WO2004077281A2 - Method and system for self-administration of medications - Google Patents

Method and system for self-administration of medications Download PDF

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Publication number
WO2004077281A2
WO2004077281A2 PCT/US2004/006217 US2004006217W WO2004077281A2 WO 2004077281 A2 WO2004077281 A2 WO 2004077281A2 US 2004006217 W US2004006217 W US 2004006217W WO 2004077281 A2 WO2004077281 A2 WO 2004077281A2
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WO
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Prior art keywords
medication
kit
administration
invention
medications
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PCT/US2004/006217
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French (fr)
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WO2004077281A3 (en )
Inventor
Robert W. Mackie, Jr.
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Mackie Robert W Jr
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D5/00Rigid or semi-rigid containers of polygonal cross-section, e.g. boxes, cartons or trays, formed by folding or erecting one or more blanks made of paper
    • B65D5/42Details of containers or of foldable or erectable container blanks
    • B65D5/4212Information or decoration elements, e.g. content indicators, or for mailing
    • B65D5/4216Cards, coupons or the like formed integrally with, or printed directly on, the container or lid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D5/00Rigid or semi-rigid containers of polygonal cross-section, e.g. boxes, cartons or trays, formed by folding or erecting one or more blanks made of paper
    • B65D5/42Details of containers or of foldable or erectable container blanks
    • B65D5/44Integral, inserted or attached portions forming internal or external fittings not used, see subgroups
    • B65D5/50Internal supporting or protecting elements for contents
    • B65D5/5028Elements formed separately from the container body

Abstract

A method and system for the self-administration of medication is provided. This method manages the types, dosages and sequencing of medication in order to facilitate its most effective administration. This method and system is particularly adapted for embodiments useful for the treatment of acute coronary syndrome and for diarrhea. The system includes a medication kit, which itself includes medication cards, information and mechanism for sequencing the administration of the medication.

Description

METHOD AND SYSTEM FOR SELF-ADMINISTRATION OF MEDICATIONS

Background of the Invention

Field of the Invention. This invention relates to methods and systems of administering medications. More specifically, this invention relates to methods and systems for self- administering of medications where the particular order and/or timing of the administration are important.

Description of Related Art. A variety of techniques and devices related to the administration of medication are well known in the art. Generally, such techniques and devices do not provide a structure for the sequence of administration of a variety of drugs. Although the following referenced documents, may not constitute prior art, the reader is referred to the following U.S. patent documents for general background material. Each of these patents is hereby incorporated by reference in its entirety for the material contained therein. U.S. Patent No. 4,004,577 describes a method of treating coronary prone patients when heart attack symptoms occur before qualified direct contact personal care can be administered to the patient.

U.S. Patent No. 4,169,550 describes an emergency medical kit having a plurality of pockets and straps, which are designed to hold medical equipment. U.S. Patent No. 4,212,392 describes a portable medical kit, which maintains medicines, instruments and equipment secure when the kit is closed.

U.S. Patent No. 4,350,245 describes a medical kit for the protective storage of teat swabs. U.S. Patent No. 4,476,016 describes an apparatus and a kit packaged for use in isolating and identifying and quantitatively measuring the MB iso-enzyme of creatine phosphokinase in fresh human blood serum and apparatus including combinations of racks, glass receptacles and other equipment for making various quantitative and qualitative blood and blood serum tests.

U.S. Patent No. 4,658,830 describes a device for initiating reperfusion treatment of a coronary prone individual prior to the establishment of qualified direct contact personal care at a time during the early minutes or hours after the onset of heart attack symptoms and after qualified personnel have participated by telephone in the decision to initiate such treatment.

U.S. Patent No. 5,207,330 describes a medical emergency carrying case. U.S. Patent No. 5,622,985 describes a method for preventing or reducing the risk of a second heart attack in a patient having a substantially normal serum cholesterol level by administering an HMG CoA reductase inhibitor such as pravastatin, alone or in combination with an ACE inhibitor.

U.S. Patent No. 5,658,801 describes a medical diagnostic test kit. U.S. Patent No. 5,848,700 describes an emergency medical kit that includes a carrying case of approximately briefcase or small suitcase sized with the upper and lower sections divided into a large number of compartments by insertion of a plastic organizer. U.S. Patent No. 5,977,160 describes a method for treating a human survivor of a heart attack and provides further improvement in survival following the heart attack by the early initiation and long-term administration of an angiotensin converting enzyme inhibitor. U.S. Patent No. 6,012,586 describes a medical procedure kit for performing an angiographic or medical procedure.

