WO2007089251A1

WO2007089251A1 - Detection and prevention of adverse drug events

Info

Publication number: WO2007089251A1
Application number: PCT/US2006/011999
Authority: WO
Inventors: William Paisley
Original assignee: William Paisley
Priority date: 2006-02-03
Filing date: 2006-04-01
Publication date: 2007-08-09

Abstract

This invention detects and avoids adverse drug events. It is emphasized that this abstract is provided to comply with the rules requiring an abstract that will allow a searcher or other reader to quickly, ascertain the subject matter of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

Description

DETECTION AND PREVENTION OF ADVERSE DRUG EVENTS

TECHNICAL FIELD OF THE INVENTION

This invention relates to the detection and avoidance of adverse drug events. An adverse drug event is a noxious and unintended reaction of a drug that has been taken by, or administered to a person for prophylaxis, diagnosis or therapy.

PROBLEM STATEMENT Interpretation Considerations

This section describes the technical field in more detail, and discusses problems encountered in the technical field. This section does not describe prior art as defined for purposes of anticipation or obviousness under 35 U.S.C. section 102 or 35 U.S.C. section 103. Thus, nothing stated in the Problem Statement is to be construed as prior art.

Discussion the term "medical service provider" is to be understood as including medical practitioners (e.g. physicians, general practitioners, surgeons, anesthetists and the like) pharmacists, nurses, physiotherapists, occupational therapists, lay health careers, dentists, paramedics and ambulance officers. In one special circumstance, a medical service provider can be a person/patient themself, where self-administration of drugs or medication, such as over-the- counter drugs, is occurring. Furthermore, any reference to "dispensing" of a drug is to be understood as including the writing or filling of a prescription for one or more drugs, and/or the administration of one or more drugs by a medical service provider (including the patient, as noted). The term "patient" is used in its broadest context, to include any person for whom one or more drugs are to be dispensed, including self-administration. The terms "drug", "pharmaceutical" and "medication" are used interchangeably.

Adverse drug events (ADEs) include prescribing, dispensing, administration, patient derived and knowledge acquisition errors. Examples are allergic effect in a patient due to a drug, an adverse reaction of a drug due to incorrect dispensing (for example over dosage), incorrect choice of the administration route, and adverse interactions between two or more drugs prescribed for concurrent use. ADEs can occur because of physician, pharmacist, nurse or patient error. A physician can prescribe incorrect medication for a particular clinical indication or have incomplete knowledge of pharmacokinetics, resulting in incorrect dosage schedule and regimen. Furthermore, a physician may have an incomplete knowledge of a particular drug's profile and also fail to adequately educate a patient in drug usage. Pharmacist error can occur by the prescribed dosage not being checked, and for the other same reasons that a physician might make an error. Nurse error can occur if the wrong drug or the wrong dosage is administered or selection of the wrong patient. Patient error can occur for failure not to heed warnings concerning a particular drug, because of deliberate non-compliance or because of self-prescribing over-the-counter medication that adversely interacts with a currently prescribed medication.

Other contributing factors can include fatigue or inexperience. Knowledge acquisition errors can occur if the healthcare practitioner fails to correctly assimilate the pharmacological data, which changes rapidly, or fails to install pharmacological data correctly on the computer. The outcome of ADEs often prove fatal or at least permanently debilitating for the person involved.

Studies have shown that ADEs contribute about 5% of total patient admissions to hospitals. This rate has been determined in other studies as being as high as 20% amongst the elderly, and it is thought that this is because the elderly consume the most medication of any section of the community, consume multiple medications, and have compounding socio-economical problems such as low income, widowhood and poor housing. However ADE 's affect all ages from neonates to seniors.

According to The Journal of the American Medical Association, it is estimated over two million Americans are hospitalized annually from ADE 's, killing as many as 180,000 and costing $136 billion in health care support. Sloppy handwriting, confusing medicine names, and substitute drugs contribute to mistakes that can be deadly. To complicate the problem, prescription spending is expected to triple by the year 2008. A drug database, no matter how comprehensive, is not the solution. The solution is a holistic approach coupled with information and web-based technology. These efforts have been limited in development, and there have been no comprehensive initiatives performed by the health industry to date. To provide high qualify patient care requires participation by the patient, the physician, and allied health care givers, the principal among the latter being the pharmacist and nurse. Patient care ideally should embody accurate physician diagnosis and appropriate treatment, which includes pharmaceutical management and patient education (of the diagnosis and the treatment), approval and thus co-operation. At present, there is no systematic solution on the market that is capable of comprehensively detecting an ADE at all points-of-care (doctors, pharmacists, hospitals, paramedics, community services, and self-diagnosis/prescription) in real-time. That is, until now. It is an object of the invention to provide methods and apparatus whereby the occurrence of adverse drug events can be detected, then avoided or at least reduced. BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the invention, as well as an embodiment, are better understood by reference to the following detailed description. To better understand the invention, the detailed description should be read in conjunction with the drawings, in which like numerals represent like elements unless otherwise stated.

