft Corporation) WINDOW T7- (Microsoft Corporation) or other systems with user-friendly graphical interfaces, for example Apple Computer Co.'s MACINTO H (trademark) or NEWTON (trademark) operating systems and General Magic's MAGIC CAP operating system. Other graphical environments can be used or are being developed and other embodiments of the invention may be 10 suitably modified to optimize the application to take advantage of the unique characteristics of each such operating system environment.

The programming language used to write svstem software depends upon the environment of the various system components. In their present stage of 15 development, some handheld PDA's require applications to be written with the tools provided by their respective operating systems such as NEWTON or MAGIC CAP
(trademarlcs). For other devices such as those supporting Microsoft's WINDOW
(trademark) operating system, including some PDA's, a range of languages can be used including for example, popular programming languages such as Microsoft 20 Corporation's "C" or Borland International's "C+ +". For Apple Computer's MACINTO H (T ADEMA IC)-based systems, languages such as THINIC
(T ADEMA IC) are appropriate.

The system is particularly advantageous when implemented on any of a variety of 25 portable computer stations especially handheld units such as personal digitalassistants and other personal information communicators equipped with wireless communicators. A ~fcl,.d embodiment for mobile professionals comprises such a handheld unit with two-way radio or infrared communication facilities. ome such devices are rcfciellced in a "BUYE ' GUIDE: PE ONAL DIGITALA I TANT "
30 PC WEEIC August 297 1994, pages ~9 and 94 the disclosure of which is hereby 3 ~ ~
WO 96/13790 9 1 PCT/US95/14118 incorporated herein bv reference thereto.

For compatibility with the currently rather limited performance specifications of such desirable handlheld devices the prescription management system of the invention is 5 ~rc.ably designed to minimize the storage and processing requirements placed on the user's terminal and to off-load storage and processing to host computer facilities.
Thus, the system's support architecture aims to supply to the user terminal onlyessential data required for screen displa~s and other user functions, on an as-needed basis, while the network stores applications and data files, for example at the host 10 computer facility.

Modified Embodiments of the Invention While the invention has been described with a reference to a particularlv valuable embodiment of a prescription management svstem, it will be understood by those 15 slcilled in the art that alternative embodiments of the invention can bring valuable benefits in their respective fields wllere informed choice is desirable and can be facilitated by interactive computer-assisted decision-malcing, especiallv in situations where decision-relevant data is or can be drawn from multiple heterogellous remote databases. ----ome such possible applications of t~e invention are to the specification of laboratory tests and also in the veterinary field, and to non-pharmaceutical environments where benefits such as valuable historical records and follow-up studies, as well as quality control improvements, can be obtained from coupling diagnostic conclusions with 25 specified problem solutions.

Thus, according to one such a modifiedL embodiment of the invention, laboratory test information can be presented to a prescribing professional by first listing patient conditions which the professional wishes to explore more fully bv specifving one or 30 more specific laboratory tests, bv reporting the laboratorv result and suggesting ~20~3~ ~

lu~L~ r testing for differential diagnostics. The system then provides a selection of laboratory tests Icnown to be useful in evaluating the relevant condition, that selection and organization of laboratory tests being made in a manner similar to that described for therapeutic drugs in the ~lcfel~d embodiments herein, and moves on5 to create, select and order a~ opliate cost-controllable diagnostic testing, in a comparable manner to that described herein for creating a prescription.

For example, an analogous diagnostic application may provide cost-effective routes to rule in or rule out specific diagnoses. The specificity and sensitivity of individual 10 procedures can be translated into positive predictive values and negative predictive values. By applying decision theory and analyzing probable outcomes of procedures or combinations of procedures in tlle light of the patient's bio-characteristics and lcnown conditions, diagnostic protocols can be worked up and maintained with current recommendations. Evaluation of the patient's history can enable pretest 15 probabilities to be established and used to modulate the predictive value of one or more tests. Thus the patient's history can drive the selection and establishment of an optimal diagnostic test matrix for identifying a patient's condition or conditions with good specificity and confidence levels.

20 Test requirements relating to patient preparations, fasting for example, and sample collection can be system specified. By generating system-maintained identifiers (e.g.
bar code labels) for attachment to samples at the point-of-care, a chain of evidence for rigorous sample accessioning can be begun.

25 Thus, a range of possible conditions can be evaluated in a differential diagnosis format designed to rule in or rule out a target condition, or conditions, depending upon the results of specified tests.

Extensions into the veterinary field will be apparent to those slcilled in the art in that 30 instead of the physician user referenced herein, reference to a veterinarian is 2~311 ~

a~lo~liate, and the patient w ill be an animal such as a pet dog or cat or valuable livestock, such as a steer or breeding pig or a race horse or breeding stallion.

Again, although the invention has been described in its ~r~fel.~d embodiments with 5 l~f~r~llce to a physician user it will be apparent that other medical professionals, especially those having prescribing~authority, can benefit from applications of it.

