Patent Document

BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention is directed to medication dispensing apparatus and methods of operating such apparatus. 
     2. Description of the Background 
     A wide variety of apparatus are used in healthcare facilities for the dispensing and inventory of medications and medical supplies. For example, U.S. Pat. No. 5,520,450 discloses a supply station with an internal computer. The supply station is comprised of a cabinet having a plurality of lockable doors. Information is provided to a computer which unlocks the doors. The computer may be used to simultaneously and automatically update a patient&#39;s record, billing information and hospital inventory. The relevant data may be displayed on a display or printed on a sheet of paper by a printer connected to the computer. Other examples of computer controlled dispensing apparatus are found in U.S. Pat. Nos. 5,346,297, 5,905,653 and 5,745,366. 
     Such computer controlled dispensing apparatus have been developed in response to a number of problems existing in hospitals and other healthcare institutions. More particularly, computer controlled dispensing apparatus are operated according to programming that addresses problems such as the removal of medications by unauthorized personnel, dispensing the wrong medication for a patient, inaccurate record keeping, to name a few. 
     The AcuDose-Rx dispensing cabinet available from McKesson Automation Inc. of Pittsburgh, Pa. is an example of a computer controlled cabinet programmed to address the aforementioned problems. The user must first logon to the computer (thereby identifying who is removing medications). The user then identifies a patient and is presented with a list a medications that has been approved for administering to the identified patient (thereby addressing the problem of incorrect dispensing). Records are kept for each dispensing event thereby creating an audit trail. 
     To ensure the safe and accurate dispensing and administration of medications, a pharmacist reviews each prescription or medication order against that patient&#39;s medication profile and other relevant patient information to identify such items as therapeutic duplication in the patient&#39;s medication regimen; appropriateness of the drug, dose, frequency, and route of administration; medication allergies or sensitivities; potentially significant drug-drug, drug-food, drug-lab, and drug-disease interactions; contraindications to use; any organizational criteria for use; and other relevant medication-related issues or concerns. If a question or concern arises, the pharmacist contacts the person who prescribed the medication. 
     Many computer controlled dispensing apparatus have a “medication order profile interface” system that requires that all new medication orders for patients be entered into a pharmacy information system, where they are checked as discussed above. After the pharmacy information system completes the necessary clinical checks, data must be transmitted to the dispensing apparatus before the nurse is free to access the medication in the dispensing apparatus. That is done to ensure that medications are not dispensed and subsequently administered without a prior review by a pharmacist. 
     Problems can arise, however, when a pharmacist is not available to provide the necessary review. In many institutions, pharmacists are not available around the clock, although patients may be admitted at any time. Additionally, an emergency may arise or a doctor may write a STAT order. Under such circumstances, when a healthcare provider, typically a nurse, must retrieve medication from the dispensing apparatus, the patient may not be recognized by the dispensing apparatus, or the desired medication may not yet be approved for the patient. As a result, to enable a dispense to occur, the nurse must exit the normal dispensing routine by entering an override mode, emergency mode, or the like. Unfortunately, in such alternative modes, control is lost over why the dispensing operation is needed, for whom, and the like. That loss of control and information has been recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In its proposed medication use standards, JCAHO provides that when a pharmacist is not on the premises, nurses can administer any medication needed for the patient without a pharmacist&#39;s prior review if the healthcare institution has developed an alternative system for medication order review that minimizes the impact of skipping the pharmacist&#39;s review prior to administration. At a minimum, that must include the following: a retrospective review of the medication orders by the pharmacist as soon as a pharmacist is available; a review of the medication order by a qualified healthcare professional prior to administration of the medication for appropriateness against a database of information (e.g., drug interaction reference and drug profile); and an ongoing analysis and monitoring of the process for the incidence of medication errors as compared to the incidence of medication errors when the pharmacy is open. The need exists for a medication dispensing apparatus that facilitates dispensing events in a controlled, traceable manner in situations where a dispensing event is requested for medication not approved for a patient. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a method, preferably practiced on a computer controlled dispensing apparatus, comprising: accessing (normally by logging on) the dispensing apparatus; identifying a patient; identifying a medication to dispense for the identified patient, the medication not having been reviewed against the patient&#39;s medication profile; prompting the user to identify an exception; and either permitting access to the dispensing apparatus&#39; storage compartment(s) for the purpose of dispensing the medication or storing the request to dispense in response to the identified exception. The method may further include transferring the plurality of override requests and override events into a database of pharmacy orders. The requests, events, and orders may be sorted according to a predetermined criterion, and presented to a pharmacist for review. 
