Method of providing a therapeutic regimen and prefabricated...

Special receptacle or package – For ampule – capsule – pellet – or granule – With indicia or indicator

Reexamination Certificate

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Details

C053S411000, C053S449000

Reexamination Certificate

active

06681935

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a method of providing a therapeutic regimen for a patient wherein specific medicament information comprising at least one of the name of the patient, the name of the medicament, the dosage of the medicament, the time of day, the day of week and the Julian date for the patient to take the medicament is provided on each of a plurality of blisters of a prefabricated medicament container and wherein the first medicament to be taken by the patient after dispensing is arranged in a first position in a first column and a first row of the prefabricated container wherein subsequent medicaments to be taken by the patient follow in sequential fashion.
2. Prior Art Statement
It is known to first provide a printed sheet having dosage information thereon and thereafter adhere previously prepackaged strip form blister packs onto the sheet alongside the printed material. The person administering the medicine removes an individual blister from the printed sheet, administers the medicine and records certain time related information for control purposes upon the sheet and upon dispensing all the medication contained on the sheet, returns the card with the blisters removed therefrom to the dispensing pharmacy as a permanent control record. For instance, see the U.S. Pat. No. 3,621,992 issued on Nov. 23, 1971, to Osborne, et al.
It is also known to manually package solid medication into integrally connected individual sealed plastic blisters covering the backing on the blisters with a label strip having drug indicia thereon as a substitute for dispensing medicine in souffle cups. For instance, see the U.S. Pat. No. 3,630,346 issued on Dec. 28, 1971 to Carl Burnside.
It is further known to provide a medicinal dispensing device comprising 25 units arranged in a square having means for accessing the contents of blisters of a blister pack by lifting the corner edge of a lidding material by gripping a corner edge of the lidding in a cutout between selected blisters. For instance, see U.S. Pat. No. 3,780,856 issued on Dec. 25, 1973 to Milton Braverman.
Additionally, it is known to provide a multiplicity of blister cards having medicaments carried on the blister cards in sequential order on the individual cards and from card to card wherein the blister cards are placed in a stacked array in a base adapted to support the stack. For instance, see the U.S. Pat. No. 4,889,238 issued on Dec. 26, 1989 to Jay A. Batchelor.
It is still further known to provide a reminder system for providing an indication when a dose of medication should be taken by providing a calendar type blister-pack initially dispensed by a physician with a separable time reminder device indicating a predetermined dosage schedule. For instance, see the U.S. Pat. No. 4,974,729 issued on Dec. 4, 1990 to Kent P. Steinnagel.
Yet another known package assembly for dispensing medications comprises an empty blister sheet selected by the pharmacist who then fills the blisters with pharmaceutical medications, positions a lidding sheet over the blisters and presses the cohesive layers together. The lidding sheet has a paper backing sheet with appropriate printed information at each blister location, the information including a given time for a given medication in the corresponding blister. The completed assembly is then placed in a framework which provides support for pushing the medication through the lidding sheet. For instance, see the U.S. Pat. No. 5,014,851 issued on May 14, 1991 to John J. Wick. Considerable assembly is required to make a completed package and the frame surrounding the assembly must be sufficiently strong to resist breakage while pushing the medication through the lidding sheet.
Another medication containing package known in the art comprises a tear-off tab having a date on the tab and an intermediate layer with a second breakaway panel aligned with a blister chamber containing the prepackaged medication. After the date tab is removed, the medicine in the blister pack is then pushed through the foil lidding material. For instance, see the U.S. Pat. No. 5,339,960 issued on Aug. 23, 1994 to Jerry Price. The date tab is preprinted and contains only dosage information, no other patient or medication information is available on the package. Additionally, the package is specifically made difficult to open to prevent children from opening the package blisters.
It is also known to provide a blister for the user to store a part of a medicament for later use. In some cases, a medicament is not available in a proper dosage and thus a multiple of the dosage is provided by the pharmacist. The patient then divides the dosage as directed and with this device then stores the unused part in a blister having a storage strip for covering the unused part of the medicament. For instance, see the U.S. Pat. No. 5,873,466 issued on Feb. 23, 1999 to Martin Hulick. Patient and medicament information is presumably provided on a separate sheet as is conventional and thus no information appears on the package to indicate to the patient that a particular medicament has been taken.
Finally, it is known to provide a travel vitamin and pill organizer which may hold one of eight interchangeable discs wherein the organizer has a LCD for displaying the current time and scheduled time for the next dose. For instance, see the Travel Vitamin & Pill Organizer available at www.sharperimage.com. This device must have the LCD reset each time one of the discs is replaced. No patient nor pill information is available on the organizer to indicate to the patient what pill is being taken.
SUMMARY OF THE INVENTION
Although there are a number of prepackaged medicaments on the market which contain preprinted information comprising the name of the medication, the dosage and possibly a date tab, there is not available a blister package having specific patient, medicament, date and time information printed on the cover of each blister at the time of dispensing of the medication, which when removed by the patient, indicates to the patient that the medication has been taken. Therefore, it is an object of this invention to provide a prefabricated medicine container package having multiple blisters, or pockets, to hold individual or multiple dosages of medicine therein. The container is constructed of a disposable material, such as plastic or cardboard, etc. The number and arrangement of the pill blisters in a particular package will typically correspond to the frequency of the particular medicine dosage for a particular patient, such as a particular package having three rows and seven columns of pill blisters for medicine to be taken by a patient three times a day for one week, although any number of rows and columns may be used. When filling a medical prescription, a pharmacist may deposit the appropriate dosage of medicine in each blister and thereafter seal the blisters with a film of appropriate material in a substantially airtight manner. The film may be constructed of a thin layer of aluminum or a clear plastic film, self adhesive label, etc., and is normally applied by a pharmacist. The film may be applied by hand or by a machine at the pharmacy.
It is also an object of this invention to provide a method of providing a therapeutic regimen for a patient comprising the step of dispensing at least one medicament of the therapeutic regimen into a prefabricated medicament container, the step of printing an outside surface of a sealing sheet with medicament information, the step of arranging the medicament in the prefabricated medicament container wherein the medicament to be first taken by the patient after the step of dispensing the medicament into the prefabricated medicament container is in a first position in a first column and a first position in a first row of the prefabricated medicament container, the step of aligning the medicament information printed on the sealing sheet with the medicament in the prefabricated medicament container, the step of closing the prefabricated medicament container b

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