SK66199A3 - Compliance package and method of improving or aiding patient compliance for complex drug regimens - Google Patents

Abstract

A pharmaceutical package for aiding or increasing patient compliance for the administration of a peroral complex pharmaceutical drug regimen, comprising: a) at least one blister card, wherein 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 in which the dose is to be administered; b) a patient information booklet comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information; c) a daily calendar comprising dosing information, side effect information, information describing the disease being treated, and patient incentive information; and d) a reminder aid. The present invention further relates to a method of aiding and/or improving patient compliance for complex peroral drug regimens by the use of an effective compliance packaging. Especially preferred are compliance packages and methods relating to the treatment of H. pylori mediated upper gastrointestinal disorders or infections.

Description

Technical field

The present invention relates to a pharmaceutical pack to aid in or improve the patient's cooperation in taking an oral complex pharmaceutical drug regimen. Furthermore, the present invention relates to a method for assisting and / or improving patient compliance in complex oral drug regimens using an effective package.

BACKGROUND OF THE INVENTION

Patient collaboration is defined as “the extent to which an individual's behavior agrees with the physician's instruction. Cooperation in therapy is a positive approach by which the patient is sufficiently motivated to contribute to prescribed treatment because he is aware of the benefits and positive outcomes (eg increased daily activity and good health). Remington's Pharmaceutical Sciences, Chap. 103, vol. II, p. 1796 (19th edition 1995).

Most doctors assume that when they diagnose a condition, they select a therapeutic agent and a regimen for the patient to treat the condition, the patient will follow their recommendations and will use the therapeutic agent as directed. However, studies on patient collaboration suggest others. Studies have shown a high incidence of treatment errors and non-cooperation in the use of prescribed medicines. Steward R.B. and Cluffa L.E. Overview of drug errors and outpatient cooperation. Clin. Pharm. Ther., 1972, 13, 463-468.

The problem of non-cooperation can actually increase the cost of healthcare. For example, it is established that more than 50% of patients taking antihypertensive drugs do not cooperate and / or discontinue drug use during the first months of treatment. Each year, hundreds of deaths and hospitalizations are the result of overdose or underuse of medicines. In addition, about 25% of admissions to nursing homes are the result of a patient's inability to properly use his (or her) medication. This may lead to increased costs for additional medical prescriptions, additional medical visits and hospitalization due to untreated or rehabilitation costs and / or home treatment costs for untreated or undertreated diseases. Of course, the consequences of non-cooperation in the use of antihypertensive drugs can be life-threatening and can lead to heart attacks, heart attacks, and the like. Eraker S.A. et al., Understanding and Improving Patient Compliance, Ann. Intern. Med., 100, 258 (1984), Forcino H. Packing Solution That Help Patient Compliance, Pharmaceutical Technology, March, 1993, p. 44-50.

Increased medical costs are also associated with non-cooperation of patients in antimicrobial therapy. Non-cooperation in antimicrobial treatment increases costs mainly due to the need to prescribe additional medicines for the treatment of infection, further laboratory tests to diagnose the infection, etc. In addition, non-cooperation in antimicrobial therapy may also contribute to the development of resistance.

Non-cooperation may take various forms. Omission is insufficient use of the medicine. For example, a patient may take less medicine or take it less often than prescribed, and may even take medicine 'holidays. The patient cannot receive the initial or maintenance dose, or may stop taking the medication very soon. Trust is increased use of medicines, which increases doses or takes doses very often. Another form is also taking low doses by omitting some doses. Patient can even share medication with family members or consciously receive food, drinks, l | ’’ Or other medicines that may interact with the prescribed medicine. Prescription Medicine Compliance: A Rewiev Of The Baseline Of Knowledge, NCPIE Report, August 1995.

A number of factors determine the likelihood of cooperation and explain why patients do not cooperate on prescribed drug therapy. One factor is the type of disease. For example, patients with chronic diseases, or those not associated with significant symptomatology, such as hypertension and hypercholesterolemia, are likely to be associated with a higher incidence of non-cooperation in drug use. To some extent, it is understandable that patients are disgusted with extended drug regimens that may not "cure the disease." However, cooperation can be expected to increase in the difficulties caused by non-cooperation.

Another reason for many patients to stop taking the medicine very soon is the disappearance of symptoms. In particular, patients taking antibiotics often stop taking antibiotics on the fourth day of treatment. At this time, symptoms begin to subside and the patient feels better. This problem can be critical when antibiotic treatment involves the administration of more than one antibiotic. An example of this type is triple therapy in the treatment of H. pylori infections consisting of: (1) a bismuth salt (e.g., a bismuth subsalicylate), (2) metronidazole, and (3) amoxicillin or teracycline. Mohler D.N. et al., Studies in the Horne Treatment of Streptococcal Disease, I. Failure of Pacients to Also Penicillin as Prescribed, New Engl. J. Med. 252, 1116 (1955). Mattar M.E.

et al., Pharmaceutical Factors Affecting Pediatrics Compliance, Pediatrics, 55, 101 (1975). U. U.S. Pat. No. 5,256, 684, Marschall, issued Oct. 26, 1993, The Procter & Gambia Company.