U.S. Patent No. 6,116,426 describes an emergency medical kit having a container with a hinged lid and a latch for use in organizing and protecting ophthalmic instruments and supplies, such as sterilized pads, drugs, extractors, lights, ointments, tape and other items needed by a physician or emergency personnel working under the auspices of a physician in rendering emergency medical assistance to a person suffering an eye injury.

U.S. Patent No. US 6,323,188 Bl describes a method of reducing the incidence and severity of stroke, primary heart attack and any subsequent heart attack or stroke in humans by daily administration of an effective amount of a combination of acetylsalicylic acid (ASA), a cyanocobalamin compound (Vitamin B 12), a folic acid compound, and pyridoxine compound (Vitamin B6) in an easy to take daily administration pack.

U.S. Patent No. US 6,382,568 Bl describes a tube and wire organizer for medical situations that is an aide to organize adjunctive equipment used by paramedical and medical people.

U.S. Patent Application Publication No. US 2001/0002025 Al describes a dosing dispenser for the alternating removal of two or more, possibly different solid forms of pharmaceutical substances to be taken, which differ in their quantitative and/or qualitative composition. U.S. Patent Application Publication No. US 2002/0025538 Al describes a medical kit which overcomes the problem with non-specific binding and interaction, thus providing a highly reliable method for qualitative or quantitative determination of a drug in a biological fluid. U.S. Patent Application Publication No. US 2002/0025917 Al describes a process of creating an admixture of liquefied aspirin or other heart attach medication and administering said admixture to the buccal mucosa of the cheek pouch and/or the nasal passages of heart attack victims. U.S. Patent Application Publication No. US 2002/0088737 Al describes an emergency pill dispenser with a sealed enclosure containing a pill or pills.

Summary of the Invention It is desirable to provide a method and system for the self administration of medication by individuals. It is particularly desirable to provide such a method and system for the self-administration of medications that both provides information regarding the medical condition-giving rise to the need for the medication, the administration of the medications, and manages the sequence of administration of a plurality of medications and/or dosages.

Accordingly, it is an object of this invention to provide a method and system for the self-administration of medication.

Another object of this invention is to provide a method and system for the self- administration of medication that dispenses information regarding the medical condition related to the medication.

A further object of this invention is to provide a method and system for the self- administration of medication that dispenses information regarding the medication themselves.

A still further object of this invention is to provide a method and system for the self-administration of medication that manages the sequence of administration of a plurality of different medications and/or dosages of medication. It is an object of this invention to provide a method and system for the self- administration of medication that is suitable for use where the patient remote from emergency medical care.

It is another object of this invention to provide a method and system for the self- administration of medication that is appropriate to a wide variety of medical conditions. It is a further object of one embodiment of this invention to provide a method and system for the self-administration of medication that is appropriate for use in treating symptoms of unstable coronary syndromes, such as myocardial infarction and unstable angina. It is a still further object of one embodiment of this invention to provide a method and system for the self-administration of medication that is appropriate for use in treating symptoms of diarrhea.

Another object of this invention is to provide a method and system for the self- administration of medication that preserves the freshness and avoids contamination of the medications.

A further object of this invention is to provide a method and system for the self- administration of medication that is consistent with requirements for distribution of prescription medications.

Additional objects, advantages and other novel features of this invention will be set forth in part in the description that follows and in part will become apparent to those skilled in the art upon examination of the following or may be learned with the practice of the invention. The objects and advantages of this invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims. Still other objects of the present invention will become readily apparent to those skilled in the art from the following description wherein there are shown and -described present preferred embodiments of this invention, simply by way of illustration of the present modes best suited to carry out this invention. As it will be realized, this invention is capable of other different embodiments, and its several details, and specific steps, language and package structure are capable of modification in various aspects without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not as restrictive.

Brief Description of the Drawings The accompanying drawings incorporated in and forming a part of the specification, illustrate present preferred embodiments of the present invention. Some, although not all, alternative embodiments are described in the following description. In the drawings:

Figure 1 is a process flow chart of the present use of the medication kit of this invention. Figure 2 is a process flow chart of the present use of the medication kit of this invention.

Figure 3 a is a perspective drawing of a first example embodiment of the kit structure of this invention.

Figure 3b is a perspective view of an example medication card used with the first example embodiment of the invention.

Figure 3c is a perspective drawing of the first example embodiment of the kit structure of this invention with the top lid open.

