EP4694856A1 - Calendar medication blister pack, method of using thereof and electronic system of management of interaction with calendar medication blister pack - Google Patents

Calendar medication blister pack, method of using thereof and electronic system of management of interaction with calendar medication blister pack

Info

Publication number
EP4694856A1
EP4694856A1 EP24729115.6A EP24729115A EP4694856A1 EP 4694856 A1 EP4694856 A1 EP 4694856A1 EP 24729115 A EP24729115 A EP 24729115A EP 4694856 A1 EP4694856 A1 EP 4694856A1
Authority
EP
European Patent Office
Prior art keywords
user
hydrochlorothiazide
hctz
pack according
calendar
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24729115.6A
Other languages
German (de)
French (fr)
Inventor
Daniel LYTOVSKYI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mili Healthcare Trade Fzco
Original Assignee
Mili Healthcare Trade Fzco
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mili Healthcare Trade Fzco filed Critical Mili Healthcare Trade Fzco
Publication of EP4694856A1 publication Critical patent/EP4694856A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61J1/035Blister-type containers
    • 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
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076Medicament distribution means
    • A61J7/0084Medicament distribution means for multiple medicaments
    • 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
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • 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
    • A61J2205/00General identification or selection means
    • 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
    • A61J2205/00General identification or selection means
    • A61J2205/10Bar codes

Definitions

  • the invention relates to the field of medicine, namely to “smart” medication blister packs, a set of actions, technologies and measures used in providing treatment to a patient and related to automated electronic systems for monitoring user adherence to a prescribed medication regimen and patient condition associated with the intake of prescribed medications.
  • a smart medication blister pack comprising cavities for storing medicine and a cover is known from the prior art (US application No. US 2021121366 Al, 04/29/2021).
  • the smart medication blister pack also includes an RFID tag, a circuit, a chip, a communication module for communicating with one or more devices, a reminding module comprising audio/visual means for reminding a patient about medication, receiving module for receiving instructions from a server and/or an authorized means, self-programming module for adjusting the instructions automatically based on one or more events, and a chip for storing the instructions and information about medicine, the tablets, a manufacturer of the medicine, dosage, diseases, side effects, usage, expiration date, manufacturing date, and batch information.
  • the smart medication blister pack is configured to receive instructions from an authorized person regarding the tablets stored in the blister pack and to store the instructions in the chip of the blister pack.
  • the smart blister pack can remind a user, such as a patient, about time, dosage, etc. based on the stored instructions.
  • the smart blister pack can exchange data with a central server to determine the authenticity of the tablets and, accordingly, inform the user about the authenticity of the tablets.
  • the smart medication blister pack also includes a feedback module or a reminding module for providing a feedback or reminder to a user, such as a patient.
  • the feedback or reminder can include at least one of an audio reminder, a video/visual reminder, and displaying a text message on an associated mobile device that communicates with the smart medication blister pack.
  • the blister pack provides a visual indication based on LEDs or a luminescent coating/ink on the layout of the smart medication blister pack.
  • a smart medication blister pack can contain batteries that power the LEDs.
  • the batteries can be solar cells.
  • the reminding module is configured to inform the user whether the blister pack is authentic or not based on at least one piece of information from the smart medication blister pack and communication with the server.
  • the disadvantages of the known smart medication blister packs include their manufacturing complexity and increased cost due to integrated technical components such as electronic circuits, batteries, sensors, and means of communication therein. Also, a particular disadvantage is the need for special conditions for the disposal of the used smart blister pack due to the presence of electronic components and power cells therein.
  • a blister pack station for use with smart blister packs is known from the prior art (US Application No. US 2021125710 Al, 04/29/2021).
  • the blister pack station includes at least one slot for receiving at least one blister pack containing one or more tablets.
  • the blister pack station further includes an input module to receive a plurality of instructions from a third party including at least one of an authorized person, a server, a blister pack, and another blister pack station.
  • the blister pack station also includes a chip configured to communicate the plurality of instructions to at least one of a central server, a device based in a cloud network, the blister pack, and another blister pack station.
  • the disadvantages of the known blister pack station are the limitation in its functional capabilities, since the station must be used as a separate device to monitor the user’s adherence to the medication schedule, the requirement to use only specially designed standardized blister packs in conjunction with it containing an integrated electronic circuit, the complexity of its manufacture and the incompatibility of the station with blister packs of different sizes and formats, as well as of different manufacturers. Also, a particular disadvantage is the need for special conditions for the disposal of the used smart blister pack due to the presence of electronic components and power cells therein.
