U.S. patent application number 14/012952 was filed with the patent office on 2014-03-06 for methods and devices for delivery and monitoring of tobacco, nicotine, or other substances.
This patent application is currently assigned to Ploom, Inc.. The applicant listed for this patent is Ploom, Inc.. Invention is credited to Gal A. Cohen.
Application Number | 20140060552 14/012952 |
Document ID | / |
Family ID | 50185712 |
Filed Date | 2014-03-06 |
United States Patent
Application |
20140060552 |
Kind Code |
A1 |
Cohen; Gal A. |
March 6, 2014 |
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.
Inventors: |
Cohen; Gal A.; (San
Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ploom, Inc. |
San Francisco |
CA |
US |
|
|
Assignee: |
Ploom, Inc.
San Francisco
CA
|
Family ID: |
50185712 |
Appl. No.: |
14/012952 |
Filed: |
August 28, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61694046 |
Aug 28, 2012 |
|
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|
Current U.S.
Class: |
131/273 |
Current CPC
Class: |
A24F 47/002 20130101;
A24F 47/008 20130101 |
Class at
Publication: |
131/273 |
International
Class: |
A24F 47/00 20060101
A24F047/00 |
Claims
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)
Description
CROSS-REFERENCE
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/694,046, filed Aug. 28, 2012, which application
is incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The use of tobacco products and the harmful side effects of
smoking tobacco and nicotine consumption continue to gain
increasing attention worldwide. As more regulations come into
effect regarding smoking in the work place or in public, interest
in developing alternative methods of protecting public health and
providing cessation products and methods is growing significantly.
As with most new therapies or drugs, the federal government has
issued regulations intended to protect the public, with enforcement
authority granted to the U.S. Food and Drug Administration
(FDA).
SUMMARY OF THE INVENTION
[0003] It is generally understood that the mission of the US Food
and Drug Administration (FDA) is to advance the public health by
helping to speed the innovations that make medicines and most foods
more effective, safer, and more affordable; and help the public get
accurate, science-based information they need to use those
medicines and foods to improve their health.
[0004] In June, 2009, The Family Smoking Prevention and Tobacco
Control Act was signed into law, creating "The Center for Tobacco
Products", a tobacco control center within the FDA, having the
authority to regulate tobacco industry in the U.S., by regulating
the content, commercial marketing, sale and distribution of tobacco
products within the United States. The law also requires tobacco
companies and importers to reveal all product ingredients and seek
FDA approval for any new tobacco products.
[0005] Under its new-found, expanded authority, the FDA now has the
ability to control the commercial sale and distribution of
traditional tobacco products, including cigarettes, pipe tobacco,
and cigars, as well as new tobacco and nicotine related products,
including; electronic nicotine vaporizers, (e.g. the electronic
cigarette); and products with potentially modified safety risk
relative to cigarettes. These products have new regulatory pathways
associated with them, including those proscribed under Section 911
(modified risk tobacco products.)
[0006] When considering whether to allow the marketing of modified
risk products, FDA must consider the benefit to health of
individuals and the population as a whole, including: "the
increased or decreased likelihood that existing users of tobacco
products who would otherwise stop using such products will switch
to the tobacco product that is the subject of the application; the
increased or decreased likelihood that persons who do not use
tobacco products will start using the tobacco product that is the
subject of the application; and the risks and benefits to persons
from the use of the tobacco product that is the subject of the
application as compared to the use of products for smoking
cessation approved under chapter V to treat nicotine
dependence."
[0007] One potential approach for FDA to address the benefits to
health of individuals and the population could be to require Risk
Evaluation and Mitigation Strategies (REMS) be put in place for
modified risk products or other tobacco products as a prerequisite
for marketing approval.
[0008] There are essentially three components to a REMS program: 1.
A medication guide or patient insert; 2. A communication plan for
healthcare providers; and 3. Elements to assure safe use, (ELASU).
A drug's REMS program may not require the provision of all three
components, as the specific components a REMS program employs will
vary based on the severity of the risks, the population likely to
be exposed, and other factors. In fact, the most common REMS only
require the provision of a medication guide.
[0009] While REMS components are not uniform, some currently do, or
in the future, may contain new provisions and requirements for
physicians and other certified health care providers. For REMS
requiring ETASU, clinicians may be required to: Obtain and dispense
drugs through specific distribution channels; Possess specific
training, education, experience, or certification(s) in order to
prescribe these drugs; Enroll patients in registry programs; and,
Issue mandatory, time-sensitive reports of patient responses to
treatment.
[0010] It is possible that one's ability to prescribe and dispense
certain medications, even some that have been on the market for
years, could be contingent upon compliance with these REMS
provisions.
[0011] Applicant has developed novel methods and devices for the
delivery and monitoring of tobacco, nicotine and other substances
that will meet or exceed any potential federal regulation in this
field.
[0012] Provided herein is a method of protecting public health
comprising: increasing the likelihood that a first subject or a
second subject will stop using a tobacco product by providing a
modified risk product for administration to the first subject
addicted to the tobacco product wherein the first subject has
previously failed nicotine replacement therapy.
[0013] In some embodiments the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0014] In some embodiments the previously failed nicotine
replacement therapy comprises abstinence, nicotine gum, nicotine
oral spray, nicotine inhaler, nicotine nasal spray, nicotine
lozenge, nicotine dermal patch, bupropion (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9,10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM. (see, for example,
WO2010023561, incorporated by reference herein in its
entirety.)
[0015] In some embodiments, the product is prescribed, provided, or
a subject's eligibility is verified by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0016] In some embodiments, the product is prescribed, provided, or
a subject's eligibility is verified by an internet or wireless
based application, service or business, or by a call center or
phone based application service or business.
[0017] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0018] In some embodiments, the subject compliance verification
comprises collecting and sending samples, taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
said samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0019] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0020] Provided herein is a method of protecting public health
comprising: increasing the likelihood that a first subject or a
second subject will stop using a tobacco product by providing a
modified risk product for administration to the first subject
addicted to the tobacco product only after at least one failed
attempt by the first subject to quit using such tobacco
product.
[0021] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0022] In some embodiments, the previously failed at least one
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 (which
includes 3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative
thereof, an analogue thereof, a bupropion metabolite, a
pharmaceutically acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM. (see, for example,
WO2010023561, incorporated by reference herein in its
entirety.)
[0023] In some embodiments, the product is prescribed, provided,
administered, or subject eligibility verified by a physician, a
nurse, a pharmacist, or an accredited healthcare provider, or an
employee of a convenience or retail store.
[0024] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0025] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0026] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0027] Provided herein is a method of protecting public health
comprising increasing the likelihood that a first subject or a
second subject will stop using a tobacco product by providing a
modified risk product for administration to the first subject
addicted to the tobacco product only after the modified risk
product is prescribed to the first subject.
[0028] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0029] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0030] In some embodiments, the product is prescribed by a
physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0031] In some embodiments, the risk evaluation and mitigation
strategy incorporates a means of subject compliance
verification.
[0032] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0033] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0034] Provided herein is a method of protecting public health
comprising decreasing the likelihood that a second subject not
using a tobacco product will start using the tobacco product by
providing a modified risk product for administration to the first
subject addicted to the tobacco product wherein the first subject
has previously failed nicotine replacement therapy.
[0035] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0036] In some embodiments, the 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 (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0037] In some embodiments, the product is prescribed, provided or
subject eligibility verified by a physician, a nurse, a pharmacist,
or an accredited healthcare provider.
[0038] In some embodiments, the product is provided or subject
eligibility verified by an employee of a convenience or retail
store.
[0039] In some embodiments, the product is provided, or subject
eligibility verified by an internet based application, service or
business.
[0040] In some embodiments, the product is provided or subject
eligibility verified by a call center or phone based application
service or business.
[0041] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0042] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0043] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0044] Provided herein is a method of protecting public health
comprising decreasing the likelihood that a second subject not
using a tobacco product will start using the tobacco product by
providing a modified risk product for administration to the first
subject addicted to the tobacco product only after at least one
failed attempt by the first subject to quit using such tobacco
product.
[0045] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0046] In some embodiments, the 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 (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0047] In some embodiments, the product is prescribed, provided or
subject eligibility verified by a physician, a nurse, a pharmacist,
or an accredited healthcare provider.
[0048] In some embodiments, the product is provided or subject
eligibility verified by or an employee of a convenience or retail
store.
[0049] In some embodiments, the product is provided, or subject
eligibility verified by an internet based application, service or
business.
[0050] In some embodiments, the product is provided or subject
eligibility verified by a call center or phone based application
service or business.
[0051] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0052] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0053] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0054] Provided herein is a method of protecting public health
comprising decreasing the likelihood that a second subject not
using a tobacco product will start using the tobacco product or an
alternative tobacco product, by providing a modified risk product
for administration to the first subject addicted to the tobacco
product, only after the modified risk product is prescribed to the
first subject.
[0055] In some embodiments, said modified risk product comprises;
an electronic cigarette, an electronic pipe, an electronic cigar,
an electronic water pipe, an electronic vaporizer, and/or a tobacco
or nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0056] In some embodiments, the product is prescribed by and
subject eligibility verified by a physician, a nurse, a pharmacist,
or an accredited healthcare provider.
[0057] In some embodiments, the product is provided or subject
eligibility verified by or an employee of a convenience or retail
store.
[0058] In some embodiments, the product is provided, or subject
eligibility verified by an internet based application, service or
business.
[0059] In some embodiments, the product is provided or subject
eligibility verified by a call center or phone based application
service or business.
[0060] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0061] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0062] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0063] Provided herein is a method of treating a first subject
addicted to a tobacco product, the method comprising administering
to the first subject who has previously failed nicotine replacement
therapy, a modified risk product.