Figure 3d is a perspective drawing of the first example embodiment of the kit structure of this invention with the end door open. Figure 4a is a perspective drawing of a second example embodiment of an alternative kit structure of this invention.

Figure 4b is a perspective drawing of the medication card used with the second example embodiment of the alternative kit of this invention. Figure 5a is a representation of the first medication card of the cardio-kit embodiment of this invention.

Figure 5b is a representation of the second medication card of the cardio-kit embodiment of this invention.

Figure 5c is a representation of the third medication card of the cardio-kit embodiment of this invention.

Figure 5d is a representation of the fourth medication card of the cardio-kit embodiment of this invention.

Figure 6a is a representation of the first medication card of the Touista-kit embodiment of this invention. Figure 6b is a representation of the second medication card of the Touista-kit embodiment of this invention.

Figure 6c is a representation of the third medication card of the Touista-kit embodiment of this invention.

Figure 7a is a section view of a third alternative embodiment of the kit of this invention.

Figure 7b is a perspective view of the third alternative embodiment of the kit container with the lid open.

Reference will now be made in detail to the present preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. Detailed Description of the Invention

This invention is a method and system for the self administration of medications for situations where the patient or user has a critical health emergency and/or does not have ready access to professional medical assistance. Although this invention can be used for a wide variety of medical conditions or symptoms, two specific embodiments of applications of this invention are described herein as examples. The applicant intends that these embodiments be considered as both examples and as descriptions of the best modes of the invention known to the inventor at the time of filing, and not as limiting the scope of patent protection. The first example embodiment of this invention is as a self administration kit to treat unstable coronary syndromes, including myocardial infarction and unstable angina pectoris in circumstances in which immediate access to emergency medical services in not available, referred hereinafter as the "cardio care kit." The second example embodiment of this invention is as a self administration kit for the treatment of traveler's diarrhea, typically caused by growth of a common bacteria, Escherichia Coli in the intestine, referred hereinafter as the "diarrhea care kit."

With regard to the cardio care kit and by way of introduction, treatment of myocardial infarction and unstable angina relies in part on improving the blood flow to the cardiac muscle or reducing the energy requirements of cardiac work. In nearly all cases of sudden onset of new cardiac ischemic symptoms, a clot in a coronary artery leads to acute vessel obstruction and the sudden onset of chest pain due to myocardial ischemia or myocardial infarction. Medical treatment typically depends on receiving intravenous blood thinners (such as fhrombolytic therapy and heparin) or having balloon angioplasty performed as an emergency procedure. Early initiation of treatment with Aspirin has been proven to reduce myocardial damage due to myocardial infarction and treatment with a new oral antiplatlelet medication, clopidrogrel, has been shown to reduce the chances of death, nonfatal myocardial infarction and stroke when given immediately after the diagnosis of the onset of acute chest pain due to coronary ischemia. Nytroglycerin reduces myocardial damage during heart attach by reducing blood pressure, dilating coronary arteries and reducing myocardial oxygen demand. Beta adrenergic blocking medication reduce heart rate, reduce blood pressure and subsequently reduce heart attach size. Beta blockers by raising the electrical threshold for ventricular fibrillation, also reduce the risk of sudden death from ventricular fibrillation in the setting of acute myocardial infarction. These treatments are not generally available to the general public unless they can be reached by advanced medical care, or if the patients can reach emergency medical services. The cardio care kit embodiment of this invention is designed to be carried by patients at risk for the development of unstable coronary syndromes including, but not limited to, myocardial infarction and unstable angina pectoris. If a patient with the symptoms of myocardial infarction or unstable angina pain cannot be treated or reached immediately by emergency medical care, the cardio care kit is designed to be self administered for treatment of acute unstable coronary syndromes. The kit provides patients with important medications, in a package which encourages the desired order of administration of the medications, along with instructions, which will improve the patient's symptoms, reduce their chances of dying and reduce the size of their eventual myocardial infarction while they await transportation to a medical facility for further medical care. This embodiment of the invention also provides information regarding the symptoms and signs of a heart attack and instructions for the sequential use of the cardio care kit's medications to improve the patient's chances of survival of a heart attack in the absence of medical care. The kit of this embodiment typically includes Aspirin, anticoagulant (typically clopidrogrel), nitroglycerin and in some cases betablocker medications. The reader should be aware that the concept of this invention is not limited to the specific medications and that it is expected that the preferred medications will change over time as the emergency treatment of heart attack and unstable angina evolves in the future. Since the cardio care kit is designed to be self administered by patients it will often be used in locations where immediate medical emergency care is not available or in which medical care is deemed to be inadequate, such as wilderness areas, rural areas, third world countries or in urban areas when circumstances such as weather, traffic, distance or disaster prevents access to emergency medical services. Typically, patients will have the cardio care kit immediately available at the time their symptoms first develop. The component medications will have been prescribed and dispensed before the user of the kit is in a location where they might have the onset of an unstable coronary syndrome. At least one-half of patients who suffer myocardial infarction and unstable angina have not sought prior medical care for their coronary risk factors or coronary artery disease warning symptoms. In the present use of the invention, the cardio care kit will be made available to the general public via Internet access after patients have completed an on-line Internet consultation to confirm they are candidates for the kit and have no contraindications to the component medications of the kit. The cardio care kit will be prescribed only by cardio care kit authorized physicians, and through cardio care kit licensed pharmacists and pharmacies. The cardio care kit only uses US FDA approved medications.

