Note: Descriptions are shown in the official language in which they were submitted.
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Method, System and Apparatus
For Biometric Identification
TECHNICAL FIELD
This invention relates to use of biometrics and the
Internet and, more particularly, to systems, methods and
apparatus wherein biometric linking of identity, is
enabled to authorize, verify and audit professional
activities such as for practice like pharmacy and
medical practice and for linking patient identity with
physician prescription orders for patient medication.
BACKGROUND ART
Medications prescribed by physicians for patients
are useful for treating the medical condition of a human
subject. Consistent with good medical practice, it is
necessary to conclusively link the prescribed medication
with the identity of the human subject for whom the
medication is prescribed. The standard method of
identifying the patient in order to dispense medication
is by using the patient name. In some cases, such as
for filling prescriptions for controlled substances, the
pharmacist may request additional information from the
patient such as address or Medicaid card or the like.
The standard method for ordering medication is for a
physician to enter a prescription in the name of a
patient. For example, the pharmacist receives a
telephone call, typically from a prescribing physician
or from a nurse authorized to act as a surrogate by the
physician, providing the patient name and instructing
the pharmacist which medication the patient is to
receive and the dosage amount and schedule. The
patient, if an outpatient, then visits or sends someone
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to the pharmacy and receives the medication from the
pharmacy after providing patient identification.
Typically all that is required for the patient to pick
up the medication is for the patient to state to the
pharmacist their name or alternatively to provide a form
of identification such as driver's license. For the
ordering of controlled substance prescriptions including
the prescribing of narcotics, for example medications
such as Demerol, Dilaudid, Marinol or the like, the
physician is typically required to provide in written or
verbal form an identifier. For example, in the USA in
order to have authority to prescribe such controlled
medications, the physician must first register with the
Bureau of Narcotics and Dangerous Drugs. Then when
prescribing such medication to a patient the physician
or his authorized representative such as his nurse must
provide to the pharmacist his BNDD number as evidence
the physician is currently licensed to prescribe such
controlled substances. However,- patients may circumvent
the system easily such as by giving a fraudulent order
form with for example a forged physician signature or a
false patient name or incorrect address or by using
another patient's Medicaid card. An associated problem
for the pharmacy filling such fraudulent order is loss
of revenue due to the fact billing in the circumstance
where a patient gives a false name and a false address
is seldom paid.
Also, in the ordering of medication there are
problems such as when physician office staff communicate
orders to the pharmacy on behalf of a physician. It is
common practice in pharmacies to accept telephone orders
from the physician's nurse for prescribing medication
for a patient. This occurs often especially when the
physician is busy, as for example in surgery, or
otherwise unable to personally telephone the order to
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the pharmacist. This circumstance leads in some cases
to false orders, as for example when a physician office
clerk leaves employment of a physician but retains a
prescription pad wherein is listed the physician BNDD
number. The former clerk then may pose as a
representative of the physician and the clerk may
fraudulently order via telephone a controlled substance
medication prescribed in the name of a friend of the
former clerk posing as patient. The pharmacy likely
will fill such a prescription and the physician will
typically be unaware since the clerk is no longer in the
physician's employ. This type of fraud is especially
difficult to detect where there is no feedback of such
unauthorized orders to the physician under whose
physician name the order is submitted.
When a patient picks up an outpatient prescription
the pharmacist typically summons the person to the
counter to collect the medication typically by repeating
the name out loud or sometimes by spelling of the name.
Errors occur where the person approaching the counter
does not clearly understand the words the pharmacist
says, as for example if the person approaching is hard
of hearing or otherwise impaired such as under the
influence of substance abuse. When a name is called and
person approaches to picking up the prescription, the
pharmacist may assume that the person approaching is the
correct patient for that prescription and then typically
the medication is given to that person. This occurs
despite the correct patient name typically being
typewritten on the prescription form or attached to the
medication bottle or container as a further means of
identification. Serious and occasionally fatal
reactions have been known to occur when the wrong
patient takes a medication prescribed for another.
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Alternatively, in the inpatient setting, the
physician writes an order for medication in~the patient
chart in the hospital and the pharmacy prepares the
medication and delivers the medication to the floor
where the patient has a bed. The nursing staff
typically is instructed to dispense the medication only
after identifying the patient in the bed by, for
example, reading the patient name from that patient's
wristband for identification. Errors are known to occur
where busy nurses do not check the wristband but
administer the medication to the occupant of a bed
number assuming that to be the correct patient. For
example the correct patient may have been moved to
another bed.
Another limitation of the current systems occurs
where a pharmacy fills a prescription written or ordered
by an out of state physician. This occurs for example
with prescriptions written on major clinic prescription
forms such as Mayo Clinic or the like. Similarly, where
the patient lives nearby across the state line in
another state often the pharmacy will honor and fill
such prescriptions from the physician in the other
state. Where a person steals a prescription pad from
such an out of state physician office or major clinic
the person may forge the physician signature. Some
pharmacies require that the prescription form be faxed
to the clinic for verification prior to filling the
prescription. However, often a pharmacy will
unknowingly honor and fill such forged prescription and
no feedback exists to alert the out of state physician
or clinic of the forgery.
