Quintal Research Group, Inc.

1905.D Palmetto Avenue Pacifica, CA 94044 650.5575708

May 14,2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Comments on FDA proposal for Barcodes on Drug packaging and Labels

Dear FDA Representative: Quintal Research Group, Inc. is a technology development corporation and is in the process of evaluating and implementing the Nellhaus Universal Pill Identification System. The Nellhaus Universal Pill Identification System was devised by the late, Dr. Gerhard Nellhaus to reduce medication errors, primarily in “out-patent” situations. Described in three issued U.S. Patents, the system: 1. Utilizes an image or picture-stamp of the actual pill, capsule or tablet for creating medication schedules for patients. This system also includes the use of a pictorial image on the label of the pill bottle or container for visual comparison. (Patent No. 5,031,937) 2. Proposes printing a barcode directly on the medication, including direct marking of pills, capsules, tablets and other solid-form drugs. (Patent No. 5,845,264) 3. Proposes the use of a two-dimensional barcode, similar to a data-matrix barcode printed or embossed on the pill, together with a human recognizable icon or symbol that identifies the general type of pill. This barcode and icon should also be printed on the container or label as well for visual and machine-read comparison. (Patent No. 6,543,692) In commenting on the proposed regulations it must be understood that Quintal Research Group generally supports the proposed regulations, but is concerned that the regulations may inhibit implementation of technologies for direct machine-identification of solid form oral drugs that comply with the marking requirements of 21 CFR $9 206,207, 314 and 330. By a combination of image recognition, character recognition and barcode recognition technologies, the machineidentification of solid form drugs that are marked to comply with FDA marking requirements is a near reality. The focus of the proposed FDA barcode regulations is reduction in the number of medication errors occurring in hospitals. This goal should not be inconsistent with reduction of medication errors in other settings, including self medication by individuals. Therefore, consistent with the primary FDA objective and the complement objective to enhance informational databases Quintal Research Group offers the following comments and suggestions:

1. The drug establishment and listing rule should require a quality digital image of side 1 and side 2 of solid oral dosage forms of drugs, now required to be described in writing on a supplemental form under 21 CFR 8 207.30. 2. The container or label on which the NDC linear barcode is imprinted should include an image of the solid form drug or at least the imprint marking that distinguishes one drug from another under the drug marking regulations. 3. The FDA should adopt a set of universal symbols to identify the type or class of drugs. The symbols should be easily recognizable by the user to distinguish one type of drug from another and should at least be printed on the label as a last barrier to medication errors. Quintal Research Group is not unmindful that it is researching a proprietary system for drug identification and therefore has a special interest. However, becauseof the technical realities in devising a barcode that can be printed on the limited real estate of a typical pill, certain compromises must be made that are inconsistent with the preference of the FDA to use linear barcodes that incorporate the NDC identifying number: 1. In order to identify at least twenty thousand different pills, by directly marking on a pill, a two dimensional barcode symbol is required. 2. To present cells of a two-dimensional barcode symbol large enough to be read by existing two-dimensional barcode readers, a modified data-matrix symbol must be used and software changes in the readers are required. 3. While the machine readable code can directly translate into alphanumeric characters,a translation table is required to relate the alphanumeric code to the National Drug Code number. Finally, in devising a system of symbolic images to identify different drug classes, symbols recognized by their outline or silhouette alone were found to be more important than an attempt to emulate symptoms or treatment procedures by pictograms as suggested by U.S. Pharmaceutical. If the goal is to eliminate or reduce all medication errors without limitation, then aids to identification by the ultimate user should be considered. Our company agrees that the FDA should be the central repository for an informational database,and if bar coding is extended to the pill itself, the FDA should control the issuance of the code system.

President REP/taz encs: Copy of Suggested Symbols Copies of Patent Nos. 5,03 1,937 5,845,264 6,543,692

P. Familiar Primitives,
N
FLOWER

N. Recognizable
P
EYE

Glyphs
N
BELL

P
BONE

P
DROP

N
CUP

N
FOOT

Bones & Toxics

Lymph & Liquids

Ears Nose & Throat

Hydration I Stomach

Endurance

P
HEART

P

P
SPADE

P
CLUB

Heart & Blood

. F .z 0
Well-Being

DIAMOND

P CROSS

N
BALLOON

P
ARROWS

. @
Sex Organs Stomach Emergency Respiratory Psyche

P
TRIANGLE

P
SQUARE

P
STAR

N
SUN

N
TREE

N
MOON

N
BURR

Nutrition

Blocker

Parn

Health & Well-Being

Hair & Limbs

Sleep

Itch / Skin

N
FISH

N
CROWN

N
HAND

N
CASTLE

P
CIRCLE

N
APPLE

P
HEXAGON

Skin & Eye

Braln / Head

Joints & Extremltles

Strength Bones

/

Target

Nutrition

Genetic/ Imune-System

.

United States Patent wl
Nellhaus
[54] [76] [Zl] [22] [51] [52] [58]

[II]
[45]

Patent Num ber: Date of Patent:
3/1989

5,031,937
Jul. 16,199l

PICI’ ORIAL GUIDANCE/REMINDER SYSTEM FOR MEDICATION
Inventor: Appl. Filed: No.:

4,815,767

Lambert . . . . .. . .. . . . .. . .. . . .. . .. . . .. . . 283/900

Gerkuud Nellhaus, 670 Vernon St. #106, Oakland, Calif. 94610
516,685 Apr.30,1!WO

Primary Examiner-Douglas D. Watts Assistant Examiner-Hwei-Siu Payer Attorney, Agenf, or Firm-Bielen, Peterson & Lampe ABSTRACT 1571 A pictorial system is devised to assist in the administration of medication, either to self or to another, based on picture stamps of a particulate medication to be taken by or given to a patient at a specified time either over a specified period of time or over an extended and unspecified calendar period. The picture stamps, each reflecting a unit of a medication, are to be pasted into discrete spaces of a sheet, card, label or box cover divided into columns and rows identified by icons for the time of day one or more units of the medication or of the medications are to be taken or given. 10 Claims, 2 Drawing Sheets

Int. cl.5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B42D 15&O U.S. Cl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283,‘ 52.1; 283/48.1; 283/900 Field of Search . .. . .. ..I............ 283/52.1, 48.1, 900;

206/534, 532, 538, 459 [561 References Cited U.S. PATENT DOCUMENTS
7/1972 Baustin . . .. .. . .. .. . .. .. . . .. .. . . . .. . .. .. 206/534 411984 Cluff et al. . .. . .. . . .. . .. .. . . . .. ... . . . 283/900 4,556,390 W1985 Rahn et al. ..................... ... . 283/48.1
4,441,739

