Devices, system and method to control the delivery of oral medications to ensure they are efficacious, taken as prescribed, and to avoid unwanted side effects

Abstract

The present invention describes a novel system, drug delivery device, mobile App, drug specific drug dispensing algorithm, and method to improve medication safety and effectiveness via the utilization of drug specific algorithms to control drug dispensing, avoid drug mediated adverse events, ensure prescription persistence and promote prescription compliance on a cost-effective real-time basis.

1 - 93 . (canceled) 
     
     
         94 . A drug dispensing system, comprising:
 (i) hardware comprising:   (a) an interface device having a computer processor and memory storing computer code to execute a drug specific app with a plurality of modules wherein the interface device has internet communication capability and is selected from the group consisting of a smart phone, a computer, or a tablet computer wherein the smart phone, the computer or the tablet computer are in communication with a separate drug dispenser device, or wherein the interface device is a standalone tamper-resistant drug dispenser device having a computer processor and memory storing computer code to execute the drug specific app with a plurality of modules, and   (b) at least one digital data capture device and/or at least one RFID drug chip;   wherein the drug specific app is assigned to a specific patient;   (ii) a biometric authentication module to authenticate the patient and to ensure digitally captured data is from the patient;   (iii) a prescription module comprising a prescription for the patient;   (iv) an application program interface (API) (a) between the separate drug dispenser device and the smart phone, the computer or the tablet computer to link the drug dispenser device to the drug specific app, or (b) in the standalone drug dispenser device to link it to the drug specific app;   (v) one or more APIs between (a) the interface device and one or more digital data capture devices, and/or (b) the interface device and one or more RFID drug chips;   (vi) a drug specific dispensing algorithm module; and   (vii) an interface device database module, comprising digitally-captured or patient-entered patient values, drug information, and dispensing-related information;   wherein the system utilizes information selected from the group consisting of prescription information, drug information, drug dispenser device information, patient self-assessment information, digitally captured physiological, psychological, lifestyle information, information of medications administered to the patient, environmental data information, and combinations thereof,   wherein the system captures such information before, during or after each drug dispensing and which is utilized by the drug specific diagnostic algorithm to decide if the separate or standalone drug dispenser device should dispense the drug or preclude dispensing and stay locked even in circumstances when the prescribed dose would have otherwise been allowed by the prescription, thereby preventing dose-mediated adverse events; and   wherein the drug specific diagnostic algorithm further utilizes symptom data obtained from the patient regarding the patient's symptoms and, based on the symptom data, decides if the separate or standalone drug dispenser device should dispense the drug or preclude dispensing and stay locked even in circumstances when the prescribed dose would have otherwise been allowed by the prescription, thereby preventing dose-mediated adverse events.   
     
     
         95 . The drug dispensing system according to  claim 94 , wherein the symptoms analyzed by the drug specific diagnostic algorithm are selected from the group consisting of pupil size, level of pain, stool and bowel movement information, respiratory rate, blood oxygen saturation, pulse, heart rhythm, blood pressure, gait, muscle spasms, and skin temperature. 
     
     
         96 . The drug dispensing system according to  claim 94 , wherein the drug dispenser comprises an opioid. 
     
     
         97 . The drug dispensing system according to  claim 94 , wherein the drug specific dispensing algorithm automatically handshakes with the separate or standalone drug dispenser device and the one or more digital capture devices. 
     
     
         98 . The drug dispensing system according to  claim 94 , wherein the drug specific dispensing algorithm downloads data captured by the one or more digital capture devices to the interface device. 
     
     
         99 . The drug dispensing system according to  claim 94 , wherein the app checks a serial number of the separate or standalone drug dispenser device to ensure it is authorized to interface with the app. 
     
     
         100 . The drug dispensing system according to  claim 94 , wherein the app checks the expiration date of the drug. 
     
     
         101 . The drug dispensing system according to  claim 94 , wherein the app checks the storage temperature history to ensure the drug has been stored within a specific temperature range. 
     
     
         102 . The drug dispensing system according to  claim 94 , wherein the app checks the storage humidity history to ensure the drug has been stored within an authorized humidity range. 
     
     
         103 . The drug dispensing system according to  claim 94 , wherein the app retrieves drug information from the separate or standalone drug dispenser device. 
     
     
         104 . The drug dispensing system according to  claim 94 , wherein the app is designed to receive alerts of unauthorized attempts to open the separate or standalone drug dispenser device. 
     
     
         105 . The drug dispensing system according to  claim 94 , wherein the app stores a drug's prescription and dosing schedule. 
     
     
         106 . The drug dispensing system according to  claim 94 , wherein the app reminds the patient to take his/her medication and after a specific period of time alerts the integrated support center and/or authorized care givers that the patient has not taken his/her medication. 
     
