Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
  • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
  • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
  • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
  • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
  • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/52—Details
  • B65D75/54—Cards, coupons, or other inserts or accessories
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
  • A61J1/035—Blister-type containers
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
  • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
  • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
  • B65D75/34—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents and having several recesses to accommodate a series of articles or quantities of material

Definitions

• the present invention relates to a pharmaceutical package for aiding or increasing patient compliance for the administration of peroral complex pharmaceutical drug regimens. Further, the present invention relates to a method of aiding and/or improving patient compliance for complex peroral drug regimens by the use of an effective compliance packaging.
• Patient compliance has been defined as "the extent to which an individual's behavior coincides with medical or health advise. Compliance with therapy implies a positive behavior in which the patient is motivated sufficiently to adhere to the prescribed treatment because of a perceived self-benefit and a positive outcome (e.g. enhanced daily functioning and well-being.” Remington's Pharmaceutical Sciences, Chpt. 103, Vol. II, p. 1796 (19th Ed.1995).
• non-compliance can increase health-care costs. For example, it is estimated that over 50% of patients taking antihypertensive medication are non-compliant and/or stop taking their medications within the first 12 months of treatment. Each year, thousands of deaths and hospital admissions result from over or undermedicating. In addition about 25% of nursing home admissions are a result of the patient's inability to take his or her medications correctly. This can result in added costs for additional prescriptions, additional physician visits, hospitalization for consequences of untreated diseases or rehabilitation cost and/or home health care costs for untreated or undertreated diseases. Of course, the consequence of non-compliance with antihypertensives can be life threatening, and can result in strokes, myocardial infarction, etc.
• Non-compliance encompasses a variety of behaviors. Acts of omission include drug underuse. For example the patient may take less medicine or take it less frequently than prescribed and may even take drug "holidays.” The patient may not obtain the initial or a refill prescription, or may stop taking the medication too soon. Acts of commission include drug overuse, taking too high a dose or taking a dose too frequently. They also include taking too low a dose such as skipping a dose. The patient may even share medication with family members or knowingly consume a food, beverage, or other drug that can interact with one's prescription drug. Prescription Medicine Compliance: A Review of the Baseline of Knowledge, NCPIE Report, Aug. 1995 Numerous factors determine the probability for compliance and explain why patients do not comply with prescribed drug therapy.
• triple-therapy regimen for the treatment of H. pylori infections, consisting of: (1) a bismuth salt (e.g., bismuth subsal icy late), (2) metronidazole and (3) amoxicillin or tetracycline.
• Non-compliance with the elderly population is generally higher than other groups. This can be attributed to a variety of factors such as declining mental functioning, increasing numbers of medication prescribed and the increase in side effects and/or drug interactions associated with these multiple drug regimens. Also, improper dosing leading to side effects may also contribute to non-compliance. In addition non-compliance among the elderly is associated with taking more than five prescription medications concurrently, an inability to read prescription labels and difficulty opening flip-off type medication container lids. Murray, M.D. et al., DICP 20: 146 (1986.)
• the physician's and pharmacist's relationship with the patient will influence medication compliance. For example, how clearly the physician and/or pharmacist explains the treatment regimen to the patient being treated will influence how likely the patient will comply with the drug therapy prescribed.
• a specific example of a complex treatment regimen includes the treatment for H. pylori mediated upper gastrointestinal disorders or infections.
• single agent antimicrobial approaches designed to eradicate infection by H. pylori provide unacceptable eradication rates (i.e., ⁇ 80%).
• treatment comprises the administration of more than one therapeutic agent.
• combination therapy include the administration of 1) at least one antimicrobial agent(s) used in combination with a proton pump inhibitor; and 2) at least one antimicrobial agent(s) used in combination with bismuth or a bismuth salt.
• An example of a particularly preferred combination includes a triple- therapy regimen consisting of: (1) a bismuth salt (e.g., bismuth subsalicylate), (2) metronidazole and (3) amoxicillin or tetracycline.