  • a system and method for managing medication is known from the prior art (US application No. US 2012166216 Al, 06/28/2012), where a user terminal notifies a user of taking medicine and recognizes whether the medicine has been taken by receiving a medication schedule corresponding to an identification code of prescription from a medication management server or generating the medication schedule for itself to thereby interoperate with a medication support device, or the user terminal recognizes whether the medicine has been taken by using a medicine packet and a medicine content area without depending on the medication support device so that a user may easily take a medicine according to the medication schedule and a medication management service may be provided through the user terminal even when the user goes out or moves.
  • the disadvantage of known technical solutions is the lack of the possibility of adjusting the medication schedule depending on the user’s behaviour model in the process of taking medications, as well as the lack of a mechanism for verifying the originality of the origin of medications and obtaining and displaying detailed information on the contents of the packet on the user terminal.
  • a method and system for packaging and dispensing medication including at least one prescription package are known from the prior art (US application No. US 2004148054 Al, 07/29/2004).
  • the package has a plurality of discrete spatially distinct locations containing the medication arranged in a two dimensional matrix.
  • the matrix includes data corresponding to time of day information and select number of days of a week information.
  • a heading region is disposed on a portion of the package.
  • the heading region contains prescription instruction data having the patient’s name, medication name, medication dosages and usage schedule.
  • a scheduling code is placed on an end of the prescription package. The scheduling code corresponds to the same time of day information as in the matrix.
  • the medication is disposed in discrete spatially distinct locations to correspond to the medication dosages and usage schedule of the prescription instruction data.
  • the known method begins with the fact that the pharmacy receives a prescription, enters the data into a computerized database, followed by packaging medications.
  • the medications are packaged by units of use, i.e., dose, with one dose in each blister cavity, and only a single medication is packaged in each blister pack. If, for example, a patient is scheduled five oral medications, five blister packs will be filled each week.
  • the medications maybe distributed via pick up, direct delivery to patient, indirect delivery to an agency or clinic, and mail.
  • the most common side effects for each medication will be included on the prescription information indicia of each blister pack. Color- coded cards for patients who cannot read may be provided. Icons such as the sun in the morning and the moon in the evening may be added.
  • the invention additionally contemplates the possibility of providing more than one type of medication in single blister cavities on the same blister pack cards as appropriate for the patient.
  • the disadvantages of the known system for packaging are that the proposed blister packs are filled with medications according to the needs and prescriptions of each specific patient that may lead to errors when filling and providing the wrong medications, the lack of a mechanism for verifying the originality of the origin of medications, the lack of the possibility of monitoring the user’s taking medications, the lack of possibility of communicating, using a graphic code, the blister pack with the electronic system that can provide additional information on the medications contained in the blister packs to the user terminal.
  • nosological units or forms are distinguished, that is, one or another particular disease with its typical combination of symptoms and functional-morphological changes that are their basis, as well as a certain etiology and pathogenesis.
  • nosological units are cardiology, diabetes, gastroenterology and others, in the treatment of which protocol methods of complex therapy are used.
  • combinations of several medications (drugs) of one or more classes of the ATC system are used for the specific profile of the patient being treated.
  • a combination of medications in calendar blister packs is intended to provide better effectiveness by increasing the effect of one indicator or by treating more than one indicator, as opposed to any drug used alone, or by that one active ingredient increases the safety or effectiveness of another active ingredient.
  • a calendar blister pack with a combination of medications can be targeted to treat multiple diseases, can increase effectiveness and can potentially save resources for patients and the healthcare system. Bioequivalence studies show that different medications retain their effectiveness when combined.
  • the aim of the invention is to create a calendar medication blister pack, a method of use of a calendar blister pack and an electronic system of management of interaction with a calendar blister pack that would provide improved patient disease management, reduce the risk of non-taking the prescribed medications by a user and the probability that a patient will miss taking the prescribed doses of medications, which is especially important in patients with chronic diseases such as hypertension or diabetes, improvement of secondary prevention of diseases, especially in patients with a previous myocardial infarction, facilitation of the routine of taking several medications
  • facilitation of monitoring of compliance with the medication schedule and patient’s adherence to treatment on a long-term basis improving the effectiveness of management of patient treatment results from a longterm care perspective by using a combination of active ingredients that are effective over a long period of time, improving patient safety through the introduction of calendar blister packs with preset combinations and doses that correspond to established international treatment protocols, as well as increasing the convenience of taking medications and facilitating compliance with the proposed treatment regime.