Patient identification systems for inpatient and
outpatient pharmacy prescriptions and administration of
medication are well known. Examples of systems for
accomplishing this include US Patent No. 4,993,068
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entitled Unforgeable Personal Identification System
filed 27 November 1989; US Patent No. 5,071,168 entitled
Patient Identification System filed 27 February 1990; US
Patent No. 5,363,453 entitled Non-Minutiae Automatic
5 Fingerprint Identification System and Methods filed 22
March 1993; US Patent No. 5,381,487 entitled Patient
Identification System filed 18 September 1991; US Patent
No. 5,291,560 entitled Biometric Personal Identification
System Based on Iris Analysis filed 15 July 1991; US
Patent No. 4,641,349 entitled Iris Recognition System
filed 20 February 1985; US Patent No. 5,592,374 entitled
Patient Identification and X-ray Examination Data
Collection Bar Code System filed 2 July 1993; US Patent
No. 5,637,851 entitled Laser Scanner for Reading Two
Dimensional Bar Codes filed 14 February 1995; US Patent
No. 4,488,678 entitled Method and Apparatus for Reading
a Bar Code filed 3 June 1982; US Patent No. 4,977,601
entitled Method of Recognizing a Fingerprint filed 27
November 1987: US Patent No. 5,563,345 entitled Device
for Ultrasonic Identification of Fingerprints filed 29
December 1994; US patent No. 5,682,142 entitled
Electronic Control System/Network filed 29 July 1994;
PCT Patent No. WO 98/50873 entitled Cyber Medicine
Disease Management filed 1 May 1998, US patent No.
5,872,834 entitled Telephone with Biometric Sensing
Device filed 16 September 1996 and US patent No.
5,883,370 entitled Automated Method for Filling Drug
Prescriptions filed 5 June 1996 which prior art is
hereby incorporated by reference.
Additional problems occur where a patient attempts
to procure controlled substances via prescription from
multiple physicians. In this circumstance a patient may
convince one physician of the need for a controlled
substance medication such as codeine for pain relief.
The same patient may have recently visited another
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physician and not disclose to the second physician that
a first physician has recently written a prescription
for the same patient for the same medication. In
similar circumstances the patient may use a pseudonym
such as maiden name and married name in order to receive
one prescription under one name and the other
prescription using another name. In this manner the
patient is able to receive multiple prescriptions for a
controlled substance. The patient then visits one
pharmacy with one prescription order and has that
prescription filled. The same patient then visits
another pharmacy, perhaps in another city or county, and
receives additional controlled substance medication by
filling the second physician's order. The two
pharmacies may be unaware of the situation wherein the
patient is receiving more medication than appropriate.
This situation may exist over a long period of time and
occurs because the tracking systems for patient
medications do not typically cover all pharmacies in a
region or alternatively may not allow positive real time
identification. Some states through the Board of
Pharmacy receive data that is collated and reveals
multiple simultaneous prescribing of control substances
to a patient. The system is, however, typically after
the fact, cumbersome and does not preclude the issuance
of the medication.
Additionally where pharmacy prescriptions are
processed over the Internet or other network systems,
certain problems may arise. These include difficulty
verifying true patient identity because of the distance
of the patient from the prescribing physician.
Similarly where the pharmacy is on-line, ordering the
prescription is done electronically and then filling the
prescription by mail can be carried out. However, in
this circumstance, the identity of the patient and in
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some cases the identity of the prescribing physician is
more difficult to establish conclusively. ~ Fraud is
possible in Internet medication orders with respect to
both patient identity and physician identity.
Problems also exist with currently available
systems in that one physician may choose to prescribe
more medication or controlled substance than is
justified. This may occur where the physician is a
party to efforts to sell prescribed medication or where
the physician is receiving favors or other inappropriate
remuneration from the prescribing of such controlled
substances. The state board of pharmacy is often unable
to detect such a pattern of unlawful prescribing habits
in the early stages since reporting is often spotty or
not collated by patient name or by prescribing physician
name. In some circumstances no statewide or unified
reporting mechanism exists. This audit function and
oversight responsibility is especially difficult for a
state board of pharmacy to carry out properly where
prescriptions are filled across state lines.
Given these and other shortcomings in the art, the
need for certain new and useful improvements is evident.
There is a need for a system and method to positively
identify the recipient of a medication as the individual
for whom the physician prescribed that medication.
Ideally the system will track on a real time basis the
prescribing of medication linking the data to a unified
database of patient identification that can be searched
quickly and accurately on a real time basis. Such a
system ideally will not rely on name alone but have the
ability to independently verify the patient identity
correctly and collate activity from one pharmacy to
another and with relation to prescriptions from more
than one physician and will function over a computer
network optionally over the Internet. Furthermore, such
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a system will have the ability to identify each
physician prescribing controlled substances and then
collate such prescribing activity in relation to the
individual physician prescribing records by patient.
DISCLOSURE OF THE INVENTION
The above problems and others are at least
partially solved and the above purposes and others are
realized in improved methods, systems and apparatus for
linking patient identity with his or her prescribed
medication prescriptions and with the health care
provider prescribing said medication, and for optionally
and substantially contemporaneously linking patient
identity to medication request data as it is processed
by one or more pharmacies. The instant invention
incorporates by reference and cites as priority
Provisional Patent 60/081,891 entitled Method, System
and Apparatus for Matching Prescribed Medication to
Intended Recipient filed 15 April 1998 which provisional
patent is filed by same inventor and owned by the same
entity.
