Ulllted States Patent [19]
`Cunningham
`
`US006055507A
`[11] Patent Number:
`[45] Date 0f Patent:
`
`6,055,507
`*Apr. 25, 2000
`
`[54] METHOD AND SYSTEM FOR DISPENSING,
`TRACKING AND MANAGING
`PHARMACEUTICAL TRIAL PRODUCTS
`
`5,181,743
`5,542,420
`5,628,530
`
`1/1993 Lloyd ................................... .. 283/48.1
`8/1996 Goldman et al.
`. 128/630
`5/1997 Thornton ................................. .. 283/67
`
`[76] Inventor: David
`Cunningham, 11929 Eagle
`Bluff CH» Ralelgh> NC 27613
`
`Primary Examiner_prantzy POinV?
`Attorney, Agent, or Firm—Coats & Bennett, PLLC
`
`Notice:
`
`This patent is subject to a terminal dis-
`
`[57]
`
`ABSTRACT
`
`I '
`
`C almer
`
`.
`
`_
`Appl' NO" 09/137’095
`F?ed;
`Aug 20, 1998
`
`Related US. Application Data
`
`A neW and improved method of dispensing, tracking and
`managing pharmaceutical product samples by communica
`tively linking prescribers and pharmacies to a central com
`puting station. The method entails utilizing product trial
`media that is exchanged for actual pharmaceutical product.
`The media is encoded With information that identi?es a
`particular pharmaceutical trial product, such as by magnetic
`encoding similar to that used With credit cards. The media is
`distributed to participating medical doctors or prescribers
`Who then activate the media via the Central Computing
`Station‘ The prescriber then transfers the activated media to
`patients Who then present the media to participating phar
`macies. Before ?lling the pharmaceutical trial product iden
`ti?ed by the media, the pharmacy validates the media via a
`link With the central computing station. Then, the pharmacy
`dispenses the prescribed pharmaceutical trial product. The
`central computing station also includes a database that
`records data related to the use of the media so that all
`pharmaceuncal mal products can be accounted for‘
`
`2 Claims, 14 Drawing Sheets
`
`Division of application No. 08/556,466, Nov. 13, 1995, Pat.
`NO- 578327449
`Int. c1.7 ................................................. .. G06F 159/00
`US. Cl. .................................................... .. 705/3' 705/2
`Field of Search
`705/1 2’ 3 28_
`67_ 3405,25’ 29’
`’
`825' 3,;
`'
`
`’
`
`’
`
`’
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`3,845,278 10/1974 Rex, Jr. ..................................... .. 35/37
`4,827,112
`5/1989 Yoshino et al.
`235/380
`4,893,270
`1/1990 Beck et al. ............................ .. 364/918
`
`1 ii
`
`Prescriber
`Terminal
`
`16
`
`Pharmacy
`Terminal
`
`Central
`Computing
`Station and
`
`Database
`
`1 8
`
`Product
`Trial Media
`
`_
`
`_
`
`Authorization
`Media
`
`1 2
`
`20
`
`Pharmacy
`Terminal
`
`Prescriber
`Terminal
`
`1 6
`
`‘l 4
`
`CFAD VI 1009-0001
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`U.S. Patent
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`Apr. 25, 2000
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`Sheet 1 0f 14
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`6,055,507
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`59521
`8566;.
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`CFAD VI 1009-0002
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`U.S. Patent
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`Apr. 25, 2000
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`Sheet 2 0f 14
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`6,055,507
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`5665a
`muoo _m>9QQ<
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`EEQEESQ
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`muoo R>9QQ< EBwCQw GEmEE?