In its present preferred embodiment, the packaging, medications and instructions are combined into a small, compact kit with printed instructions for use of each of the medications. The sequencing of use of the medications is clearly labeled in the kit as well as side effects and contraindications to further use of components of the kit based on the patients symptoms of shock, heart failure and heart rate and blood pressure during their acute ischemic coronary attack. Acute coronary syndromes are usually a result of coronary thrombosis on superimposed vulnerable atherosclerotic coronary artery plaque. The erosion of the surface of mildly obstructive coronary plaque, causes local vessel clotting and leads to sudden coronary artery closure, and often is not preceded by warning symptoms of chest pain or shortness of breath. Myocardial infarction and unstable angina often develop without warning. Rapid treatment of myocardial infarction and unstable angina reduces mortality and improves the chances of survival for patients. Patients that do not have access to emergency medical care may die suddenly of cardiac rhythm disturbances or suffer extensive myocardial damage leading to cardiac shock; if they survive. Myocardial damage may lead to future congestive heart failure. The cardio care kit embodiment of this invention improves patient's chances to receive further care for what otherwise might be fatal coronary atherosclerosis.

For patients unable to reach definitive cardiac care immediately, treatment with antiplatelet medications will improve their chances of survival and possible abort death in the case of coronary thrombosis. Aspirin, which affects platelet thromboxane production, is available without a prescription in the United States and is a prescribed treatment for acute coronary syndromes and, moreover, has been shown to reduce mortality in the setting unstable coronary syndromes. Nitroglycerin is approved by the US FDA for chest pain during acute coronary syndromes and relieves chest pain and reduces the size of myocardial infarction. Cardio care kit patients are instructed to take clopidogrel if their pain is not relieved by aspirin followed by nitroglycerin. Following the administration of aspirin and clopidogrel, the patients will typically have a significant antiplatelet effect and will have an anticoagulant effect for about three days. Betablocker medications can also be used to reduce the incidence of fatal arrhythmias and to reduce mortality when they are taken at the onset of acute myocardial infarction. Betablockers have been recommended by the American College of Cardiology / American Heart Association (ACC/AHA) Guidelines for the Management of Patients with acute myocardial infarction. Cardio care patients, of this invention, are instructed to take betablockers typically about one hour into the onset of their heart attach if they feel that the will be delayed more than two hours from receiving medical care. For kits of this invention containing betablockers, patients are instructed to take metoprolol, typically about 25mg, orally every six hours based on their blood pressure, heart rate and symptoms. Cardio care kit, of this invention, patients can be advised to purchase a portable blood pressure monitor to keep with them when they are away from emergency medical care for an extended period of time and may need to use the contents of the cardio care kit.

In the basic cardio care kit of this invention, instructions and medications for patients suffering symptoms of acute myocardial ischemia (myocardial infarction and unstable angina pectoris) who do not have immediate access to emergency medical services. Patients are typically advised by the invention's provided instructions to contact, typically by telephone, their local emergency medical provider and to initiate transport as soon as possible to the nearest medical facility. In the present basic embodiment of the invention, patients are instructed to chew and swallow four 81mg tablets of aspirin, to use nitroglycerin every five minutes, depending on the level of chest pain and symptoms, and finally to take four tablets of 75mg of clopidogrel, if symptoms are not relieved by three sequential nitroglycerin tablets. In the extended care embodiment of the invention, patients are supplied with a kit with aspirin, nitroglycerin and clopidogrel, as in the basic embodiment, and will also be supplied with betablocker therapy. In this embodiment, patients are also instructed to take betablockers one hour after the onset of symptoms of heart attack based on the presence or absence of symptoms and signs of shock, heart failure and pulmonary edema. This embodiment of the kit contains 25mg metoprolol tablets. The instructions for the use of metoprolol will be based on heart rate and blood pressure.