3,675,620

22 2342-

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U.S. Patent

July 16, 1991

Sheet 1 of 2

5,031,937

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FIG. I

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. U.S. Patent

July 16, 1991

Sheet 2 of 2

5,031,937

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FIG. 3
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72

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FIG. 4

FIG. 7

FIG. 6

FIG. 5

$03 1,937
PICTORIAL GUIDANCE/REMINDER FOR MEDICATION SYSTEM also permits ready identification of the medication an individual may be taking, which may be of crucial importance to the treating and prescribing physician in the recognition and prevention of polypharmacy and drug5 drug interaction, and determination of a suitable regimen for the client. Finally, the ready identification of drugs being taken by a person may be of critical importance in life-threatening situations. Preferably, the visual depictions of the medications 10 can be directly reproduced on picture stamps from the Physicians Desk Reference(PDR) published by Medical Economics Company, from the Compendium of Drug Therapy,published by McGraw-Hill Book Company, or From their equivalents in other countries. The icon or IS stamp of a particular medication preferably includes the name and strength of the drug as additional reminders to the patient or caregiver, providing a learning experience in associating the appearance of the drug with its name and strength. 20 The principal object of this invention is to provide a convenient and inexpensive means of identifying particular medication and the time of day and period that the medication is to be taken to assist in self-administration or the giving of medications while reducing the risks of 25 improper medication that could result in serious consequences.

BACKGROUND OF THE INVENTION This invention relates to a visual guidance or reminder system to assist in the administration of medications, whether taken by oneself or given by a caregiver. The pictorial medication system is-desirable since many patients must take multiple medications, often at different times of the day. The taking or giving of medications often becomes confusing because of the complex identifying names of the medications, similarities of the containers for the medications, and the circumstance of the patient who may be ill, infirm, or limited in ability to read or to grasp pharmacologic or medical terminology. The NATIONAL COUNCIL ON PATIENT INFORMATION AND EDUCATION, Washington, D.C. published the following data for the U.S.A. for 1987: (1) Nearly 2.3 billion inpatient and outpatient prescriptions were dispensed; (2) An estimated $23 billion was spent on prescription drugs; (3) The average pharmacy dispensed nearly 27,500 prescriptions that year; (4) In 1986, the Food and Drug Administration received almost 54,000 reports of adverse drug reactions, including 1,347 deaths and 4,1481 hospitalizations; (5) Sales of nonprescription drugs were rising by SUMMARY OF THE INVENTION 6% a year, as two-thirds of Americans self-medicate; (6) The pictorial guidance or reminder system for adminAlmost 100% of over-the-counter (OTC) medication 30 istration of medications of this invention is a convenient purchasers used self-selected regimens, and even those means to visually identify the medication to be taken, taking prescription drugs complied only about 50% of and the dosage, time, and period of administration. This time with the regimens advised. visual reminder system is based on paste-on picture Among the many problems and complications that arise from the improper timing of medication are inef- 35 stamps depicting a specific medication in a specific strength, and can be used with a sheet, card, or label fectiveness, as with antibiotics or anticonvulsants when having a matrix format with rows and columns that doses are missed, or oversedation when doses are taken divide the sheet, card, or label into discrete spaces to too close together as with antihistamines. Often, there receive the stamps. The stamps can also be mounted may be failure to identify the correct medication to be taken or the correct dosage to be administered. Fre- 40 directly on the covers of plastic medication boxes that have a preformed matrix format. quently, the very infirmity that requires a patient to take Preferably, the number of rows are selected to convemedication, may debilitate judgment and memory. niently indicate the times of d8y in which the medicaThe interval between doses of a drug, or how fretion is to be taken. The columns preferably indicate the quently during the day a drug must be taken, is determined by its pharmacokinetics, i.e. the rate of absorp- 45 number of units that make up the total dose at the indicated time as well as the starting and stopping dates of tion, peak blood or tissue level, and rate of degradation the medication, or alternately, indicate consecutive and elimination. Thus while the administration of medicalendar days of the medication period, or that the cations is not always critical as to the precise time of the medication is to be taken continuously without restricday, it is necessary to take most drugs within readily identifiable periods or at fairly regular intervals. While 50 tion as to time, or even on a pm--“as necessary”basis. Of course, the format can be reversed with the columns various dispensers have been devised for periodic disrepresenting the periods during a day in which the pensing of preselected pills and the like, such devises require preloading by the patient, a caregiver or the medications are to be taken, and the rows dedicated to pharmacist, and are usually expensive. The visual rethe dates or days on which the medications are to be minder system of this invention is cost effective, is corn- 55 administered. The former arrangement has been found prised solely of paper goods, and enablesthe pharmacist to be preferable for a pictorial display that can be ar(or less frequently the physician) to quickly and easily ranged in a booklet form of convenient size. While the select the pictorial representation of the medication to four icons or ideograms for times of day cover by far be taken, and to paste such representation on a sheet, in most of the commonly prescribed regimens, pictures of a booklet, on a card, the top of a box, or as a part or tag 60 a clock showing three or four hour intervals can be used of a label that can then guide the patient or caregiver in to head the columns when such regimens are desired, as the administration of the medication. Further significant with certain anti-parkinsonian drugs. Thus, while differadvantages of this pictorial reminder system are that ent formats can be selected and the format shown in the such filied-in sheetsmay be kept posted in several places detailed descfiption of this invention may be modified about a home such as on the refrigerator door and by 65 by the physician, the essential concept will be the same. the bedside, or kept in a booklet or a card which can be This holds true also for application of this visual rereadily carried on one’ person as in a purse or wallet. s minder system in cultures where reading is from right to This latter application of the visual guide to medication left, or is vertical rather than horizontal.