Fig. 1 is a schematic representation of medical service provision sites;

Fig. 2 is a view of apparatus located at certain sites;

Fig. 3, 3 A and 3B are views of apparatuses located at other sites; Fig. 4 is a schematic view of communications between a host(s) and medical service providing site;

Fig. 5 is a schematic diagram of the flow of information in any instance of drug dispensing;

Fig. 6 is a flow diagram illustrating the steps in each instance of drug 20 dispensing;

Fig. 7 is a flow diagram of additional chosen drug screening; and

Fig. 8 is a flow diagram of drug prescription calculation.

EXEMPLARY EMBODIMENT OF A BEST MODE Interpretation Considerations

When reading this section one should keep in mind several points. First, the following exemplary embodiment is what the inventor believes to be the best mode for practicing the invention at the time this patent was filed.

Thus, since one of ordinary skill in the art may recognize from the following exemplary embodiment that substantially equivalent structures or substantially equivalent acts may be used to achieve the same results in exactly the same way, or to achieve the same results in a not dissimilar way, the following exemplary embodiment should not be interpreted as limiting the invention to one embodiment.

Likewise, individual aspects of the invention are provided as examples, and, accordingly, one of ordinary skill in the art may recognize from a following exemplary structure (or a exemplary act) that a substantially equivalent structure or substantially equivalent act may be used to either achieve the same results in substantially the same way, or to achieve the same results in a not dissimilar way. Additional alternatives to achieve an aspect of the invention may arise. Such advances are hereby incorporated within their respective genus, and should be recognized as being functionally equivalent or structurally equivalent to the aspect shown or described. Additionally, the only essential aspects of the invention are identified by the claims. Thus, aspects of the invention, including elements, acts, functions, and relationships (shown or described) should not be interpreted as being essential unless they are explicitly described and identified as being essential. Third, a function or an act should be interpreted as incorporating all modes of doing that function or act, unless otherwise explicitly stated. Unless explicitly stated otherwise, conjunctive words (such as "or", "and", "including", or "comprising" for example) should be interpreted in the inclusive, not the exclusive, sense. The language and each word used in the invention should be given the ordinary interpretation of the language and the word, unless indicated otherwise. Description of the Drawings

Therefore, in one aspect, the invention discloses a method for detection of adverse drug events, the method comprising the steps, at any instance of prescribing, dispensing or administering a drug to a person, of: (a) reading data contained on an electronic data storage device for that person; and

(b) checking for conflict between information concerning a drug to be dispensed to the person and data already stored on the data storage device.

If there is no conflict the method can further comprise the step of updating the data of the storage device with information concerning the drug dispensed. If there is a conflict, there can be the further step of alerting the medical service provider and/or the patient.

The step of reading preferably includes reading the person's current medication data. The step of checking thus can comprise the steps of comparing the current medication data with information concerning the drug to be dispensed for an adverse reaction there between. The comparing step can include accessing a database of drugs, the database including a list of known adverse reactant properties for each said drug, and for the drug to be prescribed, checking the respective said list for an adverse reaction with said current medication data.

The step of reading further includes reading the person's known drug allergies from the electronic data storage device. The step of checking can further comprise the step of comparing the known allergy data with information concerning the drug to be dispensed for conflict. The method can comprise the further steps, if there is no conflict, of checking one or more of the prescribed dosage, periodicity and route of administration against permissible respective dosages, periodicities and routes, and issuing a warning if any of said prescribed dosage, periodicity and route are impermissible. In addition there also includes checking the selected drug against past and present diseases in the patient's history and issuing a warning if there is a conflict between the drug to be dispensed and the medical history.