In a particular embodiment, the instant invention
may also provide registration within a database of
biometric codes of physicians authorized to prescribe
medication. Furthermore, the invention may also provide
for registration of biometric codes from all ancillary
personnel authorized to transmit verbal orders for
prescriptions from a physician via telephone to a
pharmacy. The invention provides for a means to verify
the identity of a patient and to sort patient
prescriptions according to patient biometric code. In a
particular embodiment, the invention provides a method
of linking a prescription by a physician with the
identity of that patient for whom the medication is
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prescribed, comprising the steps of collecting biometric
data indicative of the identity of the patient, and
linking the biometric data with the prescription of
medication for that patient to form a prescription order
expressing the physician request that said medication be
dispensed to said patient. The steps of collecting the
patient biometric data and prescribing the medication
may occur substantially contemporaneously if desired.
The step of collecting the physician biometric may,
however, occur subsequent to the step of collecting the
patient biometric code. The step of collecting the
physician biometric may occur remote from the location
of the patient and may occur via a biometric scanner
linked to a cellular telephone or the like. The method
may further include the step of storing the patient
biometric code as linked to the prescription order to
form a record in a database of a computer in the form of
a data file. The method may further include the step of
storing the prescribing physician biometric code as
linked to the said prescription order to form a record
in said data base linked to said data file. To ensure
the record concerns a specific patient, the method may
further include the steps of re-collecting biometric
data indicative of the identity of the patient and
comparing the re-collected biometric data with the
biometric data of the prescription order and data file.
The invention further provides a means for tracking
professional activities of licensed professionals such
as prescribing activities of physicians and of
authorized surrogates such as nurses of said physicians.
A further embodiment of the invention provides for a
real time feedback to prescribing physicians of
prescribing activities of their surrogates and others
attempting to act as surrogates for a physician in
ordering prescription medications.
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BRIEF DESCRIPTION OF THE DRAWINGS
5 The foregoing and further and more specific objects
and advantages of the instant invention will become
readily apparent to those skilled in the art from the
following detailed description thereof taken in
conjunction with the drawings in which:
Fig. 1 is a flow chart illustrating a method of
collecting patient biometric data and prescribing
physician biometric data and linking the said biometric
data with a prescription;
Fig. 2 is a flow chart illustrating a method of
monitoring reports issued from a computer used for
sorting prescriptions by biometric data of patient or
prescribing physician or physician surrogates;
Fig. 3 is an illustration of a surrogate at a
physician office receiving authorization by a physician
to order medication in his name;
Fig. 4 is an illustration of a patient at a
physician office receiving a prescription for a
medication bearing a two-dimensional bar code;
Fig. 5 is an illustration of a physician
authorizing a prescription by providing a biometric
reading using a cellular telephone with built in
biometric scanner;
Fig. 6 is an illustration of a nurse confirming
patient identity as intended patient to receive a
medication; and
Fig. 7 is an illustration of the authorization of a
prescription over the Internet using biometric code
authorization to a website.
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BEST MODES FOR CARRYING OUT THE INVENTION
Ensuing embodiments of the invention comprise new
and improved methods. systems and apparatus for linking
human subject biometric measurements or data with his or
her prescription for medication, prescribing doctor,
data regarding prescription including amount of
medication, type, refill orders, identity of patient and
identity of physician.
The instant invention, in one embodiment, includes
the use of a network of linked computers preferably with
a computer at each pharmacy and at each physician
office. The system uses, as identification for a
person, a biometric measurement or data of a portion of
the anatomy of that person. Biometric measurements or
data can include fingerprint or iris of the eye
patterns, or measurement of a function of the anatomy of
said person such as signature or voice recognition or
voice print, etc. Various biometric measurements or
data and methods of collecting the measurements or data
are disclosed in U.S. patent application serial number
08/686,211, filed on 23 July 1996 and entitled "Method,
Apparatus and System for Anonymous Verification of
Infectious Status of Humans" which is an invention of
the same inventor and which is owned by the same entity,
and hereby incorporated by reference. The biometric
measurements or data are then encoded for storage in a
computer database or other storage medium. Encoding
typically takes place during the process of obtaining
biometric data.
As a preferred embodiment, the use of an iris scan
is herein disclosed wherein each physician authorized to
prescribe medication such as controlled substances
within a geographic region or jurisdiction, such as
.within one state, is registered by his or her iris code
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created from an image of his or her iris. This
registration is made using an iris scanner such as
produced by IriScan of Marlton, New Jersey or the
autofocus iris scanner of LG Technologies of Korea. The
iris scan measurement is encoded and filed in a
computerized database optionally within a single
database of a central computer. The prescribing
physician when prescribing a controlled substance for a
patient will have in his office an iris scanner and will
instruct the patient to enter iris data, typically from
the right eye, into the scanner. This scanner is linked
to the central database. The patient encoded iris scan
data and the physician encoded iris scan data are thus
linked in a data file which optionally includes further
specifications such as time, date, prescribed medication
and pharmacy for which the prescription is written. It
will be understood that while an iris scan is used in
this specific embodiment, other biometric measurements
or data can be employed and encoded for storage into the
computer data base.
