Drug interaction checking tool, method for checking drug interactions, and non-transitory machine-readable recording medium containing machine-readable instructions for causing a system core to perform the method

Abstract

The present invention is a drug interaction checking tool for use without a medication order or CPOE, comprising: an interface subsystem for receiving messages from a medical information technology system having information about a patient, such as the patient's allergies, medications the patient is currently taking, patient factors and comorbidities; the interface subsystem further receives messages from a distributed pharmacy system having information about retrieved medications, clinicians, and patients; a data repository subsystem for storing the received data, such as the patient's allergies, administered, prescribed, or currently used medications, patient factors and comorbidities, retrieved medications, and clinician identity; a guidance engine subsystem for accessing a drug interaction database and performing a drug interaction check on the patient and generating an alert if a risk of medical error or adverse reaction is identified; and a notification subsystem for delivering the alert to one or more devices / systems. [Selected Figure] Figure 1

Description

[Background technology]

[0001] The Coordinating Council for Medical Error Reporting and Prevention defines a medical error (ME) as "any preventable phenomenon that, while under the control of a healthcare professional, patient, or consumer, causes or may result in the improper use of a medicine or harm to a patient." Therefore, an ME can occur due to a mistake at any stage in the drug handling process, and defines an adverse drug event (ADE) as "an injury resulting from a medical procedure related to a medicine."

[0002] Although ADEs are often the result of ME, not all ADEs are associated with ME. ADEs can be further divided into categories, including preventable versus non-preventable, remediable versus non-remediable, and potential versus actual.

[0003] ME occurs significantly more frequently than ADE. Both are associated with significant patient morbidity, mortality, and costs. For example, in the United States, it is estimated that hospital patients experience 1 ME per day, and 1 in 20 hospital patients experience an ADE. ME is also estimated to contribute to 7,000 deaths per year and cost the healthcare system $21 billion annually.

[0004] An important step in minimizing ME is to check the medication against the patient, known patient allergies, other medications the patient is currently taking or prescribed, and the patient's comorbidities and / or contraindications before administering the medication.

[0005] Technology offers a significant opportunity to mitigate MEs and ADEs in an era of high patient acuity, complex workflows, and increasing clinician burnout. Electronic medication orders present one opportunity to perform basic safety checks on each prescribed medication. Typically, physicians create medication orders using a CPOE (or Computerized Physician Order Entry) system. CPOE systems can utilize the patient's allergies, other prescribed / administered medications, and several of the patient's comorbidities / factors that may contraindicate the medication the physician intends to prescribe. CPOE systems perform this check automatically, providing the physician the opportunity to review the results before electronically signing the order. After reviewing these results, the physician can decide to remove the order and prescribe a different medication or proceed with the originally intended medication, weighing the benefits and risks.

[0006] CPOE is precluded in certain clinical workflows, such as medication administration in most procedural settings (e.g., operating rooms, cardiac catheterization laboratories, etc.). Here, CPOE systems are considered unable to keep up with complex clinical workflows. The immediate presence of a physician and / or advanced practice provider is also interpreted as mitigating the need to use CPOE. However, a recent study showed that 1 in 20 medication administrations in the operating rooms of a large teaching hospital were associated with MEs, and 1 in 20 patients undergoing surgery. Patient emergencies in any clinical setting where time is considered critical (e.g., ICU, PACU, emergency room, floor) also often preclude CPOE use. The prevalence of verbal orders and clinician fatigue may further reduce CPOE effectiveness.

[0007] Barcode medication administration (BCMA) systems present a second opportunity to mitigate ME / ADE, but a recent Leapfrog / Castlight Health survey found that approximately two-thirds of all responding hospitals did not meet the Leapfrog National Standard for BCMA use due to poor integration with electronic health records and a lack of decision support tools.

[0008] While technologies such as Computerized Physician Order Entry (CPOE) and Bar Code Medication Administration (BCMA) systems have proven useful in multiple hospital workflows, these technologies fall short in more complex clinical workflows (e.g., in the operating room or during patient emergencies).