In a more general sense, the invention provides a service professional with significant new benefits, especially during a service encounter with a customer or client, in I 0 selecting, specifying or providing techn;cal remedies to consumer problems. For example, in specifying automotive replacement parts a service technician can benefit from an autonnotive service management svstem according to the invention in which a database of replacement parts is classified according to the seIvice problem for which the parts might provide a remedv. Thus, for a customer with the problem ofbreak squeal, the system may provide a list of parts, for example, bralce pads, bralce pins, bralce shims or brake rotors, any of whicll may provide a remedy to the customers problem of bralce squeal. Existillg systems permit a service technician, having once identified the type of part they need, to obtain a number or part price and inventory on that part for the customer's specific model of car.
However, lcnown systems do not permit the professional to query the system by customer problems, nor do they provide a summary of all facets of a solution to a problem leading to a summarized cost of treatment. In addition the inventive system can provide access to technical literature on relevant problems, for example an explanation of the factors causing bralce squeal which can be printed out for customers. This is a rather simple example. More complex examples will be apparent to those slcilled in the automotive and other arts, especially as this art develops, with .
sophisticated engine management and other microprocessor controlled systems raising new problems and new technical solutions being required. The inventive system can provide customer problem lists useful for outcome analvsis to drive the ~ 2~ ~ 3 ~ ~
WO 96tl3790 94 PCT/US95114118 development of better cars.

Of great value in the automotive and allied fields, equating a parts supplier, such as a factory or warehouse distributor with a plan benefit company is the ability to provide 5 new product descriptive and price information or updates from multiple sourcesdynamically, in real time as transactions are created. Noting the desire of a benefits company to apply practical selection guidelines in an unobtrusive manner to the prescribing process, an equivalent technique can be used by car factories to help control warranty service decisions at their dealerships.
In another embodiment of the invention illustrating its generality, possible insurance vendors and coverage information may be classified according to customer problems so that, for example, an insurance agent mav list different vendors and coverageproviding specific technical remedies to a customers specific; problem, for example, a 15 recent major automobile collision claim. The relevant novel supportive ~t~b~ce could include information differentiating bet~veen parties at fault, collision damage, personal injury settlements and so on. In both these examples a problem history related either to the customer or to the customer's automobile can also be created.

20 It will be clear to those slcilled in the art that use of the prescription management system described herein, employing carefully maintained databases of accurate, reliable prescribing data will produce high quality prescriptions free of many of the problems now plaguing prescription dnlg use. With confidence that a physician isprescribing ap~ro~liate, cost-effective dmgs selected from user-personalized lists 25 which link to comprehensive condition and dnug lists including the latest available drugs, and that the prescribed dnug has been reviewed for contraindications, patients benefit, oversight of the prescribing process by benefit companies and regulatory bodies can be retl-lce-~, and litigation resulting from prescribing errors will be reduced.
ignificant improvements in the quality of care, substantial savings and the 30 elimination of waste can accnue to a national or regional health care system from 2~3~ ~
WO 96/13790 95 ' PCT/US9S114118 widespread deployrnent of the inventive prescription management system described herein.

Phvsical embodiment of system software - 5 The foregoing specification, read with the accompanying drawings provides anextensive disclosure of, inter alia, various embodiments of systems and softwarefacilitating professionals to select or specify technical products to solve practical problems, and also to create, or assist the professional to create, new products which will assist the professional or their client in achieving desired problem-solving goals.
It will be understood that the svstems and software referenced herein include, either explicitly7 or implicitlv, software implemented on computers or other appropriate hardware, including user devices S~lCil as the personal digital assistants described herein, and such other intelligent data processing devices having a processor, data 15 storage means and the ability to support an operating system, Wit}l or without user interfaces (for example, file servers,), as may be useful in achieving the objectives of this invention.

oftware components and applications exnbodving the invention can be distributed 20 in electronic bit storage on magnetic, optical, bubble or other media, optionally in transportable form to be interactive witll an electronic reading device, for example on computer or optical diskettes, or mav be distri}~uted over wired or wireless networlcs for storage by the recipient on such media.

25 Plefel~d embodiments of the invention provide such media-stored software in acommercial paclcage accompanied by instructions in printed book or booldet form,for deployment of the software on particular embodiments of general purpose computer to cause same to operate as a special purpose computer, in accordance with the objectives of the invention. License agreements, and registration means for 30 updating mav also be included. Alternativelv, the instmctions mav also be provided ~2~3~ ~

as data files.

It will further be appreciated that such media-stored software constitutes an electronic customizing machine which can interact with a magnetically or optically 5 cooperative computer-based input device enabling the computer to be customized as a spécial purpose computer, according to t'he contents of the software. To cause a computer to operate in such customized, special-purpose mode, the software of the invention can be installed by a user, or other, and will usually interact efficiently with the device on which it is resident to provide the desire special-purpose qualities, only 10 after selection of configuration parameters. When so configured, tl-e special-purpose computer device has enhanced value, especially to the professional users for whom it is intended.