  • the technical effect of the proposed invention is in the creation of a calendar medication blister pack that provides inclusion of fixed combinations of medications in accordance with international treatment protocols owing to the presence of blister cells adapted for placing a plurality of medications therein; providing information on the scheme of taking medications, the time of taking and recommendations owing to the presence of an information zone; verifying the originality of its origin and receiving all information on the contents of the calendar blister pack on the user terminal, as well as associating a specific pack with the user owing to the presence of a unique identifier of the calendar blister pack; control of opening and control of taking medications by the user owing to equipping the dosing sections with a hidden special graphic code.
  • Another technical effect is in the creation of a method of use of a calendar medication blister pack that ensures user protection against counterfeit medications and the inadvertent use of counterfeit or falsified drugs by verifying the originality of origin of the calendar blister pack using its unique identifier; control of taking the prescribed medications by the user and reducing the probability that the patient will miss taking the prescribed doses of medications owing to the proposed mechanisms of reminders about the necessity to take medications and control of opening of the cells by a hidden special graphic code; providing the user with details regarding potential adverse side effects or reactions owing to the mechanism for sending messages to the user terminal; modification of the medication schedule if it's detected that the user has missed a dosage.
  • Another technical effect is the creation of an electronic system of management of interaction with the calendar medication blister pack that, through the utilization of proposed servers, services, and their interaction mechanisms, facilitates the monitoring of compliance with the medication schedule and the patient adherence to treatment on a long-term basis; improving the effectiveness of management of patient treatment results by monitoring and adjusting the medication schedule; increasing the patient safety through introduction of a mechanism for verifying calendar blister packs for the originality of their origin; integration with electronic medical information systems to obtain up-to-date and archival information on the user’s electronic prescriptions, his/her state of health, and based on this information, adjusting the treatment program and controlling risks upon taking medications.
  • FIG. 1 shows a block diagram of an electronic system of management of interaction with a calendar medication blister pack.
  • FIG. 2A-2U show possible embodiments of the proposed calendar blister pack according to the proposed invention that illustrate only, but do not limit the essence of the proposed invention.
  • the proposed calendar medication blister pack contains an upper layer and a lower layer, between which a blister layer is placed, wherein the upper layer contains an information zone with a special graphic code applied thereon and a section zone equipped with a marking and/or perforation forming one or more dosing sections defining a single taking medications, each dosing section being equipped with an opening tab configured to provide access upon its opening to a hidden special graphic code, the open special graphic code including a unique identifier of the calendar blister pack and an authorization link, and the hidden special graphic code including a unique identifier of the taking section, the lower layer contains an information zone and a section zone equipped with a marking and/or perforation forming one or more dosing sections defining a single taking medications, the information zone and the dosing sections of the lower layer corresponding to the information zone and the dosing sections of the upper layer, the blister layer includes one or more blister cells, each blister cell being configured to contain one or more
  • the open special graphic code is applied on the information zone of the pack in an open form and is used to register the calendar medication blister pack in the electronic system of management of interaction with the calendar blister pack and to launch the scenarios for taking medications contained in the pack in association with a specific user who has scanned the special graphic code from the pack or entered it manually.
  • the open special graphic code contains a unique identifier of the calendar blister pack that can be verified by the user, and an authorization link for registering the pack in the electronic system and verifying the originality of its origin.
  • the open special graphic code can contain additional information, for example, regarding regional restrictions on the use of the calendar blister pack, if it contains medications approved for circulation only in certain countries or regions. Also, the open special graphics code is used to access additional interactive content.
  • the authorization link of the open special graphic code is, in a preferred embodiment, a direct link that includes a unique identifier of the calendar blister pack in an open form or an indirect link that includes an encrypted or open unique identifier of the calendar blister pack that leads to a redirect server of the electronic system of management of interaction with the calendar blister pack.
  • the authorization link can be formed with the possibility of collecting information on the hardware of the user terminal, requesting additional user data including meta or direct data on the operating system of the user terminal, geodata, system settings and other parameters.
  • the open special graphic code is a two-dimensional graphic code such as a QR code, or a bar code, or a DataMatrix code, or a code with special anti-counterfeiting protection - with integrated security elements.