• a bismuth salt e.g., bismuth subsalicylate
• metronidazole e.g., metronidazole
• amoxicillin or tetracycline e.g., amoxicillin or tetracycline.
• a compliance package is defined as "a prepackaged unit that provides one treatment cycle of the medication to the patient in a ready-to-use package.” Remington's Pharmaceutical Sciences, Chpt. 103, Vol. II, p. 1804 (19th Ed.1995). D.L. Smith, Compliance Packaging: A Patient Education Tool, Amer Pharm, Vol. NS29, No. 2, p. 42-53,1989. Packages for oral contraceptives were possibly the first packaging of this type to be introduced and continue to be used extensively for these agents. Specific examples of oral contraceptive compliance packaging are listed in the Physicians' Desk Reference, p. 306, 322, 323, 49 ed. 1995.
• Ovcon® 35 and 50 (Bristol-Meyers Squibb), Ortho-Novum® Dialpak 1/35, 1/50, 10/1 1 and 7/7/7 (Ortho Pharmaceutical Corp.), Loestrin® Fe 1/20 and 1.5/30 (Parke-Davis), etc. are oral contraceptives packaged in blister cards. These packages are generally a single blister card, with 21 or 28 day regimens. Each tablet is labeled with a particular day of the week so that the patient can tell if any doses have been missed. Written patient information, which informs the patient of risks and benefits of therapy, is a mandatory requirement for oral-contraceptive packaging.
• compliance packaging examples include Rheumatrex® Dose Packs made by Lederle Laboratories, containing four blister-pack cards each containing either 2, 3, 4, 5, or 6 tablets (for 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per week, respectively) for 1 -week's therapy of ethotrexate.
• Medrol® Dosepak (Upjohn Company), is a packaging designed for the administration of steroids, (i.e. methylprednisolone) which require staggered dosing. For each day of drug treatment the number of tablets (and total dose) that the patient must take, decreases.
• the Medrol Dosepak contains 21 , 4mg tablets for 6 days of treatment where for each day of treatment, the total daily dose decreases by one tablet.
• Axid® Convenience Pak previously made by Eli Lilly & Company, which contained a 30-day supply of nizatidine in a single medication blister card, is another example. This medication is to be taken once a day and is for the treatment of duodenal ulcers.
• Zithromax® Z-Pak made by Pfizer Laboratories, contains a single medication blister card with 6, 250mg capsules. Each blister medication card is labeled with "Day 1 to Day 5" for each dose, the first dose being two, 250 mg capsules labeled "Day 1.” Each subsequent capsule is labeled with "Day 2" to "Day 5.”
• a further example of a compliance package includes "MacPac®” made by Norwich Eaton. Although no longer available on the market, this package contained an information booklet and seven blister-pack cards each card containing a daily dose (i.e. four capsules) of Macrodantin (nitrofurantoin macrocrystals.) Each dose (capsule) was labeled “Breakfast,” “Lunch,” “Dinner,” and “Bedtime.”
• the MacPac also contained two stickers for the pharmacist to apply to the package upon dispensing. These stickers contained the information: “Take with food or milk” and "Complete the full time of treatment prescribed by your physician.” Furthermore, this package contained a reminder card between the third and forth medication cards, i.e between the third and forth day of treatment.