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`mm 225
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`END 93306 Emzwm
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`EMmEDZ n: EmNEOIPD<
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`Figure 2 & 3
`
`mm 25E
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`ow
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`CFAD VI 1009-0003
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`

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`U.S. Patent
`
`Apr. 25, 2000
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`Sheet 3 0f 14
`
`6,055,507
`
`Pharmaceutical Manufacturer
`Delivers Product Trial Media to
`Prescribers
`
`( Terminal Initialization by Prescribers ]
`
`(
`
`Authorization By Prescribers
`
`L)
`
`l
`
`[ Activation of Product Trial Media By
`Prescribers
`
`Transfer of Activated Product Trial J
`Media to Patients
`
`l
`
`[ Patients Present Activated Product
`Trial Media to Pharmacies
`
`Figure 4A
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`CFAD VI 1009-0004
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`U.S. Patent
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`Apr. 25, 2000
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`Sheet 4 0f 14
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`6,055,507
`
`[ Terminal Initialization by Pharmacies J
`
`C
`
`Y
`Authorization by Pharmacies
`
`)
`
`Pharmacies Validate Activated
`Product Trial Media
`
`[ Pharmacies Dispenses Trial Product )
`
`Accounting to Pharmacies Based on
`Central Computing Database
`
`Central Computing Station Provides
`Data Warehouse for Analysis.
`
`Figure 48
`
`CFAD VI 1009-0005
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`U.S. Patent
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`Apr. 25, 2000
`
`Sheet 5 0f 14
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`6,055,507
`
`Entry Of Verifying information into Terminal
`a.) General data such as terminal serial number,
`name and address of terminal user
`b.) Authorization media
`
`l
`
`Uploading of Verifying Information From Terminal
`To Central Computing Station
`
`l
`
`Central Computing Station Checks Entered
`Verifying Information Against Reference Data
`Previously Stored in The Central Computing
`Station
`
`Identifying
`Information
`Verified
`
`STOP
`initialization
`Process
`
`User Enters Personal Identification Codes
`
`.
`
`.
`
`Personal
`ldentmcatlon
`Codes
`Verified
`
`.
`
`STOP
`
`Initialization
`Process
`
`Central Computing Station Downloads
`System's Application Into Terminal
`
`Figure 5
`
`CFAD VI 1009-0006
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`

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`U.S. Patent
`
`Apr. 25, 2000
`
`Sheet 6 0f 14
`
`6,055,507
`
`Prescriber's Authorization
`Media And Personal
`Identification Code (PIC)
`Entered Into Terminal
`
`Terminal
`validates
`Authorization
`Media And
`PlC
`
`STOP
`Authorization
`Process
`
`Terminal Prompts Enter
`Product Trial Media To Be
`Activated lnto Terminal
`
`Figure 6A
`
`CFAD VI 1009-0007
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`

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`U.S. Patent
`
`Apr. 25, 2000
`
`Sheet 7 0f 14
`
`6,055,507
`
`Prescriber Enters Product Trial
`Media To Be Activated lnto
`Terminal
`
`Product Trial
`Media
`Verified
`
`STOP
`Authorization
`Process
`
`Data From Prescriber's
`Authorization Media, Personal
`Identification Code, Product Trial
`Media Uploaded From Terminal To
`Central Computing Station
`
`Figure 6B
`
`CFAD VI 1009-0008
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`

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`U.S. Patent
`
`Apr. 25, 2000
`
`Sheet 8 0f 14
`
`6,055,507
`
`Valid
`Prescriber And
`Prescriber
`Location
`
`STOP
`Authorization
`Process
`
`Central Computing Station
`Uploads Entered Data From
`Product Trial Media
`
`l
`
`Central Computing Station Checks
`Authenticity And Validity of Product
`Trial Media
`
`Figure 6C
`
`CFAD VI 1009-0009
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`

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`U.S. Patent
`
`Apr. 25, 2000
`
`Sheet 9 0f 14
`
`6,055,507
`
`Product Trial
`Media Authentic
`and Valid
`
`STOP
`Authorization