When the patient visits the pharmacy to retrieve
the medication or controlled substance, the pharmacy
asks the patient to re-enter the iris data by using an
iris scanner located at the pharmacy such as at the
drive up curb side window or inside the pharmacy at the
counter. The computer searches the database of iris
codes of patients who are taking controlled substance
prescribed medication in comparison to the newly encoded
iris data entered by the visiting patient. When a match
of encoded iris data occurs, the data is displayed to
the pharmacist. In the circumstance where a patient has
recently filled another controlled substance
prescription in the same region, the data of the prior
prescription is displayed, and alerts the pharmacist
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that the patient may have a controlled substance abuse
problem.
In another embodiment of the instant invention the
computer at the physician office is a stand alone
computer linked to a two dimensional bar code printer
such as available from NipponDenso of Japan or Symbol
Technologies of Holtsville, New York and an iris
scanner. It will be understood that other biometric
measurement devices and storage mediums can be used. In
this specific embodiment the physician provides his iris
pattern as the biometric measurement or data using the
iris scanner which is linked to a computer that encodes
the iris data as a two-dimensional bar code. The
prescription form receives as a printout the two-
dimensional bar code representation of said physician
iris data. The patient for whom the physician is
prescribing a controlled substance is then asked by the
prescribing physician to enter patient iris pattern data
using the iris scanner. The computer receives and
encodes the iris measurement or data and causes the bar
code printer to print onto the prescription form the
two-dimensional bar code representation of the patient
iris data. The patient then takes this prescription
form to the pharmacy for filling. The pharmacy in this
embodiment has linked to the pharmacy computer a two-
dimensional bar code scanner such as available from
NipponDenso of Japan or Symbol Technologies of
Holtsville, New York. The prescription with the bar
codes is given to the pharmacist who scans the bar
codes. The computer recognizes the physician bar code
as representing the iris data of the physician and sorts
through the database of encoded physician iris data to
find the match. The display of the pharmacy computer
displays the name of the physician, which the pharmacist
verifies matches the physician's name on the
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prescription. The pharmacist then scans the_patient bar
code and the computer receives the encoded patient iris
data. The computer compares the encoded patient iris
data to the database of encoded patient iris data in the
computer memory. Where the computer finds a match the
display of the pharmacy computer displays the name of
the patient found as a match which the pharmacist
verifies matches the patient's name on the prescription.
When a problem occurs, such as when the physician name
from the computer database match of encoded iris data
does not match the physician name on the prescription
form or when a patient name from the computer database
match of encoded iris data does not match the patient
name on the prescription form, the pharmacist is
alerted.
In the instant invention it is envisioned that the
unified database of patients and physicians can be
searched based on criteria of search. For example, a
computer search can be performed for all patients
receiving controlled substance prescriptions from more
than five physicians within the past 12 months. Such a
search of the database is enabled through the use of
encoded iris data matching of patient to prescription
and avoids name mix-ups or pseudonym. The data
retrieved may alert authorities such as the state Board
of Pharmacy to a problem in patient substance abuse.
Similarly the database search criteria may be set to
identify all physicians who prescribe more than a set
number of controlled substance prescriptions within a
12-month period. The data retrieved may alert
authorities such as the state Board of Pharmacy to a
problem with a physician prescribing habits.
The accompanying drawings, in which like reference
characters indicate corresponding elements throughout
the several views, illustrate the foregoing embodiments
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of the invention. Turning to Fig. 1, shown is a block
diagram illustrating the steps involved for~a physician
prescribing medication for a patient and for a patient
to receive said medication from a pharmacy. A patient A
5 visits a physician M and physician M decides to
prescribe medication for patient A. At the request of
physician M, patient A at 101 provides a biometric
measurement or data by having a biometric reading taken
by a biometric scanner located, for example, on the desk
10 of physician M and connected to a computer. At 103
physician M optionally provides biometric data using the
same biometric scanner or optionally another biometric
scanner. The computer and/or the scanner encodes the
biometric data and links encoded patient A biometric
15 data to the prescription order and electronically
records the date and the order entered by physician M.
In the preferred embodiment, the order is written onto a
prescription pad that also contains the printout of a
two-dimensional bar code encoding patient A biometric
data or measurement and optionally also the physician
biometric data and date. The physician then writes the
prescription medication order, the amount of the
medication and the dosage schedule onto the prescription
form in the standard manner. At 109 patient A visits
the pharmacy and delivers the prescription form to the
pharmacist with the request that the prescription be
filled. The pharmacist uses a two-dimensional bar code
scanner linked to a computer to scan the bar codes on
the prescription form. The two-dimensional bar code
from the form provides to the computer of the pharmacy
the encoded biometric data of patient A and optionally
the encoded biometric data of physician M. The
pharmacist then requests patient A to provide biometric
data by using the pharmacy biometric scanner linked to
the pharmacy computer at 115. The pharmacy computer
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encodes the newly scanned biometric data and compares
patient A biometric data as obtained ~ from the
prescription form bar code to the encoded biometric data
provided by the person representing themselves as
patient A and providing the biometric data at step 115.
Where the computer comparison of the encoded biometric
data determines a match the computer alerts the
pharmacist of the match and the pharmacist verifies the
patient name and fills the prescription at 1I7. Where
the computer determines a match does not exist the
computer signals the pharmacist who declines and does
not fill the prescription as shown at step 118. The
computer o.f the pharmacy optionally records encoded
physician M biometric data in the database of pharmacy
records as linked to the order for patient A medication
submitted on the prescription form and presented to the
pharmacist by patient A.