• the present invention relates to a pharmaceutical package for aiding or increasing patient compliance for the administration of a peroral complex pharmaceutical drug regimen, comprising:
• each blister card comprises the total daily dose of the peroral complex drug regimen; wherein the blister card is divided into sections, preferably perforated sections, separating each complex drug regimen dose; wherein each dose section comprises an indicia denoting the time the dose is to be administered; and wherein preferably each blister card comprises an indicia denoting each separate day of treatment;
• a patient information booklet comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• a daily calendar comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• one or more reminder cards comprising information to remind the patient when to take a dose of the complex drug regimen
• one or more adhesive stickers comprising information to remind the patient when to take a dose of the complex drug regimen; 3) a case of the size to contain a single blister card, the case comprising an alarm which can be set by the patient to sound at the time that the next dose is to be administered; and
• the complex drug regimen comprises varying the dosage level or the dosage interval for a single therapeutic agent, the simultaneous administration of more than one therapeutic agent, or the concurrent administration of more than one therapeutic agent. It is understood that all of the above listed elements of the compliance package of the present invention are housed in a container made of any suitable material. Preferably the container is made of any suitable paper and/or plastic material.
• the blister package is child resistant and "senior friendly."
• the blister cards are separated, at approximately one-fourth to three- fourths of the way between the start and the finish of the complex drug regimen, by a card comprising patient information and patient incentive information. This card preferably contains a statement on the importance of completing the full course of drug therapy to avoid disease or symptom reoccurrence.
• the compliance package comprises a number of reminder cards or adhesive stickers equal to the number of daily doses to be administered by the patient.
• the reminder aid is one or more adhesive stickers.
• each reminder aid is provided in a form to allow the patient to place the sticker or card at a location that the patient will be, at the time a dose of the complex drug regimen is due to be taken by the patient.
• the present invention relates to a method of aiding and/or improving patient compliance for complex peroral drug regimens by the use of an effective compliance packaging.
• the present invention relates to a pharmaceutical package for aiding or increasing patient compliance.
• the present invention reduces the risk of omission of doses, dosage errors (amount of individual dose), drug administration errors, errors in the time of administration and/or premature discontinuation, for peroral complex drug regimens.
• the present invention relates to a pharmaceutical package for aiding or increasing patient compliance for the administration of a peroral complex pharmaceutical drug regimen, comprising:
• each blister card comprises the total daily dose of the peroral complex drug regimen to be administered by the patient; wherein the blister card is divided into sections, preferably perforated sections, separating each complex drug regimen dose; wherein each dose section comprises an indicia denoting the time the dose is to be administered; and wherein preferably each blister card comprises an indicia denoting each separate day of treatment;
• a patient information booklet comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• a daily calendar comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• one or more reminder cards comprising information to remind the patient when to take a dose of the complex drug regimen
• the complex drug regimen comprises varying the dosage level or the dosage interval for a single therapeutic agent, the simultaneous administration of more than one therapeutic agent, or the concurrent administration of more than one therapeutic agent.
• the container is made of any suitable material.
• the container is made of any suitable paper and/or plastic material.
• this container is preferably of square or rectangular dimensions.
• the outer container for the above listed components is of a size and dimension to accommodate standard pharmacy prescription labels.
• the blister package is child resistant and senior friendly.
• the blister cards are separated, at approximately one-fourth to three-fourths of the way between the start and the finish of the complex drug regimen, by a card comprising patient information (side effect, dosing, and/or disease information) and patient incentive information.
• This card preferably contains a statement on the importance of completing the full course of drug therapy to avoid disease or symptom reoccurrence.
• the methods and packages of the present invention comprise a safe and effective amount of one or more therapeutically active agent(s).
• safe and effective amount means an amount of therapeutically active agent high enough to provide a significant positive modification of the condition to be treated, but low enough to avoid serious side effects (at a reasonable benefit/risk ratio), within the scope of sound medical judgment.
• a safe and effective amount of therapeutically active agents will vary with the particular condition being treated, the age and physical condition of the patient being treated, the severity of the condition, the duration of the treatment, the nature of concurrent therapy, the specific therapeutic agent selected, and like factors.
• administering refers to any method which, in sound medical practice, delivers the therapeutically active agents or compositions containing the therapeutically active agents, used in the compliance package of the present invention, to the patient to be treated in such a manner to be effective in the treatment of the disorder.