     The present invention prevents dispensing medication when the medication has not been approved for the patient and no acceptable reason exists for not waiting until a pharmacist can make the necessary review. If an acceptable reason exists for dispensing before the necessary review by a pharmacist has taken place, the present invention provides documentation and an audit trail of the reasons for the dispensing event. With electronic collection and distribution of dispensing events or requests for a dispensing event, efficiencies and cost savings are enabled. Further, that information can be sent to centralized 24/7 pharmacies that provide after-hours services to small and rural healthcare institutions that are not staffed in off hours, thereby insuring compliance even with reduced hours and staff. Those advantages and benefits, and others, will be apparent from the description below. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     For the present invention to be easily understood and readily practiced, the present invention will now be described, for purposes of illustration and not limitation, in conjunction with the following figures, wherein: 
     FIG. 1 is a diagram illustrating the relationship between a centralized storage location and, among other things, a plurality of storage locations; 
     FIG. 2 is one example of apparatus located at a decentralized location implementing a closed system for performing dispensing operations; 
     FIG. 3 is a flow chart illustrating a method according to the present invention; 
     FIG. 4 is an exemplary screen illustrating one way of prompting a user for information; and 
     FIG. 5 is a flow chart illustrating another method according to the present invention. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1 is a diagram illustrating the relationship between a centralized storage location  10  and various inventory destinations, including a plurality of decentralized storage locations  12 - 1 ,  12 - 2  through  12 -n, patients  13 , and a remote facility  14 . Each of the decentralized storage locations  12 - 1  through  12 -n is capable of dispensing items stored at the location. The items may include medications, controlled medical supplies, medical supplies or items of a nature consistent with the facility in which the system illustrated in FIG. 1 is located. Items may be dispensed directly from centralized storage location  10  to patients  13 , or from the centralized storage location  10  to a remote facility  14 . Data typically flows from the decentralized storage locations  12 - 1  through  12 -n to the centralized storage location  10 . In response to that data, items are typically moved from the central storage location  10  to the decentralized storage locations  12 - 1  through  12 -n or to the remote facility  14  to restock such locations to either replenish dispensed items or to stock new items. Decentralized locations could include satellite pharmacies, computerized medication cabinets, stationary/mobile medication carts, nurse servers, remote hospital pharmacies, supply closets, supply cabinets, etc. Supplies can be reordered from distributors based on levels of stock in the centralized storage location  10 . 
     FIG. 2 illustrates one example of an apparatus that may be located at any of the decentralized locations  12 - 1  through  12 -n. The apparatus illustrated in FIG. 3 is comprised of an AcuDose-Rx™ cabinet  26  and an AcuDose-Rx™ auxiliary cabinet  28  available from McKesson Automation Inc. A supply tower  30  is also illustrated. A control computer  32  controls the operation of the cabinet  26 , auxiliary cabinet  28 , and supply tower  30 . The control computer  32  is also in communication with a central database (not shown). The reader will understand that the present invention is not limited to the AcuDose-Rx™ cabinet  26 , but rather the method of the present invention may be implemented on any type of computer controlled dispensing apparatus. 
     Turning now to FIG. 3, a flow chart illustrating a method according to the present invention is illustrated. To perform a dispensing operation a user logs onto the control computer  32  at step  36 . In that manner, the computer receives information identifying the user. The user information is compared to stored information at step  38 . At step  40  a patient is identified. The information could be entered on a keypad, either by name or by an ID number, the information could be scanned, selected from a pick list, or any other known method of entering the patient information. In that manner, the computer receives information identifying the patient. 
