`Cunningham
`
`I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US005832449A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,832,449
`Nov. 3, 1998
`
`[54] METHOD AND SYSTEM FOR DISPENSING,
`TRACKING AND MANAGING
`PHARMACEUTICAL TRIAL PRODUCTS
`
`[76]
`
`Inventor: David W. Cunningham, 11929 Eagle
`Bluff Cir., Raleigh, N.C. 27613
`
`[21]
`
`Appl. No.: 556,466
`
`[22]
`
`Filed:
`
`Nov. 13, 1995
`
`[51]
`[52]
`[58]
`
`Int. Cl.6
`................................................... G06F 159/00
`U.S. Cl. ...................................................... 705/3; 705/2
`Field of Search ..................................... 395/201, 202,
`395/203, 228, 601, 610; 235/385, 375;
`340/825.29, 825.34; 283/55, 67; 705/1,
`2, 3, 28; 707 /1, 10
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,845,278
`4,827,112
`4,893,270
`5,181,743
`5,542,420
`5,628,530
`
`10/1974 Rex, Jr ........................................ 35/37
`5/1989 Yoshino et al. ......................... 235/380
`1/1990 Beck et al. . .... ... ... ... ... .... ... ... ... 364/918
`1/1993 Lloyd ..................................... 283/48.1
`8/1996 Goldman et al. ....................... 128/630
`5/1997 Thornton ................................... 283/67
`
`Primary Examiner--Frantzy Poinvil
`Attorney, Agent, or Firm-Rhodes, Coats, & Bennett, LLP
`
`[57]
`
`ABSTRACT
`
`A new and improved method of dispensing, tracking and
`managing pharmaceutical product samples by communica(cid:173)
`tively linking prescribers and pharmacies to a central com(cid:173)
`puting station. The method entails utilizing product trial
`media that is exchanged for actual pharmaceutical product.
`The media is encoded with information that identifies 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(cid:173)
`macies. Before filling the pharmaceutical trial product iden(cid:173)
`tified 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
`pharmaceutical trial products can be accounted for.
`
`30 Claims, 14 Drawing Sheets
`
`14
`
`Prescriber
`Terminal
`
`Pharmacy
`Terminal
`
`16
`
`/
`
`10
`
`18
`
`Product
`Trial Media
`
`Authorization
`Media
`
`12
`
`20
`
`16
`
`Pharmacy
`Terminal
`
`Central
`Computing
`Station and
`Database
`
`Prescriber
`Terminal
`
`14
`
`CFAD VI 1009-0001
`
`
`
`14
`l
`Prescriber
`Terminal
`
`16
`
`Pharmacy
`Terminal
`
`Central
`Computing
`Station and
`Database
`
`\
`)
`
`I
`Prescriber
`Terminal
`
`I
`
`14
`
`Pharmacy
`Terminal
`
`16
`
`/
`
`10
`
`18
`
`Product
`Trial Media
`
`Authorization I
`Media
`
`12
`
`20
`
`) Figure 1
`I
`
`d •
`\JJ.
`•
`~
`~ ......
`= ......
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`.....,
`'"""'
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`Ul
`....
`00
`~
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`~
`~
`\C
`
`CFAD VI 1009-0002
`
`
`
`....
`
`,,
`
`1 8
`
`\
`
`TRIAL PRODUCT TRADE NAME
`TRIAL PRODUCT GENERIC NAME
`TRIAL PRODUCT FORM & STRENGTH
`TRIAL PRODUCT QUANTITY
`
`CARD SERIAL NUMBER
`CARD EXPIRATION DATE
`
`,
`
`Figure 2A
`
`AUTHORIZER ID NUMBER
`
`AUTHORIZER NAME
`CARD EXPIRATION DATE
`Figure 3A
`
`I
`
`20
`
`1 8
`
`\
`
`Physician
`Approval Code
`I I I I I
`Pharmacist
`Approval Code
`I I I I I
`
`Physician Signature
`
`Pharmacist Signature
`
`Patient Signature
`
`Figure 28
`
`Authorizer Signature
`
`Figure 38
`
`I
`
`20
`
`d •
`\JJ.
`•
`~
`~ ......
`
`~ = ......
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`z
`0
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`~ .....
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`0 .....,
`'"""'
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`Ul
`....
`00
`~
`N
`....