In the case of a database. of encoded biometric data
linked on-line to the physician office, a patient B is
shown at step 119 receiving an order for medication from
a physician N. Patient B is instructed by physician N
to provide biometric data by using a biometric scanner
in the physician office. Said scanner is linked by
computer, which encodes the newly obtained biometric
data, to the pharmacy database. The database optionally
searches for a match to encoded patient B biometric data
input at step 119. A match displays the name and
demographic data and optionally the medication data for
patient B onto the computer display screen of physician
N. At step 121 physician N optionally enters his own
biometric data which is encoded. The pharmacy database
links the encoded physician biometric data to the order
for medication that physician N is prescribing for
patient B. Optionally, encoded physician N biometric
data may necessarily precede and authorize the display
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of any matching data found for patient B from search of
the pharmacy database. At step 123 physician N enters
the order for medication, specifying for example, the
name of the medication, amount, dosage and any refill
orders. The pharmacy database computer receives the
order and provides physician N with information
regarding the time the prescription will be ready. When
the search of the pharmacy database for a match to
encoded patient B biometric data retrieves data which
physician N interprets as data indicating a problem with
his intended prescription order, such as a pattern of
abuse of prescription medications by patient B, then
physician N optionally may delay or cancel his order for
additional medication. Similarly where the search for
patient B match demonstrates a pseudonym for patient B
wherein patient B has received controlled substances
under an assumed or different name, the physician may
optionally notify authorities or optionally may counsel
patient B regarding need for drug rehabilitation or the
like. The database optionally records a record of the
data provided to physician N at the time of match of
encoded patient B biometric data in a format whereby the
record can be audited by computer program. Where
encoded patient B biometric data is not found to match
encoded patient biometric data in the computer database,
then a new file can be created for patient B and linked
to physician N as the prescribing physician. Where
physician N decides to continue with the prescription at
step 123, physician N enters the medication order which
order is received by the pharmacy computer and entered
into the pharmacy computer database. At step 125,
patient B visits pharmacy Y which may be a different
pharmacy from pharmacy X visited by patient A. The
computer database of pharmacy X is optionally linked to
the computer database of pharmacy Y and optionally
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linked by unified database to a state Board of Pharmacy
computer suitable for search and report functions for
the state board regulatory oversight functions. Patient
B provides to the pharmacist at pharmacy Y her patient
name and states that she is present to pick up the
prescription medication ordered for her by physician N.
The pharmacist asks patient B to enter her biometric
data using the biometric scanner at the pharmacy and
attached to the pharmacy computer. At step 127 patient
B enters biometric data using the same portion of her
anatomy as she used in the physician B office. In the
embodiment described it is envisioned that the anatomy
used is the same part of anatomy for each patient, in
other words standardized i.e. all patients use the right
eye for iris scan or alternatively all patients use the
index finger of the right hand for fingerprint biometric
data. The biometric data of patient B is received via
the pharmacy biometric scanner and encoded by the
computer of the pharmacy and the computer then searches
the database to retrieve the order having matching
encoded patient biometric data. The computer displays
the search results for patient B and the pharmacist
makes the determination whether the data are in order or
alternatively whether the data suggest a problem.
Problems can include a pattern of medication drug abuse
by patient B indicated by previous prescriptions filled
for the patient using a patient pseudonym or the like.
Where the search indicates the order is correct and the
pharmacist determines that the order should be filled,
the pharmacist at step 129 fills the order. The
computer database records the order as filled and links
patient B name and biometric data to the filled order
and places this information into the database as an
update to patient B file. Similarly, physician N's name
is linked to the filled order and placed into the
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database linked to physician N's data file. Where the
pharmacist has a question whether the order should be
filled, for example where the search data displays a
match to records for patient B indicating several
physicians have recently prescribed similar controlled
substances for patient B, then the pharmacist may delay
the filling of the physician N order. Optionally, the
pharmacist can telephone physician N and inform
physician N of the multiple physician orders for
controlled substances for patient B. Where the patient
sends another person to pick up the prescribed
medication the biometric data of that person is
optionally registered as a person picking up medication.
The database of such persons who pick up medication is
established and the computer can optionally match the
encoded biometric data of a person appearing to pick up
medication for another against the database of
individuals who have previously picked up medication for
others. In this way the frequency of a person picking
up medication for another person is monitored for
indication that a person is picking up~ medication from
multiple pharmacies and for multiple individuals as
might indicate a pattern of substance abuse in the case
of fraudulent controlled substance prescriptions.
~ It is envisioned that the step of a physician
ordering a medication prescription in the instant
invention can be a surrogate carrying out the order of
the physician. For example, all those authorized to
carry out such a medication prescription input for
physician N are registered by encoded surrogate iris
data linked to encoded physician N iris data. The
surrogate iris data is again re-entered when the
surrogate orders a medication prescription for a patient
following order to do so from physician N. The.entry of
the surrogate iris data is encoded and linked in the
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computer to the order and the data file is linked to
physician N name and encoded biometric data.' Thereafter
when the activity is audited as shown in Fig. 2 the
surrogate name is listed in the report of physician N
5 ordering activity. Similarly where a person alleging to
be an authorized surrogate for physician N is, in fact,
not registered as a surrogate by iris data (or other
biometric data), that person, when entering his or her
iris data during the ordering of a medication
10 prescription, will not match the surrogate biometric
list linked to physician N's name. Hence the biometric
data of the alleged surrogate will not be accepted by
the pharmacist who will be alerted to the attempt and
who may choose to report such activity to physician N or
15 to the state Board of Pharmacy.