     At step  42  a medication profile for the patient is displayed. The display may include all of the medications which have been approved by a pharmacist for administration to the patient. For a normal dispensing event, not shown in detail but represented by the box  43 , the user then selects from the displayed medications. However, if the medication has been ordered on a STAT or emergency basis, it may not be displayed at step  42 . The user then selects at step  44  an override mode. The use of the phrase “override mode” is not intended to limit the present invention. In the vernacular of the AcuDose cabinet, when a user wishes to select a medication not in the patient&#39;s medication profile, the override mode is enabled. Sometimes a patient has not yet been admitted on the system, thus requiring creation of a patient record prior to proceeding. In those cases, the user is taken directly to the list of medications available for dispensing. Other cabinet manufacturers may use other terminology. The concept is that the user wishes to select a medication for dispensing which is not on the patient&#39;s medication profile or, in other words, the user wishes to dispense a medication prior to review by a pharmacist or other qualified healthcare provider, regardless of whether that is referred to as an override mode, an emergency mode, or any other phrase specific to a particular manufacturer. 
     At step  46 , the control computer  32  displays a list of medications available for dispensing. The list could include all of the medications in the various cabinets, auxiliary cabinets, supply towers and the like under the control of the control computer  32 , or some set of that list for which the particular user has authority to dispense. At step  48 , the user selects the desired medication or medications. Selection could be via a touch screen, entry through a keypad, or any other known method of entering information for enabling the selection. In that manner, the control computer receives information identifying a medication to dispense. At step  50  the user is prompted to enter information. The information being entered may be variously described as an “exception” to the general rule that a medication cannot be dispensed unless the order has been reviewed by a pharmacist or the “reasons” why the dispense is necessary. There are two recognized exceptions for when an nurse can dispense prior to a pharmacists review, e.g. in the override mode. The first is a situation in which a physician or other qualified healthcare provider controls the ordering, dispensing and administration of the medication, such as in an operating room, endoscopy suite, or an emergency room. The second exception is for those emergencies when there is not sufficient time to obtain the necessary review. Those include STAT orders or those orders where the clinical status of the patient would be significantly compromised by the delay that would result from waiting for a pharmacist&#39;s review. Not all first orders meet these criteria. 
     An example of an exemplary screen  60  used to prompt the user to provide the required information is illustrated in FIG.  4 . In FIG. 4, two exceptions acceptable to an organization such as JCAHO are illustrated: physician controlled dispensing  62  and STAT order  64 . The curser may be placed in the appropriate box and a keystroke entered. However, the information may be input in any known way such as selecting a reason or exception from a pick list, or the like. The exceptions or reasons shown to the user may be hard coded by the manufacturer, soft coded to allow the user to create the text, or customizable hard code, where the user selects which exceptions from among numerous exceptions will be displayed, or any other known manner. 
     In addition to a listing of various exceptions a text box  66  may be provided. The text box may be used to record textual information which the nurse wishes to add to the record. In an alternative embodiment, the textbox may be used in place of a list. In that embodiment, the text in the text box is subjected to character recognition followed by a search for keywords to determine if the exception or reason for the dispense is adequate. A reason for dispensing each medication selected at step  48  must be provided at step  50 . 
     At step  52 , an evaluation is made to determine if the reasons input at step  50  are sufficient. For example, if one of the reasons is an exception recognized by a committee such as JCAHO, and the box  62 ,  64  next to that reason has been selected, then the process continues at step  54  where the “override” event is stored and a dispensing event takes place at step  58 . It should be recognized that the analysis performed at step  52  will depend to a large degree on the type of information input at step  50 . For example, if at step  50  the user&#39;s only options are to choose amongst acceptable exceptions, then perhaps the only analysis that needs to be performed at step  52  is whether one of the exceptions has been selected. If, however, at step  50  the user is prompted to select from a list of numerous exceptions, some of which are acceptable and some of which are not, it may be necessary at step  52  to determine if an acceptable exception has been selected. In yet another embodiment, where all that is provided is a text box, at step  52  it may be necessary to perform character recognition, and then perform an analysis upon the recognized characters to determine if the proper keywords or phrases have been used for a recognized exception. The present invention is not to be limited by the manner in which the user is prompted to input reasons at step  50  and the manner in which those reasons are evaluated at step  52 . 
     It should also be noted that code may be provided for disabling steps  50  and  52 . For example, in a hospital or other healthcare institution in which procedures are already in place to properly document dispenses in an “override” mode, the institution may choose to disable steps  50  and  52  and proceed directly to storage of the override event  54  and dispensing at step  58  as soon as the user selects the medications at step  48 . 