The present cardio care kit embodiments of the invention contain instructions for the signs and symptoms of myocardial infarction as well as instructions for the use of each of the component medications. Patients are generally instructed to call 911 before taking the medications and to go or be transported to the nearest hospital emergency room, if 911 or the equivalent emergency medical number cannot be reached. Patients are not prescribed the kit of this embodiment of the invention if they have a history of bleeding, prior intracerebral bleeding, a history of cerebral aneursym, recent major trauma, a history of aortic dissection or allergies or hypersensitivity to any of the components of aspirin, clopidrogrel, nitroglycerin or betablockers. A patient with a history of asthma will not be prescribed the remote-cardio care kit embodiment that contains betablockers. As noted above, at present two embodiments of the cardio care kit embodiments are available. The "rural-cardio care kit" embodiment consists of a folded kit with medications in a film tab package, with aspirin, clopidrogrel and a sealed bottle of 25 nitroglycerin tablets. This embodiment is typically used by patients with contra indications to betablockers or by patients that anticipate reaching medical care within two hours from the onset of a heart attack, but know that emergency medical care is not immediately available. The second "remote-cardio care kit" embodiment, includes the medications of the "rural-cardio care kit" plus the betablocker medication, typically metoprolol. This "remote-cardio care kit" embodiment includes instructions for patients not to take betablockers if their blood pressure is below 90mmHg or if the patient has symptoms of shock, heart failure, pulmonary edema, asthma or have a heart rate below 50 beats per minute. The extended or "remote" embodiment of the kit of this invention is for patients who do not expect to reach medical care for time periods of two hours to several days after the onset of their heart attack. Such patients include patients who plan to travel in wilderness locations, third world countries where medical care is limited, and/or for patients who live in locations where it is likely to take over two hours to be transported to an emergency room. The medications contained in the present kit of this invention typically have a shelf life of about one year. The kit is typically available to patients only after a licensed physician has prescribed each component medication of the kit. Patients are preferably required to complete a cardiology consultation prior to the dispensing of the components of the kit. The patients also receive with the kit of this invention explicit instructions concerning the use of the kit and information concerning the symptoms and signs of acute coronary syndromes. Contraindications to the use component medications of the kit are also included. Patients are also generally instructed to acquire a portable blood pressure and heart rate monitor if they intend to use the remote cardio care kit and who expect to be out of touch with emergency medical services for more than two hours after the onset of chest pain.

In a second example embodiment of this invention, the medications and kit instructions provide treatment for traveler's diarrhea. Traveler's diarrhea affects nearly one quarter of travelers to tropical vacation lands, and even more who travel to developing and third world countries. The disease is normally caused by a growth of a common bacteria, Escherichia Coli in the patient's intestine. Traveler's diarrhea commonly occurs in areas where hygiene is poor. The Medical Letter recommends, "Travelers should avoid raw vegetables, fruit they have not peeled themselves, unpasteurized dairy products, cooked food not served steaming hot and tap water including ice."

This embodiment of the invention, referred to generally as the Tourista Euro Kit, is designed for use in treating severe cases of Traveler's Diarrhea (TD). The Tourista Euro Kit embodiment is also designed for use by patients who do not have immediate access to emergency medical services. It presently contains three medications, each of which has been proven to help in the cessation of common diarrhea. It is also packaged with detailed instructions to inform the patient the sequence and timing of taking the medications. Patients are also instructed to begin self treatment when diarrhea symptoms are distressing or persistent.

Preferably embodiments of the kits of this invention are provided as a kit with medications to be dispensed in a sequential timed fashion. The kit may be folded or may be provided with shelves with the medications installed in cards or film tab packaging. Large print instructions indicating the sequence and timing of administration of the medications along with general emergency medical information, such as 911 calls, the local emergency medical telephone numbers, and directions to the nearest hospital. The present kit embodiments of this invention include instructions not to take the components of the kit if they have contraindications to use of the kit medications as the patient's attack evolve. For example, a patient may have a normal heart rate and blood pressure at the start of his or her attack, but develop significant bradycardia, in which event they are instructed not to take the nitroglycerin, which could aggravate a right ventricle infarction or be a sign of heart block. Such patients will be instructed not to take clopidogrel in the presence of active bleeding or recent injury, and are instructed not to take betablockers in the presence of symptoms or signs of shock, bradycardia, heart failure, pulmonary edema or asthma. The basic designs of the interior and exterior of two embodiments of the kit are show in several of the following drawings.