Turning now to Fig. 2, the audit function of the
system is detailed. The database of prescription data
linked to physician biometric data and patient biometric
data and physician surrogate biometric data is
20 optionally prompted each month to print out a series of
reports. These reports provide the State Board of
Pharmacy with oversight data regarding the medication
ordering activities of each physician or health care
provider registered in the system. Similarly, the
reports provide the State Board of Pharmacy with
oversight data regarding the medication prescriptions
filled for each patient registered. In step 201 the
computer audits the database and prints a monthly
activity report regarding physician M. At 203 the data
which appears on the report wherein a medication
prescription was ordered by physician M for Patient A on
the date specified and through the entry of biometric
data of an authorized surrogate whose name is listed on
the report, is summarized. The report in step 205 is
automatically sent by e-mail or optionally by standard
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21
mail to physician M. At step 207 the report is
automatically sent by e-mail or optionally by standard
mail to the State Board of Pharmacy. At step 209 the
database computer audits the database to produce a
report specific to patient B. The specifics of this
report are summarized at 211 wherein physician N
prescribed medication on a specific date for patient B
with surrogate Y placing the order. In addition, this
report includes four prescriptions entered for patient B
by surrogate X for physician P. This data when sent to
physician P, optionally by e-mail, may alert physician P
that an unauthorized surrogate ordering activity is
occurring. In the circumstance where physician P did
not order such prescriptions be placed for patient B
listed on the report, Physician P may alert the
authorities. In addition, the feedback of activity
under his name may alert physician P that surrogate X
needs to be deleted from physician P linked list of
authorized surrogates. Also, the report indicates that
physician Q ordered medication for a patient whose
biometric data matches patient B biometric data, but who
used a patient pseudonym. In this circumstance,
physician Q may call the pharmacy and report this
apparent inconsistency. The report is sent to the state
Board of Pharmacy at step 217. Each physician linked
to patient B medication orders at step 215 receives a
report concerning patient B which references that
physician's listed data and which optionally alerts all
the physicians that patient B has a report that raises a
question regarding unusual medication use and
potentially substance abuse.
Turning now to Fig. 3, illustrated is the use of
multiple biometric scanners of two types within the
scope of the instant invention. Physician 312
undertakes steps to register a surrogate 314 by first
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22
inputting his own iris data via iris scanner 305 coupled
to computer 307. Physician 312 then inputs his own
right index finger image as biometric data via
fingerprint scanner 301 coupled to computer 307. Iris
scanner 305 may be from IriScan Inc. of Marlton New
Jersey and fingerprint scanner 301 may be from UltraScan
Inc of Holtsville New York. The physician biometric
data is encoded and compared to stored encoded biometric
data. Physician 312 receives from computer 307 an
indication that physician 312 is recognized and then
physician 312 enters onto keypad 303 of computer 307
instructions to register surrogate 314 as surrogate of
physician 312 authorized to carry out input of
medication prescription orders for physician 312.
Computer 307 indicates via display on monitor 311 that
the computer is prepared to accept and register
biometric data of surrogate 314 to be linked to
physician 312 data file. Then physician 312 instructs
surrogate 314 to enter surrogate iris data of left eye
using iris scanner 317. Then computer 107 signals
surrogate 314 to enter right hand index finger biometric
data via fingerprint scanner 319. This input of dual
surrogate biometric data registers surrogate 314 as
surrogate for physician 312. Physician 312 is enabled
to specify which type of medication prescriptions
surrogate 314 is authorized to order in the name of
physician 312, for example non-control substances. The
computer database optionally registers surrogate 314 for
a specific time period, for example for 1 year. At the
end of that time computer 307 prompts physician 312 to
re-enter his dual biometric data in order to re-certify
surrogate 314 as his surrogate for an additional year.
In this manner a surrogate who leaves the employ of
physician 312 is automatically removed from the
surrogate list if not re-certified by physician 312. A
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23
printer 321 can be linked to the system to print a hard
copy 322 of the registration. Hard copy 322 preferably
includes a two-dimensional bar code 323 representative
of the encoded physician iris data and fingerprint data
and optionally the time and date physician registered
the surrogate and a two-dimensional bar code 325
representative of encoded iris data and fingerprint data
of the registered surrogate.
Turning now to Fig. 4 illustrated is a patient 414
receiving a medication order from a physician 412. In
this circumstance physician 412 instructs patient 414 to
place a finger onto fingerprint scanner 415 and
physician 412 is at the same time positioning the iris
of his eye into view of an iris scanner 417. Each
scanner is linked to a computer 416 of the system which
encodes and stores the biometric data. In this example,
the physician has previously been registered into the
system using his iris data only. The computer
recognizes physician 412 based on a comparison of his
stored encoded iris data and re-input of his iris data.