While some illustrative embodiments of the invention have been described above, it 15 is, of course, understood that various modifications will be apparent to those of ordinary slcill in the art. uch modifications are within the spirit and scope of the invention, which is limited and defined onlv by the appended claims.

Thus, while certain aspects of the invention have been disclosed as embodied in 20 connection with a prescription management system, it will be apparent that they have broader application in other systems or environments. ome of tl-ese aspectsare: dynamic assembly of records from source record elements retrieved across a network from heterogenous remote databases; requirements for those elements to be time- and date-stamped for retrospective recreation of records from archival logs;
25 physician-centric drug formularies; data-access control systems and software; the novel directory services described herein and associated online point-to-point e-mail and data retrieval systems; data retrieval networlcs with API-enabled end-to-endtransparency; novel outcome studies, monitoring and alerting procedures, studies and related products; novel scheduled dosage drug paclcs and dispensing devices, and so 30 on.

Claims (85)

1. Claim 1. A computer-implemented prescription management system for use by a prescriber in creating a prescription at a point of patient care, the prescription being usable by a pharmacist to dispense drugs, the prescription management system being characterized by comprising:
   a) electronic posting means to select and capture in the prescription:
   i) a patient identifier;
   ii) a prescribed drug (118);
   iii) a dosage for the prescribed drug (118); and iv) a patient condition (116) intended by the prescriber to be treated by the prescribed drug (118); and b) a displayable library of prescribable drugs (118);
   whereby a historical data resource associating conditions with prescribed drugs can be created for generating treatment recommendations to assist prescribing physicians.
2. Claim 2. A prescription management system according to Claim 1 characterized by having means to track preferred data usage by a user and to adapt data displays to favor such preferred usage, whereby the system learns and adapts to a user's habits.
3. Claim 3. A prescription management system according to Claim 2 characterized in that at least one said preferred usage data display comprises a personal-preference condition-selection list for each system user.
4. Claim 4. A prescription management system according to Claim 2 or 3 characterized in that at least one said preferred usage data display comprises apersonal-preference drug-selection list for each system user.
5. Claim 5. A prescription management system according to Claim 1 further characterized by comprising a patient history record displayed online, the patient history record listing electronically available prior prescriptions, the prior prescriptions each including a prescribed drug (118) and a condition treatment objective for each drug prescribed, system-created prescriptions being system-added to the history record.
6. Claim 6. A prescription management system according to Claim 5 characterized by comprising a patient condition list for selection of a patient condition (116) for posting to the prescription, the patient condition list includes patient conditions (116) listed in the patient history record.
7. Claim 7. A prescription management system according to Claim 1 characterized by comprising a source-oriented data-retrieval subsystem, the data retrieval subsystem accessing at least one data-retrieval network to supply an array of up-to-date prescribing information and patient-related data to the point-of-care from remote source databases.
8. Claim 8. A prescription management system according to Claim 7 characterized in that the data-retrieval subsystem is linked to the prescription management system to provide one or more indicators of allergy and interaction alerts, drug formularychanges and new drug approvals, and to lock out or warn against, the prescribing of inappropriate or recalled drugs.
9. Claim 9. A prescription management system according to Claim 5 characterized by comprising a patient history record dynamically assembled online in response to a user request from multiple source record elements retrieved from multiple heterogenous remote databases.
10. Claim 10. A prescription management system according to Claim 9 implemented on a user interface device configured for networked digital communication with a host computer facility, characterized in that the patient history record is retrieved in the form of record elements from the remote databases by the host computer facility in response to a call from the user device, the remote source databases being selected and identified according to the patient's prior geographical locations and health-care service providers.
11. Claim 11. A prescription management system according to Claim 5 characterized in that the patient history record is a virtual patient record newly assembled online in response to each user request for the record thereby to be current with regard to possible remote updates of the source record elements.
12. Claim 12. A prescription management system according to Claim 11 characterized in that the host computer facility logs the time, date and user calling for the virtual patient record to provide an audit trail of access to the patient's record, or aprovider's or organization's data.
13. Claim 13. A prescription management system according to Claim 11 deployed comprehensively throughout a geographical area, demographic, company, plan or community group whereby all drug prescriptions created in the area are products of the system and characterized in that all the drug prescriptions are posted to source databases accessible to the system whereby a complete patient history record of all drug prescriptions created for the patient in the geographical area, demographic, company, plan or community group can be listed in the dynamically assembled virtual patient record.
14. Claim 14. A prescription management system according to Claim 1 characterized in that the drugs (118) in the drug list are classified according to a patient condition (116) for which the drugs (118) have efficacy and the prescription management system further comprises a patient-condition specification procedure for selecting the condition (116) from groups of possible conditions (116) and an onscreen drug selection procedure for selecting the prescribed drug (118) from the library, listing multiple drugs (118) for treating each the patient problem.
15. Claim 15. A prescription management system according to Claim 1 characterized by comprising:
    c) displayable patient drug formulary information to indicate to the prescriber-user selected ones of the prescribable drugs included within a drug formulary associated with the patient to enable compliance with drug formulary guidelines at the point-of-care.