4
Referring to FIG. 1 and 2, one preferred embodiment Ibe main purpose of-this invention is to improve the of the visual guidance system is shown as a booklet 10 administration, or the taking or giving of medication by having a cover 12 with a form 14 for conventional a system that does not require literacy and which can be patient information, and a number of pages 16 having a quickly and easily understood by almost ah patients or caregivers becauseof its intuitive and visual foundation. 5 matrix format 18 with identification spaces 19 into which information is placed to indicate the time or time Frequently, a patient must self-administer a number of day medication is to be taken. In both the cover form of medications that are all dispensed in similar appearing bottles or boxes.The name and strength of the medi14 and in the matrix format 18 the use of icons and other cation and the dose and frequency of administration are pictorial representations is preferred to enable the paoften typed on small labels adhered to the cylindrical 10 tient to self-administer or be administered medication pill containers or to boxes making accurate reading by a visual guidance or reminder system. For example, difficult even for those with unimpaired vision and with in the cover form 14 are various icon identifiers 20 that medical literacy. Using the visual guidance system of represent the patient, his/her address, his/her doctor, this invention, which is basedon picture stamps,enables etc. Similarly, in the matrix format 18 are icon identinot only the patient booklet to be filled with picture 15 fiers 22 to identifying rows to represent the four periods stamps that visually represent the medication to be of the day during which particular medications are to be taken but also permits a stamp to be applied to the pill taken by or administered to the patient. The matrix container for the medication, to assistin the selection of format 18 divides a surface 23 into discrete spaces 25 the proper-pill container when taking medications. Furwhere identifiers for medications are inserted. The medthermore, once the container has been selected and the 20 ications are identified by picture stamps 24 which at correct number of pills removed, the visual system least include a pictorial representation 26 of the particuwhich utilizes an accurate pictorial representation of the lar drug or other medication to be taken. In addition to medication and dosage at a specified time, will provide the pictorial representation 26 the stamp may preferably a final check before the medication is taken by or given include the name 28 of the drug and the strength 30 of to the patient. As described, a sheet or sheets depicting 25 the drug printed thereon. Additionally, the stamp can the medication regimen can also be posted at conveinclude printed or hand written representations alternient spots around a home, such as on a refrigerator nately 32 indicating the number of the pill or capsule to door or by a bedstand, or in nursing/convalescent be taken, or by cross hatch 34 whether only a half of a homes and even in hospitals by a patient’ bedside. s As a collateral benefit, the likelihood of misprescrib- 30 unit is to be taken. Furthermore, it is understood that more than a single picture stamp 24 maybe pasted into a ing drugs will be diminished by the visual check that is single space 25 formed by the matrix format 18 by wetrequired by the pharmacist or the physician pasting the ting only a portion of the back of the added stamp or medication stamp to the container and to the appropristamps when inserting, such that the stamp can be lifted ate locations in the booklet. In addition, the pictorial system of medication regi- 35 up to determine one or more other stamps underneath as shown for the eye drop icon stamp 36 in FIG. 2. men can be applied to a card easily carried on one’ s In the embodiment of FIG. 2, the matrix format 18 is person, and even to the printed containers of over-thedivided into rows and columns with the icon identifiers counter nonprescription drugs. 22 representing rows and date markers indicating colBRIEF DESCRIPTION OF THE DRAWINGS 40 umns, which may be broken either into days of the week or calendar days as shown by the hand written identiFIG. 1 is a perspective view of the pictorial guidance tiers 40 along the top of each column. Other informasystem in the form of a booklet. tion such as a Start date marker 41 and a finish date FIG. 2 is a perspective view of the system of FIG. 1 marker 42 may be applied and utilized, particularly with the booklet opened to a schedule page showing the matrix format and pictorial stamps, 45 where the top column markers are merely days of the week, such as Monday, Tuesday, Wednesday, etc. FIG. 3 is a front view of the pictorial guidance system Referring now to FIG. 3 an alternate embodiment of in the form of a wallet-size card. the pictorial medication system is shown. A matrix FIG. 4 is a front view of a sheet of identical picture format 44 is printed on a card 46 that includes icon StZlRlPS. FIG. 5 is a perspective view of a medication con- 50 identifiers 48 to represent periods during the day, and printed markers 50 representing the days of the week. tainer having an identifying picture stamp. The icon markers 48 include both a pictorial representaFIG. 6 is a perspective view of a medication contion of periods in a day and a pictorial representation of tainer having a matrix format tab with picture stamps an analog clock. As in the former embodiment, the pasted thereon. FIG. 7 is a perspective view of a medication box with S5 matrix format is broken into columns and rows with the an integral matrix format having picture stamps and icon markings for the periods of the day segregating icon stamps pasted thereon. rows and the print markings for the days of the week, identifying the columns. Miniature picture stamps 52 DETAILED DESCRIPTION OF THE identify the particular medication or medications that PREFERRED EMBODIMENTS 60 are to be taken or administered. The pictorial system of this invention relates to a The picture stamps 24, 36 and 52 preferably come means to assist in the administration of medication to from a source of sheets,one of which is shown in FIG. self or to another based on picture stamps of particular 4. Alternately, the stamps can come in rolls or other medications to be taken by or given to a patient at a convenient meansfor grouping stamps of identical kind. specified time over a day or a number of days. Several 65 The representative stamp sheet 54 of FIG. 4 includes a embodiments of the system are shown and described to plurality of identical stamps which are separated by present the system in various forms such that the genperforation 56 allowing individual stamps to be easily eral concept is readily understood. separated from the sheet and pasted on the surface of

.