[0009] To minimize MEs, the safety provided by both CPOE and BCMA must be augmented to meet the needs of today's complex clinical workflow. At its core, where time is of the essence, a solution must be fast enough to keep up with the medication administration process to be effective. It must also minimize nuisance alerts and cognitive overload, function across existing data silos, and seamlessly integrate into clinical workflows. Summary of the Invention [Means for solving the problem]

[0010] The present invention relates to a drug interaction checking tool for use without a medication order or CPOE. The drug interaction checking tool includes an interface subsystem for receiving messages from a medical information technology system having information about a patient, such as the patient's allergies, other medications the patient is currently taking, other medications administered or prescribed to the patient, patient factors and comorbidities, the interface subsystem further receiving messages from a distributed pharmacy system having information about the retrieved medication, the clinician who retrieved the medication, and the patient for whom the medication is intended, a data repository subsystem for storing the received data, such as the patient's allergies, the administered, prescribed, or currently used medications, patient factors and comorbidities, the medications retrieved for the patient, and the identity of the clinician who retrieved the medication, a guidance engine subsystem for accessing a drug interaction database, performing a drug interaction check for the patient, and generating an alert if a risk of medical error or adverse reaction is identified, and a notification subsystem for delivering the alert to one or more devices / systems, such as a clinician's mobile device (e.g., a smart watch), a clinician's wearable device, a dashboard screen, a point-of-care subsystem, a paging system, a messaging system, etc.

[0011] These and other features and advantages of the present invention will become apparent to those skilled in the art to which the present invention pertains from a reading of the following description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is an overview of the present invention and other systems with which it interacts. [Figure 2] FIG. 2 is a diagram of the subsystems of the present invention showing interactions between the subsystems of the present invention and between the subsystems of the present invention and other systems external to the present invention. [Figure 3]FIG. 3 is a sequence diagram showing the sequence of interactions between a clinician end user and the present invention / other systems, as well as the sequence of interactions between the present invention and other systems external to the present invention as described in Example 1. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present invention fills a gap left unmet by systems such as CPOE and BCMA to meet the needs of complex clinical workflows, providing a significant opportunity to mitigate medical errors and adverse drug events in an era of high patient acuity, resulting in complex workflows and increasing clinician burnout.

[0014] The present invention relates to a medication administration process (or method) and tool (or system), which is particularly applicable to medications administered without a medication order. The systems and methods of the present invention are effective for identified patients regardless of location and can support any distributed pharmacy station. User interaction (e.g., notification alerts) may be via any number of mobile devices, including wearable devices, such as, but not limited to, tablets, smartphones, and / or smart watches.

[0015] As shown in FIG. 1 , the method of the present invention involves identifying the medication intended for administration as early as possible, quickly checking it for allergies, other medications, contraindications and / or comorbidities, and other patient factors, and notifying the clinician as early as possible before the clinician has an opportunity to administer the medication via (clinical decision support) notifications sent to the clinician's personal mobile devices and wearables, and / or other appropriate point-of-care (POC) subsystems where the correct patient may be, and sending guidance to a dashboard to support the notification.

[0016] As shown in Figures 1 and 2, the present invention includes an interface subsystem 010, such as that described in co-pending U.S. patent application Ser. No. 16 / 238,187, filed January 2, 2019, the disclosure of which is incorporated herein by reference, to receive messages from a medical information technology system 001 containing information about a patient, such as the patient's allergies, medications the patient is currently taking, other medications administered or prescribed to the patient, patient factors, and comorbidities. This interface subsystem 010 also receives messages from a distributed pharmacy station 003 containing information about the medication retrieved, the clinician who retrieved the medication, and the patient for whom the medication is intended. A data repository subsystem 011 stores the received data, such as the patient's allergies, other medications, medications retrieved for the patient, and the identity of the clinician who retrieved the medication. Using access to a drug interaction database 004, a guidance engine subsystem 012 performs drug interaction checks for the patient and generates alerts if a risk of medical error or adverse reaction is identified. The notification subsystem 012 delivers the alert to one or more devices / systems 005, 006, 007, 008, such as a clinician's mobile device (e.g., smartphone, tablet, etc.), a clinician's webvalve device (e.g., smartwatch, etc.), a dashboard screen, a paging system, a messaging system, a point-of-care subsystem 006, etc.

[0017] In the system and method of the present invention, the system receives patient information, such as allergies, other medications, patient factors, and comorbidities, from a medical information technology system 001, such as an electronic health record (EHR) or personal health record (PHR) system. Additionally, a clinician can capture a barcode scan of a patient's wristband using the point-of-care subsystem 006 of the present invention. Because the point-of-care subsystem 006 of the present invention is pre-configured at a fixed location (e.g., operating room 5), the present invention can associate the patient with that location. The clinician identifies themselves by logging into the distributed pharmacy station 003. The clinician identifies the patient for whom the medication is intended and the specific medication retrieved. The clinician retrieves one or more medications from the distributed pharmacy station 003. The system of the present invention receives a transaction for each retrieved medication. Using a drug interaction database 004, the system automatically performs the following checks: a) Drug-allergy interactions by checking the retrieved medication (and its drug class) against the patient's allergies received from the health information technology system. b) Drug interactions by matching the retrieved medication (and its medication class) with medications the patient is currently taking, as received from the health information technology system, and other medications (and medication classes) the patient has been administered or prescribed. c) Drug-patient interactions by checking the retrieved medication (and its medication class) with patient factors (e.g., pregnancy) and comorbidities received from the health information technology system.