`~
`~
`\C
`
`CFAD VI 1009-0003
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 3 of 14
`
`5,832,449
`
`Pharmaceutical Manufacturer
`Delivers Product Trial Media to
`Prescribers
`
`Terminal Initialization by Prescribers
`
`Authorization By Prescribers
`
`Activation of Product Trial Media By
`Prescribers
`
`Transfer of Activated Product Trial
`Media to Patients
`
`Patients Present Activated Product
`Trial Media to Pharmacies
`
`Figure 4A
`
`CFAD VI 1009-0004
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 4 of 14
`
`5,832,449
`
`Terminal Initialization by Pharmacies
`
`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
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 5 of 14
`
`5,832,449
`
`Entry Of Verifying Information Into Terminal
`a.) General data such as terminal serial number,
`name and address of terminal user
`b.) Authorization media
`
`Uploading of Verifying Information From Terminal
`To Central Computing Station
`
`Central Computing Station Checks Entered
`Verifying Information Against Reference Data
`Previously Stored in The Central Computing
`Station
`
`No
`
`STOP
`Initialization
`Process
`
`User Enters Personal Identification Codes
`
`Personal
`Identification
`Codes
`Verified
`
`No
`
`STOP
`Initialization
`Process
`
`Central Computing Station Downloads
`System's Application Into Terminal
`
`Figure 5
`
`CFAD VI 1009-0006
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 6 of 14
`
`5,832,449
`
`Prescriber's Authorization
`Media And Personal
`Identification Code (PIG)
`Entered Into Terminal
`
`Terminal
`Validates
`Authorization
`Media And
`PIC
`
`Yes
`
`Terminal Prompts Enter
`Product Trial Media To Be
`Activated Into Terminal
`
`No
`
`STOP
`Authorization
`Process
`
`Figure 6A
`
`CFAD VI 1009-0007
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 7 of 14
`
`5,832,449
`
`Prescriber Enters Product Trial
`Media To Be Activated Into
`Terminal
`
`Product Trial
`Media
`Verified
`
`No
`
`STOP
`Authorization
`Process
`
`Yes
`
`Data From Prescriber's
`Authorization Media, Personal
`Identification Code, Product Trial
`Media Uploaded From Terminal To
`Central Computing Station
`
`Figure 68
`
`CFAD VI 1009-0008
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 8 of 14
`
`5,832,449
`
`Valid
`Prescriber And
`Prescriber
`Location
`
`No
`
`STOP
`Authorization
`Process
`
`Yes
`
`Central Computing Station
`Uploads Entered Data From
`Product Trial Media
`
`Central Computing Station Checks
`Authenticity And Validity of Product
`Trial Media
`
`Figure 6C
`
`CFAD VI 1009-0009
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 9 of 14
`
`5,832,449
`
`Product Trial
`Media Authentic
`and Valid
`
`No
`
`STOP
`Authorization
`Process
`
`Yes
`
`Central Computing Station Issues a
`Prescriber Approval Code for
`Product Trial Media
`
`Product Trial Media Now Activated
`And Prescriber Approval Code
`Entered Onto Product Trial Media
`
`Prescriber Prescribes
`Pharmaceutical Trial Product To
`Patient and Corresponding
`Activated Product Trial Media
`Delivered To Patient
`
`Patient Presents Activated Trial
`Media To Pharmacy
`
`Figure 60
`
`CFAD VI 1009-0010
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 10 of 14
`
`5,832,449
`
`Pharmacist's Authorization
`Media And Personal
`Identification Code (PIG)
`Entered Into Terminal
`
`Terminal
`Validates
`Authorization
`Media And
`PIG
`
`Yes
`
`Terminal Prompts Enter
`Product Trial Media To Be
`Activated Into Terminal
`
`No
`
`STOP
`Authorization
`Process
`
`Figure 7A
`
`CFAD VI 1009-0011
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 11 of 14
`
`5,832,449
`
`Pharmacist Enters Product Trial
`Media To Be Activated Into
`Terminal
`
`Product Trial
`Media
`Verified
`
`No
`
`STOP
`Authorization
`Process
`
`Yes
`
`Data From Pharmacy Authorization
`Media, Personal Identification Code,
`Uploaded From Terminal To Central
`Computing Station
`
`Figure 78
`
`CFAD VI 1009-0012
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 12 of 14
`
`5,832,449
`
`Valid
`Pharmacist
`And Pharmacy
`Location
`
`No
`
`STOP
`Authorization
`Process
`
`Yes
`
`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
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 13 of 14
`
`5,832,449
`
`Product Trial
`Media Authentic
`and Valid
`
`No
`
`STOP
`Authorization
`Process
`
`Yes
`
`Central Computing Station Issues a
`Pharmacy Approval Code for
`Product Trial Media
`
`Product Trial Media Now Activated
`And Pharmacy Approval Code
`Entered Onto Product Trial Media
`
`Pharmacy Records Approval Code
`Onto Validated Product Trial Media
`And Signs the Same
`
`Figure 70
`
`CFAD VI 1009-0014
`
`
`
`U.S. Patent
`
`Nov. 3, 1998
`
`Sheet 14 of 14
`
`5,832,449
`
`Patient Signs Validated Product
`Trial Media
`
`Pharmacy Dispenses
`Pharmaceutical Trial Product To
`Patient
`
`Figure 7E
`
`CFAD VI 1009-0015
`
`
`
`5,832,449
`
`1
`METHOD AND SYSTEM FOR DISPENSING,
`TRACKING AND MANAGING
`PHARMACEUTICAL TRIAL PRODUCTS
`
`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(cid:173)
`ing prescribers and pharmacies to a central computing 10
`station.