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5,03 1,937 _ 5

6

to identify specified days or dates or even continuOIX of the various alternative devices for eXemplifYhg ous open-ended series of days (with cut-off to be the system. determined by the physician during the course of As shown in FIG. S a stamp from the stamp sheet 54 treatment) and the other plurality of identifying can be used on a conventional pharmacy container 58 spacesbeing adapted to identify specific times in a used to dispense drugs to identify the contents of the 5 day for taking or giving of medication, and a plucontainer. Alternately, the system can be applied as a rality of different groups of pasteablestamps, each tab 60 attached to the container label with the miniature group having a plurality of individual, identical stamps 52 pasted into appropriate boxes of the matrix picture stamps visually identifying a select medicaformat to visually represent a medication schedule for tion, wherein each stamp has depicted thereon an the patient for whom the prescription is filled as shown 10 accurate picture of the actual medication visually in FIG. 6. identified, and wherein each group consists of a AIthough the primary embodiments of this invention different medication, visually identified in each of have shown the pictorial medication system utilizing its stamps, the plurality of groups comprising a one or more printed sheets, it is to be understood that source from which selected stamps are removed the invention can be embodied in the physical structure 15 and pasted in discrete spaceson the surface repreof a surface medium such as the top on a medicationsenting the time and date the pictorially identified containing container 62 as shown in FlG. 7. In the medication is to be taken wherein when pasted on container 62 of FIG. 7, the plastic top 64 is molded with such surface, the filled-in surface provides a visual a unitary grid matrix 66 of raised ribs 68 which define a guide or reminder to the patient or caregiver of the series of boxes 69. If desired, the interior of the con- 20 tamer can be similarly divided into separate comparttype of medication and total dose to be taken or ments by dividers (not visible). The top 64 of the congiven at a particular time during the day and on a tainer 62 has pasted in certain of the divider icon stamps ‘ particular date or during a specified or open-ended calendar period. 70 depicting an analog clock with the clock hands representing certain periods of the day, and, word markers 25 2. The medication system of claim 1 wherein one of the two pluralities of identification spaces has icon 72 depicting the days of the week. In the particular embodiment shown in FIG. 7 the analog clock stamps markings identifying discrete periods in the day. 70 designate six columns for six periods during the day 3. The medication system of claim 2 wherein the icon markings include an icon marking visually depicting in which selected medications should be taken or administered. The word markers 72 indicate the seven 30 morning, an icon marking visually depicting mid-day, days during the week which are available for the taking an icon marking visually depicting evening, and an icon of the medications. As is evident from the various emmarking visually depicting bed time. bodiments shown the concept of this invention can be 4. The medication system of claim 1 wherein the incorporated in various types of devices to effectively surface comprises a sheet, sized to a wallet-size card. achieve the r&&s desired. Variations in the format can 35 5. The medication system of claim 1 wherein the also be made without departing from the concepts dissurface comprises a sheet, sized to a calendar-size wall closed. poster. While in the foregoing, embodiments of the present 6. The medication system of claim 1 wherein the invention have been set forth in considerable detail for surface comprises a plurality of like sheets formed into the purposes of making a complete disclosure of the 40 a booklet for extended medication periods. invention, it may be apparent to those of skill in the art 7. The medication system of claim 1 wherein the that numerous changes may be made in such detail surface comprises the cover of a pill box. without departing from the spirit and principles of the 8. The medication system of claim 1, wherein the invention, surface comprises a label sheet attached to a medication What is claimed is: 45 container. 1. A pictorial guidance or reminder system to assista 9. The medication system of claim 1 wherein the patient in self-administration of medications or to assist picture stamp groups are perforated sheetswith individa caregiver in the administration of medications to a ual pasteablestamps separableby perforations, wherein patient, comprising: individual stamps are separated from the sheetsby teara surface with a matrix format having rows and col- 50 ing along the perforations. umns dividing the surface into discrete spaces 10. The medication system of claim 1 wherein the adapted to receive paste-on stamps with a first pictorial representation of the actual medication is replurality of identification spaces for identifying produced from one of the authoritative references,Phydiscrete rows and a second plurality of identificasician’ Desk Reference and Compendium of Drug Thers tion spaces for identifying discrete columns, the 55 spy. l l * l l first plurality of identification spacesbeing adapted

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[54] [76] B A R C O D E IDENTIFICATION Inventor: OF DRUGS

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P e t eL i p p m a n , “B a r C o d e s :A n Introduction”. reprintedfrom Industrial L a u n d e r e r ,Apr. 1 9 8 8 . T h e B a r C o d e B o o k : R e a d i n g .Printing. a n d Specification of B a r C o d e Symbols, Palmer. R o g e r C.. copyright 1 9 8 9 . pp. 11-45,81-85, 91-99 and 172-175. B a r C o d e s F A Q . Whiting. Jerry. copyright 1 9 9 5 , pp. 1-5.
P r i m a r y E x m n i n e r - - - G a i l 0. H a y e s Assistant E x a m i n e r - A l e x a n d e r Kalinowski A ttorney, Agent, or F’km--Bielen. P e t e r s o n& L a m p e

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[21] [22]

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ABSTRACT

A system for the identification of medications in pill. capsule, tablet. a n d caplet for the system including the 4 . 8 1 8 , 8 5 0 4 1 1 9 8 9G o m b n c het al. . . ... ... ... ... .... ... . 2 3 5 / 4 9 4 p l a c e m e n t of m a c h i n e s c a n n a b l eb a r c o d e symbols o n the 3 , 8 3 5 , 3 7 2 . 5 / 1 9 8 9G o m b n c het al .. ... .. . ... ... .... .. .. 2 3 5 1 3 7 5 - 1 : 8 5 7 , 7 1 3 S / 1 9 8 9 B r o w n . .... ... ... ... ... ... .. .. ... ... . .. . .. . 7 0 5 l 3 7 3 surface of the medication a n d the identification of the medication b y u s e of the b a r code. T h e resulting identika4.967,928 1111990 Carter.. .... .. . ... ... ... . .. .... ... ... ... ... .. .. . 2 2 1 R 5,129,974 7 1 1 9 9 2 A u r e l u u s. ... .. . ... ... ... ... . ... . .. .. . .... .. 1 5 6 1 6 4 tion information c a n b e a n a l y z e d b y a c o m p u t e r p r o g r a m . 5 . 2 3 7 , 1 5 7 S / 1 9 9 3 K a p l a n .... ... ... ... ...._..................2 3 5 1 3 7 5 permitting b o t h a d r u g identification a n d verification m e t h o d 5 . 4 6 3 , 2 0 9 l o / 1 9 9 5 Flgh et al. ... .. . . .. ... ... ... ... ... ... 2 3 5 / 3 8 3 for u s e b y a doctor, pharmacist. e m e r g e n c yr o o m o r o t h e r 5,542.420 S / l 9 9 6 G o l d m a n al. ... ... .. . .. . .._...._... 0 0 / 3 0 1 et 6 x 5 9 7 , 9 9 5 l/1997 W d l i a m set al. ,,..................... 2 3 5 1 3 7 5 medical staff. paramedics. law e n f o r c e m e n t p e r s o n n e l . patient a n d / o r family m e m b e r s . o r i n d e e d a n y o n e w h o m a y OTHER PUBLICATIONS n e e d to k n o w a d r u g ’s identity. a n d a tracking system b y inclusion of the identification d a t a into a n a p p r o p r i a t einforA M e B u s h . ‘T e c h n o l o g y turns the local c o r n e r d r u g s t o r e mation database to monitor a n individual’s prescription d r u g into national p h a r m a c y ”. Automatic I.D. News. Feb. 1. c o n s u m p t i o n a n d to alert of potential harmful d r u g interac1995. tions. U S H H S . FDA. ?mprinting of Solid O r a l D o s a g e F o r m D r u g Products for H u m a n Use-Final R u l e ”. 5 8 F R 4 7 9 4 8 , S e p . 13. 1 9 9 3 . 5 Clahus, 3 D r a w i n g S h e e t s