[0064] In some embodiments the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0065] In some embodiments the previously failed nicotine
replacement therapy comprises abstinence, nicotine gum, nicotine
oral spray, nicotine inhaler, nicotine nasal spray, nicotine
lozenge, nicotine dermal patch, bupropion (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0066] In some embodiments, the product is administered by a
physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0067] In some embodiments, the product is administered by an
employee of a convenience or retail store.
[0068] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0069] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0070] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0071] In some embodiments, the subject compliance verification
comprises collecting samples and measuring nicotine levels in blood
samples, measuring nicotine levels in expelled breath samples,
measuring nicotine levels in saliva samples, measuring nicotine
levels in hair samples, and measuring nicotine levels in urine
samples.
[0072] In some embodiments, the subject compliance verification is
performed by a physician, a nurse, a pharmacist, or an accredited
healthcare provider.
[0073] In some embodiments, the subject compliance verification is
performed by or an employee of a convenience or retail store.
[0074] Provided herein is a method of treating a first subject
addicted to a tobacco product, the method comprising administering
to the first subject a modified risk product only after at least
one failed attempt by the first subject to quit using such tobacco
product.
[0075] In some embodiments the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0076] In some embodiments the previously failed nicotine
replacement therapy comprises abstinence, nicotine gum, nicotine
oral spray, nicotine inhaler, nicotine nasal spray, nicotine
lozenge, nicotine dermal patch, bupropion (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0077] In some embodiments, the product is administered by a
physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0078] In some embodiments, the product is administered by an
employee of a convenience or retail store.
[0079] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0080] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0081] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0082] In some embodiments, the subject compliance verification
comprises collecting samples and measuring nicotine levels in blood
samples, measuring nicotine levels in expelled breath samples,
measuring nicotine levels in saliva samples, measuring nicotine
levels in hair samples, and measuring nicotine levels in urine
samples.
[0083] In some embodiments, the subject compliance verification is
performed by a physician, a nurse, a pharmacist, or an accredited
healthcare provider.
[0084] In some embodiments, the subject compliance verification is
performed by an employee of a convenience or retail store.
[0085] Provided herein is a method of treating a first subject
addicted to a tobacco product, the method comprising administering
a modified risk product to the first subject only after the
modified risk product is prescribed to the first subject.
[0086] In some embodiments, said modified risk product comprises;
an electronic cigarette, an electronic pipe, an electronic cigar,
an electronic water pipe, an electronic vaporizer, and/or a tobacco
or nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0087] In some embodiments, the modified risk product is prescribed
and administered by a physician, a nurse, a pharmacist, or an
accredited healthcare provider.
[0088] In some embodiments, the product is administered by an
accredited employee of a convenience or retail store, or an
employee of an accredited convenience or retail store.
[0089] In some embodiments, the product is administered by an
internet or wireless based application, service or business.
[0090] In some embodiments, the product is administered by a call
center or phone based application service or business.
[0091] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0092] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0093] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0094] In some embodiments, the subject compliance verification
comprises collecting samples and measuring nicotine levels in
blood, expelled breath, saliva, hair, and/or urine.
[0095] In some embodiments, the subject compliance verification is
performed by a physician, a nurse, a pharmacist, or an accredited
healthcare provider.
[0096] In some embodiments, the subject compliance verification is
performed by an employee of a convenience or retail store.
[0097] Provided herein is a method for increasing the likelihood
that the first subject or a second subject will stop using the
tobacco product.
[0098] Provided herein is a method for decreasing the likelihood
that a second subject not using the tobacco product will start
using the tobacco product.
[0099] Provided herein is a method for verifying the at least one
prior failed attempt to stop using tobacco products prior to the
modified risk product being provided to a first subject.
[0100] In some embodiments, the verification comprises collecting
samples and measuring nicotine levels in blood samples, in expelled
breath samples, in saliva samples, in hair samples, and in urine
samples 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 after verification that the subject had
previously attempted to stop using tobacco products.
[0101] In some embodiments, the previously failed attempt may have
comprised using abstinence, nicotine gum, nicotine oral spray,
nicotine inhaler, nicotine nasal spray, nicotine lozenge, nicotine
dermal patch, bupropion (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0102] Provided herein is a method for verifying that a first
subject meets at least one eligibility requirement for use of a
modified tobacco risk product.
[0103] Provided herein is a method for verifying a subject's
eligibility requirement comprising: possession of an eligibility
card, meeting qualifications for the eligibility card, possessing a
valid verification code, possessing a physician-provided
eligibility record, possessing a pharmacist-provided eligibility
record, and passing a pharmacist-provided eligibility
evaluation.
[0104] In some embodiments of a method having an eligibility
requirement, the identity verification step comprises at least one
of:
[0105] evidence of meeting a minimum age requirement,
[0106] evidence of a previously failed nicotine replacement
therapy, and
[0107] evidence of a at least one failed attempt by the patient to
quit using such tobacco product,
[0108] electronic or telephonic verification of a unique subject
eligibility card or code identifier,
[0109] software verification of a unique subject eligibility card
or code identifier,
[0110] electronic fingerprint verification of an eligible
subject,
[0111] an activation code, or
[0112] an electronic dongle, electronic security key fob, or
equivalent.
[0113] Provided herein is a method for verifying a subject's
eligibility requirement wherein the verifying step is performed by
a physician, a nurse, a pharmacist, an accredited healthcare
provider an accredited employee of a convenience or retail store,
or an employee of an accredited convenience or retail store.
[0114] Provided herein is a method for providing a prescription for
a modified risk product, wherein said prescription is provided by a
qualified healthcare provider.
[0115] In some embodiments, said modified risk product comprises;
an electronic cigarette, an electronic pipe, an electronic cigar,
an electronic water pipe, an electronic vaporizer, and/or a tobacco
or nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0116] Provided herein is a method of verifying eligibility of a
first subject addicted to a tobacco product, to be provided with a
modified risk product, the method comprising, measuring nicotine
levels present in the system of a first subject prior to
administration of said modified risk product and confirming that
said nicotine levels are above or consistent with those of a
tobacco or nicotine product user.
[0117] In some embodiments the method of verifying eligibility
comprises; measuring nicotine levels in blood samples, expelled
breath samples, saliva samples, hair samples, and urine
samples.
[0118] Provided herein is a method of monitoring compliance of a
first subject addicted to a tobacco product and participating in a
REMS program comprising a modified risk product, the method
comprising, measuring nicotine levels of a first subject prior to
administration of said modified risk product and measurement of
nicotine levels after administration of said modified risk product,
and comparing said prior nicotine prior levels to anticipated
nicotine levels after administration of said modified risk
product.
[0119] In some embodiments, a method of monitoring comprises; using
an electronic signature to track the pattern of use of a vaporizer,
electronic cigarette, or other modified risk product wherein said
product transmits a record of use over a given period of time.
[0120] In some embodiments, a record of use comprises levels of
nicotine consumed, times, and dates it was consumed.
[0121] In some embodiments, the record of use is stored to a data
storage device and later downloaded for use by a qualified
healthcare provider or REMS monitor or administrator.
[0122] In some embodiments, the record of use is transmitted
wirelessly to a data storage device and later downloaded for use by
a qualified healthcare provider or REMS monitor or
administrator.
[0123] In some embodiments, the record of use is stored within the
device, and later downloaded for use by a qualified healthcare
provider or REMS monitor.
[0124] In some embodiments, the record of use may be wirelessly
transmitted from a data storage device or a component of the
modified risk product to a remote location for use by a qualified
healthcare provider or REMS monitor or administrator.
[0125] Provided herein is a method of monitoring the use of a
modified risk product by a first subject addicted to a tobacco
product, the method comprising, requiring an identification
recognition system be activated before use of a modified risk
product can occur.
[0126] In some embodiments, the identification recognition system
comprises a fingerprint scanner, a lip print scanner, face
recognition, a retinal scan, a combination code, an activation
code, security key fob, or dongle.
[0127] In some embodiments, the identification recognition system
comprises an electronic application for a smartphone, laptop,
desktop, or tablet computing device, capable of communicating with
the modified risk product by a wireless communication system.
[0128] In some embodiments, the identification recognition system
must be within a fixed distance of the modified risk product for
product to continue to work.
[0129] In some embodiments, the identification recognition system
must be within about 5 to 20 feet of the modified risk product.
[0130] In some embodiments, the identification recognition system
must be within 10 feet of the modified risk product.
[0131] In some embodiments, the identification recognition system
must be within 5 feet of the modified risk product.
[0132] Provided herein is a method of protecting the public health
comprising increasing the likelihood that a first subject will stop
using a tobacco product by providing a modified risk product for
administration to the first subject addicted to the tobacco product
wherein the modified risk product provides a faster onset of
nicotine delivery, or a higher peak level of nicotine delivery.
[0133] Provided herein is a method of risk mitigation wherein the
potential risk of misuse or abuse of a modified risk product is
ranked or stratified in comparison to other tobacco products.
[0134] In some embodiments, the relative potential risk of the
modified risk product is determined by comparing the
pharmacokinetic profile of the modified risk product to
nicotine.
[0135] In some embodiments the pharmacokinetic profile of the
modified risk product is determined by the maximum plasma
concentration (Cmax) of nicotine, compared to a cigarette.
[0136] In some embodiments the pharmacokinetic profile of the
modified risk product is determined by the time after
administration of the product for nicotine to reach maximum plasma
concentration (Tmax), compared to a cigarette.
[0137] In some embodiments the pharmacokinetic profile of the
modified risk product is determined by the rate-of-increase of
nicotine delivery or concentration in the plasma of a subject
compared to a cigarette.
[0138] In some embodiments, the relative potential risk of the
modified risk product is determined by comparing the nicotine
concentration of the modified risk product other nicotine products
in the market.
[0139] In some embodiments, the relative potential risk of the
modified risk product is ranked by ease of access associated with
the prescriber/administrator.
[0140] In some embodiments, the relative potential risk of the
modified risk product is ranked by ease of access through various
distribution channels.
[0141] In some embodiments the modified risk product comprises
vaporizing tobacco leaves above their pyrolytic temperature.