`Process
`
`Central Computing Station Issues a
`Prescriber Approval Code for
`Product Trial Media
`
`l
`
`Product Trial Media Now Activated
`And Prescriber Approval Code
`Entered Onto Product Trial Media
`
`l
`
`Prescriber Prescribes
`Pharmaceutical Trial Product To
`Patient and Corresponding
`Activated Product Trial Media
`Delivered To Patient
`
`l
`
`Patient Presents Activated Trial
`Media To Pharmacy
`
`Figure 6D
`
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`U.S. Patent
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`Apr. 25,2000
`
`Sheet 10 0f 14
`
`6,055,507
`
`Pharmacist's Authorization
`Media And Personal
`Identification Code (PIC)
`Entered Into Terminal
`
`Terminal
`validates
`Authorization
`Media And
`PIC
`
`STOP
`Authorization
`Process
`
`Terminal Prompts Enter
`Product Trial Media To Be
`Activated Into Terminal
`
`Figure 7A
`
`CFAD VI 1009-0011
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`U.S. Patent
`
`Apr. 25,2000
`
`Sheet 11 0f 14
`
`6,055,507
`
`Pharmacist Enters Product Trial
`Media To Be Activated Into
`Terminal
`
`Product Trial
`Media
`Verified
`
`ST_OP
`Authorization
`Process
`
`Data From Pharmacy Authorization
`Media, Personal Identification Code,
`Uploaded From Terminal To Central
`Computing Station
`
`Figure 7B
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`CFAD VI 1009-0012
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`U.S. Patent
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`Apr. 25,2000
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`Sheet 12 0f 14
`
`6,055,507
`
`STOP
`Aulgggéggon
`
`-
`
`-
`
`Pharmacist
`
`Valid
`And Pharmacy
`Location
`
`Central Computing Station Uploads
`Entered Data From Product Trial Media
`
`Central Computing Station Checks
`Authenticity And Validity of Product
`Trial Media
`
`Figure 7C
`
`CFAD VI 1009-0013
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`

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`U.S. Patent
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`Apr. 25,2000
`
`Sheet 13 0f 14
`
`6,055,507
`
`Product Trial
`Media Authentic
`and Valid
`
`STOP
`Authorization
`Process
`
`Central Computing Station Issues a
`Pharmacy Approval Code for
`Product Trial Media
`
`l
`
`Product Trial Media Now Activated
`And Pharmacy Approval Code
`Entered Onto Product Trial Media
`
`l
`
`Pharmacy Records Approval Code
`Onto Validated Product Trial Media
`And Signs the Same
`
`Figure 7D
`
`CFAD VI 1009-0014
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`U.S. Patent
`
`Apr. 25,2000
`
`Sheet 14 0f 14
`
`6,055,507
`
`Patient Signs Validated Product
`Trial Media
`
`Pharmacy Dispenses
`Pharmaceutical Trial Product To
`Patient
`
`Figure 7E
`
`CFAD VI 1009-0015
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`

`
`1
`METHOD AND SYSTEM FOR DISPENSING,
`TRACKING AND MANAGING
`PHARMACEUTICAL TRIAL PRODUCTS
`
`RELATED APPLICATION
`
`This application is a Division of US. patent application
`Ser. No. 08/556,466 ?led Nov. 13, 1995 now US. Pat. No.
`5,832,449.
`
`FIELD OF THE INVENTION
`
`The present invention relates generally to the distribution
`of pharmaceutical product samples and more particularly to
`an improved method of dispensing, tracking, and managing
`pharmaceutical product samples by communicatively link
`ing prescribers and pharmacies to a central computing
`station.
`
`BACKGROUND OF THE INVENTION
`
`In the pharmaceutical industry, the primary method for
`product promotion of ethical products is the use of outside
`sales representatives. Company sales representatives target
`speci?c physicians and detail the features and bene?ts of
`particular pharmaceutical products. Pharmaceutical manu
`facturers have documented that the most effective method of
`product promotion involves providing pharmaceutical prod
`uct samples to prescribers of the products Who then pass
`along the product samples to patients. Physicians therefore
`receive numerous quantities of pharmaceutical product
`samples for purposes of conducting patient trials. These
`trials enable physicians to determine the effectiveness of
`certain drugs in certain patients for certain diseases, as Well
`as to determine patients’ tolerance of the drugs and their
`compliance With drug administration directions.