• therapeutic agent includes any pharmaceutical agent useful for the treatment of a disease or condition, to alleviate symptoms, etc.
• oral complex drug regimen includes any peroral drug regimen which requires the administration by the patient being treated, of: 1. Varying dosage regimens for a single therapeutic agent (i.e. where the dose of a single therapeutic agent is varied over the course of the drug treatment or where the intervals between dosage administration for a single therapeutic agent is varied over the course of the drug treatment.)
• peroral complex drug regimens include those described in U.S. Pat. No. 5,256,684, Marshall, issued October 26, 1993, The Procter & Gamble
• Particularly preferred peroral complex drug regimens include those for the treatment of H. pylori mediated upper gastrointestinal disorders or infections.
• gastrointestinal disorders are those affecting the upper-gastrointestinal tract, and those mediated by H pylori (herein referred to as "H. /Ty/o ⁇ -mediated gastrointestinal disorders)."
• H. /Ty/o ⁇ -mediated gastrointestinal disorders Such gastrointestinal disorders include, for example: H.
• non- ulcerative gastrointestinal disorder including chronic or atrophic gastritis, non-ulcer dyspepsia, esophogeal reflux disease and gastric motility disorders; and "peptic ulcer disease", i.e., gastric, duodenal and jejunal ulcers.
• H. pylori treatment comprises the administration of more than one therapeutic agent. Examples of such combination therapy include the administration of 1) at least one antimicrobial agent(s) used in combination with a proton pump inhibitor and 2) at least one antimicrobial agent(s) used in combination with bismuth or a bismuth salt.
• Proton pump inhibitors include, but are not limited to omeprazole (known under the tradename of Prilosec® available from Astra Merck), lansoprazole (known under the tradename of Prevacid® available from TAP Pharm), pantoprazole, and mixtures thereof.
• Bismuth salts include, but are not limited to, bismuth aluminate, bismuth citrate, bismuth subcitrate, bismuth nitrate, bismuth subnitrate, bismuth tartrate, bismuth subcarbonate, bismuth subgallate, bismuth subsalicylate, and tripotassium dicitrato bismuthate, bismuth subgallate, and mixtures thereof.
• a particularly preferred bismuth salt is bismuth subsalicylate.
• compositions containing bismuth salts are commercially-available, including, for example, DeNol®, containing tripotassium dicitrato bismuthate (sold by Gist-Brocades N.V.), Noralac®, containing bismuth aluminate, alginic acid, and magnesium carbonate (manufactured by North American Pharmaceuticals), Roter bismuth, containing bismuth subnitrate (sold by Roter Laboratories), Fensobar Polvo, containing bismuth subcarbonate among other materials (manufactured by USV Pharmaceutical Corporation), Pepto-Bismol®, containing bismuth subsalicylate (sold by The Procter &
• ranitidine bismuth citrate (Tritec® available from Glaxo Wellcome p.l.c).
• antimicrobials refer to any naturally-occurring, synthetic or semi-synthetic compound or composition, or mixture thereof, which is safe for human use as used in the packages and methods of this invention, and is effective in killing or substantially inhibiting the growth of H. pylori when used in the methods/package of this invention.
• Antibiotics are among the preferred antimicrobials useful herein.
• antibiotics can be generally classified by chemical composition, into the following principal groups: the aminoglycosides, such as gentamicin, neomycin, kanamycin, and streptomycin; the macrolides, such as erythromycin, clarithromycin, azithromycin, dirithromycin, troleandomycin, clindamycin, and rifampin; the penicillins, such as penicillin G, penicillin V, ampicillin and amoxicillin; the polypeptides, such as bacitracin and polymyxin; the tetracyclines, such as tetracycline, chlortetracycline, oxytetracycline and doxycycline; the cephalosporins, such as cephalexin and cephalothin; and such miscellaneous antibiotics as chloramphenicol and clindamycin.