`
`BACKGROUND OF THE INVENTION
`
`2
`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-
`s 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(cid:173)
`ucts.
`Because the current climate in the pharmaceutical indus-
`try prohibits the unrestrained shifting of costs to final
`consumers, pharmaceutical manufacturers have taken sev(cid:173)
`eral new approaches to reducing costs associated with
`promoting product samples. Nevertheless, pharmaceutical
`15 manufacturers are attempting to maintain the marketing
`advantages of using sales representatives to distribute prod(cid:173)
`uct samples.
`One cost-reducing approach that pharmaceutical manu(cid:173)
`facturers have attempted is the distribution of sample vouch-
`20 ers to prescribing physicians, retail pharmacies, and phar(cid:173)
`maceutical sales representatives. With this approach, instead
`of giving drug product samples directly to patients, physi(cid:173)
`cians give the patients vouchers for the drug product
`samples. The vouchers may then be redeemed at retail
`25 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
`30 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(cid:173)
`sician office from third-party pharmaceutical supply ware-
`35 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, effi(cid:173)
`cient and practical system for distributing the trial or sample
`40 products to patients and at the same time recording pertinent
`data, which is easily accessible, relating to prescribing and
`dispensing the pharmaceutical trial products.
`
`In the pharmaceutical industry, the primary method for
`product promotion of ethical products is the use of outside
`sales representatives. Company sales representatives target
`specific physicians and detail the features and benefits of
`particular pharmaceutical products. Pharmaceutical manu(cid:173)
`facturers have documented that the most effective method of
`product promotion involves providing pharmaceutical prod(cid:173)
`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(cid:173)
`tatives to prescribing physicians. Pharmaceutical manufac(cid:173)
`turers are required to account for all sample product
`inventories, as well as the time, location, and specific
`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(cid:173)
`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 50
`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(cid:173)
`maceutical manufacturers' expenses for promoting and dis(cid:173)
`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- 60
`ers are therefore attempting to reduce expenses and maintain
`acceptable profits 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
`
`SUMMARY AND OBJECTS OF THE
`INVENTION
`
`45
`
`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(cid:173)
`ering pharmaceutical trial products to patients, the present
`system and method contemplates the prescriber prescribing
`a pharmaceutical trial product to a patient and the filling of
`that prescription by a participating pharmacy. This method
`and program is managed through a central computing station
`ss that is communicatively linked to terminals located at par(cid:173)
`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
`encoded with specific information that particularly identifies
`a certain pharmaceutical trial product. Encoded media is
`then distributed to participating medical doctors or prescrib-
`65 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
`
`CFAD VI 1009-0016
`
`
`
`5,832,449
`
`5
`
`3
`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 filling the prescriptive pharmaceutical trial product iden(cid:173)
`tified 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 10
`pharmacy communicatively links the presented media to the
`central computing station via the pharmacy terminal. After
`making selected verifications, the central computing station
`validates the presented product trial media. Validation
`results in the pharmacy dispensing the pharmaceutical trial 15
`product identified by the presented media.
`Prior to activation and validation, the system and method
`of the present invention requires that the participating phar(cid:173)
`macies and prescribe rs establish "authorization", that is that
`they are in fact authorized participants in the pharmaceutical 20
`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 25
`procedures can follow. Particularly, dispensed pharmaceu(cid:173)
`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- 30
`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(cid:173)
`pensing fee that can be determined based on the records of
`the database associated with the central computing station. 35
`It is therefore an object of the present invention to provide
`a more effective and efficient 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 45
`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 50
`system and method for managing the distribution of phar(cid:173)
`maceutical trial products that provides for the computerized
`recordation of selected transactions surrounding the pre(cid:173)
`scription and distribution of pharmaceutical trial products.
