Abstract:
A device for providing drug verification may work in conjunction with drug delivery devices such as medical pumps to provide a chemical and concentration analysis of drugs being delivered forming a signature that can be compared to a signature associated with the proper drug, reducing errors in medicine delivery and ensuring proper use of medicines throughout their lifecycle.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. provisional application 62/280,999 filed Jan. 20, 2016 and hereby incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates to medical systems that may monitor and manage patients and patient treatment, and in particular to a system for confirming proper medicine type and medicine formulation contemporaneous with the delivery of that medicine to the patient. 
         [0003]    The delivery of medicines, for example, in a hospital or other healthcare setting, is an important yet challenging part of healthcare management. It is essential not only that the correct medicines be delivered to the proper patients but also that a particular formulation of the medicine, for example, the medicine concentration, be correct. 
         [0004]    Some medicines, such as painkillers, may be subject to misuse and accordingly their formulation and delivery must be monitored with particular care. Normally, such monitoring involves careful recording of the dispensing of the medicine, for example, from a central pharmacy and properly labeling the medicine containers so dispensed. Yet after the dispensing of the medicine, there can be a substantial delay before the medicine is delivered to the patient raising opportunities for mix-up, loss or diversion of the medicine. To address these latter problems, normally the attending healthcare professional, for example, a nurse at bedside, is relied upon to confirm that the proper medicine and proper medicine concentration is being delivered to the proper patient. This endpoint confirmation may be ineffective in cases where the medicine was incorrectly labeled or identified when delivered to the pharmacy or where the label on the dispensing container has been altered or is an error, or where the contents of the medicine container have been manipulated after dispensing, or where the healthcare professional deliberately or mistakenly authorizes the incorrect medicine or medicine concentration. 
         [0005]    Ideally medicines might be tested immediately before delivery to the patient, however, the equipment and techniques necessary to accurately analyze and uniquely characterize medicines in such settings would be prohibitively expensive. 
       SUMMARY OF THE INVENTION 
       [0006]    The present inventors have recognized that the goal of reducing medication errors can be largely met by characterizing the medicines according to “signatures” that uniquely characterize their chemical content or formulation. Such signatures can be readily generated at the point-of-delivery by compact automated sensor systems such as Raman spectrometers. Although the medicine cannot be directly identified in the sense of a complete chemical analysis, the characterization provided by the signature operates effectively to deter or detect medication errors. 
         [0007]    Accordingly, one embodiment of the present invention provides a system for automatic verification of medicine type and/or concentration contemporaneous with the delivery of the medicine to the patient. In one embodiment, a medicine signature sensor is incorporated into the medical pump delivering the medicine to the patient so that real time medicine type and formulation information can be verified. In an alternative embodiment, a similar medicine signature sensor is provided in a freestanding appliance shared among spatially proximate delivery pumps to provide contemporaneous verification. 
         [0008]    In both cases, by independently assessing the medicine characteristics at the latest possible moment before delivery to the patient, the present invention address a wide range of tampering or other errors that can occur during and after dispensing of the medicine but before delivery to the patient. By taking advantage of a central medical database indicating the type of drug intended to be delivered to the patient, an automated medicine signature sensor becomes practical, needing only to distinguish between specific categories of drugs and formulations rather than providing a full chemical analysis. A trade-off between false positive error detection and comprehensive elimination of errors can be flexibly implemented. 
         [0009]    Specifically, in one embodiment, the invention provides a point-of-delivery drug verification apparatus having a sensor system adapted to analyze a drug in a package for delivery to a patient to establish a measured drug signature dependent on the formulation of the drug. The drug verification apparatus also has an input for receiving a nominal identity of the drug in the package linked to the package. The measured drug signature is a function of chemical formulation of the drug. An electronic computer executes a stored program to: (1) receive the nominal identity of the drug to determine a correct drug signature associated with the drug and to compare the correct drug signature with the measured drug signature: and (2) provide an output indicating if the correct drug signature differs from the measured drug signature by a predetermined amount. 
         [0010]    It is thus a feature of at least one embodiment of the invention to provide a point-of-delivery auditing of medication addressing a variety of possible sources of medication error. 
         [0011]    It is also a feature of at least one embodiment of the mention to provide the benefits point-of-delivery auditing using achievable current technology recognizing that successful auditing need not require a comprehensive chemical analysis. 