`A responsibility of the Food & Drug Administration
`(FDA) is the regulation of pharmaceutical product samples.
`The PDMA (Pharmaceutical Drug Manufacturing Act) Act
`of 1987 requires pharmaceutical manufacturers to track and
`account for product samples distributed by sales represen
`tatives to prescribing physicians. Pharmaceutical manufac
`turers are required to account for all sample product
`inventories, as Well as the time, location, and speci?c
`physicians Who receive promotional samples. Pharmaceuti
`cal sales representatives are required to record receipts of
`product samples, adjustments to sample inventories, and
`distribution of product samples, and to report any loss or
`theft of product samples. Additionally, PDMA Warehousing
`requirements dictate inventory storage methods and loca
`tions both Within pharmaceutical companies themselves and
`for outside pharmaceutical sales representatives.
`HoWever, it is often the case that accountability for
`pharmaceutical product samples ends When the samples
`reach the physicians. Most physicians do little to account for
`their inventories of product samples. Rather, physicians tend
`to distribute pharmaceutical product samples to patients
`much more informally than retail pharmacies, keeping feW
`if any records and often not even counting the precise
`number of product samples given to patients.
`The PDMA’s accountability requirements increase phar
`maceutical manufacturers’ expenses for promoting and dis
`tributing product samples as Well as the complexity of
`administering sampling programs. As competition Within the
`pharmaceutical industry increases, costs associated With
`product samples place an increasingly greater burden on the
`pharmaceutical manufacturers. Pharmaceutical manufactur
`ers are therefore attempting to reduce expenses and maintain
`
`10
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`6,055,507
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`2
`acceptable pro?ts While incorporating the PDMA’s neW
`requirements into established promotional practices.
`Although product samples are an extremely effective
`promotional tool, the manufacturing of drug product
`samples in addition to normally packaged drug products has
`proven to be increasingly costly. Pharmaceutical product
`samples are typically elaborately and expensively packaged
`and are extremely bulky compared to normally packaged
`drug products. Pharmaceutical manufacturers must utiliZe
`separate product sample packaging lines to specially pack
`age drug product samples. Distribution of product samples
`requires delivery via separate carriers and distribution
`routes. In addition, drug product samples are typically
`Warehoused separately from normally packaged drug prod
`ucts.
`Because the current climate in the pharmaceutical indus
`try prohibits the unrestrained shifting of costs to ?nal
`consumers, pharmaceutical manufacturers have taken sev
`eral neW approaches to reducing costs associated With
`promoting product samples. Nevertheless, pharmaceutical
`manufacturers are attempting to maintain the marketing
`advantages of using sales representatives to distribute prod
`uct samples.
`One cost-reducing approach that pharmaceutical manu
`facturers have attempted is the distribution of sample vouch
`ers to prescribing physicians, retail pharmacies, and phar
`maceutical sales representatives. With this approach, instead
`of giving drug product samples directly to patients, physi
`cians give the patients vouchers for the drug product
`samples. The vouchers may then be redeemed at retail
`pharmacies for the actual drugs. Alternately, the patients
`may receive cash or credit rebates at the pharmacies.
`Another cost-reducing approach that pharmaceutical
`manufacturers have attempted is the distribution of product
`samples via mail order. With this approach, pharmaceutical
`sales representatives provide prescribing physicians With
`request authoriZation forms. Physicians then use the forms
`to authoriZe deliveries of product samples directly to phy
`sician of?ce from third-party pharmaceutical supply Ware
`houses.
`The above neW approaches to distributing pharmaceutical
`product samples have not met With substantial and universal
`acceptance. All of these approaches lack an effective, ef?