  • a special graphic code an alphanumeric sequence or a combination of an alphanumeric sequence with a two-dimensional graphic code can be used.
  • Codes with embedded security elements are designed to protect products from counterfeiting and unauthorized distribution across multiple sectors, notably in the pharmaceutical industry, and they are an alternative to traditional means of protection such as special paints, materials and holograms.
  • These unique identifiers are implemented as unique graphic elements, underpinned by cryptographic methods, used in codes that exclude the possibility of their copying or duplicating. Each unique graphic element is generated individually for each product or a batch of products which ensures the uniqueness of a product identifier.
  • Unique graphic elements can be presented in various formats, including QR codes, onedimensional barcodes and codes that use existing product design elements of the product and are integrated into it in the form of a periodic machine-readable signal.
  • Such codes with special protection against couterfeiting can be, for example, the code "CipherME” (https://cipherme.com/) or Digimarc Barcode (https://wvxw.digimarc.com). or SICPA REVEO
  • the hidden special graphic code remains inaccessible until the calendar blister pack is opened and it is used to confirm that the user has taken the appropriate medications.
  • the hidden special graphic code is unique to each medication dosing section for the calendar blister pack which allows unmistakably identifying the blister cell and/or the taking section.
  • the hidden special graphic code can be applied on the inner side of the opening tab of the pack or applied on the inner portion of the blister cell, or can be applied on an insert or a sticker that is placed inside, for example, at the bottom of the blister cell together with medications.
  • the hidden special graphic code becomes accessible for scanning/entering only upon opening of the necessary blister cell.
  • each hidden special graphic code is unique, it is possible to accurately identify the open blister cell that the user has opened, as well as its contents that he has taken. Thus, the correctness of taking medications is controlled, the miss or disruption of the medication schedule is identified, as well as the mechanism for adjusting the medication schedule is launched in the case of disruption being detected.
  • additional information on the content of the dosing section can also be applied, for example, instructions for taking, a list of contained medications, day of the week and/or taking time, etc.
  • the amount of such additional information can depend on the size of the dosing section or vice versa - the size of the section is chosen depending on the amount of information placed thereon, and the location of additional information can be chosen depending on the option of applying the hidden special graphic code.
  • the instructions for taking can be applied on the inner side of the opening tab of the pack and the hidden special graphic code can be applied on the inner side of the blister cell (FIG.
  • the instructions for taking can be applied on the inner side of the blister cell and the hidden special graphic code can be applied on the inner side of the opening tab of the pack (FIG. 2K), or the instructions for taking and the hidden special graphic code can be applied on one insert or sticker from different sides (FIG. 2N), or on one side with subsequent folding of the sticker, or in the form of a mini-book, etc. Any other options of location and their combinations can be used.
  • information on the contained medications can be additionally applied on the outer side of opening tab.
  • the hidden special graphic code is a two-dimensional graphic code such as a QR code, or a bar code, or a DataMatrix code, or a code with special anti-counterfeiting protection - with integrated security elements.
  • a special graphic code an alphanumeric sequence or a combination of an alphanumeric sequence with a two-dimensional graphic code can be used.
  • the upper layer and the lower layer of the calendar blister pack are made of cardboard.
  • the information zone of the upper layer of the calendar blister pack can contain information on the general medication schedule, for example, days of the week, a breakdown by the time of taking medications, for example, morning, afternoon and evening, and information on the medications contained in the pack.
  • information on the contained medications can, if necessary, include information on the visual representation of the contained medications, in particular, the shape, colour of the tablet or capsule, etc., the composition of the contained medications, their dosage and quantity (FIG. 2A, 2C, 2D).
  • the information zone of the upper layer of the calendar blister pack can be divided into four separate zones.
  • the first zone contains an open special graphic code, the name of the calendar blister pack and information on the number of days for which the calendar blister pack is designed.
  • the second zone contains a general division by type of taking, namely, information on the general medication schedule, breakdown by time of taking, information on contained medications, visual graphic presentation of medications, composition of one or more components, dosage and number of medications.
  • the third zone contains text information on the time of day of taking, visual presentation of information on days of taking, for example, using day/night icons in the form of the sun and moon, serial number of taking.
  • the fourth zone contains an indication of the day of taking, in two formats: the serial number of the day of taking and the name of the day of the week.
  • the information zone is intended for placing the main content and can be folded according to the additionally made perforation, and it is also made in the form of an extended element of the structure. If it is necessary to place additional content, the size of the information zone can be increased.