In addition, there are other factors related to non-cooperation, such as the patient's age. The non-cooperation of the elderly population is generally higher than that of other age groups. This can be attributed to various factors, such as a decrease in mental function, an increase in the number of prescriptions, and an increase in side effects and / or drug interactions in multiple drug regimens. Incorrect dosing also leads to side effects, which can lead to non-cooperation. Non-cooperation in the elderly is also associated with the use of more than five medicines at the same time, the inability to read the label and the difficulty of opening the caps on the packages. Murray M.D. et al., DICP 20: 146 (1986).

The doctor's and pharmacist's relationship to the patient will be influenced by cooperation in the use of medicines. For example, as a doctor and / or pharmacist clearly explains a treatment regimen to a patient, it will affect how likely the patient will cooperate in prescribed drug therapy.

Multidrug use, complex drug regimens, frequent dosing regimen, and physical characteristics of the dosage form (tablets, capsules, liquids) may also contribute to non-cooperation. Studies show that non-cooperation increases when the number of tablets taken daily increases from one to four per day. Gatley M.S. To be taken as directed. J.R. Coli. Gen. Pract., 1968, 16, 39-44, by Eisen S.A. et al., Ar. Intern. Med. 150, p. 1881, 1990 “The administration of medication at frequent intervals makes it more likely that the normal routine or work schedule will be interrupted to such a dose of medication and in many casses the patient will forget, not want to be inconvenienced or be embarrassed to do so. Remington's Pharmaceutical Sciences, Chap. 103, vol. II, p. 1800 (19th edition 1995).

A specific example of a complex treatment regimen is the treatment of diseases and infections of the upper gastrointestinal tract caused by H. pylori. Ordinarily, one antimicrobial targeted to eradicate H. pylori infection has insufficient eradication results (i.e. <80%). Therefore, the treatment consists of administering more than one drug substance. Examples of such combination therapy are administration of 1) at least one antimicrobial agent (s) in combination with a proton pump inhibitor, and 2) at least one antimicrobial agent (s) in combination with bismuth or bismuth salt. An example of a particularly preferred combination is a triple treatment regimen comprising: (1) bismuth salt (e.g., bismuth subsalicylate), (2) metronidazole and (3) amoxicillin or tetracycline. These types of treatment regimens, due to their complexity, are particularly vulnerable to patient non-cooperation.

Numerous approaches have been designed and developed to improve patient cooperation in drug use. In addition to oral and written communication / advice from a physician and / or pharmacist to a patient, patient collaboration and improving the relationship between the patient / doctor or pharmacist may also enhance autovisual materials.

In addition, aids have been developed for co-operation in the use of drugs to improve collaboration. One example is a convenient package. A conforming package is defined as a "packaged unit that provides one treatment cycle to a patient in a package directly for use by Remington's Pharmaceutical Sciences, Chap. 103, vol. II, p. 1804 (19th edition 1995). D.L. Smith, Compliance Packaging: A Patient Education Tool, Amer. Pharm., Vol. NS29, no. 2, p. 42-53, 1989.

Packs for oral contraceptives were probably the first packs of this type to be put into use and continue to be used extensively for these substances. Specific examples of preferred packaging for oral contraceptives are given in Physicians' Desk References, p. 306, 322, 323, 49th ed. 1995th

For example, Ovcon® 35 and 50 (Bristol-Meyers Squibb), OrthoNovum® Dialpak 1/35, 1/50, 10/11 and ΊΠΠ (Ortho Pharmaceutical Corp.), Loestrin® Fe 1/20 and 1.5 / 30 (Parke) (Davis) and the like, oral contraceptives are packaged on blister cards. These packs are generally one blister card with a 21 or 28 day schedule. Each tablet is labeled with the appropriate day of the week so that the patient may know when some doses have been missed. PACKAGE LEAFLET: INFORMATION IN THIS PACKAGE LEAFLET: INFORMATION FOR THE PACKAGE ORAL PACKAGE LEAFLET:

Another example of suitable packaging is Rheumatrex® Dose Packs manufactured by Lederle Laboratories, which contains four blister 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) for weekly methotrexate therapy.

The Medrol® Dosepak package (Upjohn Company) has been designed for the administration of steroids (eg methylprednisolone) which requires an evenly distributed dose. Each day of drug therapy, the number of tablets (and total dose) a patient must take is decreasing. For example, Medrol Dosepak contains 21 - 4 mg tablets for 6 days of treatment when the total daily dose decreases by one tablet for each day of treatment.

Another example is Axid® Convenience Pak, previously manufactured by Eli Lilly & Company, which contained a 30-day supply of nizatidine in a single blister card. This medicine should be taken once a day for duodenal ulcers.

Zithromax® Z-Pak from Pfizer Laboratories contains one blister pack of drugs with six 250 mg capsules. Each blister card is labeled "day 1 to day 5 for each dose, the first dose being two, 250 mg capsules labeled" day 1. Each subsequent capsule is labeled "day 2 to" day 5.

