U.S. patent application number 10/429766 was filed with the patent office on 2004-11-11 for kit for pharmaceuticals.
This patent application is currently assigned to Barr Laboratories, Inc.. Invention is credited to Niemann, Amy C..
Application Number | 20040222123 10/429766 |
Document ID | / |
Family ID | 33416115 |
Filed Date | 2004-11-11 |
United States Patent
Application |
20040222123 |
Kind Code |
A1 |
Niemann, Amy C. |
November 11, 2004 |
Kit for pharmaceuticals
Abstract
The present invention is directed towards a kit to accompany a
supply of a long-term use pharmaceutical. The kit includes at least
a supply of a long-term use pharmaceutical, printed matter, and a
pre-recorded media device. The kit may also include a planner and a
reminder tool. The present invention also includes a container for
storing at least the supply of the long-term use pharmaceutical,
the printed matter, and the pre-recorded media device.
Inventors: |
Niemann, Amy C.; (Point
Pleasant, NJ) |
Correspondence
Address: |
STERNE, KESSLER, GOLDSTEIN & FOX PLLC
1100 NEW YORK AVENUE, N.W.
WASHINGTON
DC
20005
US
|
Assignee: |
Barr Laboratories, Inc.
|
Family ID: |
33416115 |
Appl. No.: |
10/429766 |
Filed: |
May 6, 2003 |
Current U.S.
Class: |
206/570 |
Current CPC
Class: |
A61J 2205/30 20130101;
A61J 2205/70 20130101; A61J 2205/50 20130101; A61J 7/04 20130101;
A61J 7/0481 20130101 |
Class at
Publication: |
206/570 |
International
Class: |
B65D 069/00 |
Claims
What is claimed is:
1. A kit to accompany a supply of a long-term use pharmaceutical,
comprising: a supply of a long-term use pharmaceutical; printed
matter; a pre-recorded media device; a planner; a reminder tool;
and a container for storing at least said supply of said long-term
use pharmaceutical, said printed matter, said pre-recorded visual
media device, said planner, and said reminder tool.
2. The kit of claim 1, wherein said printed matter is one of a
book, booklet, brochure or leaflet.
3. The kit of claim 1, wherein said pre-recorded media device is
one of a DVD, a videotape cassette, a CD-ROM, an audiocassette or
an audio compact disk.
4. The kit of claim 1, wherein said planner is one of a weekly
planner, a monthly planner, a multi-month planner, a yearly
planner, or a multi-year planner.
5. The kit of claim 1, wherein said reminder tool is one of a
magnet, a permanent sticker, a removable sticker, an alarm, a
watch, a clock or a calendar.
6. The kit of claim 1, wherein said container is a bag, a box or an
envelope.
7. The kit of claim 1, wherein said long-term use pharmaceutical is
a hormonal agent.
8. The kit of claim 7, wherein said hormonal agent is an oral
contraceptive.
9. The kit of claim 8, wherein said oral contraceptive is designed
for a regimen longer than a conventional 28-day regimen.
10. The kit of claim 9, wherein said oral contraceptive is designed
for a 91-day regimen.
11. The kit of claim 1, wherein said supply is at least one package
comprising more than one daily dose of said long-term use
pharmaceutical.
12. The kit of claim 1, wherein said supply is at least one
administrative device for continuous release of said long-term use
pharmaceutical.
13. The kit of claim 1, wherein said container comprises an
identifying means permanently affixed to an exterior of said
container.
14. A kit to accompany a supply of a hormonal agent, comprising: a
supply of said hormonal agent; printed matter; and a pre-recorded
media device.
15. The kit of claim 14, wherein said hormonal agent is an oral
contraceptive.
16. The kit of claim 15, wherein said oral contraceptive is
designed for a regimen longer than a conventional 28-day
regimen.
17. The kit of claim 16, wherein said oral contraceptive is
designed for a 91-day regimen.
18. The kit of claim 14, wherein said printed matter is one of a
book, booklet, brochure or leaflet.