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Pat. No. 5.031.937. issued 16 Jul. 1991. entitled, “Pictorial Guidance/Reminder System for Medication.” The system includes a pictorial graphic representation showing the drug BACKGROUND OF THE INVENTION and providing for the use of such graphic representations for This mventlon relates generally to a system for identif- 5 a medication table for scheduled taking of medications. cation of prescription medications that has a primary feature Because of the many similarly appearing generic and prothe placement of identification markers on the outside of the prietary drugs. visual identification is frequently difiicult. medication. Specifically. this invention relates to a system Recent trends in health care also indicate that patients are for prescription medication identification using bar code being placed at risk because of the increased workload on symbols placed on the outside of the medication. 10 pharmacists. Several national pharmacy associations have The proliferation of new prescription medications created identified the problems caused by increased cost-cutting by advances in pharmacology and the steady increase of pressures on pharmacists. Examples cited include patients generics unfortunately has unintentionally created health receiving the wrong medication dosage or even the wrong problems when: (1) patents misidentify and thereby misuse medication. Pharmacists are often cited for failing to comply their prescribed drugs; (2) patients suffer adverse drug 15 with state laws requiring patient notification and counseling interactions when two or more prescribed drugs taken conupon receipt of prescribed medications. currently combine in a harmful manner; or (3) doctors The identification problems described above are solved misprescribe medications based on a lack of information when medications are individually labeled with bar code regarding the patient’ history. Health problems based on s symbols that uniquely identify the medication. or class of these scenarios are likely to grow over time because the 20 medications, when the medication is scanned through a introduction of every new medication increases the number common bar code reader. The bar code reader is connected of potential interactions with the prior existing set of meclto a computer containing the appropriate software to transcations. late the output provided by the bar code reader into a data Several related problems occurring most frequently in the identifier that can be referenced to a database table that elderly population are beginning to receive attention in 25 operates as an index of bar code-medication pairs. The research publications such as The Journal of the American computer could then display the medication name plus Medical Associafion (JAMA). as well as the popular press. additional information desired. A recent JAMA study based on review of nursing home This identification system could be utilized both by the subjects concluded that roughly 23% of Americans ages 65 patient at home and by the dispensing pharmacist. and would and over are using at least one of twenty medications that are 30 increase patient safety while decreasing health care costs. notorious for triggering insomnia, fainting spells, or amnesia As early as 1989. individuals in the bar code community among the elderly. The study also stated broader educational generally suggested that bar codes could be used by health and regulatory initiatives are needed, and a companion care providers in areas such as patient billing, pharmacy. and JAMA editorial referred to this study as illuminating “the tip bedside medication verification. However, there was no of the iceberg”. 35 suggestion that this should extend to actually placing a bar This widespread problem prevails despite the well-known co& on the drug item itself. medical technique doctors often employ. called the “brownThis system can operate using at least one of the many bag” test. The brown-bag test consists of a patient. typically commercially available bar code symbologies that meet elderly. being instructed to empty the contents of their desired requirements based on: (1) the number of unique medicine chest into a bag and then to bring the bag into the 40 codes available; (2) medication size constraints; and (3) physician’ office or to a pharmacist for analysis. s error detection and correction tolerances. Once Additionally, physicians are beginning to trace health implemented. this system will eliminate nearly all human problems in the elderly to the overprescription of medicaerror in confirming medication identification and will serve tions in amount or duration. This phenomena has been as a low-cost medication verification system. explained as the result of the human body’ changing 45 s Additionally, this system could be incorporated into an reaction to medications as part of the aging process. extended system that includes a database containing indiCurrently. patients and doctors who cannot readily idenvidual patient medication histories. and a database of known tify a prescribed medication can attempt to consult a guide harmful drug interactions. Through this system, a patient s such as Th Physician’ Desk Reference (PDR) that contains 50 would then receive a brown-bag test at a pharmacy or a pictorial index of commonly prescribed drugs. However, medical office that would reveal potentially dangerous medithe elderly patients most at risk for these problems probably cation interactions that no individual pharmacist or physifail to possess the visual or mental acuity necessary to cian could have discovered, because of incomplete medical complete these tasks. and even the professionals who can records. consult the PDR may fail to locate their medication because 55 it is a generic equivalent not shown. For the physician to SUMMARY OF THE INVENTION consult the PDR each time the identity of a drug is in The bar code drug identification system is accomplished question. is an imposition that is time consuming and hence by: (1) the application of a bar code identifier to the outside an added cost of service. surface of the medication; and (2) the programming of a The patient’ recourse is to visit a physician, physician’ 60 central processing unit (CPU) that is connected to a bar code s s assistant or pharmacist who will conduct a brown-bag test. reader and able to convert the electrical signals input by the A physician, health provider. or law enforcement agent who bar code reader into the appropriate computer output idencannot identify a medication using the PDR may be forced tifier corresponding to the medication scanned by the bar to conduct expensive laboratory tests on the unknown medicode reader. cation. 65 1. Application of the Bar Code Identifier This inventor has devised a graphical system to assist in Several bar code symbologies have been commercially the identification of drugs. This svstem is described in U.S. developed that permit numbers or alphanumeric characters