[0142] In some embodiments the modified risk product comprises
heating tobacco leaves below their pyrolytic temperature.
[0143] In some embodiments the modified risk product comprises
vaporization of a nicotine salt.
[0144] In some embodiments the modified risk product comprises
heating of a nicotine salt below its pyrolytic temperature.
[0145] Provided herein is a method of protecting the public health
wherein the provider of a modified risk product is subject to a
compliance verification system.
[0146] In some embodiments, the provider verification is performed
by an independent auditor.
[0147] Provided herein is a system for verification of subject
eligibility, tracking, and reporting use of a modified risk product
comprising: an electronic cigarette, an electronic pipe, an
electronic cigar, an electronic water pipe, or an electronic
vaporizer, comprising a battery, an atomizer, electronic circuitry,
a memory storage device for tracking components of usage activity,
a means of memory transfer, and a charging circuit, a charger base
station comprising a memory storage device, a means for receiving
data from said modified risk product memory storage device and
transmitting said data to a third party, activation software for
recognition of a specific device, keyed to said charger base,
capable of interfacing with an external device, wherein said
external device comprises; a smart phone, computer, electronic fob,
electronic dongle, and a wireless communication device, e.g.:
Bluetooth device.
[0148] In some embodiments, the system is used in combination with
a risk evaluation and mitigation strategy.
[0149] In some embodiments, the system comprises activation means,
for recognition and verification of a subject to establish user
eligibility prior to use.
[0150] In some embodiments, the system is used to verify subject
compliance for use of a modified risk product.
[0151] In some embodiments the system comprises a means for
validating overall success of the risk mitigation product when used
with the risk evaluation and mitigation strategies.
INCORPORATION BY REFERENCE
[0152] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0153] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0154] FIG. 1A illustrates a possible configuration of an overall
Risk Evaluation and Mitigation Strategy (REMS) where a subject has
previously used a nicotine replacement therapy;
[0155] FIG. 1B illustrates another possible configuration of an
overall Risk Evaluation and Mitigation Strategy (REMS) where a
subject has not used a nicotine replacement therapy;
[0156] FIG. 2 illustrates a possible configuration of a REMS
component program for the authorization, verification and program
compliance of qualified prescribers and dispensers of modified risk
products;
[0157] FIG. 3A illustrates a possible configuration of a REMS
component program for the authorization and dispensation of
prescriptions for a Modified Risk Product when a subject has
previously used a nicotine replacement therapy;
[0158] FIG. 3B illustrates a possible configuration of a REMS
component program for the authorization and dispensation of
prescriptions for a Modified Risk Product when a subject has
previously not used a nicotine replacement therapy;
[0159] FIG. 3C illustrates a representative test strip for
verification of nicotine presence in a subject's system;
[0160] FIG. 4 illustrates a possible configuration of a REMS
component program for the purchase of Modified Risk Products;
[0161] FIG. 5 illustrates a possible configuration of a REMS
component program for User Verification of a Modified Risk
Product;
[0162] FIG. 6 illustrates a possible configuration of a REMS
component program for User Verification, Tracking, and Automated
Reporting Method of a Modified Risk Product and also illustrates a
possible system for verification, tracking, and reporting use of,
and or subject compliance for the use of a Modified Risk
Product;
[0163] FIG. 7A illustrates a possible configuration of a REMS
component program for User Eligibility for, or User Compliance of,
a Modified Risk Product; and
[0164] FIG. 7B illustrates a representative test strip for
verification of nicotine presence in a subject's system which could
be adapted for use in a REMS program for User Compliance or testing
for misuse or abuse of a Modified Risk Product.
DETAILED DESCRIPTION OF THE INVENTION
[0165] Provided herein are methods of protecting the public health
by increasing the likelihood that a subject addicted to a tobacco
product will stop using a tobacco product wherein the subject has
previously failed to stop using a tobacco product by other
means.
[0166] It should be understood that at a minimum, terms used
throughout this specification have the following meanings.
[0167] Definitions:
[0168] Abstinence: Abstinence has diverse forms and several
potential definitions. Commonly it refers to a temporary or partial
refrain from food, alcohol, sexual activity, or drugs, such as
nicotine in tobacco products. Alternately, it could be used to
describe total abstinence where something is completely removed
from one's lifestyle for a period of time. As it applies herein,
abstinence is generally intended to have the more common meaning of
temporary or partial, self-enforced, restraint from indulgence.
However, the term may also imply long-term restraint, wherein a
subject has maintained a sustained abstinence; i.e.: several years,
without necessarily having quit using said products entirely.
[0169] Administer/Administration: Is intended to mean that a
product or service has been provided to a subject. Such service may
include performing a test, delivering a prescription, or carrying
out/providing a verification process.
[0170] Fail/Failed/Failure: is intended to mean that a subject has
not succeeded with a previous therapy and returned to previous
levels (or greater levels) of tobacco product use. It is commonly
understood in therapy programs that early "failure" is a normal
part of trying to stop, and more than one attempt at stopping
smoking prior to longer-term success is common. Alternatively it
could mean inability to refrain from total or sustained
abstinence.
[0171] Fail/Failed/Failure: May also mean that a subject continues
to use a NRT product longer than indicated by the prescribing
method or suggested use, with or without additional use of a
tobacco product in addition to the NRT product. For example; a
subject may continue using a nicotine patch while continuing to
smoke cigarettes, beyond the intended "weaning off" period.
[0172] Initiate: Is intended to mean that a subject has at some
point begun using any tobacco cessation therapy or Nicotine
Replacement Therapy (NRT) product.
[0173] Modified Risk Product: Is intended to mean a tobacco product
that is sold, distributed, or marketed under regulatory authority,
with a claim to reduce harm or the risk of tobacco related
diseases, or a tobacco product that is shown to substantially
reduce the overall exposure to harmful substances.
[0174] Modified Risk Product: May also mean a tobacco or nicotine
delivery device or product that is sold, distributed, or marketed
under regulatory authority comprising a non-combustion-based, or
vaporization-based nicotine delivery mechanism with a lower risk
factor for one or more tobacco related diseases or exposure to one
or more harmful substances, which may be substituted for any other
oral, combustion, or vaporization-based nicotine delivery product
having a higher risk factor for one or more tobacco related
diseases or exposure to one or more harmful substances.
[0175] Prescribe/Prescription: Is intended to mean that a product
has been authorized for distribution to a subject by order of an
accredited healthcare provider (a physician); i.e.: by prescription
(Rx).
[0176] Prescribe: May also mean a commonly available
over-the-counter product that has been recommended by an accredited
healthcare provider (a physician, a nurse, a pharmacist); i.e.: by
suggestion the use an OTC product, not requiring a Rx, but still
requiring verification of a type to meet local, state, or federal
regulation by an accredited individual, at the point of
distribution. Alternately a person may self-prescribe an available
OTC product.
[0177] Quit: is intended to mean that a subject has completely
stopped using a (tobacco) product; i.e.: total (i.e.: smoking)
cessation.
[0178] Tobacco product: Is generally intended to mean any product
produced from any genus of Nicotiana plants or nightshade family of
plants, or a by-product derived therefrom, comprising nicotine,
nicotine salts, or nicotine derivatives, which may produce
by-products that can be ingested utilizing oral, combustion, or
vaporization delivery.
[0179] Tobacco alternative: May also comprise substitute herbal
tobacco products such as corn silk, mint, cinnamon, lemongrass,
clover, bugasse, and shisha, among others, comprising nicotine,
nicotine salts, or nicotine derivatives, which are often mixed or
flavored with various fruit flavors, energy drink flavors, or other
appealing flavors and which may produce byproducts that can be
ingested utilizing oral, combustion, or vaporization delivery.
[0180] Treat: Is generally intended to mean providing an alternate
remediation to a tobacco product to a subject. Providing a
remediation to act upon a subject by providing an agent intended to
be a substitute for a tobacco product.
[0181] Treat: May also mean substitution of a first tobacco product
with a second tobacco product, wherein the second product has a
preferable risk profile, i.e.: substitution of a tobacco product
which utilizes combustion with a tobacco or nicotine product which
does not utilize combustion or which utilizes vaporization.
[0182] Validate/Validation: Is intended to mean a procedure for
checking that a product, service, or system has met the needs or
requirements of the stakeholder(s), and is typically done in the
later phases of product, process, or system development to assure
that the development and verification procedures for a product,
service, or system result in a product, service, or system that
meets initial requirements, specifications and regulations.
[0183] Vapor/vaporize/vaporization: Is intended to mean converting
a normally liquid or solid substance into an aerosol, gaseous or
semi-gaseous state, where it is diffused or suspended in the air;
i.e.: haze, mist, or steam. Vaporization is also defined as the
process for producing a gaseous by-product that is produced from a
normally liquid or solid state material, at a temperature which is
below the combustion temperature of said material.
[0184] Verify/verification: Is intended to mean a procedure for
checking that a product, service, or system complies with a
regulation, requirement, specification, or imposed condition; e.g.:
has met an initial set of requirements, specifications or
regulations and typically performed in the initial or development
phases of product, process, or system development.
[0185] Methods:
[0186] Provided herein are methods of protecting the public health
by increasing the likelihood that a subject addicted to a tobacco
product will stop using a tobacco product wherein the subject has
previously failed to stop using a tobacco product by other means.
Such methods may include the use of controlled Risk Evaluation and
Mitigation Strategies (REMS) such as that illustrated in FIGS. 1A
& 1B. These REMS may be applied to drugs, biologics, devices,
or combination devices that include any two or more of these
things. REMS are intended to answer the question: "Do the benefits
of the drug, biologic, (and/or device) outweigh the risks?" Some of
the factors taken into consideration include: Seriousness of the
disease or condition to be treated
[0187] Size of the patient population;
[0188] Expected benefit of the drug or biologic (and/or
device);
[0189] Expected duration of treatment;
[0190] Seriousness of the known or potential adverse events.