`cient and practical system for distributing the trial or sample
`products to patients and at the same time recording pertinent
`data, Which is easily accessible, relating to prescribing and
`dispensing the pharmaceutical trial products.
`
`SUMMARY AND OBJECTS OF THE
`INVENTION
`
`The present invention entails a system and method for
`managing and tracking the distribution of pharmaceutical
`trial or sample products by utiliZing medical prescribers and
`pharmacies. Instead of the medical prescriber directly deliv
`ering pharmaceutical trial products to patients, the present
`system and method contemplates the prescriber prescribing
`a pharmaceutical trial product to a patient and the ?lling of
`that prescription by a participating pharmacy. This method
`and program is managed through a central computing station
`that is communicatively linked to terminals located at par
`ticipating prescriber and pharmacy sites. This system, as Will
`be discussed in greater detail beloW, manages, tracks and
`records selected transactions involving the participating
`prescribers, pharmacies and patients.
`To identify various pharmaceutical trial products, the
`system utiliZes a medium, such as a magnetic card, Which is
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`3
`encoded With speci?c information that particularly identi?es
`a certain pharmaceutical trial product. Encoded media is
`then distributed to participating medical doctors or prescrib
`ers. Once the encoded product trial media is received by the
`prescribers, the prescribers then activate the selected product
`trial media. Activation is accomplished, in part at least, by
`utilizing a prescriber terminal to communicatively link the
`selected product trial media With the central computing
`station or host. Once the product trial media has been
`activated, the prescriber then transfers the activated product
`trial media to patients. The patients then present the acti
`vated product trial media to participating pharmacies. Prior
`to ?lling the prescriptive pharmaceutical trial product iden
`ti?ed by the media, the pharmacy engages in a procedure
`designed to validate the patient-presented pharmaceutical
`trial media. To validate the presented product trial media, the
`pharmacy communicatively links the presented media to the
`central computing station via the pharmacy terminal. After
`making selected veri?cations, the central computing station
`validates the presented product trial media. Validation
`results in the pharmacy dispensing the pharmaceutical trial
`product identi?ed by the presented media.
`Prior to activation and validation, the system and method
`of the present invention requires that the participating phar
`macies and prescribers establish “authorization”, that is that
`they are in fact authoriZed participants in the pharmaceutical
`trial product distribution program.
`After validation and dispensing, a database associated
`With the central computing station Will have recorded the
`activation and validation transactions and other data related
`thereto. Based on the recorded data, audit and accounting
`procedures can folloW. Particularly, dispensed pharmaceu
`tical trial products can noW be replaced at the pharmacy
`level, via Wholesalers, by simply replenishing quantities of
`pharmaceutical products dispensed by the participating
`pharmacies. Replenishment of the pharmaceutical trial prod
`uct can be carried out and managed in accordance With the
`records of the database. Moreover, it is contemplated that
`participating pharmacies Will be remunerated With a dis
`pensing fee that can be determined based on the records of
`the database associated With the central computing station.
`It is therefore an object of the present invention to provide
`a more effective and ef?cient process for managing the
`distribution of pharmaceutical trial products.
`Another object of the present invention is to provide a
`system and process for the distribution of pharmaceutical
`trial products that inherently includes “checks and balances”
`and Which in the end is designed to ensure integrity and
`accountability throughout the entire process.
`It is also an object of the present invention to provide a
`system and process for distributing pharmaceutical trial
`products that is more cost effective than conventional
`processes, especially processes that require special trial or
`sample packaging.
`It is also an object of the present invention to provide a
`system and method for managing the distribution of phar
`maceutical trial products that provides for the computeriZed
`recordation of selected transactions surrounding the pre
`scription and distribution of pharmaceutical trial products.
`Another object of the present invention is to provide an
`improved method of distributing pharmaceutical product
`samples that eliminates the need for pharmaceutical manu
`facturers to specially package drug product samples differ
`ently from normally packaged drugs, thereby cutting costs
`associated With manufacturing, storing, and distributing
`drug product samples.