The method can yet further comprise the step of issuing said data storage device to said person. The method can provide the further step of disseminating information concerning a new drug that can be dispensed in advance of, or contemporaneously with, public release of said new drug.

In another broad form, the invention discloses a method for avoiding adverse drug events comprising the step, at any instance of a drug dispensing, of screening a drug to be dispensed for conflict with patient-specific current medication information. The invention further discloses a system for the avoidance of adverse drug events, the system comprising: a plurality of electronic data storage devices each including stored data relevant to a person; a plurality of data processing means located at sites of medical service provision, and including a data storage device, readers for reading data from and writing data to a said data storage device, a barcode scanner to correctly identify both the patient and the medication and operable such that at each instance of dispensing a drug to a person, data from said data storage device and barcode scanner is read and checked for conflict against information concerning a drug to be dispensed.

The information can include, for each drug to be dispensed, a list of known adverse reactant drags and in checking, the data processing means compares the relevant list for inclusion of said current medication. The data processing means can further comprise a drug database that is updated by a communications link to a host site with information concerning a new drug in advance of, or contemporaneously with, release of the new drag. The invention further discloses an electronic read-writable electronic data storage device containing at least data concerning a person's current medication, allergic history and medical history. ADEs are avoided, or at least reduced in frequency of occurrence, by screening any drug to be prescribed, dispensed or administered for conflict with current medication in the form of adverse reactions with current medication, allergic reaction, and dosage miscalculation amongst a host of errors that can occur in a patient. ADEs are further avoided, or at least reduced in frequency of occurrence, for reason of restrictions being placed by the medical service provider so far as the allowable prescribing, dispensing or administering of a drug is concerned. That is, a drug can only permissibly be prescribed, dispensed or administered if the chosen drug, its dosage, periodicity and route of administration are correct or within an acceptable range. It is therefore only in fewer instances than presently is the case, that a medical service provider can purposefully choose to ignore the checking/screening outcome.

The regime of checking/screening at every occasion of a drug prescribing, dispensing and administration means that the opportunity for errors to occur is greatly reduced. Medical service providers, including patients, also are better informed and confident in the dispensing of drugs.

As shown in Fig. 1, a person/patient 10 has in their possession a data storage device 15 containing information specific to that person or the information can also be stored on a remote server. This information typically includes data concerning the person's name, address, date of birth, height, weight, next of kin, name of general practitioner, and so on. Furthermore, the information includes the person's medical history, a listing of known allergies, current medication regime, past medication regime and so on. The data storage device 15 is read- writable, and can include devices such as the devices known as 'Smartcards', portable RAM devices. By temporary, the patient is "in-patient" in the hospital or is taking medication(s). The data storage device (patient card) 15 must be produced at every instance where a drug is to be dispensed, and such instances can arise in the course of a person visiting a baby health care 20 with a small child for the purpose of inoculations, attendance at a doctor's surgery 25 for an examination, a visit to a hospital 30 for in-patient or out-patient treatment, and a visit to a pharmacy 35 to have a prescription filled. It is also within the scope of embodiments of the invention for dispensing of a drug to occur at a person's home 40, particularly in the self-administration of over-the- counter drugs. Furthermore, a publicly accessible information booth 45 may be provided to allow any person to obtain information concerning current medication, prescribed drugs or self-prescribed drugs to avoid an ADE.

On any instance of dispensing of a drug, the data contained on the person's data storage device 15 is read, and that personal data checked against information concerning the drug to be dispensed to determine whether there may be a conflict that would lead to an adverse drug event. In the instance of a conflict occurring, a warning could be given to the medical service provider and/or the patient, and dispensing of that drug be inhibited. If the prescribed drug does not result in a conflict it can be dispensed, and updating information then is written to the patient card 15, in particular updating the current medication field information. The detailed description of each interaction between a patient and a medical service provider at different ones of the types of sites 20-45 will presently be given. Fig. 2 shows representative apparatus located at certain medical service provision sites, including a doctor's surgery, a hospital and a pharmacy. The apparatus comprises a conventional personal computer or a laptop computer 50 to which is connected a reader (and writer) 55 for reading data contained on the patient card 15 and a barcode scanner 80 for scanning the barcode on an in-patient's wristband and also for scanning the barcode on medications. The personal computer 50 also has a communications connection to the web, 60, by which information is received and transmitted for purposes that presently will be described. The personal computer 50 is provided with a suite of computer programs that put into effect the checking/screening and data reading/writing of the methodology of the present embodiment. Fig. 3 shows another form of apparatus that is a portable data processing device, such as the Palm Pilot, that includes a slot-type reader 70 for reading and writing to a patient card 15. The data processing device 65 also includes a data port 75 for the transmission and reception of data. The processing device 65 is purpose-configured for the data checking/screening operation in the same manner as is a personal computer 50 shown in Fig. 2. The data processing device 65 is suited to be carried by a patient, or for use by medical practitioners in making house calls, and also for use in mobile environments such as field hospitals, by paramedics or ambulance officers. Fig. 3 A shows another form of apparatus comprising a television set 67 with a reader 68. The remote 66 can be used with the displayed data on the television 67. Fig. 3B illustrates the use of a patch 72 on the chest of a patient 71 as a personal health device.