5.835264 5 6
tion side effects and interactions. as indicated in item step 74 Once all necessary input patient information is complete, in FIG. 3. The information report 71 includes information the video display screen 24 indicates that the user may begin regarding possible harmful medication interactions. is then to issue read commands from the bar code scanner 12. as indicated in item step 58 in FIG. 3. The user then points the shown as a report on the display screen 24. as indicated in face 26 of the bar code scanner 12 at the bar code symbol 42 5 item step 76 in FIG. 3. The computer software program 15 marked on the outer surface of an exemplar medication item then displays a request for the user to indicate if a printed 40. as shown in FIG. 2. Alternatively. to stop the procedure record is requested at the step 78. If yes. then a printed the user issues an exit system command from the mouse 18 record is generated at item step 79 by a printer 80 in or keyboard 20. as indicated in item step 58 in FIG. 3. communication with the computer 16 by a communication The location of the face 26 of the bar code scanner 12 10 link. here a cable 82. As noted. the system may be used with a portable unit that relative to the medication item 40 necessary to achieve an because of memory limitations only identifies the drug using optimal scan will vary due to the physical specification of the text database 100 and does not include the extended the bar code scanner 12. the choice of bar code symbology. database 102 that contains data related to specific patients. and the physical dimensions of the medication 40. Once the user has positioned the face 26 of the bar code 15 to graphical images or to adverse side effects and harmful interactions. Once the report is printed. the computer softscanner 12 relative to the medication item 40, the user issues ware program 15 then stops. If after the inquiry at step 84 no a read command typically by pressing a trigger button 28 on report is requested. then the software program stops at step the bar code scanner 12. The bar code scanner 12 analyzes 84 after display of the report at item step 76. the bar code symbol 42 and sends data corresponding to the While, in the foregoing, embodiments of the present bar code symbol 42 through the communications cable 14. 20 invention have been set forth in considerable detail for the If the user issues an exit system command. the computer purposes of making a complete disclosure of the invention, software program 15. displays an appropriate exit message it may be apparent to those of skill in the art that numerous and stops operation, as indicated in item step 60 in FIG. 3. changes may be made in such detail without departing from Once the user attempts a scan operation using the bar code 25 the spirit and principles of the invention. scanner 12. the computer software program 15 first analyzes What is claimed is: the data received from the bar code scanner 12 to check that 1. A computerized drug identification system for the the scan operation did not yield an error corresponding to identification of medication items in pill, capsule, tablet. and events such as the mispositioning of the bar code scanner 12 caplet form. comprising: relative to the medication item 40. as indicated in item step 30 a plurality of medication items. each medication item 60 in FIG. 3. If a scan error is detected. the computer having an outer surface marked with a machine scansoftware program 15 displays an error message and graphics nable bar code symbol identifying the medication item; on the video display screen 24 of the monitor 13 to direct the scanner means for electronically scanning the bar code user to attempt another scan. as indicated in item step 64 in symbol and decoding the bar code symbol into binary FlG. 3. 35 data; If no scan error is detected. the computer software pro a general purpose computer having a random access gram 15 searchesthrough a drug identification database 100 memory and a database of medication identifier codes; carried within the software program 15 that typically contains a list of matching medication numeric drug identifiers means for transmitting the binary data from the scanner and an ASCII character string that contains the name of the 40 means to the random access memory of the computer; medication plus additional ASCII character strings and means for processing the binary data in the random access graphical images. as indicated in item step 66 in FIG. 3. memory of the computer and comparing the processed For example, a record from the drug identification databinary data to the database of medication identifier codes to match the processed binary data with a medibase 100 might appear as: cation identifier code; and 667, 50 mg. Zoloft (sertrahne HCl), F’ fizer. Roerig Divi- 45 sion means for display of the medication identification data meaning that the computer software program 15 would associated with the matched medication identifier code. interpret a bar code symbol 42 that was deco&d into the 2. The computerized drug identification system of claim 1 medication identifier integer value 667 as 50 milligrams of wherein the system contains means for computer input of the medication “Zoloft”. 5o patient identifier information. The result of the database search will indicate whether a 3. The computerized drug identification system of claim 2 successful match was found If the match was unsuccessful, wherein the database of medication identifier codes contains an error message is shown on the display screen 24. as patient identifier information supplied by the user. indicated in item step 68 in FIG. 3. If the match is successful. 4. The computerized drug identification system of claim 1 information corresponding to the medication item 40 is 55 wherein the system displays a pictorial graphic of the shown on the display screen 24. as indicated in item step 70 medication item. in FIG. 3. The display screen 24 then prompts the user to 5. The computerized drug identification system of claim 4 scan another medication or to create an informational sumwherein the system contains a database of harmful medicamary report 71 on the display screen 24. as indicated in item tion interaction identifiers, wherein the system displays an 60 step 72 in FIG. 3. information report indicating the set of scanned medication Once the user requests an information report 71, the items that includes a combination appearing in the database computer software program 15 first performs a comparison of harmful medication interaction identifiers. of the set of medications scanned with reference to an * * * * * extended database 102 containing known harmful medica-

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USOO5845264A

United States Patent [I91
Nellhaus
[54] [76] BAR CODE IDENTIFICATION Inventor: OF DRUGS

[III
1451

Patent Number: Date of Patent:

5,845,264
Dec. 1, 1998

Pete Lippman. “Bar Codes: An Introduction”. reprinted from Industrial Launderer. Apr. 1988. The Bar Code Book: Reading. Printing. and Specification of Bar Code Symbols. Palmer. Roger C.. copyright 1989. pp. 11-45, 81-85, 91-99 and 172-175. Bar Codes FAQ, Whiting. Jerry. copyright 1995, pp. l-5.
Primary Examiner-Gail 0. Hayes Assistant Examiner-Alexander Kalinowski Attorney, Agent, or Firm--Bielen. Peterson & Lampe
r571

Gerhard Nellhaus. 670 Vernon St. #207. Oakland. Calif. 94610

[21] [22] [51] [52] [SS] [56]

Appl. No.: 612,372 Filed: Mar. 7, 1996

Int. CL6 .. ... .. . .. . .... ... ... . .. ... ... .. .. . .. ... ... ... ... . ... . G06F 17/60 U.S. Cl. ... . .. ... .. . .... ... ... ... .. . .. . ... 705/B; 705/2: 235/375 Field of Search .... . .. ... ... .. .. .. .... ... ... .. 705/2. 3. 22. 28, 705129; 7 1513; 235137.5 References Cited U.S. PATENT DOCUMJZNTS
411989 Gombnch et al. .. ... ... ... .. . ... . ... . 2351494 4,818,850 S/1989 Gombdchet al. .. ... ... ... ... .... ... . 2351375 4,835,372 811989 Brown . .... .._............................. 7051373 4,857,713 22112 II/1990 Carter .. . ... ... ...._............................ 4.967,928 5.129,974 7/1992 Auremus . ... ... .._.........................156164 5237,157 811993 Kaplan .... ... .. . ... ... . .. .... ... ... ... ... . 2351375 .5.463,209 1011995 Fqh et al. . .. . .. .... ... .. . .. . ... .. . .... . 235/383 8/1996 Goldmanet al. .._....................600/301 5,542,420 5,597,995 111997 Wfiams et al ... .. .. ... .. .. . .... ... . 2351375

ABSTRACT

OTHER PUBLICATIONS Anne Bush. ‘ Technology turns the local corner drugstore into national pharmacy”. Automatic LD. News. Feb. 1, 1995. US HHS. FDA. “Imprinting of Solid Oral Dosage Form Drug Products for Human Use-Final Rule”, 58 FR 47948, Sep. 13. 1993.