Also preferred is a "MacPac® (Norwich Eaton). Although no longer on the market, this pack had an information brochure and seven blister cards containing a daily dose (eg four capsules) of Macrodanthin (nitrofurantoin macrocrystals). Each dose (capsule) was labeled "breakfast," lunch, "dinner, and" bedtime. MacPac also contained two labels for the pharmacist to label when dispensing the medicine. These labels included: “take with food or milk,” and observe the time of use as prescribed by your doctor. Further, the package contained a reminder card interposed between the third and fourth medicament cards, i. on the third and fourth day of use.

Despite the development of the above types of suitable packaging, further improvements are needed to improve patient compliance, particularly with complex oral drug regimens. Further improvements are needed to ensure that the patient understands the information accompanying the package and to provide sufficient motivation, through appropriate packaging, to complete the entire cycle of drug use.

SUMMARY OF THE INVENTION

The present invention relates to a pharmaceutical package for improving patient compliance in administering an oral complex pharmaceutical drug regimen. It Includes:

(a) at least one blister card wherein each blister card comprises a total daily dose of an oral complex drug regimen; wherein the blister card is divided into portions, preferably perforated portions, dividing the individual doses of the complex drug regimen; wherein each dose portion has a marked time to take a dose; and wherein preferably each blister card is labeled for each individual treatment day.

(b) patient information brochure with dosage information, side effects, description of the disease being treated and patient motivation information;

(c) a daily calendar with dosage information, side effects, disease treatment information and patient motivational information; and (d) preferably a reminder aid selected from the group consisting of:

1) one or more reminder cards with patient information when to take a dose of a comprehensive drug regimen;

2) one or more self-adhesive labels indicating to the patient when to take the dose of the complex drug regimen;

3) a blister-sized pouch, the pouch comprising an alarm clock which the patient can set to ring at the time of the next dose; and

4) combinations thereof.

Preferably, the complex drug regimen comprises different dosages or intervals of use for each agent, concomitant administration of more than one therapeutic agent, concomitant administration of more than one therapeutic agent.

It will be understood that all of the above-mentioned elements of the preferred package of the present invention are placed in a package of any suitable material. Preferably, the wrapper is made of any suitable paper and / or plastic material.

Preferably, the blister pack is unavailable to children and

I “friendly for the elderly.

Preferably, the blister cards are also separated, at approximately one-quarter to three-quarters, between the beginning and the end of the complex drug regimen by a card containing patient information and patient motivation information. This card preferably includes a note of the importance of ending the entire cycle of drug therapy to avoid the recurrence of disease and symptoms.

Preferably, such a package comprises a plurality of reminder cards or self-adhesive labels, the amount corresponding to the number of daily doses to be taken by the patient. A preferred reminder aid is one or more self-adhesive stickers.

Preferably, each reminder device (self-adhesive stickers or auxiliary card) is in a form such as to allow the patient to place the label or card in a location where the patient will be at the time of taking the doses of the complex drug regimen.

The present invention further relates to a method of assisting and / or enhancing patient cooperation in oral drug regimens using an effective convenient package.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a pharmaceutical package for helping or improving patient compliance. In particular, the present invention reduces the risk of missed doses, dosage errors (single dose amount), drug use errors, drug use time errors and / or premature interruption, for orally complex drug regimens. In particular, the present invention relates to a pharmaceutical pack for assisting or enhancing patient cooperation in taking an oral complex pharmaceutical drug regimen comprising:

(a) at least one blister card, wherein each blister card comprises a total daily dose of an oral complex drug regimen for use by patients; wherein the blister card is divided into portions, preferably perforated portions, dividing the individual doses of the complex drug regimen; wherein each dose portion has a marked time to take a dose; and wherein preferably each blister card is labeled for each individual treatment day.

(b) patient information brochure with dosage information, side effects, description of the disease being treated and patient motivation information;

(c) a daily calendar with dosage information, side effects, disease being treated and patient motivation information; and (d) preferably a reminder aid selected from the group consisting of:

1) one or more patient reminder cards when the dose of the complex drug regimen needs to be taken;

2) one or more self-adhesive labels indicating to the patient when the dose of the complex drug regimen needs to be taken;

3) a blister card-sized pouch, the pouch comprising an alarm clock which the patient can set to ring at the time of the next dose; and

4) combinations thereof;

wherein preferably the complex drug regimen comprises different dosages or dosing intervals for a single therapeutic agent, simultaneous administration of more than one therapeutic agent, and concomitant administration of more than one therapeutic agent.

It is to be understood that all of the above-mentioned elements of the preferred packaging of the present invention are placed in a package of suitable material. Preferably, the wrapper is made of any suitable paper and / or plastic material. The wrapper preferably has square or rectangular dimensions. Preferably, the outer wrapper for the above listed components has a size and dimensions for accommodating standard pharmaceutical prescriptions.

Preferably, the blister pack is unavailable to children and "friendly to the elderly."

Preferably, the blister cards are also separated, at about one quarter to three quarters between the beginning and the end of the complex drug regimen, by a card containing patient information (side effect, dosage, and / or disease information) and patient motivational information. This card contains a note on the importance of completing the entire cycle of drug therapy to avoid the recurrence of the disease or symptom. · *. ,.