19. The kit of claim 14, wherein said pre-recorded media device is
one of a DVD, a videotape cassette, a CD-ROM, an audiocassette or
an audio compact disk.
20. The kit of claim 14, wherein said supply is at least one
package comprising more than one daily dose of said hormonal
agent.
21. The kit of claim 14, wherein said supply is at least one
administrative device for continuous release of said hormonal
agent.
22. The kit of claim 14, further comprising one or more components
selected from the group comprising a planner, a reminder tool and a
container.
23. The kit of claim 22, wherein said planner is one of a weekly
planner, a monthly planner, a multi-month planner, a yearly
planner, or a multi-year planner.
24. The kit of claim 22, wherein said reminder tool is one of a
magnet, a permanent sticker, a removable sticker, an alarm, a
watch, a clock or a calendar.
25. The kit of claim 22, wherein said container is a bag, a box or
an envelope.
26. The kit of claim 22, wherein said container comprises an
identifying means permanently affixed to an exterior of said
container.
27. A kit to accompany a supply an oral contraceptive, comprising:
a supply of an oral contraceptive; printed matter; a pre-recorded
videotape cassette; a planner; a reminder tool; and a bag for
storing at least said supply of an oral contraceptive, said printed
matter, said pre-recorded videocassette, said planner, and said
reminder tool.
28. The kit of claim 27, wherein said oral contraceptive is
designed for a regimen longer than a conventional 28-day
regimen.
29. The kit of claim 28, wherein said oral contraceptive is
designed for a 91-day regimen.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention is related to a kit to be provided to
patients with a supply of a long-term pharmaceutical regimen.
[0003] 2. Background Art
[0004] The pharmaceutical industry has long provided physicians
with samples of prescription medication for them to distribute to
patients. This is especially true when the intent is for the
patient to enter into or continue a long-term regimen for taking
the pharmaceutical or if the patient has been using the
pharmaceutical for a period of time. For example, a physician may
give patients with arthritis, a disease for which there is no cure,
samples of pain relieving medication. The pain medication may be
one that the patient will use or has used for an extended period of
time. Likewise, oral contraceptives are often provided to female
patients in the form of a sample. Oral contraceptives are also
designed to be used for an extended period of time.
[0005] Different pharmaceuticals may be packaged in differing
amounts. A typical sample provided by a physician will have a
sufficient supply of the pharmaceutical for the patient to observe
any side effects and/or benefits thereof. Thus, depending upon the
type of pharmaceutical and the number of packages a physician gives
away, it may be several weeks to several months that a patient is
taking a pharmaceutical without returning to a physician's
care.
[0006] This is especially true for oral contraceptives and other
hormone therapies. For example, conventional oral contraceptive
regimens typically include daily doses of a pharmaceutical that
includes the active ingredient for three weeks and daily doses of a
placebo for one week, produced in 28-day supply packages. These
conventional oral contraceptive regimens have repeating 28-day
cycles. In a few 28-day cycles, any side effects and/or benefits
will be known and can quickly be addressed by a physician.
[0007] Recently, new oral contraceptive regimens have been
developed with cycles much longer than 28-days. For example, one
oral contraceptive regimen directs the patient towards taking a
pharmaceutical including the active ingredients continuously for
twelve weeks and either no pharmaceutical, a placebo or a
pharmaceutical including a variation of or different active
ingredients the following week, in order to reduce the number of
menstruation cycles a year from thirteen to four. A typical package
of a new oral contraceptive regimen may contain a thirteen-week
(91-day) supply. Thus, any side effects and/or benefits will not be
known within the first few months. Instead, it may take a few
cycles before the side effects and/or benefits of taking the oral
contraceptive are discovered and addressed by a physician. A
patient may be taking the oral contraceptive for up to six
months.
[0008] Other long-term treatment regimens may require several
months before any noticeable benefits and/or undesirable side
effect can be realized. For example, patients on replacement
hormone therapy such as post-menopausal estrogen supplements,
thyroid hormone replacement medications, anti-depressant
medications or any other pharmaceuticals prescribed for long-term
use may have to become accustomed to taking the medication on a
regular basis without immediately noticing any side effects and/or
experiencing any benefits.