• These antibiotics can be generally said to function in one of four ways: inhibition of cell walls synthesis, alteration of cell wall permeability, inhibition of protein synthesis,
• antimicrobials useful herein include the sulfonamides; nitrofurans, such as nitrofurazone nitrofurantoin, and furozolidone; and metronidazole, tinidazole, and nimorazole. Antimicrobials among those useful herein are described in the following publications, incorporated by reference herein: Remington's Pharmaceuticals Sciences ( 15th edition 1975); F.H. Meyers, et al., Review of Medical Pharmacology (7th edition 1980); Gaddum's Pharmacology (8th edition 1978); and A. Goodman, A.G. Goodman and L.S. Gilman, The Pharmacological Basis of Therapeutics (6th edition 1980).
• antimicrobials penicillin, erythromycin, tetracycline, doxycycline, metronidazole, tinidazole, amoxicillin, ampicillin, clarithromycin, and nitrofurantoin are among the preferred antimicrobials for use in the present invention.
• Examples of particularly preferred peroral complex drug regimen include regimens such as: 1) a bismuth salt (e.g., bismuth subsalicylate), metronidazole, and amoxicillin or tetracycline; 2) lansoprazole, amoxicillin, and clarithromycin; 3) ranitidine bismuth citrate (Tritec® available from Glaxo Wellcome p. I.e.); 4) omeprazole and clarithromycin; and 5) ranitidine bismuth citrate and amoxicillin and/or clarithromycin.
• a bismuth salt e.g., bismuth subsalicylate
• metronidazole e.g., metronidazole
• amoxicillin or tetracycline e.g., metronidazole, and amoxicillin or tetracycline
• lansoprazole amoxicillin, and clarithromycin
• ranitidine bismuth citrate Tritec® available from
• the specific method of aiding and/or improving patient compliance by administering one or more therapeutically active agent(s), according to the packaging or process of this invention, may depend upon such factors as the particular therapeutic agent used, the site of action desired, the amount of therapeutic agent to be administered per day, the presence or potential of any adverse side effects, and the potential for any interactions between therapeutic agents used.
• the therapeutic agent(s) can be administered by single daily doses, or be administered in two, three, or four or more doses per day. Whether two or more therapeutic agents are administered simultaneously, concurrently or sequentially depend on potential interactions between these agents, which are known to those skilled in the art.
• the compliance package of the present invention comprises at least one blister card.
• Each blister blister card comprises the total daily dose of the peroral complex drug regimen to be administered by the patient.
• the blister card is divided into sections, preferably perforated sections, separating each complex drug regimen dose; wherein each dose section comprises an indicia denoting the time in which the dose is to be administered, i.e. "Breakfast,” “Lunch,” “Dinner,” “Bedtime,” etc.
• the blister cards are arranged in sequential order of administration.
• the blister card can comprise an indicia denoting each separate day of treatment ("Day 1,” “Day 2,” “Day 3”, or "Monday,” “Tuesday,”
• the first card to be used will be placed at the beginning of the blister card stack in the compliance package container.
• the blister card and/or compliance package is child resistant and/or tamper evident, which, while providing easy access to the end user, has child-resistant features.
• Child resistant blister packages are disclosed in U.S. Pat. No. 3,809,221, Compere, issued May 7, 1974; U.S. Pat. No. 4,398,634, McClosky, issued Aug. 16, 1983, Wrapade Machine Company, Inc.; U.S. Pat. No. 3,809,220, Arcudi, issued May 7, 1974, Becton
• each dose is labeled with the time of day that the dose is to be administered, for example, "Breakfast,” “Lunch,” “Dinner,” and “Bedtime.” This is to help patients take the medication at the correct times. In addition this will help the patients to recognize when and if they have missed a dose.
• the blister cards are arranged in sequential order of administration. Therefore, preferably each blister card comprises an indicia denoting the order that each separate blister card is to be administered. For example the blister card can be optionally marked with "Day 1,” “Day 2,” “Day 3", or "1,” "2,” “3,” or "Card 1,” “Card 2,” “Card 3,” etc.