     
         107 . The drug dispensing system according to  claim 94 , wherein the app is designed to automatically handshake with the patient's digital diagnostic, monitoring and/or tracking devices. 
     
     
         108 . The drug dispensing system according to  claim 94 , wherein the app presents drug specific patient self-assessment and/or data input screen(s). 
     
     
         109 . The drug dispensing system according to  claim 94 , wherein the app maintains a database of patient responses captured by self-assessment and/or data input screen(s) and digitally captured values. 
     
     
         110 . The drug dispensing system according to  claim 94 , wherein the interface device is a smart phone. 
     
     
         111 . The drug dispensing system according to  claim 94 , wherein the app allows the patient to click on a screen to automatically call the integrated support center. 
     
     
         112 . The drug dispensing system according to  claim 94 , wherein the app records all unsuccessful attempts to dispense a dose earlier than prescribed. 
     
     
         113 . The drug dispensing system according to  claim 94 , wherein the app has reporting routines that allow the patient to request certain reports created using the patient self-assessment, digital captured information, drug dispenser information, and/or dosing information to ascertain if the drug is efficacious for the patient and the effect that dosing has on the patient's condition and/or symptoms. 
     
     
         114 . The drug dispensing system according to  claim 94 , wherein the app effectuates a handshake with the integrated support center's computers. 
     
     
         115 . The drug dispensing system according to  claim 94 , wherein the app downloads the patient's drug related dispensing information, comprising drug dispenser, patient self-assessment, or digitally captured information into the patient's records in the integrated support center's database. 
     
     
         116 . The drug dispensing system according to  claim 94 , wherein the app allows the patient to request specific drug related information stored in the app. 
     
     
         117 . The drug dispensing system according to  claim 94 , wherein the app allows the patient to request specific reports or information stored on the integrated support center's servers. 
     
     
         118 . The drug dispensing system according to  claim 94 , wherein the app allows the patient to correct responses entered in prior screens before dispensing the medication. 
     
     
         119 . The drug dispensing system according to  claim 94 , wherein the app contains a copy of or enables access to a patient app and drug dispenser operations training and troubleshooting manual. 
     
     
         120 . The drug dispensing system according to  claim 94 , wherein the app further comprises a GPS module to record the patient's location to ascertain where the patient is when the medication is dispensed. 
     
     
         121 . The drug dispensing system according to  claim 94 , wherein the drug dispenser device comprises an integrated drug cassette or a replaceable drug cassette. 
     
     
         122 . The drug dispensing system according to  claim 98 , wherein the drug specific dispensing algorithm prompts the patient self-assessment module to ask the patient one or more questions about his/her condition. 
     
     
         123 . The drug dispensing system according to  claim 94 , wherein the drug dispenser device further comprises a replaceable drug cassette and wherein the app further comprises a security system to limit the ability to change the replaceable drug cassette to an authorized medical professional. 
     
     
         124 . A method of treating a patient having a condition or disease utilizing a drug dispensing system, comprising:
 (i) hardware comprising:   (a) an interface device having a computer processor and memory storing computer code to execute a drug specific app with a plurality of modules wherein the interface device has internet communication capability and is selected from the group consisting of a smart phone, a computer, or a tablet computer wherein the smart phone, the computer or the tablet computer are in communication with a separate drug dispenser device, or wherein the interface device is a standalone tamper-resistant drug dispenser device having a computer processor and memory storing computer code to execute the drug specific app with a plurality of modules, and   (b) at least one digital data capture device and/or at least one RFID drug chip;   wherein the drug specific app is assigned to a specific patient;   (ii) a biometric authentication module to authenticate the patient and to ensure digitally captured data is from the patient;   (iii) a prescription module comprising a prescription for the patient;   (iv) an application program interface (API) (a) between the separate drug dispenser device and the smart phone, the computer or the tablet computer to link the drug dispenser device to the drug specific app, or (b) in the standalone drug dispenser device to link it to the drug specific app;   (v) one or more APIs between (a) the interface device and one or more digital data capture devices, and/or (b) the interface device and one or more RFID drug chips;   (vi) a drug specific dispensing algorithm module; and   (vii) an interface device database module, comprising digitally-captured or patient-entered patient values, drug information, and dispensing-related information;   wherein the system utilizes information selected from the group consisting of prescription information, drug dispenser device information, patient self-assessment information, digitally captured physiological, psychological, lifestyle information, information of medications administered to the patient, environmental data information, and combinations thereof,   wherein the system captures such information before, during or after each drug dispensing and which is utilized by the drug specific diagnostic algorithm to decide if the separate or standalone drug dispenser device should dispense the drug or preclude dispensing and stay locked even in circumstances when the prescribed dose would have otherwise been allowed by the prescription, thereby preventing dose-mediated adverse events; and   wherein the drug specific diagnostic algorithm further utilizes symptom data obtained from the patient regarding the patient's symptoms and, based on the symptom data, decides if the separate or standalone drug dispenser device should dispense the drug or preclude dispensing and stay locked even in circumstances when the prescribed dose would have otherwise been allowed by the prescription, thereby preventing dose-mediated adverse events.   
     