The methods and packages of the invention comprise a safe and effective amount of one or more therapeutically active agents. As used herein, the term "safe and effective amount" means an amount of the therapeutically active agent in an amount sufficient to significantly modify the condition being treated, but low enough to avoid side effects (at an appropriate benefit / risk ratio). The safe and effective amount of therapeutic active ingredients will vary with the particular condition being treated, the age and physical condition of the subject being treated, the binding status, the duration of treatment, the nature of the concomitant therapy, the specific therapeutic agent selected and the like.

As used herein, "administration refers to any method, within the meaning of medical practice, the use of therapeutically active agents or therapeutically active agent formulations, used in a suitable package of the invention, to a treated patient in an effective manner for treating a disorder.

As used herein, the term "therapeutic agent" includes any pharmaceutical agent useful for treating a disease or condition for alleviating symptoms, and the like.

The term "oral complex drug regimen" refers to any oral drug regimen that requires administration to a treated patient:

1. Different dosage regimens for a single therapeutic agent (e.g., when the dose of one therapeutic agent changes over a treatment cycle, or when the intervals between use of a single therapeutic agent change over a cycle of a drug regimen).

2. Concomitant use of more than one therapeutic agent. As used herein, the term "simultaneously" means that two or more therapeutic agents are administered at the same time, starting and ending on the same day.

3. Consistently using more than one therapeutic agent. As used herein, the term "consistently" means that the use of two or more substances partially overlaps.

4. Use more than one therapeutic agent sequentially. The term "sequentially" here means that the use of two or more therapeutic agents is consecutive, i.e., the use of two or more agents is separated by no more than about 24 to 48 hours.

Examples of oral complex regimens are those described in U.S. Pat. Patente no. No. 5,256,684 Marshall, issued October 26, 1993, to the Procter & Gambia Company, which describes a method of treating human patients and lower animals with gastrointestinal disorders associated with H. pylori, which comprises administering bismuth and at least one antimicrobial agent. A literary reference to Marshall is incorporated herein by reference.

Particularly preferred oral drug regimens are those used in the treatment of disorders or infections of the upper gastrointestinal tract caused by H. pylori. Such gastrointestinal disorders are those that act on the upper gastrointestinal tract and those caused by H. pylori (referred to herein as "H. pylori caused gastrointestinal disorder (s)"). Such gastrointestinal disorders include, for example, H. pylori-induced disorders not manifested by the presence of gastric mucosa ulcers (herein "non-ulcer gastrointestinal disorders ⁷ '), including chronic or atrophic gastritis, non-ulcer dyspepsia, esophageal reflux disease and gastric motility disorders; and "peptic ulcer disease" means gastric, duodenal and jejunal ulcers. Treatment with H. pylori comprises administration of more than one therapeutic agent. Examples of such combination therapy include administration of 1) at least one antimicrobial agent (s) I in combination with a proton pump inhibitor, and 2) at least one antimicrobial agent (s) in combination with a bismuth or bismuth salt.

Proton pump inhibitors are, but are not limited to, omeprazole (known under the trade name Prilosec® from Astra Merck), lansoprazole (known under the trade name Prevacid® from TAP Pharm), pantoprazole and mixtures thereof.

The salts of bismuth are, but are not limited to, aluminum bismuth, bismuth citrate, bismuth subcitrate, bismuth nitrate, bismuth subnitrate, bismuth tartrate, bismuth subcarbonate, bismuth suballate, bismuth subalicylate, and bismuth subalicylate, and bismuth triflate.

bismuth subgallate and mixtures thereof. Particularly preferred is the bismuth subsalicylate salt.

A large number of bismuth salt compounds are available commercially, for example, DeNol® containing tripotassium dicitrate bismuth (sold by Gist-Brocades NV), Noralac® containing bismuth aluminum, alginic acid and magnesium carbonate (manufactured by North American Pharmaceuticals), Roter bismuth bismuth containing bismuth. (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 & Gambia Company) and ranitidine bismuth citrate (Tritec® from Glaxo Wellcome plc) .

A large number of antimicrobial agents are useful for the present invention. As used herein, "antimicrobial refers to a naturally occurring semi-synthetic compound or composition, or mixtures thereof, that are safe for human use when used in the packaging and methods of the invention, and is effective in killing or substantially inhibiting growth H. pylori when used by the method of packaging according to the invention. Antibiotics are preferred antimicrobial agents used herein. Such antibiotics can generally be classified according to their chemical composition into the following groups: aminoglycosides such as gentamicin, neomycin, kanamycin and streptomycin; macrolides such as erythromycin, clarithromycin, azithromycin, dirithromycin, troleandomycin, clindamycin and rifampin; penicillins such as penicillin G, penicillin V, ampicillin and amoxicillin; polypeptides such as bacitracin and polymyxin; tetracyclines such as tetracycline, chlortetracycline, oxytetracycline and doxycycline; cephalosporins such as cephalexin and cephalotin; and such various antibiotics as chloramphenicol and clindamycin. In general, these antibiotics act in one of four ways: inhibiting cell wall synthesis, altering cell wall permeability, inhibiting protein synthesis, or inhibiting synthesis and inhibiting nucleus.