• Each blister card of the present invention contains a full daily dose of the peroral complex drug regimen. Therefore, the patient can carry a 1-day supply with them during the day, in either their purse or pocket, etc.
• the blister card is approximately
• one preferred embodiment of the present invention is a compliance package or kit also comprising a separate cover or case to hold a single-blister card. This case will protect the blister card from damage.
• this case is another way for the patient to transport the blister card during the day so that the doses of the complex drug regimen are readily accessible to patient.
• this blister card cover or case will also comprise an alarm as the reminder aid. Therefore, the patient can set the alarm to sound when the next scheduled dose is to be administered by the patient.
• the portability of the single blister cards eliminates the need for the patient to carry the entire kit or compliance package. It also eliminates the need to transfer the complex drug regimen to another unlabeled vial or container.
• the transportability of the single blister cards allows the patient to have the dose at hand when the patient is away from home.
• the single dose sections on the blister cards are arranged in order of the time of administration intervals.
• the peroral drug regimen comprises 4 daily doses of one or more therapeutic agent(s)
• the blister card will preferably comprise four does sections, preferably of equal dimensions, and preferably separated by perforations.
• the blister card has only one medication per blister cavity. However these units of medication will be located in the same dose section of the blister card. This will avoid any potential physical interactions between two or more different therapeutic agents.
• the blister cards provide positive (or negative) feedback to the patient or physician since they can look at the blister cards to see whether all of the doses of the complex peroral drug regimen have been taken by the patient.
• the compliance package of the present invention additionally comprises the following:
• a patient information booklet comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• a daily calendar comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• a reminder aid selected from the group consisting of:
• one or more reminder cards comprising information to remind the patient when to take a dose of the complex drug regimen
• one or more adhesive stickers comprising information to remind the patient when to take a dose of the complex drug regimen
• Information includes, but is not limited to, anticipated benefits of the therapy with the peroral complex drug regimen, the importance of complying with the dosage and administration instructions, side effect information, the point in time during therapy that side effects occur, dosage information, and information regarding the disease or condition being treated.
• the multiple components of the compliance package of the present invention are critical in that they provide repetition of the information (dosing information, side effect information, disease information, and patient incentive information) to the patient. This is to ensure that the patient remembers the information and is sufficiently motivated to complete the full course of treatment.
• the multiple components such as the booklet, calendar, indicia and other printed information on the blister cards, reminder aids, etc. provides a continuous source of information to the patient.
• the side effect information, dosing information, disease information, and patient incentive information is repeated at least two times, more preferably at least 3 times in the compliance package.
• information, dosing information, side effect information, information describing the disease being treated and patient incentive information means educational information that the patient is able to understand and use.
• the this information is written at a low readability level, i.e. is written such that the average patient or consumer can understand the information.
• Complex and difficult medical terminology should be translated into more simple words.
• the readability level of the patient information is very important since it has been reported that patients do not understand many medical terms used in patient information materials. D.L. Smith, Compliance Packaging: A Patient Education Tool, Amer Pharm, Vol. NS29, No. 2, p. 42-53,1989.
• this information also includes graphics and illustrations for providing further repetition and reinforcement of the written information.
• the side effect information should not only list the possible side effects but should be complete enough to allow the patient to manage side effects. For example, the statement “bismuth may darken the stool or tongue but this darkening will go away after the therapy is complete,” helps the patient manage this side effect. Also, the side effect information can instruct the patient to contact the prescriber if side effects are bothersome to the patient. Furthermore, for medications causing hypersensitivity of the patient's skin to sun exposure, the patient is instructed to avoid the sun and sunlamps as much as possible and to wear a high numbered SPF sunscreen.
• the patient is instructed how and when to made up any missed doses of the medication.