Similarly for this illustration patients are identified
by fingerprint data. Therefore the registration of
patient 414 occurs via the input of her fingerprint
data. Physician 412 encoded biometric data and patient
414 encoded biometric data are linked by computer 416 in
a data file representing the prescription and linked to
time and date of prescription order. Physician 412 then
enters into the computer the prescription information
for patient 414. If computer 416 is coupled to a
network, such as the Internet, patient 414 may proceed
to the pharmacy without the need to carry a paper
prescription sheet since the computer at the pharmacy
has access to the electronic prescription and will
recognize patient 414 from the fingerprint data.
Optionally, computer 416 prints, via linked printer 419,
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a corresponding set of two-dimensional bar codes onto a
prescription pad sheet 418. Two-dimensional bar code
423 is representative of the encoded iris data of
physician 412 and the time and date of order and two-
s dimensional bar code 425 is representative of the
encoded fingerprint data of patient 414. In this
circumstance the physician 412 may write onto the
prescription pad sheet 418 the details of medication he
is prescribing for patient 414 including medication
name amount and dosage. The patient then is given the
prescription form to take to the pharmacy for filling.
Because the bar code includes the time and date of the
medication order as represented in code form in the two
dimensional bar code, the copy of the bar code cannot be
duplicated and successfully used later to fraudulently
represent that the copy is a prescription of a purported
later date.
Turning now to Fig 5, illustrated is a patient 414
at the pharmacy delivering a prescription form 418 to a
pharmacist 501. Pharmacist 501 scans bar code 425 from
prescription form 418 using a bar code scanner 527. A
computer 503 linked to the system uses the biometric
data from two-dimensional bar code 425 to search for a
match among the patient biometric files registered in
the database. Where a match is found, the pharmacist
views the matching data on the display of computer 503
that may include for example the name of the patient as
found in the matching data file. The pharmacist
compares the name information in the matching computer
file to the identification and name given by patient
414. The pharmacist then asks patient 414 to input her
fingerprint biometric data by placing her right index
finger onto fingerprint scanner 505 linked to pharmacy
computer 503. Computer 503 encodes and compares the
patient 414 biometric data to bar code 425 from form
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418. Alternatively the computer compares patient 414
input fingerprint biometric data to the database
biometric data of the patient matched by the computer to
the form 418 bar code 425. Where the identity of the
5 patient is confirmed as matching the prescription form
or alternatively matching the database in regards to
name of the patient matched by the computer to the form
418 bar code 425, then the pharmacist proceeds to
confirm the physician biometric data. The pharmacist
10 scans the physician bar code 423 from the prescription
form 418 and the computer searches the database for a
match to the encoded physician iris data. The display
of the pharmacy computer displays the matching physician
name and the time and date the physician placed the
15 medication order. Optionally where the pharmacist seeks
additional confirmation, the pharmacist telephones the
physician whose name is displayed by the pharmacy
computer as matching bar code 423. Physician 412, in a
location remote from the pharmacy, is requested by
20 pharmacist 501 to verify that the physician prescribed
the medication listed on the prescription form 418, for
example a controlled substance, for patient 414. The
physician enters his iris data using iris scanner 531
linked to his cellular telephone 533. The pharmacy
25 computer 503 receives the physician 412 iris data
encoded by iris scanner 531 via link to the cellular
telephone and the computer compares the physician 412
iris data from the telephone input to the iris data from
bar code 423 of form 418. Alternatively, iris data from
the telephone can be compared to the iris data found in
the matching physician file from the computer database.
Where the computer confirms a match, then the computer
displays the physician authorization as a match
confirmation for the pharmacist on the display of the
pharmacy computer 503. The computer optionally forms a
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26
data file linking time and date of physician
verification to the medication order in the database and
to the physician name and BNDD number. A similar
sequence of events may occur where physician 412
authorizes refills for patient for controlled substance
medication. Physician 412 may know the condition of
patient 414, for example cancer which is terminal and
for which the prescribing of narcotic pain relief is
appropriate. The physician may in this circumstance
verify via telephone input of physician biometric to the
pharmacy computer the fact that physician 412 has
decided to authorize a refill of the prescription of the
controlled substance for patient 414. Alternatively
where the match of patient 414 biometric data in the
database includes information the pharmacist interprets
as a pattern of controlled substance abuse the
pharmacist may decline to fill the prescription or
alternatively alert physician 412 to the possible abuse
of controlled substance medication by patient 414.
Turning now to Fig. 6, illustrated is a patient 601
in a hospital bed who has previously received a
prescription order from his physician for medication.
Said prescription order was sent to the pharmacy of the
hospital on a prescription form that included the
patient iris data as encoded in a two-dimensional bar
code 425. The pharmacy has prepared the medication for
patient 601 per instructions of the ordering physician.
The pharmacy has placed the medication into an infusion
bag 602 and the pharmacist has placed on the infusion
bag exterior a sticker bearing two-dimensional bar code
425 encoding the_patient iris data. The pharmacist has
also placed a lock device 699 onto the outlet aspect of
the infusion bag 602 wherein this lock device has a port
to receive a computerized signal to unlock and release
from the outlet aspect of the infusion bag when such
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27
signal is received. Nurse 603 on the floor of a
hospital has a belt mounted computer 607 with software
enabled to compare encoded biometric iris data received
from an iris scanner 605 linked thereto, to the
biometric iris data received from bar code 425 using a
bar code scanner 611 linked to computer 607. The nurse
upon receiving the infusion bag containing the
medication ordered for the patient proceeds to the
bedside of the patient she believes to be patient 601
for whom she believes the medication is intended. The
nurse using bar code scanner 611 scans two-dimensional
bar code 425 from infusion bag 602 and computer 607
mounted on the nurse belt forms a data file of this
encoded iris data which represents the patient iris data
of the intended patient. The nurse then using iris
scanner 605, scans the iris of the patient in the bed.