16. Claim 16. A prescription management system according to Claim 15 characterized in that the patient drug formulary display means comprises a condition-driven formulary drug list (120), and a condition-driven nonformulary drug list, the drug lists being changeable according to the patient selected.
17. Claim 17. A prescription management system according to Claim 15 or 16characterized in that the system provides drug efficacy guidelines based on patient information and formulary information.
18. Claim 18. A prescription management system according to claim 3 characterized in that the prescriber-user's personal-preference list of drugs isdisplayed with formulary drugs indicated.
19. Claim 19. A prescription management system according to Claim 15 or 16characterized by including relative cost information for displayed formulary drugs.
20. Claim 20. A prescription management system according to Claim 15 or 16characterized in that the drug formulary is generated by a prescription benefitsmanagement company by providing computer access to remote databases containing the drug formulary information whereby appropriate formulary drugs are presentedto the user on screen on a user interface device deployable at the point-of-care, to facilitate compliance with drug formulary guidelines at the point-of-care.
21. Claim 21. A prescription management system according to Claim 15 or 16 characterized in that prescribability of a drug pursuant to formulary guidelines is formulary-qualified according to the patient condition (116).
22. Claim 22. A prescription management system according to Claim 15 or 16 characterized by comprising built-in logic for accessing drug formulary information from multiple drug formulary providers wherein the drug formulary list is selected from the multiple available drug formularies according to the patient identification, the patient having a prior arrangement with the drug formulary provider to provide prescription-related benefits to that patient, the drug formulary list information being dynamically presented to the prescriber-user in the form of at least one selection of patient-specific formularies from which a formulary status indication relevant to a patient therapy-related choice made by the prescriber-user is made.
23. Claim 23. A prescription management system according to Claim 22 characterized by comprising network data communication means to update and maintain the multiple available formularies from remote source databases of formulary information.
24. Claim 24. A prescription management system according to Claim 1 characterized by comprising means to categorize and display the patient conditions (116) in multiple condition lists (112), the condition lists being selected from the group consisting of a personal condition list of conditions encountered by the prescriber, a historical condition list of conditions exhibited by the patient, one or more prescriber-customized condition lists, a body system condition list, conditions organized according to disease pathology, therapy, personal knowledge and others.
25. Claim 25. A prescription management system according to Claim 24 characterized in that drug selection is condition driven and the prescriber selects a patient condition (116) to be treated via at least one of the condition lists.
26. Claim 26. A prescription management system according to Claim 24 or 25 characterized by intelligent data access means for a prescriber-user to access a large body of drug data selections via multiple condition-driven routes to provide multiple mapping so that the user can find a suitable drug or selection of drugs via different pathways according to their preferred work methods.
27. Claim 27. A prescription management system according to Claim 1, 5, 15 or 24 characterized in that the electronic posting means can select and capture dosageand route of administration information, and optionally, length-of-treatment andgeneric substitution authorization information, for a selected drug, the information being system-available for all listed drugs.
28. Claim 28. A prescription management system according to Claim 27 characterized by comprising network data communication means to update and maintain the dosage information the dosage information being dynamically supplied from a remote source database when called by the system.
29. Claim 29. A prescription management system according to Claim 1, 5, 15 or 24 characterized by comprising a prescription expiration routine including dosing, amount and expiration drug quantifiers and system calculation of a relationship between the drug quantifiers where the system provides default values for unspecified ones of the drug quantifiers in response to user selection of one or more of the drug quantifiers and optionally patient history information, formulary information indicating preferred drug lists for treatment.
30. Claim 30. A prescription management system according to Claim 1, 5, 15 or 24 characterized by comprising a patient data access control subsystem including data access control specification means enabling a patient to authorize a user to access the patient's history data and by comprising data access control means whereby only an authorized user can access the patient's data.
31. Claim 31. A prescription management system according to Claim 1, 5, 15 or 24 characterized by comprising a patient data access auditor, the patient data access auditor generating an access record logging information as to the time date and identity of entities accessing the patient history data, the prescriber's prescribing history or the organization's prescribing history, to provide a patient data access audit trail, a prescriber's data access audit trail or an organization's data access audit trail.
32. Claim 32. A prescription management system according to Claim 1, 5, 15 or 24 characterized by comprising a patient data access subsystem providing patient-directed control of the flow of their own data.
33. Claim 33. A prescription management system according to Claim 32 characterized in that the patient-directed data-access control is achieved by centrally inputting to the patient data access subsystem at a host computer facility, patient-generatedrecord-access specifications determining which parties can access what data during what period of time.
34. Claim 34. A prescription management system according to Claim 32 characterized in that the patient-generated record-access specifications provide a patient security profile in a pre-authorization file the pre-authorization file being used to control access to the patient's data.