         [0012]    The point-of-delivery drug verification apparatus may further include a scale for measuring a weight of the drug and the measured signature and correct signature may include weight components. 
         [0013]    It is thus a feature of at least one embodiment of the invention provide a signature that reflects drug concentration. 
         [0014]    The correct ding signature and measured drug signature may he a function of both chemical formulation and concentration of the drug. 
         [0015]    It is thus a feature of at least one embodiment of the invention to provide an, auditing both as to the chemical formulation of the medicine but also its amount (possibly a combination of concentration and weight) to detect not only medication type errors but also dosage or diversion issues. 
         [0016]    The sensor may be a spectrometer. 
         [0017]    It is thus a feature of at least one embodiment of the invention to provide sophisticated chemical analysis of a contain drug amenable to non-contact measurements, for example, through an IV tube. 
         [0018]    The spectrometer may be selected from the group consisting of: Raman spectrometers, surface enhanced Raman spectrometers, nuclear magnetic resonance spectrometers, and optical spectrometers. 
         [0019]    It is thus a feature of at least one embodiment of the invention to take advantage of current sophisticated sensor technology in improving healthcare delivery. 
         [0020]    The point-of-delivery drug Verification apparatus may further include a medical pump for delivery of the drug to the patient and communicating with the computer, and the output may control the medical pump to prevent delivery of drug to the patient when an alert is output. 
         [0021]    It is thus a feature of at least one embodiment of the invention to provide close cooperation between delivery drug auditing and drug delivery pumps to better react immediately to possible medication errors. 
         [0022]    The sensor system may receive an IV line passing through the medical pump to conduct the drug to the patient. 
         [0023]    It is thus a feature coat least one embodiment of the invention to integrate the sensor system into currently employed medical pumps to leverage existing pump technology for auditing drug use. 
         [0024]    The sensor system may employ a specially treated IV line having an inner surface interacting with the drug. 
         [0025]    It is thus a feature of at least one embodiment of the invention to provide sophisticated analysis of delivered medicines while preserving sterility through the use of disposable IV lines having sensing treatment, for example, to provide surface enhanced Ramen spectroscopy, chemical reactants, or the like. 
         [0026]    The sensor system may associate the package with a measured drug signature and the electronic computer may use the measured drug signature associated with the package for comparison to the correct drug signature. 
         [0027]    It is thus a feature of at least one embodiment of the invention to permit use of a separate shared appliance that assesses measured drug signatures that are then linked to packages provided to medical pumps performing the final comparison step. 
         [0028]    The association of the package with the measured drug signature may write the measured drug signature to a label on the package. 
         [0029]    It is thus a feature of at least one embodiment of the invention to provide a simple method of communicating audit results from a separate shared appliance to individual pumps making use of drug type reading systems contemplated for such pumps. 
         [0030]    The association of the package with a measured drug signature may include a timestamp and the computer may further control the medical pump to prevent delivery of drug to the patient when the timestamp has expired before initiation of the delivery. 
         [0031]    It is thus a feature of at least one embodiment of the invention to reduce the risk of tampering when there is a transfer of drugs between the sensor system and the pump at the point-of-delivery, The timestamp may be a relatively short time necessary for the transfer process. 
         [0032]    The point-of-delivery drug verification apparatus may further include a network circuit for communicating with a remote electronic medical record system identifying a patient, prescribed drug, and prescription expiration for the prescribed drug, and the correct drug signature may be determined from the remote electronic medical record system. 
         [0033]    It is thus a feature of at least one embodiment of the invention to provide a central server for drug signatures allowing a wide variety of different types of drugs to be audited. 
         [0034]    The remote electronic medical record system may communicate the prescription expiration for the prescribed drug in this information may be used by the medical pump to prevent delivery of drug to the patient when the prescription expiration has passed. 
         [0035]    It is thus a feature of at, least one embodiment of the invention to further audit medicine delivery with respect to timeliness. 
         [0036]    The electronic computer may communicate through the network circuit with the remote electronic medical record system to provide the identity of the patient to obtain information providing the correct drug signature. 
         [0037]    It is thus a feature of at least one embodiment of the invention to provide a simple index structure for obtaining correct drug signature information. 