     
         125 . The method of  claim 124 , wherein the symptoms analyzed by the drug specific diagnostic algorithm are selected from the group consisting of pupil size, level of pain, stool and bowel movement information, respiratory rate, blood oxygen saturation, pulse, heart rhythm, blood pressure, gait, muscle spasms, and skin temperature. 
     
     
         126 . The method of  claim 124 , wherein the drug cassette comprises an opioid. 
     
     
         127 . The method of  claim 124 , wherein the drug specific dispensing algorithm automatically handshakes with the separate or standalone drug dispenser device and the one or more digital capture devices. 
     
     
         128 . The method of  claim 124 , wherein the drug specific dispensing algorithm downloads data captured by the one or more digital capture devices to the interface device. 
     
     
         129 . The method of  claim 124 , wherein the app checks a serial number of the separate or standalone drug dispenser device to ensure it is authorized to interface with the app. 
     
     
         130 . The method of  claim 124 , wherein the app checks the expiration date of the drug. 
     
     
         131 . The method of  claim 124 , wherein the app checks the storage temperature history to ensure the drug has been stored within a specific temperature range. 
     
     
         132 . The method of  claim 124 , wherein the app checks the storage humidity history to ensure the drug has been stored within an authorized humidity range. 
     
     
         133 . The method of  claim 124 , wherein the app retrieves drug information from the separate or standalone drug dispenser device. 
     
     
         134 . The method of  claim 124 , wherein the app is designed to receive alerts of unauthorized attempts to open the separate or standalone drug dispenser device. 
     
     
         135 . The method of  claim 124 , wherein the app stores a drug's prescription and dosing schedule. 
     
     
         136 . The method of  claim 124 , wherein the app reminds the patient to take his/her medication and after a specific period of time alerts the integrated support center and/or authorized care givers that the patient has not taken his/her medication. 
     
     
         137 . The method of  claim 124 , wherein the app is designed to automatically handshake with the patient's digital diagnostic, monitoring and/or tracking devices. 
     
     
         138 . The method of  claim 124 , wherein the app presents drug specific patient self-assessment and/or data input screen(s). 
     
     
         139 . The method of  claim 124 , wherein the app maintains a database of patient responses captured by self-assessment and/or data input screen(s) and digitally captured values. 
     
     
         140 . The method of  claim 124 , wherein the interface device is a smart phone. 
     
     
         141 . The method of  claim 124 , wherein the app allows the patient to click on a screen to automatically call the integrated support center. 
     
     
         142 . The method of  claim 124 , wherein the app records all unsuccessful attempts to dispense a dose earlier than prescribed. 
     
     
         143 . The method of  claim 124 , wherein the app has reporting routines that allow the patient to request certain reports created using the patient self-assessment, digital captured information, drug cassette information, and/or dosing information to ascertain if the drug is efficacious for the patient and the effect that dosing has on the patient's condition and/or symptoms. 
     
     
         144 . The method of  claim 124 , wherein the app effectuates a handshake with the integrated support center's computers. 
     
     
         145 . The method of  claim 124 , wherein the app downloads the patient's drug related dispensing information, comprising drug dispenser, patient self-assessment, or digitally captured information into the patient's records in the integrated support center's database. 
     
     
         146 . The method of  claim 124 , wherein the app allows the patient to request specific drug related information stored in the app. 
     
     
         147 . The method of  claim 124 , wherein the app allows the patient to request specific reports or information stored on the integrated support center's servers. 
     
     
         148 . The method of  claim 124 , wherein the app allows the patient to correct responses entered in prior screens before dispensing the medication. 
     
     
         149 . The method of  claim 124 , wherein the app contains a copy of or enables access to a patient app and drug dispenser operations training and troubleshooting manual. 
     
     
         150 . The method of  claim 124 , wherein the app further comprises a GPS module to record the patient's location to ascertain where the patient is when the medication is dispensed. 
     
     
         151 . The method of  claim 124 , wherein the drug dispenser device comprises an integrated drug cassette or a replaceable drug cassette. 
     
     
         152 . The method of  claim 127 , wherein the drug specific dispensing algorithm prompts the patient self-assessment module to ask the patient one or more questions about his/her condition. 
     
     
         153 . The drug dispensing system according to  claim 124 , wherein the drug dispenser device further comprises a replaceable drug cassette and wherein the app further comprises a security system to limit the ability to change the replaceable drug cassette to an authorized medical professional.