[0018] This process immediately notifies the clinician who retrieves the medication of any risk of adverse reactions to medication obtained from a decentralized pharmacy station and sends a message directly to the clinician as soon as possible, regardless of the clinician's physical location. To achieve this speed, the present invention sends notifications / alerts to the clinician's mobile and / or wearable devices (e.g., smartwatches).

[0019] The process can send a notification to the point of care 006. A display device located at the point of care can alert anyone at the point of care to a risk of medical error or adverse reaction to a medication obtained from the decentralized pharmacy station 003. The process can send a notification to a supervising physician. The process can send a notification to a dashboard screen 007 indicating that a risk of medical error or adverse reaction to a medication obtained from the decentralized pharmacy station 003 has been identified. Once the barcode on the patient's wristband is scanned and the patient and point of care location are associated, the dashboard 007 displays the patient's location from which the medication was retrieved.

[0020] Below are examples of unordered drug interaction checking tools. Although they are described in the context of an anesthesiologist, they can be applied to any clinician with the authority to dispense unordered medications. [Example]

[0021] A patient undergoing surgery has a cephalosporin allergy. The system of the present invention receives patient information from a medical information technology system within a hospital. The patient's medical history of cephalosporin allergy is received and stored by the present invention. The anesthesiologist will be in the operating room with the patient during the procedure, and the patient will require antibiotics during this stage of the procedure.

[0022] The anesthesiologist returns to the distributed pharmacy station 003 in the operating room and identifies himself within the system. The anesthesiologist identifies the patient for whom the medication is to be administered. The anesthesiologist selects to retrieve the antibiotic cefazolin. The distributed pharmacy station 003 dispenses the cefazolin medication. The distributed pharmacy system 003 sends a message to the system core 002 of the present invention containing the following details: -Transaction timestamp -Identity of the clinician who retrieved the medication -Identity of the patient from whom the drug was removed -Medication taken for the patient (cefazolin in this example)

[0023] In this type of clinical workflow, receipt of such a message from distributed pharmacy system 003 is the earliest opportunity for the present invention to know that the anesthesiologist intends to administer the cefazolin antibiotic. Receipt of the message from distributed pharmacy system 003 triggers the present invention to perform a series of medication checks against previously received patient information.

[0024] When a drug-allergy check is performed, the drug interaction database 004 identifies the risk of adverse drug reactions when administering cefazolin due to a known interaction with the patient's cephalosporin allergy. The system core 002, i.e., the drug interaction check tool, generates an alert and immediately notifies the anesthesiologist of the risk of adverse drug reactions due to a drug-allergy interaction between the retrieved cefazolin antibiotic and the patient's recorded cephalosporin allergy. A notification is sent to the anesthesiologist's smartwatch or smartphone, maximizing the likelihood that the alert notification will be seen before administering the drug. Upon receiving the notification, the anesthesiologist, based on their education and knowledge, can decide whether to select a different antibiotic or proceed with administering cefazolin as originally planned, weighing the risks and benefits. [Example]

[0025] As a further example, a patient undergoing surgery has a history of malignant hyperthermia. The system core 002 of the present invention receives patient information from a hospital's medical information technology system 001. The patient's history of malignant hyperthermia is received and stored by the system of the present invention.

[0026] When a patient enters the operating room, a certified registered nurse anesthetist barcode scans the patient wristband into the point-of-care subsystem 006 of the present invention. The system core 002 of the present invention associates the patient with the pre-specified location of the point-of-care subsystem 006 where the patient wristband was scanned.

[0027] During surgery, the anesthesiologist is not in the operating room with the patient, but rather oversees multiple operating rooms with certified registered nurse anesthetists physically present at each point of care.

[0028] The anesthesiologist uses a decentralized pharmacy station 003 located in the hallway outside the operating room to identify himself or herself in the system, identify the patient for whom the medication is intended, and select to retrieve the muscle relaxant succinylcholine. The decentralized pharmacy station 003 dispenses the succinylcholine medication. The decentralized pharmacy system sends a message to the system of the present invention containing the following details: -Transaction timestamp -Identity of the clinician who retrieved the medication -Identity of the patient from whom the drug was removed -The medication retrieved for the patient (in this case, succinylcholine)

[0029] Upon receiving such a message from the distributed pharmacy system 003, the system core 002 of the present invention is activated to perform a series of drug checks against the previously received patient information. The drug-disease check identifies the risk of side effects when succinylcholine is administered to a patient with a history of malignant hyperthermia according to the drug interaction database 004.