`
`4
`A further object of the present invention is to provide an
`improved method of distributing drug product samples
`While maintaining the role of outside pharmaceutical sales
`representatives in promoting and marketing drug products.
`Other objects and advantages of the present invention Will
`become apparent and obvious from a study of the folloWing
`description and the accompanying draWings, Which are
`merely illustrative of such invention.
`
`10
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a schematic illustration of the system of the
`present invention for managing the distribution of pharma
`ceutical trial products.
`FIG. 2A is a front side vieW of the pharmaceutical trial
`product media that forms a part of the present invention.
`FIG. 2B is a back side vieW of the pharmaceutical trial
`media.
`FIG. 3A is a front side vieW of the authoriZation media
`that forms a part of the present invention.
`FIG. 3B is a back side vieW of the authoriZation media.
`FIGS. 4A—4B depicts a How chart that shoWs the basic
`steps entailed in distributing, tracking and managing phar
`maceutical trial product distributed in accordance With the
`present invention.
`FIG. 5 is a How chart that depicts the basic steps entailed
`in terminal initialiZation, Whether it be at the prescriber or
`pharmacy level.
`FIGS. 6A—6D depicts a How chart that shoWs the basic
`steps involved in the prescribers activating pharmaceutical
`trial media.
`FIGS. 7A—7E depicts a How chart that shoWs the basic
`steps involved in validating activated product trial media
`and dispensing pharmaceutical trial products in response to
`the validation of product trial media.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`With further reference to the draWings and particularly to
`FIG. 1, the system utiliZed for carrying out the present
`invention is shoWn therein and indicated generally by the
`numeral 10. System 10 includes a central computing station
`12 that has associated thereWith a database for storing data
`and information communicated to the central computing
`station 12 during various steps or phases of the pharmaceu
`tical trial product distribution process. As Will be appreci
`ated from subsequent portions of this disclosure, the present
`invention contemplates the utiliZation of participating medi
`cal doctors or prescribers and pharmacies to effectuate the
`distribution of pharmaceutical trial products. In order to
`communicate With the central computing station 12, each
`participating prescriber and pharmacy is provided With a
`terminal communicatively linked With the central computing
`station 12. Therefore, it is appreciated that the system 10 of
`the present invention Will include prescriber terminals 14
`located at various participating prescriber sites and phar
`macy terminals 16 located at various participating pharmacy
`sites. Both the prescriber terminals 14 and the pharmacy
`terminals 16 are capable of communicatively linking
`encoded media With the central computing station 12 Where
`the encoded information associated With the media can be
`recorded in the associated database. Various types of com
`munication terminals can be utiliZed at prescriber and phar
`macy sites. HoWever, as Will be appreciated from subsequent
`portions of this disclosure, one such type of terminal is a
`conventional magnetic card reader that is adapted to accept
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`magnetic cards and to read or interpret encoded information
`provided thereon and to communicate With the central
`computing station 12.
`System 10 further includes What is referred to as a
`pharmaceutical product trial media that in FIG. 1 is indicated
`by the numeral 18. As Will be appreciated from subsequent
`portions of the disclosure, the product trial media 18 iden
`ti?es and is associated With a particular pharmaceutical trial
`product and is transferred and passed betWeen participating
`prescribers, patients and pharmacies. The product trial
`media 18 is particularly encoded With pertinent information
`that identi?es a particular pharmaceutical trial product and is
`designed to be compatible With the prescriber and pharmacy
`terminals 14 and 16. In particular, prescriber and pharmacy
`terminals 14 and 16 are capable of reading the product trial
`media 18 and communicating encoded information associ
`ated thereWith to the central computing station 12 for
`processing and recordation.