[0009] Therefore, what is needed is a kit to accompany a supply of
a pharmaceutical, which is intended for use over an extended period
of time. In particular, what is needed is a kit, which includes
information to help patients acclimate to and comply with a
long-term pharmaceutical regimen.
BRIEF SUMMARY OF THE INVENTION
[0010] The present invention is directed towards a kit to accompany
a supply of a long-term use pharmaceutical. The kit includes a
supply of a long-term use pharmaceutical, printed matter, and a
pre-recorded media device. Further, the kit may include a planner
and/or a reminder tool. The present invention also includes a
container for one or more of the supply of the long-term use
pharmaceutical, the printed literature, the pre-recorded media
device, the planner, and the reminder tool.
[0011] The printed matter may be, for example, one of a book,
booklet, brochure or leaflet. The pre-recorded media device may be,
for example, one of a DVD, a videotape cassette, a CD-ROM,
audiocassette, audio compact disk, or software application. The
planner may be, for example, one of a weekly planner, a monthly
planner, a multi-month planner, a yearly planner, or a multi-year
planner. The reminder tool may be, for example, one of a magnet, a
permanent sticker, a removable sticker, an alarm, a clock or a
calendar. The container may be, for example, a bag, a box or an
envelope and may have a logo permanently printed on its
exterior.
[0012] The long-term use pharmaceutical may be, for example, a
hormonal agent or oral contraceptive. In particular, it may be a
hormonal agent or an oral contraceptive designed to be taken in a
regimen that includes longer than 28-day cycles.
[0013] The supply may be any package having more than one daily
dose of the long-term use pharmaceutical. Alternatively, the supply
may be one cycle of a particular pharmaceutical regimen or one or
more continuous release devices of the particular pharmaceutical.
The appropriate supply would vary depending upon the particular
pharmaceutical.
[0014] Preferably, the present invention is directed towards a kit
that includes a supply of an oral contraceptive to be used in a
regimen that has cycles longer than 28-days.
[0015] More preferably, the present invention is directed towards a
kit to accompany a supply of a long-term use pharmaceutical,
including at least a 91-day supply of an oral contraceptive
designed for a twelve-week daily dose of active ingredients
followed by a one week daily does of a placebo or a pharmaceutical
including a variation of or different active ingredient; a printed
brochure; a videotape; a yearly planner; and a reminder tool. The
present invention also includes a bag for containing the at least a
91-day supply of an oral contraceptive, the printed brochure, the
videotape, the yearly planner, and a reminder tool.
[0016] Further embodiments, features, and advantages of the present
invention, as well as the structure and operation of the various
embodiments of the present invention, are described in detail
below.
BRIEF DESCRIPTION OF THE DRAWING
[0017] FIG. 1 is a schematic diagram of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0018] The present invention is directed towards a kit 10 that
includes many of the items necessary to inform, protect and
familiarize or refamiliarize a patient with a long-term
pharmaceutical and is intended to accompany a supply of the
pharmaceutical. Kit 10 may provide information on, for example,
dosage amounts, what to do if a dosage is missed or skipped, how to
administer the pharmaceutical, advice on how to incorporate the
pharmaceutical into the patient's daily life, information on any
expected side effects or reactions, information on human anatomy
and physiology and/or the way the pharmaceutical works thereon and
other information that may be outside the scope of information
provided by a physician or by the standard pharmaceutical insert or
labels.
[0019] The types of pharmaceuticals for which a patient may need
this extra information are those that are particularly suited for
long-term use. This type of pharmaceutical includes one intended
for the treatment or relief from chronic illnesses, syndromes or
diseases, such as diabetes, AIDS, cancer, Chronic Fatigue Syndrome,
heart disease, neurological diseases, arthritis or any other
illness that has a duration of several months to several years.