Fig. 4 is a schematic view of the communications arrangements between a host site 80 and a number of distributed medical service providing sites 85 The sites can be any one or more of the various site that were described with reference to Fig. 1, and can be distributed not only on a town or city basis, but throughout a country, or' throughout a number of countries. Each of the sites 85 has a communications link 90 with the world-wide-web 95, thereby having access to the host 80. The various sites also have access to ones of others of the sites by the network 95. In one embodiment, a single host 80 may be provided, although it is equally possible for there be other hosts 80', 80", all of which are in communication with each other and may jointly be in communication with the network 95 through a common gateway 100. The host 80 has the primary function of disseminating information to the distributed sites 851-n concerning new drugs and updating the drug information residing at each site. This update function occurs in advance of, or at least contemporaneously with, release of a new drug into the public arena. The host 80 also has the function of providing a bulletin board that can be accessed by any one of the distributed sites 85 by way of posting valuable information concerning topical matters or practical experiences to all other medical service providers. That bulletin board function also has provision for the dissemination of learned papers, much in the nature of conventional bulletin boards. Fig. 5 is a schematic diagram of the flow of information and any instance of interaction between a patient and a medical service provider. The information stored on the patient card 15 is represented as a database having communication, in this embodiment, through the agency of the card reader 55, to a distributed arrangement of databases residing on the personal computer 50. The core data base is the drug interaction database 150, to which is logical connected a number of auxiliary data bases, including the drug information data base 155 and the person-type data base 170.

The patient information includes the following fields: Field No. Field Type Data Type 0 Card ID number (encrypted)

1 name characters

2 address characters

3 weight number

4 height number 5 date of birth number

61 — 6n medical history (number) n

71 - 7n known allergies (number) n

81 - 8n current medication (ID, dosage, date) n

91 - 9n past medication (ID, dosage, date) n Much of the information is conveniently coded by number. As is apparent, each n medication record includes an identification number, dosage and date of prescription. The drag interaction database 150 includes the following fields: Field No. Field Type Data Type

1001 drag no. 1 (ID, generic name, trade name, (al lergies) (adverse reactants ID) 1002 drug no. 2 (ID, generic name, trade name, (allergies) (adverse reactants ID)

1003 drug no. 3 (ID, generic name, trade name, (allergies) (adverse reactants ID)

1004 drug no. 4 (ID, generic name, trade name, (allergies) (adverse reactants ID) ( -.. )

Each known drag is listed with a unique ID number, generic and trade names, allergies, and appended IDs for other known adverse reactant drugs.

The drag information database 155, as for the drag interaction database, has a listing for each individual drag, and further includes the following information:

Drag ID Generic name

Trade name

Half life

Pregnancy warning

Sports ratification Actions and indications

Adverse effects

Warnings/precautions, contraindications

Formulation

Strength UPC barcode (for Drag name, formulation and strength of formulation)

Dosage

Route of administration

Disease (medical history)

Risk Factors The person- type database 170 comprises standard pharmacological formulas for use in deriving prescribed drag dosage and periodicity, based on patient age, height, weight, and so on. It thus is not directly involved in the immediate choice of a drug to be prescribed, upon which the primary screening is performed.

For any instance of a drug being dispensed, there are a minimum number of steps (exchanges of information and processing) that must occur, as will be described with reference to Fig. 6. The parenthesized reference numerals refer to the sequential steps of the method.