A system for the identification of medications in pill, capsule. tablet. and caplet for the system including the placement of machine scannable bar code symbols on the surface of the medication and the identification of the medication by use of the bar code. The resulting identification information can be analyzed by a computer program. permitting both a drug identification and verification method for use by a doctor. pharmacist. emergency room or other medical staff. paramedics, law enforcement personnel. patient and/or family members, or indeed anyone who may need to lmow a drug’ identity. and a tracking system by s inclusion of the identification data into an appropriate information databaseto monitor an individual’ prescription drug s consumption and to alert of potential harmful drug interactions. 5 Claims, 3 Drawing Sheets

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U .S . P a te n t

Dec. 1, 1998

Sheet2 of 3

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S O F T W A R E , H A R D W A R E INITIA L IZA T IO N

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PROMPT USER TO SCAN DRUG O R E X IT S Y S T E M

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TEXT DATABASE

IS P L A Y E R R O R

INFO R M A T IO N

IN O

5.845.264 1
BAR CODE IDENTIFICATION BACKGROUND OF DRUGS OF THE INVENTION
5

2
Pat. No. 5.031.937. issued 16 Jul. 1991. entitled. “Pictorial Guidance/Reminder System for Medication.” The system includes a pictorial graphic representation showing the drug and providing for the use of such graphic representations for a medication table for scheduled taking of medications. Because of the many similarly appearing generic and proprietary drugs. visual identification is frequently diflicult. Recent trends in health care also indicate that patients are being placed at risk because of the increased workload on pharmacists. Several national pharmacy associations have identified the problems caused by increased cost-cutting pressures on pharmacists. Examples cited include patients receiving the wrong medication dosage or even the wrong medication. Pharmacists are often cited for failing to comply with state laws requiring patient notification and counseling upon receipt of prescribed medications. The identification problems described above are solved when medications are individually labeled with bar code symbols that uniquely identify the medication. or class of medications, when the medication is scanned through a common bar code reader. The bar code reader is connected to a computer containing the appropriate software to translate the output provided by the bar code reader into a data identifier that can be referenced to a database table that operates as an index of bar code-medication pairs. The computer could then display the medication name plus additional information desired. This identification system could be utilized both by the patient at home and by the dispensing pharmacist. and would increase patient safety while decreasing health care costs. As early as 1989, individuals in the bar code community generally suggested that bar codes could be used by health care providers in areas such as patient billing. pharmacy. and bedside medication verification. However, there was no suggestion that this should extend to actually placing a bar code on the drug item itself. This system can operate using at least one of the many commercially available bar code symbologies that meet desired requirements based on: (1) the number of unique codes available; (2) medication size constraints; and (3) error detection and correction tolerances. Once implemented. this system will eliminate nearly all human error in confirming medication identification and will serve as a low-cost medication verification system Additionally, this system could be incorporated into an extended system that includes a database containing individual patient medication histories. and a database of known harmful drug interactions. Through this system, a patient would then receive a brown-bag test at a pharmacy or medical office that would reveal potentially dangerous medication interactions that no individual pharmacist or physician could have discovered, because of incomplete medical records. SUMMARY OF THE INVENTION The bar code drug identification system is accomplished by: (1) the application of a bar code identifier to the outside surface of the medication; and (2) the programming of a central processing unit (CPU) that is connected to a bar code reader and able to convert the electrical signals input by the bar code reader into the appropriate computer output identifier corresponding to the medication scanned by the bar code reader. 1. Application of the Bar Code Identifier Several bar code symbologies have been commercially developed that permit numbers or alphanumeric characters

This mvention relates generally to a system for identifcation of prescription medications that has a primary feature the placement of identification markers on the outside of the medication. Specifically. this invention relates to a system for prescription medication identification using bar code symbols placed on the outside of the medication. The proliferation of new prescription medications created by advances in pharmacology and the steady increase of generics unfortunately has unintentionally created health problems when: (1) patents misidentify and thereby misuse their prescribed drugs; (2j patients suffer adverse drug interactions when two or more prescribed drugs taken concurrently combine in a harmful manner; or (3) doctors misprescribe medications based on a lack of information regarding the patient’ history. Health problems based on s these scenarios are likely to grow over time because the introduction of every new medication increases the number of potential interactions with the prior existing set of medications. Several related problems occurring most frequently in the elderly population are beginning to receive attention in research publications such as The Journal of the American Medical Association (JAMA). as well as the popular press. A recent JAMA study based on review of nursing home subjects concluded that roughly 23% of Americans ages 65 and over are using at least one of twenty medications that are notorious for triggering insomnia. fainting spells, or amnesia among the elderly. The study also stated broader educational and regulatory initiatives are needed. and a companion JAMA editorial referred to this study as illuminating “the tip of the iceberg”. This widespread problem prevails despite the well-known medical technique doctors often employ. called the “brownbag” test. The brown-bag test consists of a patient. typically elderly. being instructed to empty the contents of their medicine chest into a bag and then to bring the bag into the physician’ office or to a pharmacist for analysis. s Additionally, physicians are beginning to trace health problems in the elderly to the overprescription of medications in amount or duration. This phenomena has been explained as the result of the human body’ changing s reaction to medications as part of the aging process. Currently. patients and doctors who cannot readily identify a prescribed medication can attempt to consult a guide such as The Physician’ Desk Reference (PDR) that contains s a pictorial index of commonly prescribed drugs. However, the elderly patients most at risk for these problems probably fail to possess the visual or mental acuity necessary to complete these tasks. and even the professionals who can consult the PDR may fail to locate their medication because it is a generic equivalent not shown. For the physician to consult the PDR each time the identity of a drug is in question, is an imposition that is time consuming and hence an added cost of service. The patient’ recourse is to visit a physician, physician’ s s assistant or pharmacist who will conduct a brown-bag test. A physician. health provider, or law enforcement agent who cannot identify a medication using the PDR may be forced to conduct expensive laboratory tests 05 the unknown mechcation. This inventor has devised a graphical system to assist in the identification of drugs. This system is described in U.S.