• the information of the compliance package and methods of the present invention is preferably not coercive, threatening or demeaning to the patient being treated. Although one can provide the patient with very comprehensive information about the complex drug regimen and the disease or condition being treated, this information will not be effective if the patient is not motivated to use the information and comply with instructions for using and administering the complex drug regimen.
• the compliance packages and methods of the present invention also comprise "patient incentive information.”
• Patient incentive information means specific written material or instructions which provides cues for appropriate behavior or prompting of the patient to comply with the therapeutic drug regimen.
• Patient incentive information includes statements providing positive feedback and/or encouragement such as congratulatory statements, statements complementing the patient during various intervals of the complex drug regimen for complying with the regimen, statements that encourage compliance by highlighting the benefits of properly administered medication (i.e. lower chance of side effects, lower chance of the reoccurrence of infection, lower chance of the development of antimicrobial resistance, lower chance of re-treatment, etc.) statements that encourage compliance by highlighting the benefits of completing the therapy (i.e. reduction or elimination of the disease symptoms), statements indicating that the patient has some control over the treatment and that the patient has chosen to participate in the regimen and is therefore involved in the decision making process concerning the regimen, etc.
• Patient incentive information can also inform the patient that compliance with the proper dosage administration may save the patient time and money as well.
• patient incentive information can inform the patient that by complying with proper dosing instruction and finishing the full course of complex drug regimen, the patient may reduce the number of trips to his or her physician, decrease the number of medications prescribed due to re-treatment of conditions due to non-compliance and due to recurrence of infections (in the case of antimicrobial non-compliance), etc.
• complying with the proper dosage regimen may avoid side effects and adverse reaction which could necessitate the need for basic laboratory work, x-rays, ECGs, diagnostic tests, intravenous and parenteral drug therapy and even hospitalization to treat severe complications.
• the calendar of the present invention comprises separate pages corresponding to each day of treatment for the peroral complex drug regimen.
• the calendar is provided so that after the patient takes the daily dosage of the drug regimen, the patient can either tear off a page of the calendar or can cross out that particular page.
• the calendar can be taken to the patient's next visit to their prescriber to confirm the level of the patient's compliance with the complex drug regimen.
• the calendar is preferably attached to the inside lid of the compliance package.
• the compliance package comprises a number of reminder cards or adhesive stickers equal to the number of daily doses to be administered by the patient.
• the compliance package reminder aid is one or more adhesive stickers.
• each reminder aid is provided in a form to allow the patient to place the sticker or card at a location that the patient will be, at the time a dose of the complex drug regimen is due to be taken by the patient.
• the reminder sticker or card can be placed on the patient's refrigerator, television, alarm clock, computer screen, bathroom mirror, medicine cabinet, desk, dining table, nightstand, coffee pot, toothbrush, etc.
• the written instruction on the adhesive sticker or reminder card comprises one or more of the following: the drug trade name, generic name, a statement such as "Don't
• the blister cards are separated, at approximately one-fourth to three-fourths of the way between the start and the finish of the complex drug regimen, by a card comprising patient information and patient incentive information.
• This card preferably contains a statement on the importance of completing the full course of drug therapy to avoid disease or symptom reoccurrence.
• this card is located approximately between day 3 and day 4 (blister card 3 and 4), day 4 and 5 (blister card 4 and 5), day 5 and 6 (blister card 5 and 6), day 6 and 7 (blister card 6 and 7), or day 7 and 8 (blister card 7 and 8). This is because symptoms generally subside with antimicrobial therapy early in the course of treatment.
• the card is located between blister card 7 and 8 and comprises a congratulatory statement for finishing approximately half of the full course of the complex drug regimen.