The sequence commences with presentation of the patient card 15 (200) to the medical service provider who inserts the card into the reader 55. The patient card ID field then is read (202), and the validity check performed

(204). This check can be performed by reference to a register that may be distributed to all active sites 85, or by a direct enquiry of the host 80. If the card is determined to be valid, then the current medication field is read (206). A drug to be dispensed then is chosen (208), after which time a check is performed (210) to determine whether that drug will adversely interact with the current medication. This is achieved by accessing the drug interaction database 150 for the chosen drug and scanning through the list of adverse reactants for that drug ID. If there is no 'hit', processing continues, whereby the patient's known allergies are read (212) from the patient card and a subsequent check made for conflict with the same chosen drug (214). This check occurs by similarly accessing the drug interaction database 150 for the chosen drug and scanning through the lists of known allergic reactions.

If the outcome of the determination of there being an adverse interaction (210) was affirmative then a warning is displayed (216). If there is no adverse interaction, however an allergic reaction is identified, then again a warning is displayed. Following display of the warning, the medical service provider can proceed by choosing a different drug (208), or to prescribe the offending drug with full knowledge of its interactions. The patient's card has its current medication field updated (220). Fig. 7 shows a further flow diagram related to Fig. 6, that particularly relates to intermediate steps between the step of choosing the drug (208) and the check for adverse interactions (210). The drug information database 155 is accessed (230) so that some or all of the information provided therein is available to the medical practitioner in assessing whether to prescribe a particular drug. A decision is therefore made as to whether to proceed with that prescription (232), and if so the test for adverse interaction with current medication is performed (210) as before, otherwise the medical practitioner can choose a different drug (208). Fig. 8 is a flow diagram illustrating in greater detail the step (218) of drug dispensing. The example is specific to the conventionally understood situation of a drug being prescribed by a medical practitioner, in that a prescription is prepared and given to the patient. Conventionally this occurs by consultation of a drug schedule, such as the publication (Physicians Desk reference) PDR and by manual calculation. The steps are not limited only to the prescribing activities of a medical practitioner, as an analogous calculation is performed when a drug is physically dispensed to a patient by a pharmacist by way of a check of a prescription generated in the manner of Fig. 8, or generated by the conventional methodology. The patient's specific data, including weight, height and age, and relevant laboratory test results are read (240) 25 from that person's card, followed by accessing the person-type database 170 where the necessary mathematical formulas reside (244). The dosage is then calculated (246) for the chosen drug, followed by the prescribing of the period and route (248). The drug thus having been dispensed, the subsequent processing shown in Fig.

6 of updating the current patient treatment takes place. Although not shown, a step of physically printing a prescription also can occur.

Other embodiments of the invention now will be described, and specifically the logical interaction steps at various types of sites where a drug can be dispensed. In the first case, reference is made to a public user, in the form of a person/patient 10 making an enquiry at a public booth 45 as shown in Fig. 1. The steps performed are:

1. Start program (by inserting card) 2. Select function: Drug Information

3. Select Drug from list using trading name or generic name

4. Read information about drug

2a. Select function: Drug Interaction 3 a. From list, select first drug 4a. From list select second drug

5. Read Interaction information 2b. Select function: Medical Data 3b. Enter password

4b. Select function: Current drugs 5b. Add to Personal Current Drug list required drug from 'pop-up' list of drugs

6b. Observe interaction scanning results

Other general information enquiries are contemplated, including access to immunization schedules, personal vital statistics, test results (e.g. blood pressure, temperatures, etc) and growth charts. It is also possible for the same steps to be performed in conjunction with a pay TV service in place of the public booth 45. Conventional pay TV service providers include the necessary set-top readers (for the purposes of billing), which can be usually modified to incorporate the enquiries and drug interaction checking described above.

The steps performed by a doctor, say in that doctor's surgery, are:

1. Start program

2. Select function: Drug Information

3. Select Drug from list using trade name or generic name 4. Read infonnation about drug 2a. Select function: Drag Interaction 3 a. From list, select first drug 4a. From list, select second drag

5. Read Interaction information 2b. Select function: Patients Data

3b. Enter password

4b. Select/ Add patient from patient list

5b. Observe Patient current/past drag/allergy lists

6. Add drag to patient list by selecting drags 7. Select dosage, routes

8. Observe interaction, limitations, restrictions and special vital drag information and notes

9. Acknowledge final choice, drag is added to patient list of drags or omitted A doctor also has access to a large number of additional functions, including medical formulas (e.g. renal function calculation formulas, body mass index calculation formulas), often-used reference tables (e.g. percentile, charts) and the latest amendments to available drag information.