[0191] These evaluations are performed not only prior to the
approval of a new drug, biologic, (and/or device), in this case, a
modified risk product device for delivering nicotine, but also
throughout the entire life cycle of the drug, biologic and/or
device. This serves as a means to continuously assess the safety
and efficacy of existing products based on adverse event reports
and results from post-marketing clinical studies.
[0192] For every drug, biologic and/or device approved by the FDA,
the risks associated with its use are communicated through the
product package insert. In some cases, however, the manufacturer
and/or the FDA may determine that expanded REMS are necessary to go
beyond product labeling in order to manage risks and thereby ensure
that the benefits outweigh the risks.
[0193] As illustrated in FIGS. 1 & 2, elements of a REMS
program for Nicotine Replacement Therapy (NRT) may include Elements
to Assure Safe Use, (ELASU). A Nicotine REMS program as proposed
herein is likely to comprise several algorithms including:
[0194] 1. A Prescriber/Dispenser Authorization Algorithm (FIG. 2):
which may include; [0195] Specific personnel authorized by statute
to prescribe or dispense a Modified Risk Product [0196] A defined
Risk Evaluation and Mitigation Strategy for the specific Modified
Risk Product [0197] An auditing and certification program to verify
that qualified prescribers/dispensers are appropriately trained and
following the REMS protocols for verification and dispensation of
Modified Risk Products
[0198] 2. A Prescription Process and Verification Algorithm (FIGS.
3A & 3B): which may include; [0199] A method for verifying that
only qualified subjects receive a Modified Risk Product, which may
include one or more of the following: [0200] i. evidence of meeting
a minimum age requirement; [0201] ii. evidence of a previously
failed nicotine replacement therapy; [0202] iii. evidence of a at
least one failed attempt by the patient to quit using such tobacco
product; [0203] iv. 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;
(FIG. 3C) [0204] v. a prescription from a physician or accredited
healthcare provider; [0205] vi. electronic or telephonic
verification of a unique subject eligibility card or code
identifier; [0206] vii. software verification of a unique subject
eligibility card or code identifier; [0207] viii. electronic
fingerprint verification of an eligible subject; [0208] ix. an
activation code; [0209] x. an electronic dongle; and [0210] xi. an
electronic security key fob, or equivalent. [0211] A process for
dispensing the Modified Risk Product which may include; [0212] i.
Directly providing a dispensing modified risk device and/or a
modified risk tobacco/nicotine product [0213] ii. Registration in a
REMS program
[0214] 3. A User Purchasing Verification Algorithm (FIG. 4): which
may include; [0215] A method for verifying that a qualified subject
may purchase a modified risk Product from an authorized
distributor, which may include one or more of the following:
[0216] i. evidence of meeting a minimum age requirement; [0217] ii.
evidence of a previously failed nicotine replacement therapy;
[0218] iii. evidence of a at least one failed attempt by the
patient to quit using such tobacco product; [0219] iv. 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; [0220] v. a prescription
from a physician or accredited healthcare provider; [0221] vi.
electronic or telephonic verification of a unique subject
eligibility card or code identifier; [0222] vii. software
verification of a unique subject eligibility card or code
identifier; [0223] viii. electronic fingerprint verification of an
eligible subject; [0224] ix. an activation code; [0225] x. an
electronic dongle; and [0226] xi. an electronic security key fob,
or equivalent.
[0227] 4. A Product User Verification (FIG. 5): which may include;
[0228] A method or process for verifying a subject is authorized to
use a Modified Risk Product before a product will be activated or
function; which may include one or more of the following: [0229] i.
software verification; [0230] ii. card or code identifier; [0231]
iii. electronic fingerprint verification of an eligible subject;
[0232] iv. lip print verification of an eligible subject; [0233] v.
a special article of clothing; [0234] vi. an activation code;
[0235] vii. an electronic ring; [0236] viii. an electronic dongle;
and [0237] ix. an electronic security key fob, or equivalent.
[0238] 5. A User Verification and Mitigation Tracking System (FIG.
6): which may include; [0239] A Modified Risk System (100)
comprising: one or more of the following: [0240] i. an electronic
cigarette; (1) [0241] ii. an electronic pipe; [0242] iii. an
electronic cigar; [0243] iv. an electronic water pipe; or [0244] v.
an electronic vaporizer (1), and also comprising one or more of the
following: [0245] 1. a battery, an atomizer or cartomizer,
electronic circuitry, a memory storage device for tracking
component usage activity, a means of memory transfer, and a
charging circuit; [0246] vi. a charger base station (2) comprising
one or more of the following: [0247] 1. a memory storage device; a
means for receiving data and transmitting said data from said
modified risk product memory storage device to a third party;
[0248] vii. an identification recognition system; [0249] viii.
activation software for recognition of a specific device keyed to
said charger base and capable of interfacing with an external
device, wherein said external device comprises one or more of the
following: [0250] ix. a smart phone (3); a computer; an electronic
fob (4); an electronic dongle; a ring; an article of clothing; and
a wireless communication device (5).
[0251] 6. A REMS Compliance Program (FIG. 7A): which may include;
[0252] A method of testing to confirm that a subject is complying
with (and not misusing or abusing) the Modified Risk Product.
[0253] i. Testing strips or other methods of compliance
verification (FIG. 7B).
[0254] Provided herein is a method of protecting public health
comprising: increasing the likelihood that a first subject or a
second subject will stop using a tobacco product or tobacco
alternative product by providing a modified risk product such as a
device for administration of nicotine in a vapor form to a first
subject addicted to the tobacco product wherein the first subject
has previously failed a nicotine replacement therapy. It is
generally understood that there are numerous recognized therapies
intended to reduce the use of tobacco and/or bring about the
cessation of addiction to tobacco products and in particular,
nicotine. These include; abstinence, nicotine gum, nicotine oral
spray, nicotine inhaler, nicotine nasal spray, nicotine lozenge,
nicotine dermal patch, bupropion (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino [2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product, or similar
medications and oral nicotine replacement products. Varenicline is
sold by Pfizer under the brand name CHANTIX.RTM.. In many cases,
these products or methods fail. The applicant believes that by
combining a REMS program with their Modified Risk Product, the user
will be more likely to switch to a preferred form of nicotine
delivery which has a preferable risk profile, while also minimizing
the risk that non-tobacco users will initiate use of the modified
risk product.
[0255] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a REMS typically
involving one or more of the following components; subject
eligibility verification, subject compliance verification to a risk
mitigation strategy, and overall validation of the success of said
risk evaluation and mitigation strategy.
[0256] Among the methods included in the REMS are methods wherein
the product is prescribed, provided, or a subject's eligibility is
verified by a physician, a nurse, a pharmacist, or an accredited
healthcare provider. FIG. 3A illustrates one embodiment of a method
wherein the potential subject may request a prescription for a
controlled product from a qualified, accredited healthcare
provider, who verifies that the subject is qualified to receive
said product, prior to issuing a prescription. A subject may be a
current tobacco or nicotine user who may have previously tried and
failed a nicotine replacement therapy.
[0257] Alternatively, the product may be regulated as an over the
counter (OTC) or retail product, wherein the subject may
self-subscribe and acquire the product by personally requesting it
from a qualified individual, authorized to dispense said product,
upon proof or verification of eligibility to acquire said product,
such as proof of a minimum age requirement, etc. FIG. 3B
illustrates another embodiment of a method wherein the potential
subject may request an FDA designated modified risk tobacco product
or a tobacco alternative product which may include a non-combustion
or vaporization-based delivery of nicotine or tobacco from a
qualified, accredited healthcare provider, or employee of a
convenience or retail store, who verifies that the subject is
qualified to receive said product. A subject may be a current
tobacco or nicotine user who may or may not have previously tried
and failed a nicotine replacement therapy. A simple nicotine test
strip may be all that is required for this verification.
Alternately, verification may require more complex tests
comprising: blood, expelled breath, hair, or urine taken for
analysis.
[0258] In some embodiments, the devices and methods of using the
modified risk product may be provided by, or subject eligibility
verified by, an accredited employee of a convenience or retail
store or by an employee of an accredited convenience or retail
store.
[0259] In still other situations, the product is prescribed,
provided, and or subject eligibility verified by an internet or
wireless based application, service or business. While in still
other situations the product may be prescribed, provided, or
subject eligibility verified by a call center or phone based
application service or business. The use of Skype or other real
time phone and internet services makes these verification and
prescribing services possible.
[0260] In any of the preceding examples, the prescribers or
providers of the modified risk product have been qualified to
deliver said modified risk product through a REMS compliance
verification program as illustrated in FIG. 2, which is typically
administered and controlled by a qualified independent party having
full authorization to qualify said providers and/or their employees
and to audit their internal systems for recordkeeping. Either the
facility employing the prescribers or providers or the individual
prescribers or providers themselves may be qualified and
audited.
[0261] In some embodiments, the subject eligibility verification
comprises providing a prescription from an accredited healthcare
provider, verifying a subject's identity, a minimum age for
eligibility, or verification of a prior nicotine replacement
therapy.
[0262] In other embodiments the subject eligibility verification
may comprise having the subject provide an 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, an
activation code, or an electronic dongle, electronic security key
fob, or the equivalent.
[0263] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, expelled breath samples, saliva samples, hair samples, and
in urine samples 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.
[0264] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0265] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0266] In some embodiments, the risk evaluation and mitigation
strategy (REMS) may incorporate a means of subject compliance
verification and or the subject's eligibility to participate in a
REMS program and have a modified risk product prescription. Subject
compliance is commonly used in clinical drug studies to verify the
concentration levels and patient compliance to protocols, among
other clinical study outcome measures. FIG. 7 illustrates one
possible configuration for such a REMS program wherein a subject's
eligibility to participate in a program is first verified prior to
being given a prescription, and the subject may be tested again at
a later date to demonstrate program compliance.