This type of pharmaceutical also includes pharmaceuticals designed
to be taken over several months or several years such as hormone
replacement therapy, contraceptives, and others. Particularly, kit
10 of the present invention is for patients who are required to
administer one or more dosages of pharmaceuticals on a daily,
weekly or monthly basis for an extended period of time. Kit 10 is
also suitable for patients that are using alternative
administration devices for continuous dosage regimens, such as
long-wearing patches, vaginal rings, implanted devices or other
time-release pharmaceuticals.
[0020] Kit 10 of the present invention was designed for
distribution along with an oral contraceptive. Kit 10 is
particularly designed for an oral contraceptive regimen, which is
administered in a cycle that lasts longer than a conventional
28-days regimen. For example, kit 10 may be used with an oral
contraceptive regimen in which a daily dose of the contraceptive is
administered in a 91-day cycle, in which the active ingredients of
the oral contraceptive are taken for 81-89 days (preferably 84
days) consecutively and no active ingredients, a placebo or a
variation of or different active ingredients are administered 2-10
days (preferably 7 days) after the 81-89 days. This type of oral
contraceptive is typically sold in packages containing at least
enough daily dosages for thirteen weeks. The oral contraceptive
regimen may include a monophasic, biphasic or triphasic
regimen.
[0021] The present invention would also be suitable for a supply of
any type of oral contraceptive (such as a long or short-term
regimen) or any other pharmaceutical of the type described above.
Further, kit 10 of the present invention would be suitable for
pharmaceuticals that are not orally administered. For example,
pharmaceuticals are often delivered via an implanted device, a
vaginal ring, a transdermal patch or other alternative delivery
method. Any pharmaceutical which is patient administered, monitored
and replaced would be perfectly suitable to kit 10 of the present
invention. One skilled in the relevant art would understand that
kit 10 of the present invention would be suitable for a variety of
pharmaceuticals.
[0022] Kit 10 of the present invention includes a supply 12 of the
particular pharmaceutical. Supply 12 may be offered and delivered
as a sample by a physician or it may be prescribed and delivered by
a pharmacist and/or pharmacy. What constitutes supply 12 will vary
depending upon the particular pharmaceutical to be administered.
For example, oral contraceptives are conventionally sold in a
4-week supply package, with a daily pill to be taken for 28 days.
Thus, supply 12 of these pills may be one or more packages of a
one-month supply. However, for an oral contraceptive regimen that
provides a daily pill for thirteen weeks, supply 12 would be one or
more packages of a 91-day supply. Supply 12 may also be, for
example, one or more administrative devices for continuous release
of the particular pharmaceutical, such as a vaginal ring or a
patch.
[0023] Although some of the advantages of kit 10 of the present
invention are for those who are unfamiliar with a certain long-term
use pharmaceutical, a physician may also distribute or prescribe
kit 10 of the present invention to a long-standing user. It would
be particularly useful to a long-standing user if the patient has
developed additional questions or concerns after extended use.
Further, information contained in kit 10 of the present invention
may not have been available to the patient at the time he or she
began the pharmaceutical regimen.
[0024] Kit 10 of the present invention further preferably includes
printed matter 13, namely, printed literature. Preferably, the
focus of printed matter 13 is different from the information
typically available to a patient via a conventional package insert
or label. However, printed literature could display similar
information in a more convenient and user friendly format. For
example, it could be a bullet pointed list, a list of frequently
asked questions (FAQ), a chart, or information in some other easy
to read format. For example, the information to be imparted to the
patient could be illustrated in non-textual terms using pictures,
graphics, or other symbols. Printed matter 13 may be provided in
the form of a book, booklet, brochure, leaflet or any other
suitable printed literature.
[0025] The present invention also includes a pre-recorded media
device 14. Pre-recorded media device 14 may be, for example, a
visual media device, such as a videotape cassette, a DVD (digital
videodisk), filmstrip, 35 mm movie or any other visual media
device. Alternatively, pre-recorded media device 14 may be an
interactive software application, such as a CD-ROM (compact
disk-read only memory) or floppy disk. A CD-ROM may provide
information in a computer friendly format. Alternatively,
pre-recorded media device 14 may be, for example, an audio media
device, such as a record, audiocassette or audio compact disk.