The steps performed in a pharmacist using the system include:

1. Start Dispensing program

2. Start dispensing

3. Enter drags or Enter and read from patient health personal memory unit patient current medications 4. List of medication is displayed on a screen

5. Scan the drag's barcode to correctly identify the drag, formulation and strength, which should match the prescribed medication, automatically selecting the drag if the match is positive

6. Observe screening process and read any information displayed on a screen 7. Acknowledge selection or act upon information

8. If acknowledgement is positive: dispensing part of program starts else go to 3

In a hospital setting, an important difference arises in that an in-patient will present their patient card 15 on admission, and at that time will be issued with a separate hospital card to be used internally in the hospital. The typical events that occur on admission are:

1. All in-patients are assigned a unique barcode to be worn on a wristband

2. When a patient is admitted to hospital either: a. A new hospital in-patient health personal memory unit (smartcard) is created, or b. Information from patient health personal memory unit (personal smartcard) is transferred to hospital in-patient health personal memory unit c. Patient's medical charts are contained on hospital network

3. The hospital patient health personal memory unit may totally replace current Patient Drug Order Data Sheet which can alternatively be kept on the hospital network

4 All patient test results, treatment details and drug management is kept either on the hospital network or on a hospital patient health personal memory unit

5 Information from hospital patient health personal memory unit can be transferred to hospital network

6 When patient is discharged, the discharge summary from hospital network, or the in-patient health personal memory unit (in-patient smartcard) is either: d. Transferred to patient health personal memory unit, or e. printed, or f. both

For the medical practitioner in the hospital, the following sequence of events occur:

1. During ward rounds, the patient health personal memory unit is inserted (e.g. laptop computer)

2. Patient hospital data is displayed on a screen

3. Doctors have the option to add a new drug, treatment or recall information about drugs

4. To add drug select drug from list 5. Screening process checks against current medications displaying interactions details

6. Enter drug administration details and acknowledge selection (Process of Entering drugs does not allow entry of wrong dosage or route)

7. Patient new data is written to hospital patient health personal memory unit and/or to hospital computer

The drug dispensing process by the hospital pharmacist is a continuation of the previous steps:

8. Hospital pharmacist with notebook dispensing computer visits ward

9. Inserts hospital patient health personal memory unit into computer

10. Starts dispensing process

11. Data is read from hospital in-patient health personal memory unit and displayed on a screen

12. Screening starts automatically and any interaction/administration information are displayed on screen

13. After acknowledgement Dispensing process is finished. Pharmacists returning to pharmacy load data to pharmacy computer for physical drug dispatch to ward 14. Alternatively the prescription is transmitted via the hospital network directly to the hospital pharmacy where the dispensing process described above can occur

Drug administration by the nursing staff is a continuation of the previous steps with the added routine of barcode scanning of the patient and the medications to be administered:

15. Nurse is notified about drug administration on nurse computer when data is loaded from hospital patient health personal memory unit after ward round is finished

16. Nurse correctly identifies patient by reading the barcode on patient's wristband

17. Nurse correctly identifies drug to be dispensed by scanning its barcode which should match the drug, formulation and strength that has already been prescribed

18. Nurse enters hospital patient health personal memory unit to acknowledge drug dispensing to patient (time and initial are entered)

19. Administer drug to patient according to directions on the screen advising of dosage and route Though the invention has been described with respect to a specific preferred embodiment, many variations and modifications (including equivalents) will become apparent to those skilled in the art upon reading the present application. It is therefore the intention that the appended claims and their equivalents be interpreted as broadly as possible in view of the prior art to include all such variations and modifications.

Claims

CLAIMS I claim:

1. A method for predicting a possible adverse drug events, comprising: at a data processing device, receiving an indication that a drug is to be dispensed to a person; reading data contained on an electronic data storage device for the person, the electronic data storage device being independent from the data processing device, the electronic data storage device being normally in the possession of the person, and the electronic data storage device comprising at least a first data regarding a health information of the person; checking for a conflict between a first data regarding the drug to be dispensed to the person, and data regarding a drug information or a patient information stored on the data storage device; and if there is no conflict, then the data of the electronic data storage device is updated with information concerning the drug dispensed; if there is a conflict, then an alert is generated.

2. The method of claim one wherein the electronic data storage device is password protected.