         [0038]    The output may be provided through the communication circuit to the remote electronic medical record system for recordation in the electronic medical record system 
         [0039]    It is thus a feature of at least one embodiment of the invention to provide an audit record of medicine delivery tied to point-of-delivery analysis of the medicine. 
         [0040]    The point-of-delivery drug verification apparatus may further include input for identifying an operator of the delivery drug verification apparatus allowing the output to be used to confirm a destruction of the drug by the operator recorded in the electronic medical record. 
         [0041]    It is thus a feature of at least one embodiment of the invention to provide an auditing mechanism for end-of-life destruction of medicines by designated individuals. 
         [0042]    It should be understood that the invention is not limited in its application to the details of construction and arrangements of the components set forth herein. The invention is capable of other embodiments and of being practiced or carried out in various ways. Variations and modifications of the foregoing are within the scope of the present invention. It also being understood that the invention disclosed and defined herein extends to all alternative combinations of two or more of the individual features mentioned or evident from the text and/or drawings. All of these different combinations constitute various alternative aspects of the present invention. The embodiments described herein explain the best modes known for practicing the invention and will enable others skilled in the art to utilize the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0043]      FIG. 1  is a simplified representation of the hospital environment showing a medical pump and a medicine verification appliance receiving information from a central medical records system holding an electronic medical record file; 
           [0044]      FIG. 2  is a block diagram of the functional components of the medical pump of  FIG. 1  according to one embodiment of the invention in which the medical pump provides real-time medicine signature analysis; 
           [0045]      FIG. 3  is a perspective view of a second embodiment of the medicine verification appliance shared among medical pumps for providing contemporaneous medicine signature analysis; 
           [0046]      FIG. 4  is a simplified cross-sectional view of the appliance of  FIG. 3  showing principle functional components of this appliance; 
           [0047]      FIG. 5  is a flowchart of the steps of operation of the device of  FIGS. 2, 3 and 4  in implementing the present invention to provide patient-specific alerts; and 
           [0048]      FIG. 6  is a diagram of a signature space showing regions allowing distinctions between drug types and formulations using a multidimensional signature. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0049]    Referring now to  FIG. 1 , medical pump  10  may be positioned adjacent to a patient  12  for delivering medicine to a patient. The medical pump  10 , as depicted, may be a peristaltic infusion pump or a syringe pump or other similar device for the delivery of medicine to the patient under computerized control. 
         [0050]    Each given medical pump  10  may communicate with databases of a central medical record system  14  in the healthcare facility or an external medical database  17  (for example, managed by a third-party) via the internet  19 . This communication may be by a variety of means including electrical or optical cables or, as shown, wireless communication, or a combination of both. 
         [0051]    The central medical record system  14  may, for example, provide a medical record server  16  communicating via wireless transceiver  18  with the medical pumps  10  and by a standard network circuit or the like with multiple data terminals  20  that may be staffed by healthcare personnel. The healthcare personnel may enter or access patient medical information and read alerts and monitor operation of the medical pumps  10  or the like. 
         [0052]    The medical record server  16  may communicate with an electronic medical database  22  holding patient medical records linked to patient identification numbers. As a general matter, medical database  22  will link a patient identifier uniquely identifying a patient with various clinical information about the patient including; weight, height, gender, age, disease, therapy, allergies and the like. 
         [0053]    The medical record server  16  may also communicate with a drug database  23  with information regarding “pharmacy orders” for specific drugs for particular patients. In the case of treating the patient by the introduction of a liquid medicament, for example, using a medical pump  10 , the drug database  23  may hold data indicating types of drugs (e.g., their chemical identity), their formulation (e.g., concentration or delivery medium), and their preferred delivery rates in rate and total quantity as a function of particular static predicate data (such as patient gender or weight) and real-time predicate data such as blood pressure, glucose level and the like. Some or all of this information may also be obtained to the external medical database  17   
         [0054]    The drug database  23  or external medical database  17  may also hold signature characteristics of the drugs being measurable parameters of the drug that reflect the drug type and formulation. As will be discussed further below, the signature characteristics of the drug will be a function of the drug chemical composition, concentration and amount but do not necessarily provide unique identification of those qualities but rather represent a simplified set of data points suitable for auditing. 