• this card comprises the statement:
• a pharmaceutical package for aiding or increasing patient compliance for the administration of a peroral complex pharmaceutical drug regimen comprising:
• each blister card comprises the total daily dose of the peroral complex drug regimen to be administered by the patient; wherein the blister card is divided into sections separating each complex drug regimen dose; wherein each dose section comprises an indicia denoting the time of day in which the dose is to be administered;
• a patient information booklet comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information
• a daily calendar comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• the complex drug regimen comprises varying the dosage level or the dosage interval for a single therapeutic agent, the simultaneous administration of more than one therapeutic agent, the concurrent administration of more than one therapeutic agent.
• Example 2 A pharmaceutical package for aiding or increasing patient compliance for the administration of a peroral complex pharmaceutical drug regimen, comprising:
• each blister card comprises the total daily dose of the peroral complex drug regimen to be administered by the patient; wherein the blister card is divided into sections separating each complex drug regimen dose; wherein each dose section comprises an indicia denoting the time of day in which the dose is to be administered;
• a patient information booklet comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• a daily calendar comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• one or more reminder cards comprising information to remind the patient when to take a dose of the complex drug regimen
• one or more adhesive stickers comprising information to remind the patient when to take a dose of the complex drug regimen
• a pharmaceutical compliance package comprising: (a) a series of 14 blister cards, wherein each blister card comprises 4 doses of the peroral complex drug regimen to be administered by the patient; wherein the blister card is divided into 4 perforated sections separating each dose; wherein each dose section comprises a "Breakfast,” “Lunch,”
• each dose comprises a bismuth salt, tetracycline and metronidazole, preferably each dose comprises two bismuth subsalicylate tablets with 102 mg of salicylate, one 500 mg tetracycline HC1 capsule, and one 250 mg metronidazole tablet; wherein each blister card has only one medication per blister cavity; and wherein preferably the blister cards are separated between the 7th and 8th blister card, by a card containing a statement on the importance of completing the full course of drug therapy to avoid disease/symptom reoccurrence and a congratulatory statement to the patient for finishing half of the complex drug regimen;
• a patient information booklet comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• a daily calendar comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information;
• a reminder aid comprising 4 reminder cards or 4 adhesive stickers, to be placed at the location that the patient will be at the time of each scheduled dose, comprising information to remind the patient when to take a dose of the complex drug regimen.

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• 1997
  • 1997-11-13 HU HU0000173A patent/HUP0000173A3/hu unknown
  • 1997-11-13 AU AU51773/98A patent/AU746021B2/en not_active Ceased
  • 1997-11-13 SK SK661-99A patent/SK66199A3/sk unknown
  • 1997-11-13 JP JP52372498A patent/JP2001504372A/ja active Pending
  • 1997-11-13 KR KR1019990704429A patent/KR20000057154A/ko not_active Application Discontinuation
  • 1997-11-13 ID IDW990374A patent/ID22445A/id unknown
  • 1997-11-13 WO PCT/US1997/020577 patent/WO1998022072A1/en not_active Application Discontinuation
  • 1997-11-13 NZ NZ335813A patent/NZ335813A/en unknown
  • 1997-11-13 CA CA002272099A patent/CA2272099A1/en not_active Abandoned
  • 1997-11-13 EP EP97946644A patent/EP0942705A1/en not_active Ceased
  • 1997-11-13 BR BR9712964-0A patent/BR9712964A/pt not_active Application Discontinuation
  • 1997-11-18 CO CO97067281A patent/CO4920200A1/es unknown
  • 1997-11-19 EG EG123797A patent/EG21215A/xx active
  • 1997-11-19 AR ARP970105413A patent/AR010623A1/es unknown
  • 1997-11-19 PE PE1997001051A patent/PE25299A1/es not_active Application Discontinuation
  • 1997-11-19 ZA ZA9710413A patent/ZA9710413B/xx unknown
• 1998
  • 1998-03-09 TW TW086117274A patent/TW370503B/zh active
• 1999
  • 1999-05-19 NO NO992397A patent/NO992397L/no not_active Application Discontinuation

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