35. Claim 35. A prescription management system according to Claim 1, 5, 15 or 24 characterized by comprising user-related historical records generated by operation of the system by a prescriber-user, a user data-access control subsystem including data-access control specification means enabling a user to authorize selective third party access to the user's history data and comprising data access control means whereby only an authorized third party can access the user's data which control means determines what data type may be accessed by what organization or provider.
36. Claim 36. A prescription management system according to Claim 36 characterized by comprising a user data access auditor, the user data access auditor generating an access record logging information as to the time date and identity of third parties accessing the user history data, to provide a user data access audit trail.
37. Claim 37. A prescription management system according to Claim 1, 5, 15 or 24 characterized by comprising organization-generated source data retrievable for display in the prescription-management system from at least one remote database, an organization-directed data-access control subsystem including data-access control specification means enabling an organization to authorize selective third party access to the organization-generated source data and comprising data access control means whereby only an authorized third party can access the organization-generated source data.
38. Claim 38. A prescription management system according to Claim 37 characterized by comprising an organization data access auditor, the organization data access auditor generating an access record logging information as to the time date and identity of third parties accessing the organization-generated source data to provide an organization data access audit trail.
39. Claim 39. A prescription management system according to Claim 1 characterized by comprising newly created prescription evaluation means to evaluate a newly prescribed drug for system-known patient allergies or drug-to-drug interactions, or drug-to-multiple drug interactions and absolute contraindications with currentlyprescribed drugs, as known to the system.
40. Claim 40. A prescription management system according to Claim 1, 5, 15, 24 or 39characterized by comprising a drug alert subsystem for communicating alerts relating to unfavorable or cautionary characteristics of particular drugs wherein the alerts are associated with system information on the drug so that when a user calls up the drug in question, they receive the warning or alert, or other special message.
41. Claim 41. A prescription management system according to Claim 39 characterized in that the drug alert subsystem is operative to communicate drug withdrawal information to system users electronically in real time or when the withdrawn drug is selected for prescribing or a warning is posted directly to the prescription.
42. Claim 42. A prescription management system according to Claim 41 comprising prescription completion control means to prevent completion of a prescription for the withdrawn drug whereby a drug can be withdrawn from a market in which the prescription management system is deployed in a single day.
43. Claim 43. A prescription management system according to Claim 41 characterized in that current users of a drug or medication can be identified from prescription history records, referencing not only drugs prescribed, but also prescription expiry dates and both the patient and their doctor are electronically notified of the drug withdrawal.
44. Claim 44. A prescription management system according to Claim 1 characterized by comprising onscreen electronic mail access to other users of the system, the electronic mail capability additionally being linked with the prescription creation function and enabling a prescriber-user to append an electronic record to a prescription or prescription-related record.
45. Claim 45. A prescription management system according to Claim 44 characterized in that the electronic mail provides a platform for accessing other artificial intelligence and expert systems and optionally providing linkage for transactionservices such as the ordering and reviewing of scheduling and similar administrative functions.
46. Claim 46. A prescription management system according to Claim 1, 5, 15, 24, 39 and 44 characterized by comprising a patient-selection subsystem whereby preliminary selection of groups of patients can be made by providing multiple patient lists selected from the group consisting of "Today's Patients", "In-Patients", "Out-Patients", "Private Patients" and others.
47. Claim 47. A prescription management system according to Claim 46 characterized in that the patient lists are system-maintained, on an ongoing basis, using the latest data available to the system and include intelligent patient selection means enabling the user to select a convenient group of patients that has a high probability ofincluding the next patient or patients to be encountered, thereby speeding access and retrieval of a desired patient record.
48. Claim 48. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized by comprising onscreen access to drug detail information as to indications, interactions, side effects and precautions.
49. Claim 49. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized by comprising a drug literature-retrieval subsystem to retrievedrug -related information across a network from a remote heterogenous database for display to the user in real time.
50. Claim 50. A prescription management system according to Claim 49 characterized in that the drug literature-retrieval subsystem provides the user with an access point to full disclosure and prescribing information on a selected drug and characterized in that the available drug information is selected from the group consisting of drug-treatment guidelines, one or more literature references supporting the guidelines, details of the particular conditions (116) for which a system-suggested alternative drug has been found effective, adverse conditions, preferred dosages and administration routes, literature sources and other relevant drug-prescribing information.
51. Claim 51. A prescription management system according to Claim 50 characterized in that the drug literature-retrieval subsystem is operative to enable a physician, to have a hard or printed copy, or other media form of relevant studies or literature sent to them by onscreen selection, the onscreen selection being system-communicated to a source for the study or literature information.
52. Claim 52. A prescription management system according to Claim 50 characterized in that the drug literature-retrieval subsystem is operative to provide a simplenonintrusive technique for bringing new drug information to physicians at a point of care when creating a prescription.
53. Claim 53. A prescription management system according to Claim 32 characterized by comprising an outcome study subsystem for selecting outcome study participants by centrally maintaining patient-directed patient-record-access specifications whereby the system can include records of patients agreeable to becoming study participants in such outcome studies pursuant to indications in their patient-record-access specifications optionally with output of the study data being controlled to comply with access specifications of prescribers and organizations having proprietary rights thereto.