Preferably, kit 10 includes a videotape cassette, as a VCR
(videocassette recorder) is the more widely available viewing
device. The videotape cassette will preferably help the patient
with their planning and daily maintenance of the
pharmaceutical.
[0026] Kit 10 may also include a planner 15. Planner 15 may be, for
example, a weekly, a monthly, a multi-monthly, a yearly, or a
multi-yearly planner. Planner 15 may be used as a diary to monitor
dosage amounts, to keep track of dosages administered, or to
prepare for future events, wherein taking a regularly administered
pharmaceutical may be difficult or the physiologic events
associated with the pharmaceutical may be inconvenient or
undesirable. For example, with respect to a 91-day regimen of an
oral contraceptive, planner 15 may be used to identify which weeks
in the up-coming year the patient may be expected to have a normal
menstrual cycle.
[0027] Alternatively, planner 15 may be a calendar provided with a
means to monitor when a dosage has been taken and when it has not
been taken. For example, the calendar may have an indicator to
identify each day that the dosage was administered properly. This
type of planner 15 is particularly useful for patients that have an
unusual schedule for administering pills. Additionally, planner 15
can be useful for the elderly, children, or other individuals who
must administer medication themselves and may become forgetful. One
skilled in the art can appreciate a variety of planning tools that
would be appropriate for use with the present invention.
[0028] Kit 10 of the present invention may also include a reminder
tool 16. Reminder tool 16 could be, for example, an adhesive (e.g.,
a paper or film adhesive, such as a sticker) or a magnet that is
placed in a location viewed daily. Thus, noticing the adhesive or
magnet will help the patient to remember to administer the
pharmaceutical. A sticker may be a permanent sticker or a removable
sticker. Reminder tool 16 may also be an alarm or other auditory
reminder that creates a unique sound precisely when the patient
should administer the next dose. Reminder tool 16 could also be,
for example, a watch, clock or calendar marked with the dates
and/or times that a dosage is to be administered. One skilled in
the art can appreciate that a variety of reminder tools 16 may be
appropriate to include in kit 10 of the present invention.
[0029] Finally, kit 10 may include container 18 for storing and
delivering all the other components of the present invention. For
example, container 18 may take the form of a bag, box, envelope or
any other container that would be suitable, as would be clear to
one skilled in the art or arts. Preferably, container 18 is large
enough to accommodate each component and/or any administrative
devices that may be necessary for the particular pharmaceutical.
However, it may be desirable to have a smaller more discrete
container 18, which can be hidden in a patient's pocketbook,
briefcase or pocket.
[0030] A bag or another device that has a handle is particularly
preferred for the patient to easily carry container 18 out of the
physician's office or pharmacy. Preferably, container 18 is
suitable for other uses once supply 12 of a pharmaceutical has been
administered. For example, container 18 may be a purse or
pocketbook, tote bag, make-up bag, other travel accessory, or the
like.
[0031] Container 18 of the present invention (as well as other
components thereof) may contain an identifying means to identify or
distinguish the long-term use pharmaceutical. The identifying means
is preferably a logo or trademark associated with the
pharmaceutical and is preferably prominently placed on the exterior
of container 18. Thus, a patient who is taking more than one
medication will be able to identify, distinguish and easily recover
the information associated with a particular pharmaceutical. In
addition, kit 10 also can function as a promotional device for the
pharmaceutical manufacturer.
[0032] The physician may distribute kit 10 of the present invention
as a free sample or it may be prescribed and delivered dosage
supplied by a pharmacy. As such, a physician may request that kit
10 be provided along with a filled prescription.
[0033] While various embodiments of the present invention have been
described above, it should be understood that they have been
presented by way of example only, and not limitation. It will be
apparent to persons skilled in the relevant art that various
changes in form and detail can be made therein without departing
from the spirit and scope of the invention. Thus, the breadth and
scope of the present invention should not be limited by any of the
above-described exemplary embodiments, but should be defined only
in accordance with the following claims and their equivalents.
* * * * *