         [0055]    Generally the drug database  23  is linked to the electronic medical database  22  to receive pharmacy orders, for example, from physicians and linked to a pharmacy system allowing a pharmacist or other dispenser to receive the pharmacy orders to fill them and to mark them as dispensed. The drug database  23  may provide for inventory control as is generally understood in the art. It will be appreciated that the drug database  23  alternatively may be incorporated into the electronic medical database  22 . 
         [0056]    The medical database  22 , the drug database  23 , and the external medical database  17  serve to provide a logical electronic medical record  25 , for example providing a logical row for each patient associated with patient information (patient ID, name, weight, height, gender, age, disease, therapy, allergies and the like), medicine delivery orders, order expiration dates (prescription expiration dates), chemical, concentration, and amount signatures for the medicines to be delivered, and audit logs of release of the drugs from the pharmacy, the delivery of the drugs to the patient or the destruction of those drugs. 
         [0057]    Infusion pumps that may communicate with centralized databases suitable for use with the present invention are described in U.S. Pat. Nos. 8,652,093, 8,945,043 and 8,469,933, all hereby incorporated by reference. Syringe pumps suitable for use with the present invention are described in co-pending patent application Ser. No. 13/659,619 filed Oct. 24, 2012, and entitled: “Syringe Pump with Improved Flow Monitoring” hereby incorporated in its entirety by reference. 
         [0058]    Referring still to  FIG. 1 , the wireless transceiver  18 , in one embodiment, may also communicate with a freestanding medicine verification appliance  15 , for example, so that the medicine verification appliance  15  may wirelessly exchange data with the drug database  23  and the central electronic medical database  22  in the same manner as the medical pumps  10 . The medicine verification appliance  15  may be positioned so as to be shared among nearby medical pumps  10  and/or to be proximate to a medicine repository  30  either being a dispenser of drugs or a storage area for drugs that have been dispensed. Ideally the medicine verification appliance  15  is close enough to the patients  12  that medicine can be verified immediately before administration. Alternatively or in addition, the medicine verification appliance  15  may be positioned near a secured disposal container  29  so that the medicine verification appliance may be used to verify proper disposal of unused or expired medicines by authorized individuals. 
         [0059]    Referring now to  FIG. 2 , the medical pumps  10  may generally include a processor  24  communicating with a memory  26 , the latter holding a program  28  providing an operating system for the medical pump  10  and specific executable programs for medicine verification as will be described below. The memory  26  may also hold data structures  31  used by the program  28  as will be described below. 
         [0060]    The processor  24  may communicate via various I/O lines  32  which also allow the processor  24  to control or monitor different components of the medical pump  10  including an interface  34  to local patient monitors  35 . Such patient monitors may include, for example, sensors measuring blood oxygen, blood pressure, pulse rate, respiration, ECG and patient temperature and may be used to provide for improved automatic control of the medicine being delivered by the medical pump  10  including, for example, painkillers, antibiotics, chemotherapy, anesthesia agents and the like. 
         [0061]    The processor  24  may also communicate with a data entry keypad  36 , for example, a membrane switch array, allowing data to be entered by medical personnel  38  associated with a particular task to be executed by the medical pump  10 . The data entry keypad  36  may be associated with an output screen (such as an LCD alphanumeric display) for facilitating the data entry and review and for providing output to medical personnel  38 . A more advanced touch screen may be used for inputting and displaying information. The data entry keypad  36 , for example, may be used to enter patient identification information, medicine information, and medicine delivery rate or volume, in the case of a medical pump. 
         [0062]    The processor  24  may further communicate with a context sensor  42  which may provide important contextual information about the environment of the medical pump  10 . Context sensor  42  may, for example, be an RFID tag reader for reading labels  39  on medicine containers  37 , for example, as held in an IV bag or syringe or held in a wristband  44  on the patient  12  (shown in  FIG. 1 ). Alternatively, the context sensor  40  may be a barcode reader, for example, for scanning a barcode label  39  on the medicine containers and wristband  44  on a patient  12  (shown in  FIG. 1 ), or the IV bag or syringe medicine containers  37  or the like. The wristband  44  may provide for a patient identification number that may be used to index one or both of the medical database  22  and drug database  23  (or the electronic medical record  25 ). 