Other useful antimicrobials are sulfonamides; nitrofurans such as nitrofurazone, nitrofurantoin and furozolidone; and metronidazole, tinidazole and nimorazole. Useful antimicrobials are described in the following publications, which are incorporated herein by reference: Remington's' Pharmaceutical Sciences (15th edition 1975); F. H. Meyers et al., Review of Medical Pharmacology (7th ed. 1980); Goddum's Pharmacology (8th edition 1978); and A. Goodman, A.G. Goodman and L.S. Gilman, The Pharmacological Basis of Therapeutics (6th Ed. 1980).

Although any of these antimicrobials may be used, penicillin, erythromycin, tetracycline, doxycycline, metronidazole, tinidazole, amoxicillin, ampicillin, clarithromycin, and nitrofurantoin are preferred antimicrobial agents for use in the present invention.

Particularly preferred oral complex drug regimens are regimens such as: 1) bismuth salt (e.g. bismuth subsalicylate), metronidazole and amoxicillin or tetracycline; 2) lansopazole, amoxicillin and clarithromycin; 3) ranitidine bismuth citrate (Tritec® from Glaxo Wellcome p.l.c.); 4) omeprazole and clarithromycin; and 5) ranitidine bismuth citrate and amoxicillin and / or clarithromycin.

Other preferred orally complex drug regimens are described in U.S. Pat. Patente no. No. 5,256, 684, Marshall, issued Oct. 26, 1993, The Procter &amp; Gambia Co., which is incorporated herein by reference in its entirety.

The specific method of assisting and / or enhancing patient compliance by administering one or more therapeutically active agents, according to the package or method of the invention, may depend on factors such as the particular therapeutic agent used, site of desired effect, daily amount of therapeutic agent administered, presence or possibility of some adverse effects. side effects and the possibility of any interactions between the therapeutic agents used. Thus, the therapeutic agent (s) may be administered in a single dose, or may be administered in two, three, or four or more doses per day.

The administration of the therapeutic agents simultaneously, concurrently or sequentially depends on the possible interactions between the agents, as is known to those skilled in the art.

Blister card

A preferred package according to the invention comprises at least one blister card. Each blister card contains the total daily dose of the oral complex drug regimen to be administered to the patient. The blister card is divided into portions, preferably perforated portions that separate each dose of the complex drug regimen; wherein each dosage portion includes an indication of the time at which the dosage is to be taken, e.g., "breakfast," lunch, "dinner," before bedtime, and the like.

When the daily dose of the complex oral drug regimen changes during treatment, it is preferred that the blister cards are arranged sequentially in order of administration. For example, a blister card may contain a label for each day of treatment ("day 1," day 2, "day 3 or" Monday, "Tuesday," Wednesday, etc.), or a label for the order of each blister card ("1," 2). , "3, or" card 1, "card 2," card 3, and the like). Preferably, in these different dosage regimens, the first card to be used is located at the beginning of the set of blister cards in the package for packaging.

Preferably, the blister card and / or pack is unavailable to children and provides easy access for the user.

Child resistant blister packs are disclosed in U.S. Pat. Patente no. No. 3,809,221, Compere, issued May 7, 1974; U. Patente no. No. 4,398,634, McClosky, issued Aug. 16, 1983, Wrapade Machine Company, Inc .; U. Patente no. No. 3,809,220, Arcudi, issued May 7, 1974, to Becton Dickinson and Company; U. Patente no. No. 3,503,493, Nagy, issued Mar. 31, 1970; U. Patente no. No. 3,924,746, Haines, issued Dec. 9, 1975, Paco Packing; U. Patente no. 4,011,949 Braber et al., Issued Mar. 15, 1977, The Lehigh Press; U. Patente no. No. 3,924,747, Gerner, issued Dec. 9, 1975, Packaging Coordinators, Inc .; U. Patente no. No. 4,537,312, Intini, issued Aug. 27, 1985. All references cited above are incorporated by reference in their entirety.

Preferably, the following information is printed on the blister card:

Preferably, each dose is indicated together with the time at which it is to be taken, for example, "breakfast," lunch, "dinner," before bedtime. This will help the patient to take the medicine at the right time. In addition, this information will help the patient to recognize if he missed a dose and when.

2. When the daily dose of the complex oral drug regimen is varied during therapy, it is preferred that the blister cards are arranged sequentially in order of use. Therefore, it is advantageous for the blister card to have an order marking. For example, the blister card may optionally be labeled "day 1, day 2," day 3, or "1," 2, "3, or" card 1, "card 2," card 3 similarly.

3. Name of the therapeutic substance or substances and doses present in the blister card and the blister portion of the blister card.

Each blister card of the present invention comprises a full daily dose of an oral complex drug regimen. Therefore, the patient may carry a 1-day supply during the day, either in a handbag or bag. Preferably, the blister card is about 3.75 x 4.75 inches in size or is sized to fit into a standard shirt bag. When the blister card is larger, it can be folded in half to reduce the size so that it is easy to store when needed in a handbag, bag or the like.