[0267] In other embodiments, the compliance verification or the
REMS program validation may comprise measuring maximum plasma
concentration (Cmax) of nicotine, compared to a cigarette, the
pharmacokinetic profile of the modified risk product to determine
the time required after administration of the product for nicotine
to reach maximum plasma concentration (Tmax), compared to a
cigarette, or alternatively, to determine the rate-of-increase of
nicotine delivery or concentration in the plasma of a subject
compared to a cigarette.
[0268] In still other embodiments, the compliance verification may
comprise measuring relative potential risk of the modified risk
product by comparing the nicotine concentration of the modified
risk product to other nicotine or tobacco products in the
market.
[0269] Some aspects of these methods may require physical tests
that must be performed to provide accurate and quantifiable data
wherein the subject must present themselves to a qualified
individual in order for the test to be completed. In some
embodiments, the subject compliance verification or the REMS
program validation testing is performed by a physician, a nurse, a
pharmacist, a phlebotomist, or an accredited healthcare provider
and the samples obtained are sent to a qualified lab for
analysis.
[0270] In other embodiments, subject compliance verification is
performed by an accredited employee of a convenience or retail
store, or an employee of an accredited convenience or retail store.
Such compliance tests would comprise verification of subject
identity and collection of saliva, hair, urine, or breath samples,
which could be forwarded to a qualified lab for analysis.
[0271] Alternatively, subject compliance or the REMS program
validation may be measured passively through the use of electronic
technology. One such example of this is illustrated in FIG. 6. In
this example, a device that is a component of modified risk system,
may comprise an electronic cigarette, an electronic pipe, an
electronic cigar, an electronic water pipe, or an electronic
vaporizer for delivering a nicotine-containing vapor, comprising a
battery, an atomizer, electronic circuitry, a memory storage device
for tracking components of usage activity, a means of memory
transfer, and a charging circuit, along with a charger base station
comprising a memory storage device, a means for receiving data from
said component device memory storage device and then having the
ability to transmit said data to a third party which passively
monitors the device and indirectly, the subject for compliance
based on the transmitted data.
[0272] The component device and the charging base would be
configured such that activation software would be required for
recognition of the specific device, keyed to said charger base.
This software could be embedded and matched to each component set
in a modified risk product, and be capable of interfacing with an
external device, wherein said external device comprises; a smart
phone, computer, electronic fob, electronic dongle and a Bluetooth
or wireless communication device, which would need to be within a
fixed range for activation and continued use.
[0273] Alternatively, the components could be configured with a
programmable code which must be entered periodically for
activation. Still further the components could be hard wired with a
timing circuit that requires periodic physical contact between the
components for activation.
[0274] In addition, the transmission of collected data could occur
over the internet via a hardwired or wireless connection through a
base computer device for analysis and validation by an accredited
healthcare professional or REMS monitor or administrator.
[0275] Provided herein is a method of protecting public health
comprising: increasing the likelihood that a first subject or a
second subject will stop using a tobacco product by providing a
modified risk product for administration to the first subject
addicted to the tobacco product only after at least one failed
attempt by the first subject to quit using such tobacco product.
These modified risk products comprise an electronic cigarette, an
electronic pipe, an electronic cigar, an electronic water pipe, an
electronic vaporizer, and/or a tobacco or nicotine product, used in
combination with a risk evaluation and mitigation strategy and may
involve subject eligibility verification, subject compliance
verification to a risk mitigation strategy and overall validation
of the success of said risk evaluation and mitigation strategy.
[0276] The previously failed attempt to quit using a tobacco
product commonly comprises abstinence, nicotine gum, nicotine oral
spray, nicotine inhaler, nicotine nasal spray, nicotine lozenge,
nicotine dermal patch, bupropion (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0277] In some embodiments of the method, the product is
prescribed, provided, administered, or a subject's eligibility is
verified by a physician, a nurse, a pharmacist, or an accredited
healthcare provider, as illustrated in FIG. 3.
[0278] In other embodiments, the product, which may be an OTC
product, is provided, administered, or subject eligibility verified
by an accredited employee of a convenience or retail store. In
still other embodiments, the product is provided, administered, or
a subject's eligibility is verified by an employee of an accredited
convenience or retail store.
[0279] In still other embodiments, the product which may be either
a prescription or OTC product, is provided, administered, or a
subject's eligibility is verified by an internet or wireless based
application, service or business. In still other embodiments of the
method the product is provided, administered, or a subject's
eligibility is verified by a call center or phone based application
service or business, using Skype or other real time phone and
internet services.
[0280] In some embodiments, the subject eligibility verification
comprises providing a prescription from an accredited healthcare
provider, verifying a subject's identity, a minimum age for
eligibility, or verification of a prior nicotine replacement
therapy.
[0281] In other embodiments the subject eligibility verification
may comprise having the subject provide an 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, an
activation code, or an electronic dongle, electronic security key
fob, or the equivalent.
[0282] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, expelled breath samples, saliva samples, hair samples, and
in urine samples 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.
[0283] In some embodiments, the risk evaluation and mitigation
strategy incorporates a means of subject compliance
verification.
[0284] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0285] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0286] In other embodiments, the compliance verification may
comprise measuring maximum plasma concentration (Cmax) of nicotine,
compared to a cigarette, the pharmacokinetic profile of the
modified risk product to determine the time required after
administration of the product for nicotine to reach maximum plasma
concentration (Tmax), compared to a cigarette, or alternatively, to
determine the rate-of-increase of nicotine delivery or
concentration in the plasma of a subject compared to a
cigarette.
[0287] In still other embodiments, the compliance verification may
comprise measuring relative potential risk of the modified risk
product by comparing the nicotine concentration of the modified
risk product to other nicotine products in the market. Analysis of
lab results and statistical analysis of subject outcomes would be
performed to provide regular reports to the manufacture(s) and the
FDA so that periodic evaluation of reports of patient responses to
treatment, medication/devices, and revisions to medication guides,
may be reassessed.
[0288] As mentioned previously, some aspects of these methods may
require physical tests that must be performed to verify subject
compliance or REMS validation wherein the subject must present
themself to a qualified individual in order for the test to be
completed. In some embodiments, the subject compliance verification
or REMS validation testing is performed by a physician, a nurse, a
pharmacist, a phlebotomist, or an accredited healthcare
provider.
[0289] In other embodiments, subject compliance verification is
performed by an accredited employee of a convenience or retail
store, or an employee of an accredited convenience or retail
store.
[0290] Provided herein is a method of protecting public health
comprising increasing the likelihood that a first subject or a
second subject will stop using a tobacco product by providing a
modified risk product for administration to the first subject
addicted to the tobacco product, only after the modified risk
product is prescribed to the first subject.
[0291] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0292] In some embodiments, the product is prescribed by a
physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0293] In some embodiments, the subject eligibility verification
comprises providing a prescription from an accredited healthcare
provider, verifying a subject's identity, a minimum age for
eligibility, or verification of a prior nicotine replacement
therapy.
[0294] In other embodiments the subject eligibility verification
may comprise having the subject provide an 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, an
activation code, or an electronic dongle, electronic security key
fob, or the equivalent.
[0295] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, expelled breath samples, saliva samples, hair samples, and
in urine samples 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.
[0296] In some embodiments, the risk evaluation and mitigation
strategy incorporates a means of subject compliance
verification.
[0297] In some embodiments, the subject compliance verification
comprises collecting and sending samples taken before and after
being provided a modified risk product, for analysis to an
accredited testing facility, and measuring the difference between
samples for nicotine levels in blood, expelled breath, saliva,
hair, and in urine.
[0298] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0299] In other embodiments, the compliance verification may
comprise measuring maximum plasma concentration (Cmax) of nicotine,
compared to a cigarette, the pharmacokinetic profile of the
modified risk product to determined the time required after
administration of the product for nicotine to reach maximum plasma
concentration (Tmax), compared to a cigarette, or alternatively, to
determine the rate-of-increase of nicotine delivery or
concentration in the plasma of a subject compared to a
cigarette.
[0300] In still other embodiments, the compliance verification may
comprise measuring relative potential risk of the modified risk
product by comparing the nicotine concentration of the modified
risk product to other nicotine products in the market. Analysis of
lab results and statistical analysis of subject outcomes would be
performed to provide regular reports to the manufacture(s) and the
FDA so that periodic evaluation of reports of patient responses to
treatment, medication/devices, and revisions to medication guides,
may be reassessed.
[0301] As mentioned previously, some aspects of these methods may
require physical tests that must be performed to verify subject
compliance or REMS validation wherein the subject must present
themself to a qualified individual in order for the test to be
completed. In some embodiments, the subject compliance verification
or REMS validation testing is performed by a physician, a nurse, a
pharmacist, a phlebotomist, or an accredited healthcare
provider.
[0302] In other embodiments, subject compliance verification is
performed by an employee of a convenience or retail store.
[0303] Provided herein is a method of protecting public health
comprising decreasing the likelihood that a second subject not
using a tobacco product will start using the tobacco product by
providing a modified risk product for administration to the first
subject addicted to the tobacco product wherein the first subject
has previously failed nicotine replacement therapy.
[0304] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy. In some embodiments, the
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 (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6,10-methano-6H-pyrazino [2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0305] In some embodiments, the product is prescribed by a
physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0306] In some embodiments, the subject eligibility verification
comprises providing a prescription from an accredited healthcare
provider, verifying a subject's identity, a minimum age for
eligibility, and/or verification of a previously failed prior
nicotine replacement therapy.
[0307] In other embodiments the subject eligibility verification
may comprise having the subject provide an 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, an
activation code, or an electronic dongle, electronic security key
fob, or the equivalent.
[0308] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, expelled breath samples, saliva samples, hair samples, and
in urine samples 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.
[0309] One such mitigation strategy is illustrated in FIG. 4. As
illustrated herein, the subject attempting to purchase or acquire a
controlled modified risk product would provide some form of
qualified proof that verifies they are qualified to obtain said
Modified Risk product and participate in the REMS. This purchase
verification requirement would typically comprises, a prescription
for a controlled substance in addition to a formal verification of
subject identity which may comprise a fingerprint, facial
recognition, retinal scan, or other biometric identification.