         [0063]    The labels  39  on the medicine containers  37  may include nominal medicine type and concentration or other formulation details of the drug in the container  37  and may further include an intended date of delivery and patient identifier identifying the patient to receive the drug. In some embodiments, the labels  39  may indicate a measured signature of the drug obtained from the separate medicine verification appliance  15 . It will be understood that the labels  39  need not actually contain the described information but may alternatively provide an index to the drug database  23  or medical database  22  (or the electronic medical record  25 ) as discussed above so that this information may be retrieved wirelessly. When the labels  39  contain the actual information or link to that information through a separate database, the packages are effectively associated with the data printed on or linked to the label. 
         [0064]    The processor  24  may also communicate with a wireless transceiver  45 , for example, a ZigBee, Wi-Fi, Bluetooth, Near Field Communication (NFC) or 3G device suitable for communicating with the other medical pumps  10  and/or the wireless transceiver  18  of the medical record server  16 . The wireless transceiver  45  may also be used to communicate with the patient monitors  35 . 
         [0065]    Referring still to  FIG. 2 , the medical pump  10  may include a pump section  50 , for example, for an IV pump, the pump section  50  providing a channel to receive an IV line  54  therethrough. Positioned across the channel  52  may be one or more sensors  56 , for example, for detecting fluid pressure, bubbles, and the presence or absence of the IV line  54  itself. These sensors may communicate with the processor  24  which may control a pump actuator element  58 , for example, being a peristaltic pump mechanism, that may pump liquid through the IV line  54  by a series of progressive compressions of the IV line  54  in the manner of peristalsis. 
         [0066]    Significantly, positioned across the channel  52  may be a medicine signature detector  60  that can evaluate the medicine type and composition of the medicine. In one embodiment, the medicine signature detector  60  may be a compact Raman Spectrometer relying on Raman scattering of a laser projected through the IV line  54  to a corresponding sensor. The IV line  54  may provide a specially prepared window for the purpose of allowing the transmission of the necessary light. Compact Raman spectrometers suitable for this purpose are commercially available through a number of vendors including, for example, Ocean Optics under the tradename of IDRaman mini handheld Raman spectrometer. 
         [0067]    Alternatively, the medicine signature detector  60  may make use of a variety of other sensor technologies including but not limited to: surface enhanced Raman spectroscopy using a treated IV line  54 , nuclear magnetic resonance, optical absorption spectroscopy, or other sensing systems. These systems may be used alone or in various combinations. When surface enhanced RAM and spectroscopy is used, the IV line  54  may be specially treated, for example, to provide a drug contacting rough metal surface or nano structure such as plasmonic-magnetic silica nanotubes to enhance the sensitivity of the spectroscope. Other reagents and reactants can be coated on the inner surface of the IV line  54 , for example, for the purpose of optical spectroscopic measurements. Generally, the measurements contemplated by the present invention can be performed without breaching the sterile envelope defined by the IV line  54  or the drug container possibly through the use of special windows are optical sections therein. 
         [0068]    Generally the medicine signature detector  60  will provide quantitative outputs that permit the development of a multivariable signature related to the medicine type and compounding (concentration, etc.) derived directly from the medicine in the IV line  54 . The signatures may, for example, be numeric vectors and will be used to reduce the risk of improper medicine types or wrong concentration of medicine are being delivered to the patient as will be discussed below. In the example of the spectroscope, the signature may be a multipoint spectrum together with a drug package net weight value. 
         [0069]    Referring now to  FIGS. 3 and 4 , in an alternative embodiment the medicine signature detector  60  may be shared among multiple, proximate medical pumps  10  by using a freestanding medicine verification appliance  15  holding the medicine signature detector  60 . This approach reduces the cost of medicine analysis and verification. Generally, in this case, the appliance  15  may provide for entry ports  62  or  62 ′ operating respectively to receive different types of medicine containers  37 , for example, with port  62  receiving IV bags  37   a  and port  62  receiving preloaded medicine syringes  37   b  within respective analysis chambers  64 . 
         [0070]    The medicine verification appliance  15  may include a processor  68  holding a stored program  28  and data files  31  to implement the verification process as previously discussed with respect to the embodiment of  FIG. 2 . This program  28  operates comparably for both of these embodiments and therefore will be described solely with respect to the medicine verification appliance  15 . 