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Once all necessary input patient information is complete. the video display screen 24 indicates that the user may begin to issue read commands from the bar code scanner 12. as indicated in item step 58 in FIG. 3. The user then points the face 26 of the bar code scanner 12 at the bar code symbol 42 marked on the outer surface of an exemplar medication item 40. as shown in FIG. 2. Alternatively, to stop the procedure the user issues an exit system command from the mouse 18 or keyboard 20. as indicated in item step 58 in FIG. 3. The location of the face 26 of the bar code scanner 12 relative to the medication item 40 necessary to achieve an optimal scan will vary due to the physical specification of the bar code scanner 12. the choice of bar code symbology. and the physical dimensions of the medication 40. Once the user has positioned the face 26 of the bar code scanner 12 relative to the medication item 40. the user issues a read command typically by pressing a trigger button 28 on the bar code scanner 12. The bar code scanner 12 analyzes the bar code symbol 42 and sends data corresponding to the bar code symbol 42 through the communications cable 14. If the user issues an exit system command. the computer software program 15. displays an appropriate exit message and stops operation. as indicated in item step 60 in FIG. 3. Once the user attempts a scan operation using the bar code scanner 12. the computer software program 15 first analyzes the data received from the bar code scanner 12 to check that the scan operation did not yield an error corresponding to events such as the n&positioning of the bar code scanner 12 relative to the medication item 40. as indicated in item step 60 in FlG. 3. If a scan error is detected, the computer software program 15 displays an error message and graphics on the video display screen 24 of the monitor 13 to direct the user to attempt another scan. as indicated in item step 64 in FIG. 3. If no scan error is detected, the computer software program 15 searches through a drug identification database 100 carried within the software program 15 that typically contains a list of matching medication numeric drug identifiers and an ASCII character string that contains the name of the medication plus additional ASCll character strings and graphical images. as indicated in item step 66 in FIG. 3. For example. a record from the drug identification database 100 might appear as: 667, 50 mg, Zoloft (sertratine HCl). Pfizer, Roerig Division meaning that the computer software program 15 would interpret a bar code symbol 42 that was decoded into the medication identifier integer value667 as 50 milligrams of the medication “Zoloft”. The result of the database search will indicate whether a successful match was found If the match was unsuccessful, an error message is shown on the display screen 24. as indicated in item step 68 in F’ 3. If the match is successful, IG. information corresponding to the medication item 40 is shown on the display screen 24. as indicated in item step 70 in FIG. 3. The display screen 24 then prompts the user to scan another medication or to create an informational summary report 71 on the display screen 24. as indicated in item step 72 in FIG. 3. Once the user requests an information report 71, the computer software program 15 first performs a comparison of the set of medications scanned with reference to an extended database 102 containing known harmful medica-

6
tion side effects and interactions. as indicated in item step 74 in FIG. 3. The information report 71 includes information regarding possible harmful medication interactions. is then shown as a report on the display screen 24. as indicated in item step 76 in F?IG. 3. The computer software program 15 then displays a request for the user to indicate if a printed record is requested at the step 78. If yes. then a printed record is generated at item step 79 by a printer 80 in communication with the computer 16 by a communication link. here a cable 82. As noted. the system may be used with a portable unit that because of memory limitations only identifies the drug using the text database 100 and does not include the extended database 102 that contains data related to specific patients. to graphical images or to adverse side effects and harmful interactions. Once the report is printed. the computer software program 15 then stops. If after the inquiry at step 84 50 report is requested. then the software program stops at step 84 after display of the report at item step 76. While. in the foregoing, embodiments of the present invention have been set forth in considerable detail for the purposes of making a complete disclosure of the invention, it may be apparent to those of skill in the art that numerous changes may be made in such detail without departing from the spirit and principles of the invention. What is claimed is: 1. A computerized drug identification system for the identification of medication items in pill, capsule. tablet. and caplet form. comprising: a plurality of medication items. each medication item having an outer surface marked with a machine scannable bar code symbol identifying the medication item; scanner means for electronically scanning the bar code symbol and decoding the bar code symbol into binary data; a general purpose computer having a random access memory and a database of medication identifier codes; means for transmitting the binary data horn the scanner means to the random access memory of the computer; means for processing the binary data in the random access memory of the computer and comparing the processed binary data to the database of medication identifier codes to match the processed binary data with a medication identifier code; and means for display of the medication identification data associated with the matched medication identifier code. 2. The computerized drug identification system of claim 1 wherein the system contains means for computer input of patient identifier information. 3. The computerized drug identification system of claim 2 wherein the database of medication identifier codes contains patient identifier information supplied by the user. 4. The computerized drug identification system of claim 1 wherein the system displays a pictorial graphic of the medication item, 5. The computerized drug identification system of claim 4 wherein the system contains a database of harmful medication interaction identifiers. wherein the system displays an information report indicating the set of scanned medication items that includes a combination appearing in the database of harmful medication interaction identifiers. * * * * *

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US006543692B 1

(12) United States Patent
Nellhaus et al.
(5-k) SCHEblA FOR IDENTIFICATION FORRl DRUGS 17h) In~rntor\. OF SOLID

US 6,543,692 Bl Patent No.: Apr. 8,2003 (45) Date of Patent:
(IO)

Gerhard Nellhaus. Kursana Residrnzen
Rabenkopfstmsw 7. Frelburg (DE). 79102. Richard E. Peterson. 537

Valley St.. San F~anc~o. CA (US) 94131 ( ) NatIce,
Subject to any dkanner. the term of this patent IX extended or adjusted under 35 U.S.C. 154(b) by 71 dayj.

Shamtr _._______._____ I5616-1 ______ Chrc . . . . . . . . I IO/316 t)clclsoI1 Si.rttord cl al. ___.____ I I ‘ I74 ._.. J! Krall Cl 31. . . . . . 53/55 Hror et al. . 42-vlO.2 wollr Cl aI . . . . 3w2s Nrllhnu\ sLI111\.;111al. ct C’ lnrk . . . . . 385/W

OTHER PUBLICATIONS IBM Techmcal Disclosure Bulletin. NA85035883. Chip ldentdication Wrltmg System. Mar. I985.” IBM Techmcal Disclosure Bulletin. NA89091 IO. Visual ldentlficatlon Tool. Sep. 19S9. I. (5 I j
(57)

(38)

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4.310.478 4.7Sh.3J 4.315.767 4.SIS.850 A A r\ .A / S/l’ )RI 3 I l/l‘ ~SS YlW9 -l/l‘ J ~S’ A&Icy __.___ .___...___... 101/-W .__ Hender\on 4lU786 Lumberl Gomhrlch et al. ._______._ 7.W-W

A: cited by exammer PI-irr~trgl Ed--tr,ilirfcr-Thien M. Le (74) &to/~+ Agcv~t. 01. Fir-jrl-Rlchnrd (57) ABSTRACT Esty Peterson

(33)

A bar code schema for identification of solid form drugs, such as pills. tablets. capsules and the hke using a data matrix type symbology for compact coding that is easily deciphered in combination with a common visual symbol that is easily recognized. the schema incorporatmg a portable code readmp pen. 11 Claims, 4 Drawing Sheets

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U.S. Patent

Apr. 8,2003

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