  • At least part of the information applied on the information zone of the upper layer of the calendar blister pack can be duplicated in Braille.
  • color coding of the calendar blister pack may be employed to simplify user interaction, especially for those with visual impairments or reading difficulties with limited capabilities, low vision, or reading difficulties.
  • the dosing sections or the blister cells can be additionally marked with color marking, for example, a coloured outline around the perimeter of the dosing section or the blister cell and the information zone can be provided with a legend explaining the meaning of the colors, for example, the taking days of the week can be marked with colors of a rainbow, etc.
  • the information and section zones of the lower layer of the calendar blister pack can contain duplicate information, including the number of days of taking for which the calendar medication blister pack is designed, as well as information on the content, dosage and other information.
  • the information zone of the lower layer of the calendar blister pack can be divided into two separate zones.
  • the first zone explicitly denotes the number of days covered by a single calendar blister pack.
  • the second zone contains information on the manufacturer of the calendar blister pack.
  • the section zone of the lower layer can contain a tear-off dosing section with duplication of information on the time of taking, the day of taking, a set of medications, a visual graphic representation of medications, the composition of one or more components, dosage and the number of medications.
  • the set of presented information can be optimized for certain tasks and the size of dosing sections (FIG. 2B).
  • the blister layer can be one continuous blister containing a plurality of blister cells (FIG. 2P, 2R), or it can be made in the form of a plurality of separate blister cells that are not attached to each other (FIG. 20, 2Q).
  • the blister layer can additionally be equipped with a marking and/or perforation that corresponds to the marking and/or perforation of the section zones of the upper layer and the lower layer so that one blister cell corresponds to one taking section.
  • the user can tear off or separate in another way, for example, cut off, from the entire pack a separate dosing section for one or more days, as well as for one or more takings (FIG. 2F).
  • dosing sections can be rectangular or square.
  • the calendar blister pack can contain an additional layer with formed tear-off cavities in the form of tear-off sections (FIG. 2U), the addiotnal layer being located between the lower layer and the blister layer and equipped with a marking and/or perforation to ensure the possibility of separation of separate tear-off sections (FIG. 2S, 2T).
  • This additional layer can be made of transparent or opaque material.
  • the calendar blister pack is made with an intuitive arrangement of elements which allows to use it effectively even without any additional hardware and software, such as a user terminal with installed applications. Consequently, the calendar blister pack encompasses a visually segmented regimen or a portion of the medication intake schedule broken down into sections (zones) of single taking. It is possible to make calendar blister pack either with sets of medications that repeat every day and every time of the day of taking or with sets of medications that differ, or both.
  • the calendar blister pack can be scaled either in height that provides the possibility of placing a greater number of takings per day or in width that provides the possibility of increasing the number of days of taking in one pack or vice versa, or both (FIG. 2E).
  • the calendar blister pack provides several embodiments, in particular, a pack for a week, a pack for a day, or a pack for a full course or for an indefinite period of use, for example, in the case of the need for lifelong taking medications.
  • Each dosing section contains a separate blister or blister cell for single taking with one or more medications of different release forms.
  • the dosing sections can be of different sizes depending on the set of medications and their sizes as well as release forms.
  • medications can be made in the form of a round tablet, oblong capsule or in other release forms.
  • the dosing section can contain a combination of different medications of different shapes and types, for example, a round tablet with another round tablet, a round tablet with an oblong capsule, two oblong capsules, etc.
  • the pack can be made with an open visible part and closed on both sides.
  • the pack with an open visible part allows to visually show the medications inside the visible blisters (FIG. 2H).
  • the pack of a closed type allows to apply more information on its both sides (FIG. 2G).
  • the calendar blister pack of a closed type can contain additional information with instructions for taking duplicated, if necessary, in Braille applied on the pack itself.
  • users with visual impairments will be able to take medication without outside help which increases the convenience and safety of using the calendar blister pack.
  • the risk of taking a wrong medication by a user with disabilities is reduced, as the instructions are applied directly on the corresponding calendar blister pack.
  • the calendar blister pack is a matrix of dosing sections that includes columns and rows.
  • the columns define the days of taking medications, for example, days of the week
  • the rows define the time of a day for taking, for example, morning, afternoon, evening, night (FIG. 2J).
  • the layout can be done in any other way, in particular, the columns can define the time of day, and the rows can define the days of taking (FIG. 21).