`Another object of the present invention is to provide an 55
`improved method of distributing pharmaceutical product
`samples that eliminates the need for pharmaceutical manu(cid:173)
`facturers to specially package drug product samples differ(cid:173)
`ently from normally packaged drugs, thereby cutting costs
`associated with manufacturing, storing, and distributing 60
`drug product samples.
`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. 65
`Other objects and advantages of the present invention will
`become apparent and obvious from a study of the following
`
`40
`
`4
`description and the accompanying drawings, which are
`merely illustrative of such invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a schematic illustration of the system of the
`present invention for managing the distribution of pharma(cid:173)
`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 flow chart that shows the basic
`steps entailed in distributing, tracking and managing phar(cid:173)
`maceutical trial product distributed in accordance with the
`present invention.
`FIG. 5 is a flow chart that depicts the basic steps entailed
`in terminal initialization, whether it be at the prescriber or
`pharmacy level.
`FIGS. 6A-6D depicts a flow chart that shows the basic
`steps involved in the prescribers activating pharmaceutical
`trial media.
`FIGS. 7A-7E depicts a flow 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(cid:173)
`tical trial product distribution process. As will be appreci(cid:173)
`ated from subsequent portions of this disclosure, the present
`invention contemplates the utilization of participating medi(cid:173)
`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(cid:173)
`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(cid:173)
`munication terminals can be utilized at prescriber and phar(cid:173)
`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
`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
`
`CFAD VI 1009-0017
`
`
`
`5,832,449
`
`6
`
`10
`
`5
`portions of the disclosure, the product trial media 18 iden(cid:173)
`tifies 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 5
`that identifies 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(cid:173)
`ated therewith to the central computing station 12 for
`processing and recordation.
`Although the type and quantity of encoded information on
`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 identification number;
`b) product identification number;
`c) product name;
`d) product form;
`e) product size;
`t) product quantity;
`g) media type;
`h) a series of manufacturer I.D. 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;
`t) media identification number;
`g) prescriber, patient and pharmacy signature areas;
`h) prescriber and pharmacy approval code areas
`The product trial media 18 can assume various tangible 40
`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(cid:173)
`rizing media specifically identifies a participating prescriber
`or pharmacy. In the case of prescriber authorizing media, the
`same would be encoded with various identifying informa(cid:173)
`tion such as:
`a) the prescriber's name,
`b) prescriber's medical identification number,
`c) prescriber's control I.D. number,
`d) prescriber location identification.
`In the case of pharmacy authorizing media, the same
`would include encoded information specific to and identi(cid:173)
`fying a particular participating pharmacy. The encoded
`information on such a pharmacy authorizing media would
`include identifying information such as:
`
`a) pharmacy name,
`b) name of individual pharmacists associated with the
`identified pharmacy,
`c) pharmacy control identification number, and
`d) pharmacy location identifier.
`Also, as illustrated in FIGS. 3A and FIGS. 3B, the
`authorization media 20 includes printed or embossed infor(cid:173)
`mation thereon such as prescriber or pharmacy I.D. number,
`pharmacy 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
`15 information associated with the individual authorizing
`media 20 can be reviewed and verified 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
`20 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.
`25 4A-4B.
`The present invention entails a pharmaceutical trial prod(cid:173)
`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
`30 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(cid:173)
`uct is filled. Prescriber and pharmacy transactions are all
`35 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(cid:173)
`aged by an independent entity referred to as a program
`45 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(cid:173)
`gram manager. However, it is to be appreciated that the
`50 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
`55 product distribution program of the present invention, par(cid:173)
`ticipating prescribe rs and pharmacies must be established. In
`this regard, it is contemplated that the program manager in
`cooperation with participating pharmaceutical manufactur(cid:173)
`ers or suppliers, sometimes referred to as pharmaceutical
`60 members, ientify certain prescribers and pharmacies that are
`authorized to participate in the program. Thereafter, the
`program manager issues specific authorizing media 20 to
`each of the prescribers and pharmacies authorized to par(cid:173)
`ticipate in the program. Note that each authorizing media 20
`65 is specifically 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
`
`CFAD VI 1009-0018
`
`
`
`5,832,449
`
`7
`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 5
`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 10
`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 fields that are used in a terminal initialization 15
`procedure that is designed to verify that a respective termi(cid:173)
`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 fields of the EPROM chip
`could include: terminal serial number, prescriber or phar- 20
`macy identification, 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 25
`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 30
`from the central computing station 12. Data fields for the
`RAM may include a series of server (central computer
`station) phone numbers, a check digit/analog code index
`field, check digit/analog code multiplier-divisor, check digit/
`analog answerer, check digit/analog code formula, and sys- 35
`tern 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 furthe