`Although the type and quantity of encoded information on 20
`the product trial media 18 can vary, it is contemplated that
`each individual product trial media 18 Would be encoded
`With at least the folloWing information:
`a) media identi?cation number;
`b) product identi?cation number;
`c) product name;
`d) product form;
`e) product siZe;
`f) product quantity;
`g) media type;
`h) a series of manufacturer ID. numbers;
`i) a date range
`In addition, as illustrated in FIGS. 2A and 2B, each
`individual product trial media 18 Will have printed or
`embossed thereon certain identifying information such as:
`a) pharmaceutical manufacturer’s name;
`b) product name (trade name, generic name);
`c) product form;
`d) product siZe;
`e) product quantity;
`f) media identi?cation number;
`g) prescriber, patient and pharmacy signature areas;
`h) prescriber and pharmacy approval code areas
`The product trial media 18 can assume various tangible
`forms. HoWever, in the eXample illustrated in FIGS. 2A and
`2B and discussed herein, the product trial media 18 is in the
`form of a conventional magnetic card Which again is
`designed to be compatible With a READ-ONLY magnetic
`reader terminal located at prescriber and pharmacy sites.
`Finally, the system 10 of the present invention includes
`authoriZing media indicated by the numeral 20 that is
`distributed to participating prescribers and pharmacies. As
`With the product trial media 18, the authoriZing media 20 can
`be in various tangible forms and in the eXample illustrated
`herein, the authoriZing media assumes a READ-ONLY
`magnetic card form that is compatible With the prescriber
`and pharmacy terminals 14 and 16. Each individual autho
`riZing media speci?cally identi?es a participating prescriber
`or pharmacy. In the case of prescriber authoriZing media, the
`same Would be encoded With various identifying informa
`tion such as:
`a) the prescriber’s name,
`b) prescriber’s medical identi?cation number,
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`6,055,507
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`c) prescriber’s control ID. number,
`d) prescriber location identi?cation.
`In the case of pharmacy authoriZing media, the same Would
`include encoded information speci?c to and identifying a
`particular participating pharmacy. The encoded information
`on such a pharmacy authoriZing media Would include iden
`tifying information such as:
`a) pharmacy name,
`b) name of individual pharmacists associated With the
`identi?ed pharmacy,
`c) pharmacy control identi?cation number, and
`d) pharmacy location identi?er.
`Also, as illustrated in FIG. 3A and FIG. 3B, the authori
`Zation media 20 includes printed or embossed information
`thereon such as prescriber or pharmacy ID. number, phar
`macy or prescriber name, card expiration date, and space for
`the signature of a physician or pharmacist.
`As Will be discussed in more detail later, the authoriZing
`media 20 is compatible With the prescriber and pharmacy
`terminals 14 and 16 and consequently, encoded identifying
`information associated With the individual authoriZing
`media 20 can be revieWed and veri?ed by the central
`computing station 12 prior to the participating prescribers
`and pharmacies having access to the central computing
`station. The authoriZing media 20 enables the system and the
`central computing station 12 in particular to verify that
`prescribers and pharmacies attempting to enter the system
`and netWork are in fact authoriZed to do so and are in fact
`authoriZed participants in the pharmaceutical trial product
`distribution program of the present invention. See FIGS.
`4A—4B.
`The present invention entails a pharmaceutical trial prod
`uct distribution method or process Where pharmaceutical
`trial products are actually prescribed by a participating
`medical doctor or prescriber and not directly delivered to the
`patient by the prescriber as is conventional practice today.
`Once the pharmaceutical trial product has been prescribed,
`the patient then proceeds to a participating pharmacy Where
`the prescription for the trial or sample pharmaceutical prod
`uct is ?lled. Prescriber and pharmacy transactions are all
`monitored and recorded by the central computing station 12.
`Periodically, the participating pharmacies are compensated
`for the trial product dispensed and the services performed.
`Compensation Would typically include replenishment of
`dispensed trial product through a Wholesaler plus a dispens
`ing fee, all of Which is established by recorded transactions
`Within the central database.