[0030] The present invention generates an alert to immediately notify the anesthesiologist of the risk of a drug-disease interaction adverse event between the administered succinylcholine muscle relaxant and the patient's documented history of malignant hyperthermia. The alert is sent to the anesthesiologist's smartwatch to maximize the likelihood of seeing the alert notification before administering the medication. Additionally, the system core of the present invention sends a notification to the point-of-care devices / systems and mobile devices of certified registered nurse anesthetists in the operating room to notify them of the adverse event risk, and sends a notification alert to the Dashboard 007 screen located on the operating room control desk to notify other healthcare providers of the patient's risk of a drug-disease adverse event in the operating room.

[0031] Upon receiving notification, the anesthesiologist makes a medical decision based on their knowledge and experience on how to proceed. The present invention provides a method for reviewing medications retrieved from a distributed pharmacy system against patient details obtained from a health information system such as an EHR or PHR 001, utilizing a drug interaction database 004 to query known risks associated with allergies, other medications, re-administration, disease, and patient factors, and providing rapid clinical decision support recommendations based on this comparison. The present invention provides a mechanism for evaluating data received from any number of sources within a global network and for communicating the necessary information to the appropriate individual(s) regardless of their current location and appropriate point of care.

[0032] As shown in Figure 3, the system of the present invention allows a reviewer to see and understand the relationships and sequences between subsystems, as well as the interactions of the present invention with external practitioners and subsystems, and how they are utilized for analysis and notification as described above. Figure 3 illustrates the value of the present invention in performing analysis and notification in a timely manner, and its importance in managing drug interaction issues prior to delivery in time-sensitive situations.

[0033] The foregoing embodiments of the present invention have been presented for purposes of illustration and description. These descriptions and embodiments are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously, many modifications and variations are possible in light of the above disclosure. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, thereby enabling others skilled in the art to best utilize the invention in its various embodiments, and with various modifications as appropriate to the particular uses contemplated.

Claims

1. configured to receive, from a medical information technology system, a first message having information regarding a plurality of patients, including information corresponding to allergies associated with a particular patient, information regarding medications currently being taken by the patient for each of the patients, information regarding medications prescribed to the patient for each of the patients, and information regarding patient factors and comorbidities corresponding to the patient for each of the patients; an interface subsystem further configured to receive a second message from the distributed pharmacy system having information corresponding to the retrieved medication, an identification of the clinician who retrieved the medication, and an identification of the patient for whom the medication is to be administered; a data repository subsystem configured to store the first message and the second message received by the interface subsystem as data; a guidance engine subsystem that performs a drug interaction check for the patient based on the stored first message and the stored second message and generates an alert if a risk of medical error or adverse reaction is identified; a notification subsystem that delivers the alert to devices associated with the identified clinician treating the patient corresponding to the alert and the clinician who retrieved the medication identified based on the stored second message; Includes a drug interaction checking tool.

2. Further comprising a point-of-care subsystem, 10. The drug interaction checking tool of claim 1, wherein one of the patients is identified by a barcode scan of a wristband worn by the patient, and the point-of-care subsystem associates the patient with the location where the scan occurred.

3. 1. A method for checking for drug interactions, comprising: receiving, storing, and processing information about the patient at a system core, the information including information about one of an electronic health record or a personal health record database and a medication dispensing transaction associated with the pharmacy station; verifying, by the system core, information regarding the medication dispensing transaction based on received and stored information regarding allergies, prescribed or currently used medications, patient factors and comorbidities associated with the patient, and the identity of a first clinician associated with the medication dispensing transaction; generating, by the system core, an alert when information regarding the medication dispensing transaction and information regarding allergies associated with the patient, medications prescribed to the patient, or medications currently being taken by the patient indicates a risk of medical error or adverse reaction; providing, by the system core, an alert to a wearable device associated with the first clinician and a second clinician associated with the patient.

4. 1. A non-transitory machine-readable storage medium containing machine-readable instructions for causing a system core to perform a method, the method comprising: receiving and processing, at the system core, information about the patient, the information including first information about the patient's allergies, prescribed or currently used medications, patient factors and co-morbidities of the patient, and second information about a medication dispensing transaction in which a medication is dispensed from a pharmacy station, the second information including an identity of a first clinician associated with the medication dispensing transaction; determining, by the system core, guidance regarding a drug interaction check for the patient based on the first information and the second information; generating a warning if the guidance suggests a risk of medical error or adverse reaction; providing, by the system core, an alert to a mobile device associated with the first clinician and a second clinician associated with the patient identified based on the second information.

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