54. Claim 54. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized by comprising a new drug surveillance subsystem to conduct postintroduction market surveillance of new drugs for adverse outcomes to the treatment of a specified condition (116) or conditions with the newly introduced drug.
55. Claim 55. A prescription management system according to Claim 54 characterized in that the new drug surveillance subsystem is operative to monitor patients reporting new problems after having been prescribed the new drug in question, refer such new problems to the physician user to qualify them for medical relevance and then statistically compare a collection of similar reports with data on a pool of similarly treated patients for significance.
56. Claim 56. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized in that the condition list comprises at least five condition (116)s, and the drug list comprises at least five drugs.
57. Claim 57. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized in that the drug information comprises associated condition information and dosage information for at least about fifty percent of all prescribable government-approved drugs.
58. Claim 58. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized by comprising means to output a newly created electronic prescription in print or other readable media, to local or remote file storage or to remote file transfer as an electronic prescription.
59. Claim 59. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized by comprising means for transmitting the electronic prescription across a network for fulfillment by a specified pharmacy.
60. Claim 60. A prescription management system according to Claim 57 characterized by comprising a printed dosage schedule output for the patient.
61. Claim 61. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized in that multiple physicians accessed by a patient utilize the prescription management system described herein, with common online access to, and assembly of, a patient's prescription history record whereby the prescription history record provides a current record of all new prescriptions for the patient, and the system enables control of prescription abuse by the patient wherein the patient presents a problem or condition to more than one physician to obtain multiple prescriptions with a view to indulging in abusive ingestion or illicit resale.
62. Claim 62. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized in that the system also provides a patient-related notificationfrom a pharmacy, or from a drug benefit plan linked to the pharmacy, of fulfillment of a prescription, and that fulfillment notification is available to the prescriber, whereby the system enables prevention of prescription abuse wherein the patient pleads loss of a prescription to obtain a duplicate.
63. Claim 63. A prescription management system according to Claim 1, 5, 15, 24, 39 or 44 characterized in that the system also provides a patient-related notificationfrom a pharmacy, or from a drug benefit plan linked to the pharmacy, of fulfillment of a prescription, and that fulfillment notification is available to the prescriber whereby a patient's failure to have a prescription fulfilled indicating discontinuance of the prescribed therapy can be monitored for correction.
64. Claim 64. A prescription characterized by being produced by the system of claim 1, 5, 15, 24, 39 or 44 output in a form selected from the group consisting of electronic, paper, digitized voice and fax.
65. Claim 65. In combination, a host computer facility and a prescription management system according to claim 1, 5, 15, 24, 39 or 44 implemented on the host computer facility the host computer facility supporting network delivery ofuser-relevant components of the prescription management system to multiple remote user interface devices and providing data and communications resources for users to draw upon employing the interface devices.
66. Claim 66. A combination according to claim 65 characterized in that the host computer facility can communicate with multiple heterogenous remote databases toretrieve complementary data elements from the databases and comprises:
    i) a dynamic record assembly procedure for online assembly of a data record from the complementary data elements; and ii) a user-device communication procedure to deliver the dynamically assembled record to a calling user-interface device as an integral data component of the prescription management system.
67. Claim 67. A prescription management system for electronic prescription creation by a prescriber at a point of patient care, the prescription being usable by a pharmacist to dispense drugs, the prescription management system being characterized by comprising electronic posting means to select and capture in the prescription:
    i) a patient identifier;
    ii) a prescribed drug; and iii) a dosage for the prescribed drug;
    and an onscreen drug selection procedure having at least one drug list specifying multiple possible prescribable drugs and having drug specification means to select and post a desired drug to the prescription wherein the system calls for, and requires, the prescriber to enter a condition (116) before proceeding to quantification of the prescription.
68. Claim 68. A prescription management system according to Claim 66 characterized by comprising drug formulary information being a selected list of drugs being preferred for prescribing by a drug benefit provider to the patient.
69. Claim 69. A computer-implemented prescription management system for use by a prescriber in creating a prescription at a point of patient care, the prescription being usable by a pharmacist to dispense drugs, the prescription management system comprising:
    a) electronic posting means to select and capture in the prescription:
    i) a patient identifier;
    ii) a prescribed drug;
    iii) a dosage for the prescribed drug;
    and characterized by comprising b) a prescription division subsystem to create a bridge prescription divided into a local prescription component intended for fulfillment at a pharmacy convenient to the patient and a remote prescription component intended for fulfillment at a remote, lower cost, mail order pharmacy.
70. Claim 70. A prescription management system according to Claim 69 characterized in that the local prescription component specifies an adequate prescribed drug quantity for short term needs and the remote prescription component provides a longer term supply.
71. Claim 71. A prescription management system according to Claim 69 or 70 characterized in that the electronic posting further selects and captures in theprescription:
    iv) a patient condition (116) intended by the prescriber to be treated by the prescribed drug;
    and the prescription management system further comprises:
    b) a displayable library of prescribable drugs; and c) displayable patient drug formulary information to indicate to the prescriber-user selected ones of the prescribable drugs included within a drug formulary associated with the patient to enable compliance with drug formulary guidelines at the point-of-care.
72. Claim 72. A time- and date-scheduled multi-drug dosage package generated by an electronic prescription according to claim 64, for containing a multi-drug prescription or prescriptions to be taken contemporaneously by a patient characterized by comprising a package having multiple labeled compartments for each of a number of dosing intervals for multiple drugs, each package compartment being intended forand labeled for a single dosage.
73. Claim 73. A multi-drug package according to claim 72 bearing time-interval descriptors prescription-relevant date, patient and doctor identification and at least one series of multi-compartment drug bays to accommodate a prescribed dosage of a solid drug formulation, each bay being labeled with a time of day at which the dosage in each bay is to be taken, zone markings extending across multiple compartments in a series of bays and labeling same as dedicated to an individual drug.
74. Claim 74. A multi-drug package according to claim 73 characterized by being configured as a card, strip, roll, book, a metal foil sheets having tear or press-out compartments or by having an accordion-pleat configuration.
75. Claim 75. A multi-drug package according to claim 74 characterized by at least some of said drug dosages being organized into unequal quantities in differentlytimed compartments to facilitate time-related dosage variations.
76. Claim 76. A dosing indicator device usable with an electronically or electro-optically readable scheduled dosage, compartmented drug package characterized by comprising a time-and-date clock and being adapted to receive at least one scheduled dosage drug package and to inspect that package to determine the presence of a drug dosage in a compartment labeled with a date and time prior to the date and time clocked by the device, and an audible or visual or remote alert triggerable in response to detection of the presence of such dosage.
77. Claim 77. A dosing indicator device according to claim 76 characterized by having light-beam means to target individual package compartments with a light beam to be reflected or diffused by an individual drug dosage or associated light-modulating tag, or by a bar code stamp or label which is required to be removed with each dosage of any drug, the device including a movable scanner that advances in relation to a package from one compartment bay to an adjacent one, scanning relevant compartments in the bay, as time passes, or comprises an array of photoelectric sensors registering with individual compartments of the package, which are electronically controlled and read in turn, as time passes.
78. Claim 78. A dosing indicator device according to claim 76 characterized by accommodating, within an aesthetically pleasing housing, a multi-bay scheduled dosage package, a time-and-date clock, a time-related sensor to detect the presence of a drug dosage in the bays one or more alerting systems, associated electronics including a microprocessor, and power supply means.
79. Claim 79. A dosing indicator device according to claim 78 characterized by beingembodied as a motor-driven single- or multi-drug dosage dispenser to house a tape, or strip-like dosage package, having a time line along the strip and advances individual bays containing one or more dosages for a given dosage time, and presents a single bay for external delivery and removal and administration in timed relationship to the dosage time and triggers one or more alerts if the dosage is not timely removed from the bay.
80. Claim 80. A professional product specification system for electronically creating a technical specification usable by a professional to specify technical products the product specification system comprising:
    a) electronic posting means to select and capture in the prescription:
    i) a customer identifier;
    ii) a specified product; and iii) product specifications;
    and being characterized by comprising b) an onscreen product selection procedure having a product benefit list specifying multiple possible customer benefits having a product list specifying multiple possible specifiable products and having product specification means to select and post a desired product to the specification;
    wherein products in the product list are classified according to a customer-useful technical purpose attainable with the products and the onscreen product selection procedure lists multiple products for providing each the customer benefit.
81. Claim 81. A system according to claim 80 characterized by enabling laboratory test information to be presented to a prescribing professional by first listing patient conditions which the professional wishes to explore more fully by specifying one or more specific laboratory tests, by reporting the laboratory result and suggesting further testing for differential diagnostics; by then providing a selection of laboratory tests known to be useful in evaluating the relevant condition (116) and to select and order appropriate cost-controllable diagnostic testing.
82. Claim 82. A system according to claim 81 characterized by comprising a diagnostic application providing cost-effective routes to rule in or rule out specific diagnoses, employing the specificity and sensitivity of individual procedures totranslate test results into positive predictive values and negative predictive values.
83. Claim 83. A computer-implemented method for dynamically assembling chronologically current virtual client records from multiple remote databases ofprimary source information characterized by comprising:
    a) online interrogation of possible primary sources of electronically recorded client history elements to locate record elements for each specified client;
    b) maintaining a directory service providing routing information to the located record elements;
    c) retrieving the located record elements for each specified client from the respective primary sources using routing information provided by the directory service; and d) assembling the retrieved record elements into a complete record for each specified client.
84. Claim 84. A method according to claim 83 of assembling medical patient records characterized in that for each patient, the patient data directory service listsinstitutional sources known to have source historical record elements for the patient, against a unique patient identifier, and record element retrieval is controlled by patient-specified access protocols detailing permissible access parameters.
    