Although, this disclosure describes in detail several embodiments of this invention which include application of the invention to cardiological distress or diarrhea, the concepts of this invention are envisioned as being applied to a wide variety of medical conditions, diseases and emergencies, for example, but without intending to limit the potential application for this invention, this invention can also be applied to the treatment of diabetes, epilepsy, asthma, food poisoning, trauma, shock, pain and various neurological conditions. Figure 1 shows a process flow chart of the present use of the medication kit of this invention. In the present preferred embodiment of the uses of this invention, initially a condition is identified 101. Typically this identification 101 is performed by recognizing symptoms or risk conditions associated with a particular medical condition. Medication for the treatment of the identified condition is recommended 102. In many instances this recommendation by constitute prescription, in other instances it may be simply be cross- references the identified condition to one or more specific medications. A kit is assembled 103. The kit is a collection of one or more medications packaged and presented so as to encourage or otherwise facilitate the administration of the medications in a particular sequence or at a particular timing interval. The kit is delivered 104 to a user. The user is typically the patient or potential patient, although in some uses of this invention, the user may be a health care worker or care giver. Symptoms are detected 105, which are likely to correlate to the onset of a medical condition or emergency medical situation. Often these symptoms are detected 105 by the patient himself or herself, in other situations the symptoms are detected by a trained professional or an interested other person. The medication is administered 106 typically by the patient himself or herself, although alternatively, another person may be required to administer the medication. Administration of the medication includes receiving (typically ingesting) a succession of medications in a specified order and often at proscribed intervals or timing. Instructions are provided to guide the user and/or patient in the administration of the medications and in identification of symptoms and contraindications relevant to the administration of the medications. Follow-up medical care is given 107, typically by medical professionals, often in a hospital, clinic or other emergency medical service provider. Figure 2 shows a process flow chart of the present use of the medication kit of this invention, which would typically be part of the medication administration 106 step of figure 1. If possible, emergency medical assistance is contacted 201. This contact may be by an automatic alarm, a telephone or other convenient method. A section of the kit of this invention is opened 202. Medication is taken 203 sequentially as instructed by the incorporated instructions of the invention. Wait 204 for the required time period. A test 205 is made to determine if additional sections of medication remain. If additional medications remain to be taken in accordance with the incorporated instructions, the process returns to the opening kit section step 202. If no additional sections remain to be taken, the user/patient continues to monitor symptoms 206. Figure 3a shows a perspective drawing of a first example embodiment 300 of the kit package structure of this invention. This kit package 300 is a generally rectangular box with two openable panels 301, 302, each of which is provided with a tab 304, 305 or other mechanism for opening the panel. The tabs 304, 305 operate by pulling or pressing the tab 304, 305 away from the package 300, thereby causing the openable panel 301, 302 to open in a door like manner along an edge. The first openable panel 301 is generally for access by the user/patient to medication/information cards 306, see figure 3b, stored within the package 300. The first openable panel 301 is typically provided with an information region 302, such as prescription information, medication information and/or condition information for identification purposes. This information region 302 may be provided by writing directly on the first openable panel 301 or by affixing a sticker or other labeling device. In alternative embodiments, this information region 302 may be located on other parts of the package 300 or may simply be located on a container, such as sack, bag or box, for the filled package 300. The second openable panel 303 is generally provided for access to the interior of the package 300 for loading the medication cards 306.

Figure 3b shows a perspective view of an example medication card 306 used with the first example embodiment of the invention. As shown this medication card 306 has one or more locations 308 for holding medications. Typically, these locations 308 are sealed plastic receptacles suitable for holding individual pills or capsules. Alternatively, in some embodiments, the location 308 are sized to accommodate a glass or other container for holding medications. An information panel 307 is provided for locating the medication, medical condition, symptom, and/or contraindication information, including specific sequence and/or timing information for the administration of the medication located in the storage locations 308.

Figure 3c shows a perspective drawing of the first example 300 embodiment of the kit structure of this invention with the top panel 301 open, exposing the interior 309 of the package 300. This embodiment 300 is provided with a number of ridges or shelves 310 for holding medication cards 306 in a desired administration order, top to bottom.

Figure 3d shows a perspective drawing of the first example embodiment of the kit structure of this invention with the end panel 303 open, exposing an alternative view of the interior 309 of the package 300. This view shows both sets of ridges or shelves 310, 311 for holding medication cards 306, and shows the package 300 open for loading the medication cards 306.

