Methods and devices for delivery and monitoring of tobacco, nicotine, or other substances

Abstract

Methods, systems, and devices are described for providing risk evaluation and mitigation strategies for use with modified risk products, and in particular, associated with nicotine and tobacco products.

1 - 10 . (canceled) 
     
     
         11 . A method of protecting public health comprising increasing the likelihood that a first subject or a second subject will stop using a first tobacco or tobacco alternative product by providing a modified risk product for administration to the first subject addicted to the first tobacco product only after at least one failed attempt by the first subject to quit using said first tobacco product. 
     
     
         12 . The method of  claim 11 , wherein said modified risk product comprises:
 an electronic cigarette, an electronic pipe, an electronic cigar, an electronic water pipe, an electronic vaporizer, or other vaporization device, and   a second tobacco or nicotine product,   used in combination with a risk evaluation and mitigation strategy.   
     
     
         13 . The method of  claim 11 , wherein said previously failed at least one attempt to quit using said first tobacco product comprises, abstinence, nicotine gum, nicotine oral spray, nicotine inhaler, nicotine nasal spray, nicotine lozenge, nicotine dermal patch, bupropion, varenicline, or a comparable oral nicotine replacement product. 
     
     
         14 . The method of  claim 12 , wherein said risk evaluation and mitigation strategy comprises subject identification and eligibility verification wherein the first subject or second subject meets at least one eligibility verification requirement for receiving said modified risk product. 
     
     
         15 . The method of  claim 14 , wherein the at least one eligibility verification requirement comprises one or more of the following:
 evidence of meeting a minimum age requirement;   evidence of a previously failed nicotine replacement therapy;   evidence of a at least one failed attempt by the patient to quit using such tobacco product;   collecting samples and measuring nicotine levels in blood, expelled breath, saliva, hair, or urine to verify that the subject's nicotine or nicotine by-product levels are above or consistent with levels expected for a tobacco or nicotine user;   measuring saliva or blood levels with a test strip for nicotine or cotinine presence in a subject's system;   a prescription from a physician or accredited healthcare provider;   electronic or telephonic verification of a unique subject eligibility card or code identifier;   software verification of a unique subject eligibility card or code identifier;   electronic fingerprint verification of an eligible subject;   an activation code;   an electronic dongle; and   an electronic security key fob, or equivalent.   
     
     
         16 . The method of  claim 14 , comprising a method wherein the first subject's or second subject's eligibility is verified by a physician, a nurse, a pharmacist, an accredited healthcare provider, an employee of a convenience or retail store, an internet or wireless based application, service or business, or a call center or phone based application, service or business. 
     
     
         17 . The method of  claim 11 , wherein said modified risk product is provided to said first subject or second subject by a physician, a nurse, a pharmacist, an accredited healthcare provider, an accredited employee of a convenience or retail store, an employee of a convenience or retail store, an internet or wireless based application, service or business, or a call center or phone based application, service or business. 
     
     
         18 - 20 . (canceled) 
     
     
         21 . A method of protecting public health comprising increasing the likelihood that a first subject or a second subject will stop using a first tobacco or tobacco alternative product by providing a modified risk product for administration to the first subject addicted to the first tobacco product only after the modified risk product is prescribed to the first subject. 
     
     
         22 . The method of  claim 21 , wherein said modified risk product comprises:
 an electronic cigarette, an electronic pipe, an electronic cigar, an electronic water pipe, an electronic vaporizer, or other vaporization device, and   a second tobacco or nicotine product,   used in combination with a risk evaluation and mitigation strategy.   
     
     
         23 . The method of  claim 22 , wherein said risk evaluation and mitigation strategy comprises subject identification and eligibility verification wherein said first subject meets at least one eligibility verification requirement for receiving said modified risk product. 
     
     
         24 . The method of  claim 23 , wherein said at least one eligibility verification requirement comprises one or more of the following:
 evidence of meeting a minimum age requirement;   evidence of a previously failed nicotine replacement therapy;   evidence of a at least one failed attempt by the patient to quit using such tobacco product;   collecting samples and measuring nicotine levels in blood, expelled breath, saliva, hair, or urine to verify that the subject's nicotine or nicotine by-product levels are above or consistent with levels expected for a tobacco or nicotine user;   measuring saliva or blood levels with a test strip for nicotine or cotinine presence in a subject's system;   a prescription from a physician or accredited healthcare provider;   electronic or telephonic verification of a unique subject eligibility card or code identifier;   software verification of a unique subject eligibility card or code identifier;   electronic fingerprint verification of an eligible subject;   an activation code;   an electronic dongle; and   an electronic security key fob, or equivalent.   
     
     
         25 . The method of  claim 23 , comprising a method wherein the first subject's eligibility is verified by a physician, a nurse, a pharmacist, an accredited healthcare provider, an employee of a convenience or retail store, an internet or wireless based application, service or business, or a call center or phone based application, service or business. 
     
     
         26 . The method of  claim 21 , wherein said modified risk product is prescribed by a physician, a nurse, a pharmacist, or an accredited healthcare provider. 
     
     
         27 . The method of  claim 22 , wherein said risk evaluation and mitigation strategy incorporates subject compliance verification. 
     
     
         28 - 39 . (canceled) 
     
     
         40 . A method of protecting public health comprising decreasing the likelihood that a second subject not using any tobacco or tobacco alternative product will start using a first tobacco product by providing a modified risk product for administration to the first subject addicted to the first tobacco product only after at least one failed attempt by the first subject to quit using said first tobacco product. 
     
     
         41 . The method of  claim 40 , wherein said modified risk product comprises:
 an electronic cigarette, an electronic pipe, an electronic cigar, an electronic water pipe, an electronic vaporizer, or other vaporization device, and   a second tobacco or nicotine product,   used in combination with a risk evaluation and mitigation strategy.   
     
     
         42 . The method of  claim 40  wherein said at least one previously failed attempt to quit using said tobacco product comprises: abstinence, nicotine gum, nicotine oral spray, nicotine inhaler, nicotine nasal spray, nicotine lozenge, nicotine dermal patch, bupropion, varenicline, or comparable oral nicotine replacement product. 
     
     
         43 . The method of  claim 41 , wherein said risk evaluation and mitigation strategy comprises subject identification and eligibility verification wherein said first subject meets at least one eligibility verification requirement for receiving said modified risk product. 
     
     
         44 . The method of  claim 43 , wherein said at least one eligibility verification requirement comprises one or more of the following:
 evidence of meeting a minimum age requirement;   evidence of a previously failed nicotine replacement therapy;   evidence of a at least one failed attempt by the patient to quit using such tobacco product;   collecting samples and measuring nicotine levels in blood, expelled breath, saliva, hair, or urine to verify that the subject's nicotine or nicotine by-product levels are above or consistent with levels expected for a tobacco or nicotine user;   measuring saliva or blood levels with a test strip for nicotine or cotinine presence in a subject's system;   a prescription from a physician or accredited healthcare provider;   electronic or telephonic verification of a unique subject eligibility card or code identifier;   software verification of a unique subject eligibility card or code identifier;   electronic fingerprint verification of an eligible subject;   an activation code;   an electronic dongle; and   an electronic security key fob, or equivalent.   
     
     
         45 - 46 . (canceled) 
     
     
         47 . The method of  claim 41 , wherein said risk evaluation and mitigation strategy incorporates subject compliance verification. 
     
     
         48 - 122 . (canceled)