    Claim 85. A computer-implemented medical treatment management method facilitating a medical professional to order a patient-specific treatment at a point-of-care characterized by comprising:
    a) retrieving multiple data elements from multiple remote heterogenous databases which data elements include patient-related data and historical treatment data;
    b) computer generation of a patient-specific treatment recommendation from the retrieved data elements; and c) computer-transmitted issuance by the medical professional of a treatment order after taking the computer-generated treatment recommendation into account.
    
    Claim 1 amendments include re-positioning of the characterizing clause in view of the references cited, minor corrections and the addition of the last two lines of the claim.
    Claim 72 has been amended to specify that each package compartment is intended for and labeled for a single dosage. minor corrections have been made to claims 73 and 74.
    
    The inventive system for the first time brings together, in an electronically generated prescription, both the treatment to be applied and the objective of the treatment. The system is also convenient, physician friendly by virtue of its presentation of drug lists which facilitate critical data entry, and treatment selection, encouraging physicians to use the system. These are the prerequisites to the claimed system's ability to create a valuable historical data resource which can generate a variety of treatment recommendations to assist a prescribing physician make decisions. Such recommendations can range from patient-specific repeat or alternative treatments to general advisories derived from epidemiological outcome studies.
    
    None of the references suggests an electronic prescription system for capturing patient conditions and treatment data which is capable of creating historical records in which the target condition is recorded in association with the prescribed treatment.
    
    Brimm et al. Brimm's objective is to automate hospital record-keeping and maintain various task lists ( see column 4, lines 10-20). This is quite different from assisting a prescribing physician to make decisions. Brimm discloses a hospital information LAN
    which lacks any centralized data storage system. Brimm merely shows an order-entry system for maintaining hospital-based data for nurses, not an electronic prescription system. The figures show nurses screens, not screens intended for physician use, for example Figure 5 is a medication flow sheet which records, inter alia, orders previously given by a physician into a task list assembled for a nurse to sign off on. Brimm does not bring a treatment and a patient condition to be treated together in an electronic prescription. Brimm is not intended for physicians and does not provide any means to assist a physician's decision making. Brimm does not provide a system capable of generating a historical data resource from which treatment recommendations can be made to assist a prescriber.
    
    Garcia. Garcia is another hospital computer system recording detailed patient-related information with the objective of prioritizing patient scheduling (claim 1 last 7 lines).
    Any treatment or condition data that happens to be captured is not used to drivetreatment selection by the physician.
    Kaufman. Kaufman discloses a drug delivery device which is also nursing focused and provides an inventory control system to dispense drugs. Kaufmann's device is an inventory control device which dispenses medication to the patient or nurse and is not a physician device nor does it address the physician side of the point-of-care interaction. Kaufman is a device for patient or nursing use: an after-prescription device which does nothing to help the physician select and order an appropriate treatment. Kaufman is not remotely relevant to the prescription management system, or prescription, as claimed in claims 1-71 or the system claimed in claims 80-82.
    
    With regard to the multi-drug dosage package of claims 72-79, Kaufman does not disclose a package having multiple labeled compartments for each of a number of dosing intervals for multiple drugs, each compartment being intended for and labeled for a single dosage, as now set forth in amended base independent claim 72.
    Kaufman stores bulk quantities of drugs in columns 208 inside compartments 202.
    
    Desired dosages are dispensed under control of a cpu 22 by a number of delivery mechanisms 206 via a chute 242 to a "medication dispenser" 244 which takes the from of a lockable tray movable between open and closed positions. (col. 16, lines 1-18). Apparently Kaufman's device delivers loose caplets or pills. Kaufman's device is not remotely a package as claimed by applicants, but is a large machine requiring wheels for mobility. Kaufman does not provide multiple labeled compartments for each of a number of dosing intervals. Kaufman's compartments 202 presumably havecomputer addresses to differentiate the drugs they hold, but they are not labeled for dosing intervals. The specific labeling description of claim 73 and the package configuration set forth in claim 74 are plainly quite different from Kaufman. Nor does Kaufman provide an electronically or electro-optically readable scheduled dosage, compartmented package as required by the device claimed in claim 76.
    Kaufman is quite unlike and does not remotely suggest applicant's claimed invention.
    
    New claims. Claim 83 enables a virtual client record which can be assembled on an as-needed basis, consulted by an authorized user, and then dissolved, without ever having been saved. By using source data, currency of the data is assured. None of the references suggests a virtual patient record as claimed in claims 83-84 or a system capable of generating treatment recommendations, as required by the method of
85. Claim 85.
    
    The Specification. Applicant notes that, owing apparently to a mysterious computer idiosyncracy, the capital letter "S" has not printed out, in a number of instances throughout the specification. While this is a minor matter causing no significant difficulty in reading the specification, corrected pages will nevertheless be filed at a later date.