Alternatively the identification and verification may comprise
having the subject providing a code, a dongle, an electronic FOB,
or web registration, to name but a few methods.
[0310] In some embodiments, the product is provided or a subject's
eligibility is verified by a physician, a nurse, a pharmacist, an
accredited healthcare provider, an accredited employee of a
convenience or retail store, or an employee of an accredited
convenience or retail store.
[0311] In some embodiments, the product is prescribed, provided, or
subject eligibility verified by an internet or wireless based
application, service or business, or by a call center or phone
based application service or business. The use of Skype or other
real time phone and internet services makes these verification and
prescribing services possible.
[0312] In some embodiments, the subject compliance verification
comprises collecting and sending samples for analysis, taken before
and after being provided a modified risk product, and measuring the
difference between samples for nicotine levels in blood, expelled
breath, saliva, hair, and in urine.
[0313] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0314] In other embodiments, the compliance verification may
comprise measuring maximum plasma concentration (Cmax) of nicotine,
compared to a cigarette, the pharmacokinetic profile of the
modified risk product to determined the time required after
administration of the product for nicotine to reach maximum plasma
concentration (Tmax), compared to a cigarette, or alternatively, to
determine the rate-of-increase of nicotine delivery or
concentration in the plasma of a subject compared to a
cigarette.
[0315] In still other embodiments, the compliance verification may
comprise measuring relative potential risk of the modified risk
product by comparing the nicotine concentration of the modified
risk product to other nicotine products in the market. Analysis of
lab results and statistical analysis of subject outcomes would be
performed to provide regular reports to the manufacture(s) and the
FDA so that periodic evaluation of reports of patient responses to
treatment, medication/devices, and revisions to medication guides,
may be reassessed.
[0316] As mentioned previously, some aspects of these methods may
require physical tests that must be performed to verify subject
compliance or REMS validation wherein the subject must present
themself to a qualified individual in order for the test to be
completed. In some embodiments, the subject compliance verification
or REMS validation testing is performed by a physician, a nurse, a
pharmacist, a phlebotomist, or an accredited healthcare
provider.
[0317] In other embodiments, subject compliance verification is
performed by an accredited employee of a convenience or retail
store, or an employee of an accredited convenience or retail
store.
[0318] Provided herein is a method of protecting public health
comprising decreasing the likelihood that a second subject not
using a tobacco product will start using the tobacco product by
providing a modified risk product for administration to the first
subject addicted to the tobacco product only after at least one
failed attempt by the first subject to quit using such tobacco
product.
[0319] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, and overall validation of the success of said risk
evaluation and mitigation strategy.
[0320] In some embodiments, the 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 (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0321] In some embodiments, the product is prescribed, provided, or
subject eligibility verified by a physician, a nurse, a pharmacist,
an accredited healthcare provider, an accredited employee of a
convenience or retail store, or by an employee of an accredited
convenience or retail store.
[0322] In some embodiments, the product is prescribed, provided, or
subject eligibility verified by an internet or wireless based
application, service or business, or by a call center or phone
based application service or business. The use of Skype or other
real time phone and internet services makes these verification and
prescribing services possible.
[0323] In other embodiments, the product, which may be an OTC
product, is provided, administered, or a subject's eligibility is
verified by an accredited employee of a convenience or retail
store, or by an employee of an accredited convenience or retail
store.
[0324] In still other embodiments, the product which may be either
a prescription or OTC product, is provided, administered, or a
subject's eligibility is verified by an internet or wireless based
application, service or business, or by a call center or phone
based application service or business, using Skype or other real
time phone and internet services.
[0325] In some embodiments, the subject eligibility verification
comprises providing a prescription from an accredited healthcare
provider, verifying a subject's identity, a minimum age for
eligibility, or verification of a prior nicotine replacement
therapy.
[0326] In other embodiments the subject eligibility verification
may comprise having the subject provide an 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, an
activation code, or an electronic dongle, electronic security key
fob, or the equivalent.
[0327] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, expelled breath samples, saliva samples, hair samples, and
in urine samples 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. If a second subject has not been using
a tobacco product or alternative tobacco product comprising
nicotine, such samples would be negative and disqualify said second
subject from obtaining a modified risk under this criteria.
[0328] As previously described, another method of decreasing the
likelihood that a second subject not using a tobacco product, will
start using the tobacco product after a first addicted subject is
prescribed a modified use product after a previously failed attempt
to quit, could comprise the passive use of electronic technology.
One such example of this is illustrated in FIG. 5. In this example,
a device that is a component of a modified risk system, may
comprise an electronic cigarette, an electronic pipe, an electronic
cigar, an electronic water pipe, an electronic vaporizer, and/or a
tobacco or nicotine product, for delivering a nicotine-containing
vapor, comprising a battery, an atomizer, electronic circuitry, a
memory storage device for tracking various aspects of component
usage activity, a means of memory transfer, and a charging circuit,
along with a charger base station comprising a memory storage
device, a means for receiving data from said component device
memory storage device and comprising the means to transmit said
data to a third party which passively monitors the device and
indirectly, the subject, for compliance to the REMS based on the
transmitted data.
[0329] The component device would be configured such that
activation software acting as a user identification system would be
required for recognition of the specific device, keyed to said
charger base. This software could be embedded and matched to each
component set in a modified risk product, and be capable of
interfacing with an external device, wherein said external device
comprises; a smart phone, computer, electronic fob, electronic
dongle, a special ring, and/or a Bluetooth or wireless device,
which would need to be within a fixed range for activation and
continued use.
[0330] Alternatively, the device could be configured to have a
fingerprint or lip print reader on the body or mouthpiece that is
matched to the first subject.
[0331] Alternatively a special ring or wrist band worn on the hand
of the first subject or other article of jewelry could provide a
user identification system and be configured to mate with the
device, wherein the device will only activate if it is in the
immediate proximity of the subject's hand.
[0332] In any of the prior examples, the devices could be
configured with proximity sensors requiring the subject to be
within a fixed distance such as 20 feet, or ten feet, or more
preferably within five feet or less.
[0333] Alternatively, the components could be configured with a
programmable code which must be entered periodically for
activation. Still further the components could be hard wired with a
timing circuit that requires a minimal period of time between uses
for activation.
[0334] In addition, the device could be configured as shown in FIG.
6 with a base having hardware and software for the transmission of
collected data as previously described. In this example, the
modified risk product configuration could be used for user
verification, user compliance, or even validation of a REMS for a
modified risk product.
[0335] Provided herein is a method of protecting public health
comprising increasing the likelihood that a first subject or a
second subject will stop using a tobacco product by providing a
modified risk product for administration to the first subject
addicted to the tobacco product, only after the modified risk
product is prescribed to the first subject.
[0336] In some embodiments, the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0337] In some embodiments, the product is prescribed by a
physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0338] In some embodiments, the subject eligibility verification
comprises providing a prescription from an accredited healthcare
provider, verifying a subject's identity, a minimum age for
eligibility, or verification of a prior nicotine replacement
therapy.
[0339] In other embodiments the subject eligibility verification
may comprise having the subject provide an 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, an
activation code, or an electronic dongle, electronic security key
fob, or the equivalent.
[0340] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, expelled breath samples, saliva samples, hair samples, and
in urine samples 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.
[0341] In some embodiments, the product is administered by
physician, a nurse, a pharmacist, an accredited healthcare
provider, or an employee of a convenience or retail store.
[0342] In some embodiments, the product is administered by an
internet or wireless based application, service or business, or by
a call center or phone based application service or business. The
use of Skype or other real time phone and internet services makes
these verification and prescribing services possible
[0343] In some embodiments, the risk evaluation and mitigation
strategy incorporates a means of subject compliance
verification.
[0344] In some embodiments, the subject compliance verification
comprises collecting and sending samples for analysis, taken before
and after being provided a modified risk product, and measuring the
difference between samples for nicotine levels in blood, expelled
breath, saliva, hair, and in urine.
[0345] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0346] In other embodiments, the compliance verification may
comprise measuring maximum plasma concentration (Cmax) of nicotine,
compared to a cigarette, the pharmacokinetic profile of the
modified risk product to determine the time required after
administration of the product for nicotine to reach maximum plasma
concentration (Tmax), compared to a cigarette, or alternatively, to
determine the rate-of-increase of nicotine delivery or
concentration in the plasma of a subject compared to a
cigarette.
[0347] In still other embodiments, the compliance verification may
comprise measuring relative potential risk of the modified risk
product by comparing the nicotine concentration of the modified
risk product to other nicotine products in the market. Analysis of
lab results and statistical analysis of subject outcomes would be
performed to provide regular reports to the manufacture(s) and the
FDA so that periodic evaluation of reports of patient responses to
treatment, medication/devices, and revisions to medication guides,
may be reassessed.
[0348] As mentioned previously, some aspects of these methods may
require physical tests that must be performed to verify subject
compliance or REMS validation wherein the subject must present
themself to a qualified individual in order for the test to be
completed. In some embodiments, the subject compliance verification
or REMS validation testing is performed by a physician, a nurse, a
pharmacist, a phlebotomist, or an accredited healthcare
provider.
[0349] In other embodiments, subject compliance verification is
performed by an accredited employee of a convenience or retail
store, or an employee of an accredited convenience or retail
store.
[0350] In some embodiments, the risk evaluation and mitigation
strategy incorporates a passive means of subject compliance
verification.
[0351] As previously described, a device that is a component of a
modified risk system, may comprise an electronic cigarette, an
electronic pipe, an electronic cigar, an electronic water pipe, an
electronic vaporizer, and/or a tobacco or nicotine product, for
delivering a nicotine-containing vapor, comprising a battery, an
atomizer, electronic circuitry, a memory storage device for
tracking various aspects of component usage activity, a means of
memory transfer, and a charging circuit, along with a charger base
station comprising a memory storage device, a means for receiving
data from said component device memory storage device and
comprising the means to transmit said data to a third party which
monitors the device and indirectly, the subject, for compliance to
the REMS based on the transmitted data.