`It is contemplated that the present system and method for
`distributing pharmaceutical trial products Would be man
`aged by an independent entity referred to as a program
`manager and that a number of pharmaceutical manufacturers
`Would join together in a consordium or the like to participate
`in the pharmaceutical trial product distribution program, all
`of Which Would be administered and managed by the pro
`gram manager. HoWever, it is to be appreciated that the
`present pharmaceutical trial product distribution system and
`method can be carried out in other forms including a
`program administered and managed totally by a single
`pharmaceutical manufacturer.
`In developing and implementing the pharmaceutical trial
`product distribution program of the present invention, par
`ticipating prescribers and pharmacies must be established. In
`this regard, it is contemplated that the program manager in
`cooperation With participating pharmaceutical manufactur
`ers or suppliers, sometimes referred to as pharmaceutical
`members, identify certain prescribers and pharmacies that
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`are authorized to participate in the program. Thereafter, the
`program manager issues speci?c authorizing media 20 to
`each of the prescribers and pharmacies authorized to par
`ticipate in the program. Note that each authorizing media 20
`is speci?cally encoded to identify a certain prescriber or
`pharmacy as Well as the physical location or locations of that
`prescriber or pharmacy. In addition to the authorization
`media 20, prescriber terminals 14 and pharmacy terminals
`16 are also delivered to the participating prescribers and
`pharmacies.
`The prescriber and pharmacy terminals 14 and 16 are
`transaction-based communication units provided With both
`an EPROM chip and random access memory (RAM) for
`application operation. Each terminal is electrically poWered
`and adapted to communicate With the central computing
`station or host 12 through a conventional telephone system.
`A user keypad having both function keys and a ten-number
`keypad are incorporated into each terminal. Application,
`prompt and approval instructions are communicated through
`an LED display that forms a part of each terminal.
`The EPROM chip of each terminal is provided With a
`series of data ?elds that are used in a terminal initialization
`procedure that is designed to verify that a respective termi
`nal is properly located physically and is under the control of
`an authorized and participating prescriber or pharmacy. In
`the Way of example, the data ?elds of the EPROM chip
`could include: terminal serial number, prescriber or phar
`macy identi?cation, location or locations (physical address)
`for the participating prescriber or pharmacy assigned to that
`terminal, and location fax and telephone number. In
`addition, the EPROM chip of each terminal Would include
`a check digit/analog code matrix used in establishing the
`authenticity of the terminal.
`NoW, turning to the RAM of the respective terminals, it is
`appreciated that the capacity of the RAM may vary but it is
`contemplated a storage capacity of 32K bytes Would be
`sufficient to handle doWnloaded application programming
`from the central computing station 12. Data ?elds for the
`RAM may include a series of server (central computer
`station) phone numbers, a check digit/analog code index
`?eld, check digit/analog code multiplier-divisor, check digit/
`analog ansWerer, check digit/analog code formula, and sys
`tem date and time.
`The above discussion deals generally With the basic
`prescriber and pharmacy terminals 14 and 16 that are
`contemplated to be used in carrying out the pharmaceutical
`trial product distribution method and program of the present
`invention. Details of the construction and programming of
`the terminals are not dealt With herein because such is not
`per se material to the present invention and further, because
`such terminal designs are Well appreciated by those skilled
`in the art and are in fact commercially available. While
`various types of terminals may be employed by participating
`prescribers and pharmacies, it is contemplated that a termi
`nal design of a conventional magnetic card reader Would be
`ef?cient and cost effective for the present pharmaceutical
`trial product distribution program.
`Initially, various pharmaceutical members distribute indi
`vidual product trial media 18 to participating medical doc
`tors or prescribers. This distribution can be carried out by
`sales representatives of the pharmaceutical members. At the
`same time, the program manager (administrator of the
`pharmaceutical trial product distribution program) may dis
`tribute both terminals and authorizing media 20 to both
`participating medical doctors and pharmacies. It is appreci
`ated that prior to the initiation of the program and in fact on
`an ongoing basis, the database associated With th