         [0071]    Within the chamber  64 , a reader  71 , for example, an RFID reader or barcode reader or the like, may view a label  39  on the container  37  indicating the medicine type, concentration and patient identification along with other possible information including medicine delivery parameters such as flow rate and total volume. in the medical pumps  10  this may be accomplished by a handheld reader or by near field communication with an RFID tag or the like. 
         [0072]    Referring also to  FIG. 5 , this information may be relayed to the processor  68  as indicated by process block  70 . 
         [0073]    As indicated by process block  72 , parameters of the contained medicine in the container  37   a  may then be measured to develop a medicine signature. Principally, the signature will be obtained using the medicine signature detector  60  as has been discussed above which may, for example, transmit a laser through the container walls of container  37   a  to measure the medicine properties including typing concentration. The container  37  may be received on a scale  66  providing a weight to a processor  68  such as may form another component of a signature of the medicine within the container  37 . 
         [0074]    Referring momentarily to  FIG. 6 , the signature (“measured drug signature”) will provide a data point  76  generally within an N-dimensional signature space  77  which may include dimensions of weight, Raman spectral peaks and the like. As noted before, Raman spectroscopy may be associated with other sensing techniques described above to include additional dimensions to the signature space  77 . 
         [0075]    Returning to  FIG. 5 , information from process block  70  and  72  may then be reviewed at process block  74  against the data obtained from the medical database  22  and drug database  23  (based on the information from process block  70 ) indicating generally the type and formulation of a medicine to be delivered to the particular patient. 
         [0076]    Referring to  FIG. 6 , this information from the medical database  22  and drug database  23  may be used to identify a signature profile  78  (“correct drug signature”) stored in the medical pump  10  or medicine verification appliance  15 , or the signature profile  78  may be returned from the drug database  23  to the medical pump  10  or medicine verification appliance  15 . The medicine signature profiles  78  also indicate a range within the signature space  77  in which data point  76  must lie in order to verify that the medicine to be delivered to the patient is the same as that indicated in the medical record databases  22  and drug database  23 , this latter information derived, for example, from the physicians order or empirically determined and associated with a particular drug. 
         [0077]    At decision block  80 , if the data point  76  does not lie within the indicated range of a given signature profile  78 , an alarm sequence of process block  82  may be entered. This alarm sequence may, for example, provide real time messages to appropriate individuals wirelessly to alert them of an error and/or may provide an alert to the healthcare practitioner  38  attending the patient using the medical pump  10  or medicine verification appliance  15  to provide an alerting tone or message. Manual override by the healthcare practitioner  38  may be possible through the entry of information identifying the healthcare professional which will be recorded for independent review. The alert will eventually be logged into a report and the electronic medical record  25  to provide an audit trail as indicated by process block  90  to be discussed below. 
         [0078]    It will be appreciated that the identification provided by the data point  76  need not provide a comprehensive or unique signature for each given medicine and formulation but in fact there can be signature profiles  78 ′ for different drugs that overlap another signature profile  78 . This may be readily accommodated with knowledge of the intended medicine and its formulation that is obtained from the electronic medical database  22  or drug database  23  thereby preventing the need to identify medicines and concentrations in isolation. Generally it is necessary only that the signature profiles  78  distinguish among medicines and variations and formulations likely to be confused or to result from tampering. The evaluation of different drugs may also make use of different dimensions of the signature space  77  based on their distinguishing capabilities of those dimensions. It is desirable that the signature space  77  include dimensions that are sensitive not only to medicine type but also medicine concentration so as to be able to detect dilutions and the like as well as total drug amount to detect diversions. For the medical pump  50  of  FIG. 2 , total drug amount may be determined by a tally of pump volume (determined from the geometric qualities of the IV tube  54  and the operation of the peristaltic pump  58 ) or a scale may be built into the IV bag hanger using load cell technology or the like. 
         [0079]    The matching of decision block  80  may also look for negative signature values associated with negative signature profiles  78 ″ indicating, for example, adulteration or contamination of the medicine, such as common dilutions or the like. In this way the output may indicate not only incorrect medicines but also distinguish among different types of medicine error. 
         [0080]    Referring to  FIG. 5 , if at decision block  80  the data point  76  lies within the indicated range of a signature profile  78 , then the proper medicine type and formulation has been established and the medicine may be “marked” for use as indicated by process block  83 . In the case of the pump  10  of  FIG. 2 , this marking may be virtual and applied to the container  37  connected to the IV pump  10  so long as that container  37  or its IV line  54  is not removed indicated by the line sensor or a loss of communication with the label  39  in the case of the near field reader. 