     Assuming that the reasons were acceptable at step  52 , as noted the override event is stored at step  54 . Thereafter, a dispensing event occurs at step  58  and the process returns to step  56 . If the reasons were unacceptable at step  52 , the override request is stored at step  60  and the process continues with step  56 . 
     After an override request has been stored at step  60 , or a dispensing event has occurred at step  58 , one important aspect from the healthcare institution&#39;s perspective is to have a pharmacist review either the override request or the override event as soon as possible. That may be implemented in at least two ways. First, the records of the override requests and override events may be printed, for example, at a pharmacy computer, or if an electronic pharmacy system is available, the records of the override requests and override events may be forwarded to the pharmacy system, as will be described in greater detail in conjunction with FIG.  5 . 
     In FIG. 5, a flow chart illustrating another method according to the present invention is illustrated. In FIG. 5, records for each override request stored at step  60  in FIG. 3, and records of each override event stored at step  54  in FIG. 3, are monitored at step  68 . A decision is made at step  70  if a pharmacy workstation exists. If there is no pharmacy workstation, then the override requests and override events are printed at step  72 , preferably in a pharmacy, so that they may be reviewed by a pharmacist as soon as practicable. If there is a pharmacy workstation, then the records representative of the override requests and override events are added to the workstation queue at step  74 . 
     The workstation queue may be created, in the first instance, by commercially available products such as the Pyxis Connect product available from Pyxis Corporation or the MedDirect product available from McKesson Automation, Inc. as represented by block  76 . The MedDirect product is an automated system for communicating medication orders and for managing documents. Using imaging technology, the MedDirect product delivers clear, scanned medication order images directly to the hospital pharmacy, where they can be viewed simultaneously with the pharmacy information system. Once the order is reviewed and approved by a pharmacist, it is entered in the pharmacy information system and made available for profile dispensing by, for example, the AcuDose cabinet  26  (FIG.  2 ). At step  74 , certain logic or rules may be applied to the queue to sort or reorder the queue. For example, records representative of override events may be placed at the front of the queue. 
     At step  78 , the user selects a record from the queue to review. At step  80 , a user, typically a pharmacist, will review the override events and/or approve override requests. The pharmacist may optionally input orders into a pharmacy information system. At step  82 , the override requests and override events are archived for later review by a decision support system or the like as represented by step  84 . 
     A hospital may received a type I recommendation from an organization such as JCAHO because nurses are accessing medication dispensing apparatus for first doses of medication. Implementation of the present invention provides a hospital with evidence that policy and procedures are being adhered to, as well as providing an audit trail of all override activities associated with computer-controlled medication dispensing apparatus. 
     Having the present invention integrated into computer-controlled medication dispensing apparatus provides an electronic transfer of the information immediately, or based on a time delay, to a location where a pharmacist is available, thus creating efficiencies and cost savings. With electronic collection and distribution of the override information, that information can be sent to centralized 24/7 pharmacies that provide after-hours services to small and rural healthcare institutions that are not staffed in off hours, thereby insuring compliance even with reduced hours and staff. Electronic communications systems can be attached, such as cell phones, beepers, and e-mail to provide notification to pharmacists of the need to address override events and/or requests. More sophisticated wireless PDAs (personal digital assistants) can actually be connected to such systems, alerting pharmacists of the need to address override events and/or requests, allowing them to review the collected information, and providing approval transactions from remote locations. 
     Patient safety is ultimately enhanced when a computer-controlled medication dispensing apparatus incorporates the present invention so as to aid caregivers during overrides. Providing the means of enforcing and auditing hospital policy and procedures directly contributes to overall patient safety in compliance with JCAHO recommendations. 
     While the present invention has been described in conjunction with preferred embodiments thereof, those of ordinary skill in the art will recognize that many modifications and variations may be implemented while still falling within the scope of the present invention. Other types of dispensing devices and process steps may be substituted for those described in the preferred embodiment while remaining within the scope of the present invention. The description of presently preferred embodiments is not intended to limit the scope of the present invention, which is defined by the following claims.

Technology Category: 3