[0352] The component device would be configured such that
activation software acting as a user identification system would be
required for recognition of the specific device, keyed to said
charger base. This software could be embedded and matched to each
component set in a modified risk product, and be capable of
interfacing with an external device, wherein said external device
comprises; a smart phone, computer, electronic fob, electronic
dongle, and a Bluetooth or wireless device, which would need to be
within a fixed range for activation and continued use.
[0353] Alternatively, the device could be configured to have a
fingerprint or lip print reader on the body or mouthpiece that is
matched to the first subject.
[0354] Alternatively a special ring or wrist band worn on the hand
of the first subject or other article of jewelry or clothing could
provide a user identification system and be configured to mate with
the device, wherein the device will only activate if it is in the
immediate proximity of the subject's hand or the subject.
[0355] In any of the prior examples, the devices could be
configured with proximity sensors requiring the subject to be
within a fixed distance such as 20 feet, or ten feet, or more
preferably within five feet or less.
[0356] Alternatively, the components could be configured with a
programmable code which must be entered periodically for
activation. Still further the components could be hard wired with a
timing circuit that requires a minimal period of time between uses
for activation.
[0357] In addition, the device could be configured as shown in FIG.
6 with a base having hardware and software for the transmission of
collected data as previously described.
[0358] Provided herein is a method of treating a first subject
addicted to a tobacco product, the method comprising administering
to the first subject who has previously failed nicotine replacement
therapy, a modified risk product.
[0359] In some embodiments the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0360] In some embodiments the previously failed nicotine
replacement therapy comprises abstinence, nicotine gum, nicotine
oral spray, nicotine inhaler, nicotine nasal spray, nicotine
lozenge, nicotine dermal patch, bupropion (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0361] In some embodiments, the product is administered by a
physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0362] In some embodiments, the product is administered by or an
employee of a convenience or retail store.
[0363] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0364] In some embodiments, the subject compliance verification
comprises collecting and sending samples for analysis, taken before
and after being provided a modified risk product, and measuring the
difference between samples for nicotine levels in blood, expelled
breath, saliva, hair, and in urine.
[0365] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0366] In some embodiments, the subject compliance verification
comprises collecting samples and measuring nicotine levels in blood
samples, measuring nicotine levels in expelled breath samples,
measuring nicotine levels in saliva samples, measuring nicotine
levels in hair samples, and measuring nicotine levels in urine
samples.
[0367] In some embodiments, the subject compliance verification is
performed by a physician, a nurse, a pharmacist, or an accredited
healthcare provider.
[0368] In some embodiments, the subject compliance verification is
performed by or an employee of a convenience or retail store.
[0369] Provided herein is a method of treating a first subject
addicted to a tobacco product, the method comprising administering
to the first subject a modified risk product only after at least
one failed attempt by the first subject to quit using such tobacco
product.
[0370] In some embodiments the modified risk product comprises; an
electronic cigarette, an electronic pipe, an electronic cigar, an
electronic water pipe, an electronic vaporizer, and/or a tobacco or
nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0371] In some embodiments the previously failed nicotine
replacement therapy comprises abstinence, nicotine gum, nicotine
oral spray, nicotine inhaler, nicotine nasal spray, nicotine
lozenge, nicotine dermal patch, bupropion (which includes
3-chloro-N-tert-butyl-.beta.-ketoamphetamine, a derivative thereof,
an analogue thereof, a bupropion metabolite, a pharmaceutically
acceptable salts thereof, R,R-hydroxybupropion,
S,S-hydroxybupropion, threo-hydrobupropion, erythro-hydrobupropion,
1-(3-chlorophenyl)-2-[(1,1dimethyl) amino]-1-propanone
hydrochloride,
2-(3-chlorophenyl)-2-hydroxy-3,5,5-trimethyl-morpholinol,
1-(3-chlorophenyl)-2-[(1,1-dimethylethanol)amino]-1-propanol and
1-(3-chlorophenyl)-2-[(1,1-dimethyl ethanol)amino]-1-propanone or
combinations thereof), varenicline or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino [2,3-h][3]benzazepine
or a pharmaceutically acceptable salt thereof, varenicline tartrate
or 7,8,9, 10-tetrahydro-6, 10-methano-6H-pyrazino[2,3-h] [3]
benzazepine, (2i?,3/?)-2,3-dihydroxybutanedioate (1:1) or
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine
tartrate or a pharmaceutically acceptable salt thereof, or
comparable oral nicotine replacement product. Varenicline is sold
by Pfizer under the brand name CHANTIX.RTM..
[0372] In some embodiments, the product is administered by a
physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0373] In some embodiments, the product is administered by an
employee of a convenience or retail store.
[0374] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0375] In some embodiments, the subject compliance verification
comprises collecting and sending samples for analysis, taken before
and after being provided a modified risk product, and measuring the
difference between samples for nicotine levels in blood, expelled
breath, saliva, hair, and in urine.
[0376] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0377] In some embodiments, the subject compliance verification
comprises collecting samples and measuring nicotine levels in blood
samples, measuring nicotine levels in expelled breath samples,
measuring nicotine levels in saliva samples, measuring nicotine
levels in hair samples, and measuring nicotine levels in urine
samples.
[0378] In some embodiments, the subject compliance verification is
performed by a physician, a nurse, a pharmacist, or an accredited
healthcare provider.
[0379] In some embodiments, the subject compliance verification is
performed by an employee of a convenience or retail store.
[0380] Provided herein is a method of treating a first subject
addicted to a tobacco product, the method comprising administering
a modified risk product to the first subject only after the
modified risk product is prescribed to the first subject.
[0381] In some embodiments, said modified risk product comprises;
an electronic cigarette, an electronic pipe, an electronic cigar,
an electronic water pipe, an electronic vaporizer, and/or a tobacco
or nicotine product, used in combination with a risk evaluation and
mitigation strategy and may involve subject eligibility
verification, subject compliance verification to a risk mitigation
strategy and overall validation of the success of said risk
evaluation and mitigation strategy.
[0382] In some embodiments, the modified risk product is prescribed
and administered by a physician, a nurse, a pharmacist, or an
accredited healthcare provider.
[0383] In some embodiments, the product is administered by an
accredited employee of a convenience or retail store, or an
employee of an accredited convenience or retail store.
[0384] In some embodiments, the product is administered by an
internet or wireless based application, service or business.
[0385] In some embodiments, the product is administered by a call
center or phone based application service or business.
[0386] In some embodiments, the subject eligibility verification
comprises collecting samples and measuring nicotine levels in blood
samples, in expelled breath samples, in saliva samples, in hair
samples, and in urine samples 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.
[0387] In some embodiments, the subject compliance verification
comprises collecting and sending samples for analysis, taken before
and after being provided a modified risk product, and measuring the
difference between samples for nicotine levels in blood, expelled
breath, saliva, hair, and in urine.
[0388] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0389] In some embodiments, the subject compliance verification
comprises collecting samples and measuring nicotine levels in blood
samples, measuring nicotine levels in expelled breath samples,
measuring nicotine levels in saliva samples, measuring nicotine
levels in hair samples, and measuring nicotine levels in urine
samples.
[0390] In some embodiments, the subject compliance verification is
performed by a physician, a nurse, a pharmacist, or an accredited
healthcare provider.
[0391] In some embodiments, the subject compliance verification is
performed by an employee of a convenience or retail store.
[0392] Provided herein is a method for increasing the likelihood
that the first subject or a second subject will stop using the
tobacco product.
[0393] In some embodiments, the subject compliance verification
comprises collecting and sending samples for analysis, taken before
and after being provided a modified risk product, and measuring the
difference between samples for nicotine levels in blood, expelled
breath, saliva, hair, and in urine.
[0394] In some embodiments, components of the subject compliance
verification may be performed by a physician, a nurse, a
pharmacist, an accredited healthcare provider, or an employee of a
convenience or retail store.
[0395] In other embodiments, the compliance verification may
comprise measuring maximum plasma concentration (Cmax) of nicotine,
compared to a cigarette, the pharmacokinetic profile of the
modified risk product to determined the time required after
administration of the product for nicotine to reach maximum plasma
concentration (Tmax), compared to a cigarette, or alternatively, to
determine the rate-of-increase of nicotine delivery or
concentration in the plasma of a subject compared to a
cigarette.
[0396] In still other embodiments, the compliance verification may
comprise measuring relative potential risk of the modified risk
product by comparing the nicotine concentration of the modified
risk product to other nicotine products in the market. Analysis of
lab results and statistical analysis of subject outcomes would be
performed to provide regular reports to the manufacture(s) and the
FDA so that periodic evaluation of reports of patient responses to
treatment, medication/devices, and revisions to medication guides,
may be reassessed.
[0397] As a result of having performed the compliance verification
testing, subjects are more likely to be interested in the outcomes
and act on those results, including increasing the likelihood that
the first subject or a second subject will stop using the tobacco
product.
[0398] Provided herein is a method for decreasing the likelihood
that a second subject not using the tobacco product will start
using the tobacco product. FIGS. 4 and 5 are both illustrations of
how a second user would be prevented from acquiring and using a
modified risk tobacco product, hence, reducing the likelihood of
starting to use the tobacco product.
[0399] Provided herein is a method for verifying the at least one
prior failed attempt to stop using tobacco products prior to the
modified risk product being provided to a first subject.
[0400] Provided herein is a method for verifying that a first
subject meets at least one eligibility requirement for use of a
modified tobacco risk product, as illustrated by FIGS. 3A &
3B.
