US20040222123A1

US20040222123A1 - Kit for pharmaceuticals

Info

Publication number: US20040222123A1
Application number: US10/429,766
Authority: US
Inventors: Amy Niemann
Original assignee: Barr Laboratories Inc
Current assignee: Barr Pharmaceuticals Inc
Priority date: 2003-05-06
Filing date: 2003-05-06
Publication date: 2004-11-11
Also published as: WO2004108073A3; WO2004108073A2

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.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is related to a kit to be provided to patients with a supply of a long-term pharmaceutical regimen.

2. Background Art

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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

FIG. 1 is a schematic diagram of the present invention.[0017]

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed towards a [0018] 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.
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, [0019] 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.
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, [0021] 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.
Although some of the advantages of [0023] 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.
The present invention also includes a [0025] 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.
Alternatively, [0027] 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.
Finally, [0029] 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.
A bag or another device that has a handle is particularly preferred for the patient to easily carry [0030] 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.
The physician may distribute [0032] 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.
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. [0033]

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.