The computer receives the iris data of the patient in
the bed and compares this iris data to the iris data
from two-dimensional bar code 423 on infusion bag 602.
When the computer finds that the iris data match the
computer sends a signal to clamp device 699 on the
outlet aspect of the infusion bag to release, allowing
the nurse to administer the infusion. When the computer
finds no match, the computer does not send a signal to
the clamp device on the outlet aspect of the infusion
bag to release, preventing the nurse from administering
the infusion.
Turning now to Fig. 7, illustrated is the use of
the Internet for prescribing and filling prescriptions
using the instant invention such as for Internet
pharmacy websites such as www.SOMA.com or
www.worldwidemedicine.com. Also illustrated is the use
of the invention wherein the steps of the method are
used with, and the devices of the system and apparatus
of the instant invention are linked to the web site of
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an Internet pharmacy 799. The patient 419 is shown
entering biometric data from home computer linked
biometric scanners 701 and 797 wherein the Internet
pharmacy computer receives the encoded patient biometric
data via a home computer 703 optionally over high speed
digital subscriber line such as DSL lines provided by
Covad Company of San Jose, California. The database
computer of the Internet pharmacy matches the biometric
data to the patient name and registration previously
received when patient registration occurred preferably
at the physician office as described above. The input
by the Internet linked physician 412 of the order for
medication for patient 414 occurs optionally to include
input by the physician 412 of his biometric data into
the computer of the Internet linked pharmacy via
physician biometric scanners 705 and 795 linked to
physician computer 707. The Internet pharmacy computer
registers the order as a linked data file in the
Internet pharmacy computer database which database
optionally is audited and reports generated in a manner
similar to that described in Figs. 1 and 2 above. The
mailing of the prescription medication to patient 414
occurs from the Internet pharmacy and e-mail summarizing
and documenting the filling of the prescription is sent
by the Internet pharmacy to the physician who prescribed
the medication and optionally to the State Board of
Pharmacy of other governing body.
It is understood that the invention herein
disclosed as preferred embodiment is for illustrative
purposes. Various changes and modifications to the
embodiments herein chosen for purposes of illustration
will readily occur to those skilled in the art, for
example the use of this invention in the case of
inpatient medications can utilize the nurse and a
computer attached to the medication cart. For the case
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of one person picking up a medication for another
person, then the system can record the biometric data of
the person picking up the medication and link that data
to the file of the transaction for later review.
Furthermore, where such second person picks up a
prescription medication for another, the patient for
whom the medication is intended can optionally be
reached by telephone and where a linked scanner is at
the patient's phone then patient biometric data can be
obtained from that person remotely and compared to the
biometric data of the intended patient by the computer
of the pharmacist. Furthermore, the invention herein
disclosed is also envisioned to be used as a national
database of biometric codes suitable for matching to the
biometric code of a person such as a physician useful
for example in researching the association of medical
practice liability claims state to state to a particular
practitioner. It is envisaged that still other
embodiments are possible within the scope of the
invention herein disclosed and those other embodiments
are included in the invention herein disclosed. For
example the cellular telephone with built in biometric
iris scanner is envisioned to be useful for verification
of identity of the user of the telephone in relation to
many other applications. For example the instant
invention is envisioned to be used where the user of the
telephone is a non-medical individual and where the user
is providing his biometric data to a computer containing
a database of encoded biometric data used to authorize
purchases or sales of various goods and services, both
professional and non-professional. Similarly, the
instant invention of the website-based use of computer
matching of encoded biometric data is envisioned to be
useful in a variety of non-medical uses including the
Internet linked website receipt of identity verification
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of the individual authorizing Internet purchases or
sales of various goods and services. Also, one skilled
in the art will realize that biometric measurements or
data can be encoded on a storage medium by the computers
5 to which the various sampling devices are coupled, by
the sampling devices themselves, which read the
biometric measurements or data or any combination
thereof. Furthermore, the encoded biometric data may be
sent to a remote site for storage either electronically
10 or by hard copy. For example, as detailed in the
previous description, the encoded biometric data may be
in the form of a two-dimensional bar code. It should be
understood by those skilled in the art that while, in
the preferred embodiment a physician is ordering a
15 prescription, other professionals may be involved in
other professional activities, herein recorded and
audited within the scope of the instant invention such
as pharmacist, chiropractor, surrogate of licensed
professional, patient, dentist, dental hygienist,
20 medical technologist, nurse, surgeon, emergency medical
technician, medical assistant, lawyer, broker, physician
assistant, optometrist or optometry technician,
engineer, certified public accountant, psychologist
pursuing such activities as verifying attendance at
25 professional education courses, re-licensing and other
types of professional testing, verification or
authorization of contracts such as professional
contracts, purchasing of professional supplies,
authenticating professional billing, obtaining release
30 of or authorizing access to patient information or other
professional confidential information.
To the extent such modifications and variations do
not depart from the spirit of the invention, they are
intended to be included within the scope thereof.