In addition, in a preferred embodiment of the present invention, the package or kit comprises a separate package or card holder. This case protects the blister card from damage. In addition, the capsule is another method for transferring a blister card during the day, so that the doses of the complex drug regimen are readily available to the patient.

In another embodiment of the present invention, the blister card holder may also include an alarm clock as a reminder aid. The patient may set the alarm to ring when the next dose is to be taken.

The option of individual blister cards eliminates the need for the patient to have the entire kit or package with him. This also eliminates the need to translate the complex drug regimen into another unlabelled container. The portability of the individual blister cards allows the patient to have a dose at hand when the patient is away from home.

Preferably, the individual dose portions on the blister cards are arranged in chronological order of use times. For example, when the oral drug regimen comprises 4 daily doses of one or more therapeutic agents, the blister card will preferably contain four dose portions, preferably of the same dimensions and preferably separated by perforations.

When the oral complex drug regimen has more than one therapeutic agent to be administered as part of the same regimen, preferably the blister card has only one drug in the opening. However, these tray units will be placed in the same portion for the dose. This avoids any possible physical interactions between two or more different therapeutic agents.

The blister card provides positive (or negative) feedback to the patient or physician, since looking at the blister card it can be seen whether all doses of the complex oral dosage regimen have been used by the patient.

Daily calendar, patient information brochure and incentive aid

In addition, a compliant package according to the invention comprises: (1) a patient information brochure on dosage, side effect, description of the disease being treated and patient motivational information;

(2) a daily calendar with dosage information, side effect, description of the disease being treated and patient motivation information;

(3) preferably the incentive aid comprises:

1) one or more auxiliary cards reminding the patient when to take a dose of a complex drug regimen;

2) one or more self-adhesive labels reminding the patient when to take a dose of a complex drug regimen;

3) a blister card-sized pouch, the pouch containing an alarm which the patient can set to ring when the next dose needs to be taken; and

4) combinations thereof.

"The information as used herein includes, but is not limited to, the anticipated benefits of an oral complex drug regimen, the importance of cooperation in dosing and compliance, side effect information, time during treatment when side effects occur and information about the disease being treated. or status.

Therefore, several components of the preferred package of the present invention are significant in providing the patient with repetition of information (dosage information, side effect information, disease information and patient motivational information). This is to remember the information and effort to motivate the patient to complete the entire treatment cycle. In addition, a number of components, such as a brochure, calendar, label and other printed information on a blister card, reminder aids, and the like, are a constant source of information for the patient. Preferably, the side effect, dosage, disease, and patient motivation information is repeated at least twice, more preferably at least 3 times in a preferred package.

As used herein, "information, dosage information, side effect information, information describing the disease being treated and patient motivational information means educational information and the patient is able to understand and use it. Preferably, this information is written in a simple form, i.e. that the average patient or user can understand the information. Complex and difficult medical terminology should be translated into simpler words. Patient information readability is very important as it has been found that patients do not understand many medical terms in patient information materials. D.L. Smith, Compliance Packing: A Patient Education Tool, Amer. Pharm., Vol. NS29, no. 2, p. 42-53, 1989.

Preferably, this information includes visual illustrations to ensure further repetition and consolidation of the written information.

The side effect information should not only list the possible side effects, but should be complete enough for the patient to handle the side effects. For example, a statement that “bismuth may cause the presence of dark stools or tongue, but this darkening will disappear when treatment is stopped will help the patient to cope with this side effect. The side effect information may also instruct the patient to contact the person prescribing the medicine when the side effects are of concern to the patient. Furthermore, in drugs that cause the patient's sun hypersensitivity to the sun, the patient is instructed to avoid as much as possible the sun and the mountain sun and to use protective creams with a high protective factor.

In addition, the patient is aware of how and when to take any missed doses of the medicine.

The information in the preferred package and methods of the invention are advantageous because they are not violent or intimidating to the patient being treated. Although it can be expected that for a patient with very comprehensive information on 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 agree to the instructions for using and using the complex drug regimen.

Preferred packs and methods of the invention therefore also include "patient motivation information." "Patient Incentive Information, as used herein, means specific written material or instructions that provide instructions for appropriate behavior or stimulation of a patient to fulfill a therapeutic drug regimen. Patient incentive information includes notices that have positive feedback and / or encouragement such as congratulations, notices reminding the patient during the various intervals of a comprehensive drug regimen to adapt to the regime, phrases encouraging patient cooperation, and highlighting the benefits of appropriately used drugs (i.e. fewer side effects, less chance of reoccurrence of infection, less chance of developing antimicrobial resistance, less chance of retreating, etc.) statements that encourage cooperation by highlighting the benefits of completing therapy (eg reducing or eliminating disease symptoms), statements that the patient has some control over the treatment and that the patient has chosen to participate in the treatment and is therefore involved in decision-making on the regimen, etc.