Figure 4a shows a perspective drawing of a second example 400 embodiment of an alternative kit structure of this invention. This kit 400 is a standard rectangular box with an openable top 401, on which is provided a marker portion 402 for presenting such as information as prescription information, medication information and/or condition information for identification purposes.

Figure 4b shows a perspective drawing of the medication card 403 used with the second example 400 embodiment of the alternative kit of this invention. As shown this medication card 403 also has one or more locations 407 for holding medications. Typically, these locations 407 are sealed plastic receptacles suitable for holding individual pills or capsules. Alternatively, in some embodiments, the location 407 is sized to accommodate a glass or other container for holding medications. An information panel 404 is provided for locating the medication, medical condition, symptom, and/or contraindication information, including specific sequence and/or timing information for the administration of the medication located in the storage locations 407. Further, this medication card 403 is provided with notches 406a,b suitable for inserting the tip of a user/patient's finger for withdrawal of the medication card 403 from the package 400. Separation from stacked medication cards 403 within the package 400 is accomplished by the wings 405 a,b provided on the medication card 403.

Figures 5a-5d and 6a-6c are representations of medication cards or panels of the present embodiment of this invention. Cards are used where it is desirable to have each separate from succeeding cards, either for preparing or for administering. Panels are used where each is connected along an edge to the next, thereby making a single "card." The panel single card embodiment is preferred where a folded medication card is desired. For the purpose of the remaining discussion, both panels and cards shall be referred to as cards, although substituting multiple cards by a single carded foldable into multiple panels is an alternative within the concept of this invention. Each card typically represents a separate prescription from the prescribing or recommending medical professional and will generally include the date of issue and expiration along with instructions for the administration of the contained medication and are clearly labeled and ordered in the package in accordance with the order in which they are to be administered. In figures 5a-5d, the first three cards 5a-5c comprise the "basic" or "rural" cardio care kit embodiment. The previously described "remote" embodiment comprises all four of the cards 5a-5d.

Figure 5a shows a representation of the first medication card 501 of the cardio-kit embodiment of this invention. A first instruction portion 505 describing the medication 507 enclosed in the card locations 506, the instructions for taking the mediation and the following step instructions is provided. A second instruction portion 515 specifically instructing the user/patient on the next step in the sequential administration of the medication is also provided. A plurality of medication storage locations 506 is provided with the medication installed. Typically, these medication storage locations 506 are constructed as sealed plastic containers or pockets. Paper and/or foil can also be substituted, as is well known in the art without departing from the concept of this invention. In this card, which is part of the cardio care kit, the medication is presently aspirin.

Figure 5b shows a representation of the second medication card 502 of the cardio- kit embodiment of this invention. A first instruction portion 508 describing the medication 510 enclosed in the card location 509, the instructions for taking the mediation and the following step instructions is provided. A second instruction portion 516 specifically instructing the user/patient on the next step in the sequential administration of the medication is also provided. A single medication storage location 509 is provided with the medication installed. Typically, this medication storage location 509 is constructed as sealed plastic containers or pockets. Paper and/or foil can also be substituted, as is well known in the art without departing from the concept of this invention. The medication 510 in this card 502 which is part of the cardio care kit embodiment of this invention is presently nitroglycerin.

Figure 5c shows a representation of the third medication card 503 of the cardio-kit embodiment of this invention. A first instruction portion 518 describing the medication 512 enclosed in the card locations 511, the instructions for taking the mediation and the following step instructions is provided. A second instruction portion 517 specifically instructing the user/patient on the next step in the sequential administration of the medication is also provided. A plurality of medication storage locations 511 are provided with the medication installed. Typically, these medication storage locations 511 are constructed as sealed plastic containers or pockets. Paper and/or foil can also be substituted, as is well known in the art without departing from the concept of this invention. This medication 512 loaded in this card 503 is presently clopidrogrel. Figure 5d shows a representation of the fourth medication card 504 of the cardio- kit embodiment of this invention. An instruction portion 519 describing the medication 514 enclosed in the card locations 513, the instructions for taking the mediation and the following step instructions is provided. A plurality of medication storage locations 513 is provided with the medication installed. Typically, these medication storage locations 513 are constructed as sealed plastic containers or pockets. Paper and/or foil can also be substituted, as is well known in the art without departing from the concept of this invention. The medication 514 in this card 504 of the cardio care kit embodiment is presently metoprolol.