         [0081]    In the case of the embodiment of  FIG. 4 , the marking may be physical by means of a label printer  84  which may print and apply an adhesive label  85  to the container  37  while the container  37  is in the chamber  64  or is data linked to, for example, serial number marked on the drug container and serving as an index to this data stored for example in the electronic medical record  25 . The label  85  providing the data or serial number may be a tamper-resistant label as implemented either physically through the use of adhesives on the physical label  85  or may be made virtually tamper-resistant by encoding within a barcode or other optical code of the physical label  85  an encrypted form of information on the label  39  so that when the bag is moved to the pump  10 , label  39  and the label  89  applied by the label printer  84  must match in order for the pump  10  to operate without an alarm. The information on the label  89  may be such as to prevent ready counterfeiting of that label, for example, by providing information that is not readily readable by a human and which incorporates information of the label  39 , for example, using public-key encryption. It will also be appreciated that the label  89  may be an RFID tag label or may encode information in an RFID tag associated with label  39 . Marking such as a fluorescent dye may be placed on the label  39  indicating that the drug container  37  has been used in the marking process to prevent reuse. This can be also accomplished through recording of information from the label  39  in the drug database  23 . 
         [0082]    Once the labeling process is complete, then at process block  90 , information regarding the assessment of the medicine and its delivery may be provided to the remote electronic medical database  22  and drug database  23 . 
         [0083]    Generally the label  85  or similar information recorded in the medical database  22  and drug database  23  with respect to the label  85  will include a date and time stamp so that the medicine must be delivered to the patient  12  within a predetermined time or else the verification process would need to be repeated. This time may be extremely short for the embodiment of  FIG. 2  since the verification may be done on a concurrent or continuous basis and may be as short as five minutes to 30 minutes for the medicine verification appliance  15  of  FIG. 1 . This delay may be logged in the medical database  22  and drug database  23  and may provide real-time alerts to individuals. 
         [0084]    Referring now to  FIGS. 1 and 3 , the medicine verification appliance  15  may also be used for an end-of-life audit mechanism for disposal of drugs for example in a secured container  29 . In this case, authorized individuals may identify themselves using the keypad  36  associated with the appliance  15  indicating that the drug is to be discarded. The drug identity is then confirmed using the sensor system  60  of the appliance  15  linked to for example a serial number on the drug package  37   a.  The appliance  15  may then compare the measured drug signature to a correct drug signature obtained from the database  25  (or this comparison can be performed elsewhere) and provides a label  85  attached to the drug container indicating that the drug is not for use and will be discarded. The authorized individual may then place the drug in the tamperproof secured container  29  providing an end-of-life verification of proper drug disposal by qualified individuals. This disposal is then recorded in the electronic medical record  25 . 
         [0085]    Certain terminology is used herein for purposes of reference only, and thus is not intended to be limiting. For example, terms such as “upper”, “lower”, “above”, and “below” refer to directions in the drawings to which reference is made. Terms such as “front”, “back”, “rear”, “bottom” and “side”, describe the orientation of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first”, “second” and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context. 
         [0086]    When introducing elements or features of the present disclosure and the exemplary embodiments, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of such elements or features. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements or features other than those specifically noted. It is further to be understood that the method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed. 
         [0087]    References to “a microprocessor” and “a processor” or “the microprocessor” and “the processor,” can be understood to include one or more microprocessors that can communicate in a stand-alone and/or a distributed environment(s), and can thus be configured to communicate via wired or wireless communications with other processors, where such one or more processor can be configured to operate on one or more processor-controlled devices that can be similar or different devices. Furthermore, references to memory, unless otherwise specified, can include one or more processor-readable and accessible memory elements and/or components that can be internal to the processor-controlled device, external to the processor-controlled device, and can be accessed via a wired or wireless network. 
         [0088]    It is specifically intended that the present invention not be limited to the embodiments and illustrations contained herein and the claims should be understood to include modified forms of those embodiments including portions of the embodiments and combinations of elements of different embodiments as come within the scope of the following claims. All of the publications described herein, including patents and non-patent publications, are hereby incorporated herein by reference in their entireties.