Patient incentive information can also inform the patient that cooperation in appropriate dosage use can save the patient time and money. In particular, patient motivational information may inform the patient that adherence to appropriate dosage instructions and completing the full cycle of the complex drug regimen may reduce the patient's visits to his or her physician, reduce prescribed medications to treat conditions due to non-cooperation and recurrence of infection ( non-cooperation in antimicrobial treatment), etc. Furthermore, adherence to the correct dosage regimen can eliminate side effects and adverse reactions that may require the need for basic laboratory examinations, X-ray examinations, ECGs, diagnostic tests, intravenous and parenteral treatment, and even hospitalization to treat serious complications.

The following are some specific forms of patient motivational information according to the present invention.

1. "The cost of your exertion can mean an exemption from your ______ (the disease or condition in question).

2. “Hold it!

3. “You are in control.

4. “You have already completed one third of your treatment!

5. “Keep up the good work!

6. “Every day of treatment releases you from ______ (disease or condition)

7. “You have already completed half the treatment!

8. “Every day of treatment helps to relieve symptoms.

9. “Congratulations! You've completed half the drug therapy. You have only one week (or number of days, etc.) ahead of you!

10. “You have just completed two thirds of your treatment.

11. "Think - Your retreat ______ (disease or condition) may be on the horizon.

12. “Think - Your symptoms may be relieved.

13. “Are you not glad that you have made efforts to take the medicine as directed?

14. “Each dose is calculated in the treatment.

15. “Retreat of your ______ (disease or condition) may be within easy reach.

16. "The relief of your symptoms may be" Now do not fade - stay tomorrow - and then hooray!

18th

17th

at your fingertips. when scheduling benefits, etc.

19th

“You did it! "Congratulations! “Enjoy all the future without

21. “Take all your medicines today (illness, condition), your medicines today and you can and you can look forward to the future without your symptoms.

22. “Get energy for your future!

20th

In the calendar of the present invention, the individual pages correspond to each day of treatment of the oral complex drug regimen. The calendar is preferably arranged such that the patient, after taking a daily dose of the drug regimen, can tear off the calendar page or strike through the respective page. The patient may take a calendar with him on the next visit to the doctor to confirm the patient's level of cooperation with the complex drug regimen. The calendar is preferably affixed to the inside of the lid of the preferred package.

The package according to the invention preferably comprises several reminder cards or self-adhesive stickers. The amount corresponds to the number of daily doses to be taken by the patient. Advantageously, the package includes reminder devices in the form of one or more self-adhesive stickers.

Preferably, the reminder device (self-adhesive stickers or reminder card) is in a form such as to allow the patient to place the label or card in a location where the patient will be at the time when they need to take a dose of the complex drug regimen. For example, a reminder sticker or card may be placed on a refrigerator, TV, alarm clock, computer monitor, bathroom mirror, medicine chest, desk, dining table, night lamp, coffee mug, toothbrush and the like.

Written advice on a sticker or reminder card contains one or more of the following: the name of the medicine, the generic name and a warning such as "Remember to take your medicine," Take your next dose _____, and the like.

Preferably, the blister cards are separated, in approximately one quarter to three quarters, between the first and last blister cards of the complex drug regimen by the card containing the patient information and the patient motivational information. The card preferably includes a notice of the importance of completing the entire cycle of drug therapy to avoid recurrence of disease and symptoms. Preferably, in a package for the treatment of H. pylori gastrointestinal tract infections, the card is placed between about 3 and 4 days (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 the symptoms of antimicrobial therapy generally resolve during treatment.

Preferably, in the treatment of H. pylori infections, the card is placed between the blister card 7 and 8 and contains congratulations for completing approximately half the cycle of the complex drug regimen. Preferably, in H. pylori infections, the card comprises:

“The healing of ulcers is on the horizon! Congratulations. You have completed the first 7 days of your 14-day treatment. You may feel better, but continue to take medication. You need to take medicines for 14 days to kill the bacteria that cause the ulcer. Now that you are done, some bacteria may not be killed and your ulcer may return. So keep up the good work! Do not stop until you have taken all the medicines.

The following are examples of preferred packaging that do not limit the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Example 1

A pharmaceutical pack to help and improve patient compliance when taking an oral complex pharmaceutical drug regimen comprising:

(a) at least one blister card wherein each blister card comprises a total daily dose of an oral complex drug regimen; wherein the blister card is divided into portions separating the individual doses of the complex drug regimen; wherein each dose portion has a marked time to take a dose;

(b) patient information brochure with dosage information, side effects, description of the disease being treated and patient motivation information; and (c) a daily calendar with dosage information, side effects, disease being treated and patient stimulus information;

wherein the complex drug regimen comprises different dosages or intervals for the use of a single agent, concomitant use of more than one therapeutic agent, concomitant use of more than one therapeutic agent.

'I t

Example 2

A pharmaceutical pack to help and improve patient compliance when taking an oral complex pharmaceutical drug regimen comprising:

(a) at least one blister card wherein each blister card comprises a total daily dose of an oral complex drug regimen; wherein the blister card is divided into portions separating the individual doses of the complex drug regimen; wherein each dose portion has a marked time to take a dose;

(b) patient information brochure with dosage information, side effects, disease being treated and patient motivation information;

(c) a daily calendar with dosage information, side effects, disease being treated and patient stimulus information; and (d) a reminder device comprising:

1) one or more reminder cards to remind the patient when to take a dose of a complex drug regimen;

2) one or more self-adhesive stickers to remind the patient when to take a dose of a complex drug regimen;

3) a pouch in the size of a package for a single blister card, the pouch comprising an alarm clock which the patient can set to ring at the next dose; and

4) combinations thereof.