[0401] Provided herein is a method for verifying a subject's
eligibility requirement comprising: possession of an eligibility
card, meeting qualifications for the eligibility card, possessing a
valid verification code, possessing a physician-provided
eligibility record, possessing a pharmacist-provided eligibility
record, passing a pharmacist-provided eligibility evaluation, as
illustrated by FIG. 4.
[0402] In some embodiments of a method having an eligibility
requirement, the identity verification step comprises at least one
of: [0403] evidence of a minimum age requirement, [0404] evidence
of a previously failed nicotine replacement therapy, and [0405]
evidence of a at least one failed attempt by the patient to quit
using such tobacco product, [0406] electronic or telephonic
verification of a unique subject eligibility card or code
identifier, [0407] software verification of a unique subject
eligibility card or code identifier, [0408] electronic fingerprint
verification of an eligible subject, [0409] an activation code, or
[0410] an electronic dongle, electronic security key fob, or
equivalent.
[0411] Provided herein is a method for verifying a subject's
eligibility requirement wherein the verifying step is performed by
a physician, a nurse, a pharmacist, or an accredited healthcare
provider.
[0412] In some embodiments, the verifying a subject's eligibility
requirement is performed by an accredited employee of a convenience
or retail store, or by an employee of an accredited convenience or
retail store.
[0413] In some embodiments, the verifying a subject's eligibility
requirement is performed by an internet or wireless based
application, service or business.
[0414] In some embodiments, the verifying a subject's eligibility
requirement is performed by an internet or wireless based
application, service or business.
[0415] Provided herein is a method for providing a prescription for
a modified risk product, wherein said prescription is provided by a
qualified healthcare provider.
[0416] Provided herein is a method of monitoring compliance of a
first subject addicted to a tobacco product, and provided with a
modified risk product, the method comprising, measuring nicotine
levels of a first subject prior to administration of said modified
risk product and routine measurement after administration of said
modified risk product, and comparing said prior nicotine levels to
anticipated nicotine levels of the first subject after
administration of said modified risk product.
[0417] In some embodiments the method of monitoring compliance
comprises; measuring nicotine levels in blood samples, measuring
nicotine levels in expelled breath samples, measuring nicotine
levels in saliva or urine samples, as illustrated in FIG. 7, or
measuring nicotine levels in hair samples.
[0418] Provided herein is a method of monitoring compliance of a
first subject addicted to a tobacco product, and provided with a
modified risk product, the method comprising, measuring nicotine
levels consumed by a first subject prior to administration of said
modified risk product and routine measurement of nicotine levels
consumed after administration of said modified risk product, and
comparing said prior nicotine levels to anticipated nicotine levels
of the first subject after administration of said modified risk
product. Numerous methods can be devised as evidence herein, and
further illustrated by one example as shown in FIG. 6.
[0419] In some embodiments, a method of monitoring comprises; using
an electronic signature to track the pattern of use of a vaporizer,
electronic cigarette, or other modified risk product wherein said
product transmits a record of use over a given period of time.
[0420] In some embodiments, a record of use comprises levels of
nicotine consumed, times, and dates it was consumed.
[0421] In some embodiments, the record of use is stored to a data
storage device and later downloaded for use by a qualified
healthcare provider.
[0422] In some embodiments, the record of use is transmitted
wirelessly to a data storage device and later downloaded for use by
a qualified healthcare provider.
[0423] In some embodiments, the record of use is stored within the
device, and later downloaded for use by a qualified healthcare
provider.
[0424] Provided herein is a method of monitoring the use of a
modified risk product by a first subject addicted to a tobacco
product, the method comprising, requiring an identification
recognition system be activated before use of a modified risk
product can take place.
[0425] In some embodiments, the identification recognition system
comprises, a fingerprint scanner, a lip print scanner, face
recognition, a retinal scan, a combination code, an activation
code, security key fob, or dongle.
[0426] In some embodiments, the identification recognition system
comprises an electronic application for a smartphone, laptop,
desktop, or tablet computing device, capable of communicating with
the modified risk product by a Bluetooth or wireless communication
system.
[0427] In some embodiments, the identification recognition system
must be within a fixed distance of the modified risk product for
product to continue to work.
[0428] In some embodiments, the identification recognition system
must be within 20 feet of the modified risk product.
[0429] In some embodiments, the identification recognition system
must be within 10 feet of the modified risk product.
[0430] In some embodiments, the identification recognition system
must be within 5 feet of the modified risk product.
[0431] Provided herein is a method of risk mitigation wherein the
potential risk of misuse or abuse of a modified risk product may be
present and require a distinct form of compliance monitoring.
[0432] For example, an addicted subject may continue to use the
first tobacco product after being provided the modified risk
product, thus increasing the potential risk for one or more tobacco
related diseases or exposure to one or more harmful substances.
[0433] In some embodiments, monitoring for misuse or abuse of a
modified risk product comprises measuring nicotine levels consumed
by a first subject prior to administration of said modified risk
product and routine measurement of nicotine levels consumed after
administration of said modified risk product, and comparing said
prior nicotine levels to anticipated nicotine levels of the first
subject after administration of said modified risk product.
[0434] For example, if an investigator suspected that the subject
was continuing to use cigarettes after receiving a modified risk
product, the results of additional nicotine in the subject's system
would be a relatively simple calculation. An example of this
calculation could be: [Nicotine or cotinine from
cigarettes]=[amount measured in blood or saliva]-[amount reported
as dispensed by modified risk device]. It is understood that a
similar calculation could be derived from any comparable
nicotine/cotinine test regardless of the testing method, provided
testing methods were consistent and/or interchangeable.
[0435] In some embodiments, multiple compliance verification and
tracking systems could be combined and randomly or non-randomly
applied as part of a REMS program. For example, results of a
subject's nicotine level testing could be compared to prior results
(FIG. 7), in addition to remotely monitoring transmitted usage
patterns of the modified risk product (FIG. 6). Upon comparison, a
skilled health professional could determine if abuse or misuse is
potentially occurring.
[0436] Provided herein is a method of protecting the public health
comprising increasing the likelihood that a first subject or a
second subject will stop using a tobacco product by providing a
modified risk product for administration to the first subject
addicted to the tobacco product wherein the modified risk product
provides a faster onset of nicotine delivery, or a higher peak
level of nicotine delivery.
[0437] Provided herein is a method of risk mitigation wherein the
potential risk of misuse or abuse of a modified risk product is
ranked or stratified in comparison to other tobacco products.
[0438] In some embodiments, the relative potential risk of the
modified risk product is determined by comparing the
pharmacokinetic profile of the modified risk product to
nicotine.
[0439] In some embodiments the pharmacokinetic profile of the
modified risk product is determined by the maximum plasma
concentration (Cmax) of nicotine, compared to a cigarette.
[0440] In some embodiments the pharmacokinetic profile of the
modified risk product is determined by the time after
administration of the product for nicotine to reach maximum plasma
concentration (Tmax), compared to a cigarette.
[0441] In some embodiments the pharmacokinetic profile of the
modified risk product is determined by the rate-of-increase of
nicotine delivery or concentration in the plasma of a subject
compared to a cigarette.
[0442] In some embodiments, the relative potential risk of the
modified risk product is determined by comparing the nicotine
concentration of the modified risk product other nicotine products
in the market.
[0443] In some embodiments, the relative potential risk of the
modified risk product is ranked by ease of access associated with
the prescriber/administrator.
[0444] In some embodiments, the relative potential risk of the
modified risk product is ranked by ease of access through various
distribution channels.
[0445] In some embodiments the modified risk product comprises
vaporizing tobacco leaves or finely chopped tobacco below their
pyrolytic temperature.
[0446] In some embodiments the modified risk product comprises
heating tobacco leaves or finely chopped tobacco below their
pyrolytic temperature.
[0447] In some embodiments the modified risk product comprises
vaporization of a nicotine salt.
[0448] In some embodiments the modified risk product comprises
heating of a nicotine salt below its pyrolytic temperature.
[0449] Provided herein is a method of validating the effectiveness
of a modified risk product used with a Risk Evaluation and
Mitigation Strategy comprising: collecting and sending a subject's
samples taken before and after being provided a modified risk
product, for analysis to an accredited testing facility, measuring
the difference between samples for nicotine levels in blood,
expelled breath, saliva, hair, and/or urine, and performing an
appropriate analysis to determine if the modified risk product met
the goals of the Risk Evaluation and Mitigation Strategy.
[0450] In some embodiments, components of the validation process
may be performed by a physician, a nurse, a pharmacist, an
accredited healthcare provider, or an employee of a convenience or
retail store or an accredited testing facility.
[0451] Provided herein is a method of protecting the public health
wherein the provider of a modified risk product is subject to a
compliance verification system.
[0452] In some embodiments, the provider verification is performed
by an independent auditor.
[0453] Provided herein is a system for verification, tracking, and
reporting use of a modified risk product comprising: an electronic
cigarette, an electronic pipe, an electronic cigar, an electronic
water pipe, an electronic vaporizer, and a tobacco or nicotine
product, comprising a battery, an atomizer, electronic circuitry, a
memory storage device for tracking components of usage activity, a
means of memory transfer, and a charging circuit, a charger base
station comprising a memory storage device, a means for receiving
data from said modified risk product memory storage device and
transmitting said data to a third party, activation software for
recognition of a specific device, keyed to said charger base,
capable of interfacing with an external device, wherein said
external device comprises; a smart phone, computer, electronic fob,
electronic dongle, and a Bluetooth or wireless device.
[0454] In some embodiments, the system is used in combination with
a risk evaluation and mitigation strategy.
[0455] In some embodiments, the system comprises activation means,
for recognition and verification of a subject to establish user
eligibility prior to use.
[0456] In some embodiments, the system comprises activation means,
for recognition and verification of a subject to establish user
eligibility prior to use.
[0457] In some embodiments, the system is used to verify subject
compliance for use of a modified risk product. In some embodiments
the system comprises a means for validating overall success of the
risk mitigation product when used with the risk evaluation and
mitigation strategies
[0458] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
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