Figure 6a shows a representation of the first medication card 601 of the Touista- kit embodiment of this invention. A first instruction portion 602 describing the medication 604 enclosed in the card locations 603, the instructions for taking the mediation and the following step instructions is provided. A second instruction portion 605 specifically instructing the user/patient on the next step in the sequential administration of the medication is also provided. A plurality of medication storage locations 603 is provided with the medication installed. Typically, these medication storage locations 603 are constructed as sealed plastic containers or pockets. Paper and/or foil can also be substituted, as is well known in the art without departing from the concept of this invention. In this card 601, which is the first card of the "tourista" embodiment of the invention the medication 604 is presently bismuth subsalicylate. Figure 6b shows a representation of the second medication card 606 of the Touista-kit embodiment of this invention. A first instruction portion 607 describing the medication 609 enclosed in the card locations 608, the instructions for taking the mediation and the following step instructions is provided. A second instruction portion 610 specifically instructing the user/patient on the next step in the sequential administration of the medication is also provided. A plurality of medication storage locations 608 is provided with the medication installed. Typically, these medication storage locations 608 are constructed as sealed plastic containers or pockets. Paper and/or foil can also be substituted, as is well known in the art without departing from the concept of this invention. The medication 609 in this second card 606 of the "tourista" embodiment is presently loperamide.

Figure 6c shows a representation of the third medication card 611 of the Touista- kit embodiment of this invention. A first instruction portion 612 describing the medication 614 enclosed in the card locations 613, the instructions for taking the mediation and the following step instructions is provided. A second instruction portion 615 specifically instructing the user/patient on the next step in the sequential administration of the medication is also provided. A plurality of medication storage locations 613 is provided with the medication installed. Typically, these medication storage locations 613 are constructed as sealed plastic containers or pockets. Paper and/or foil can also be substituted, as is well known in the art without departing from the concept of this invention. The medication 614 of this third card 611 of the tourista care kit embodiment of the invention is presently ciprofloxin.

Figure 7a shows a section view of a third alternative embodiment 700 of the kit of this invention. A generally rectangular box with a top lid 701 is provided. Within the interior of the box a number of ridges or shelves 703 a-f provide the vertical support for the inserted medication cards 704a-d. The top lid 701 is secured in a closed position by placing latches 702a,b over protrusions 705 a,b

Figure 7b shows a perspective view of the third alternative embodiment 700 of the kit container with the lid 701 open. The latches 702a,b are shown in an open position, as are the protrusions 705a,b.

The described embodiments are to be considered in all respects only as illustrative of the current best modes of the invention known to the inventors at the time of filing this application, and not as restrictive. Although the several embodiments shown here include specific components, drugs (medications), packages and steps, these are provided in order to show examples of the present embodiments of this invention. Rather, the specifics of these embodiments are provided to show several examples. This scope of this invention is, therefore, indicated by the appended claims rather than by the foregoing description. All devices and processes that come within the meaning and range of equivalency of the claims are to be embraced as within the scope of this patent.

Claims

ClaimsI claim:
1. A method for the administration of medication, comprising:
(A) identifying a medical condition; (B) recommending a medication;
(C)preparing a kit of medication;
(D) delivering a kit to a user;
(E) detecting symptoms related to said medical condition; and
(F) administrating said medication by said user.
2. A method for the administration of medication, as recited in claim 1, wherein said medical condition is related to a coronary syndrome.
3. A method for the administration of medication, as recited in claim 1, wherein said medical condition is related to diarrhea.
4. A method for the administration of medication, as recited in claim 1, wherein said preparing a kit of medication further comprises:
(1) selecting a plurality of medications;
(2) organizing said plurality of medications into a sequence for administration;
(3) providing recommended medical information related to said plurality of medications; and (4) loading said plurality of medications into a container, wherein said container further encourages the sequencing of administration of said medications.
5. A method for the administration of medication, as recited in claim 1, wherein said administrating said medication, further comprises:
(1) opening a kit section; (2) receiving instruction regarding medication in said open kit section;
(3) administrating said medication in said open kit section;
(4) waiting the recommended time period; and
(5) if further sections are available, opening a further section, receiving instruction regarding medication is said further section.
6. A system for the administration of medication, comprising:
(A) a container;
(B) a plurality of cards within said container;
(C) a medication located on said plurality of cards; and (D)a mechanism for sequencing the use of said cards in said container.
PCT/US2004/006217 2003-02-27 2004-02-26 Method and system for self-administration of medications WO2004077281A3 (en)

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