Example 3

A pharmaceutical preferred package comprising:

(a) a series of 14 blister cards, each blister card containing 4 doses of an oral complex drug regimen; wherein the blister card is perforated divided into 4 portions separating the individual doses; wherein each dosing portion is labeled "breakfast," lunch, "dinner, and" before bedtime, which means the time at which the dose is to be taken; wherein each dose comprises bismuth salt, tetracycline and metronidazole, preferably each dose contains 2 tablets of bismuth subsalicylate with 102 mg salicylate, 1 capsule of 500 mg tetracycline HCl and 1 tablet of 250 mg metronidazole; wherein each blister card has only 1 medicament in the opening on the blister card; and wherein preferably between a 7 and 8 blister card is inserted a card indicating the importance of completing the entire drug therapy cycle to avoid returning the disease / symptoms and congratulating the patient on completing half of the complex drug regimen;

(b) patient information brochure with dosage information, side effects, disease being treated and patient motivation information;

(c) a daily calendar with dosage information, side effects, disease being treated and patient stimulus information; and (d) a reminder device with 4 reminder cards or 4 self-adhesive labels to be placed where the patient will be at the time of taking each scheduled dose to remind the patient to take a dose of a complex dosage regimen.

Claims (9)

PATENT CLAIMS 1) one or more reminder cards to remind the patient when to take a dose of a complex drug regimen; A pharmaceutical package for assisting or enhancing patient cooperation in taking an oral complex pharmaceutical drug regimen comprising: (a) at least one blister card, preferably inaccessible to children, wherein each blister card comprises a total daily dose of an oral complex drug regimen; wherein the blister card is divided into portions separating the individual doses of the complex drug regimen; wherein each dose portion has a marked time to take a dose; (b) patient information brochure with dosage information, side effects, description of the disease being treated and patient motivation information; and < (c) a daily calendar with dosage information, side effects, disease being treated and patient stimulus information; wherein the complex drug regimen comprises different dosages or intervals for a single therapeutic agent, concomitant use of more than one therapeutic agent, or concomitant use of more than one therapeutic agent. 2) one or more self-adhesive stickers to remind the patient when to take a dose of a complex drug regimen; 2. A pharmaceutical pack for assisting or enhancing patient compliance with an oral complex pharmaceutical drug regimen comprising: (a) at least one blister card, preferably inaccessible to children, wherein each blister card comprises a total daily dose of an oral complex drug regimen; wherein the blister card is divided into portions separating the individual doses of the complex drug regimen; wherein each dose portion has a marked time to take a dose; (b) patient information brochure with dosage information, side effects, description of the disease being treated and patient motivation information; and (c) a daily calendar with dosage information, side effects, disease being treated and patient stimulus information; and (d) a reminder aid selected from the group consisting of: 3. A pharmaceutical pack for assisting or enhancing patient compliance with an oral complex pharmaceutical drug regimen comprising: (a) a series of 14 blister cards, preferably inaccessible to children, each blister card containing 4 doses of an oral complex drug regimen; wherein each blister card is perforated divided into 4 portions separating the individual doses; wherein each dosing portion is labeled "breakfast," lunch, "dinner, and" before bedtime, which means the time at which the dose is to be taken; (b) a patient information brochure with information on dosing, side effects, disease being treated and patient information; (c) a daily calendar with dosage information, side effects, disease being treated and patient stimulus information; and (d) a reminder device with 4 self-adhesive labels to be placed at the location where the patient will be at the time of taking each scheduled dose, indicating when the patient is to take the dose of the complex dosage regimen; wherein the complex drug regimen involves concomitant use of bismuth, tetracycline, and metronidazole subsalicylate. * t, 3) a blister card-sized pouch, the pouch comprising an alarm clock which can be adjusted by the patient to ring at the next dose; and Preferred pack according to claim 1, 2 or 3, characterized in that the patient motivational information includes reports that the patient has some control over the treatment. 4) combinations thereof. Preferred package according to claim 1 or 2, characterized in that the complex drug regimen comprises the simultaneous administration of at least one antimicrobial agent and bismuth. Preferred package according to claim 1 or 2, characterized in that the complex drug regimen comprises the simultaneous administration of at least one antimicrobial agent and a proton pump inhibitor. 7. A preferred package according to claim 2, wherein each blister card comprises an indication in which each individual blister card of the complex drug regimens to be administered sequentially or when doses or intervals between doses for one is to be used. the therapeutic agent varies from day to day, wherein the label preferably denotes every single day of treatment. 8. A preferred package according to claim 2, wherein, in the middle of the treatment regimen, the blister cards are separated by a card with patient information and patient motivational information. 9. The preferred package of claim 3, wherein a patient information card and a patient motivation card are inserted between the 7 and 8 blister cards, indicating the importance of completing the entire drug therapy cycle to prevent the recurrence of the disease or symptom.