  • a different order of taking can be used, indicated, for example, by a line showing the sequence of taking of medications. The line can be supplemented with an arrow that defines the beginning of taking.
  • the line in particular, can be made in the form of a “snake” or a circle.
  • numerical ordinal numbering of the days of taking that does not depend on the days of the week can be used.
  • a course of two calendar blister packs for two weeks can have consecutive numbering so that the first pack has days 1 to 7 and the second pack has days 8 to 14.
  • a combination of the said indications can be used, in particular, numbering of dosing sections and a line showing the sequence of taking.
  • the taking can be started on any day of the week.
  • a box can contain seven calendar blister packs per week of taking, each of the seven calendar blister packs containing medications for a day, the dosing sections of which are divided by time of a day. Otherwise, the box can contain several identical calendar blister packs that can be used for a long course of treatment.
  • the proposed calendar medication blister pack can be used for convenient and controlled protocol methods of complex therapy in the treatment of, in particular, cardiac and diabetic diseases.
  • the calendar blister pack contains a combination of medications for the treatment of hypertension in patients with high and very high risk of cardiovascular complications and includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers)/CCBs (Calcium Channel Blockers)/Diuretic, Acetylsalicylic acid and Statin.
  • ARBs Angiotensin Receptor Blockers
  • CBs Calcium Channel Blockers
  • Acetylsalicylic acid Statin.
  • the fixed dose of ARBs/CCBs/Diuretic is Olmesartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Olmesartan (40 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (320 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (160 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Losartan (50 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Losartan (100 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Eprosartan (600 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ
  • the calendar blister pack contains a combination of medications for the treatment of uncomplicated hypertension in patients with high and very high risk of cardiovascular complications and includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers)/Diuretic, Acetylsalicylic Acid and Statin.
  • ARBs Angiotensin Receptor Blockers
  • Diuretic Angiotensin Receptor Blockers
  • Acetylsalicylic Acid Acetylsalicylic Acid
  • Statin the fixed dose of ARBs/Diuretic is Losartan (50 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Losartan (100 mg) and
  • Hydrochlorothiazide (12.5 mg), or Eprosartan (600 mg) and
  • Hydrochlorothiazide 25 mg
  • Irbesartan 150 mg
  • Hydrochlorothiazide (12.5 mg), or Irbesartan (300 mg) and
  • Hydrochlorothiazide (25 mg), or Olmesartan (20 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Olmesartan (40 mg) and
  • Atorvastatin (20 mg) or Atorvastatin (40 mg).
  • the calendar blister pack contains a combination of medications for the prevention of atherosclerotic cardiovascular disease (ASCVD) and includes two fixed-dose combinations: Statin and Acetylsalicylic acid.
  • the fixed dose of Statin is Atorvastatin (20 mg), or Atorvastatin (40 mg), or Rosuvastatin (10 mg), or Rosuvastatin (20 mg); and the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg).
  • the calendar blister pack contains a combination of medications for the treatment of uncomplicated resistant hypertension and includes two fixed-dose combinations of ARBs (Angiotensin Receptor Blockers)/CCBs (Calcium Channel Blockers)/Diuretic and MRAs (Mineralocorticoid Receptor Antagonists).
  • ARBs Angiotensin Receptor Blockers
  • CBs Calcium Channel Blockers
  • MRAs Mineralocorticoid Receptor Antagonists
  • the fixed dose of ARBs/CCBs/Diuretic is Olmesartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Olmesartan (40 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (320 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (160 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Losartan (50 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Losartan (100 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Eprosartan (600 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ
  • the calendar blister pack contains a combination of medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD) and/or chronic kidney disease (CKD) and includes three fixed- dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitor/Diuretic, CCBs (Calcium Channel Blockers) and MRAs (Mineralocorticoid Receptor Antagonists).
  • CHD coronary heart disease
  • CKD chronic kidney disease
  • ACE Angiotensin-Converting Enzyme
  • CCBs Calcium Channel Blockers
  • MRAs Mineralocorticoid Receptor Antagonists
  • the fixed dose of the ACE Inhibitor/Diuretic is Lisinopril (20 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Lisinopril (20 mg) and Hydrochlorothiazide (HCTZ) (25 mg);
  • the fixed dose of CCBs is Amlodipine (5 mg); and the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
  • the calendar blister pack contains a combination of medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD) and includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), 0-blocker/Diuretic, and MRAs (Mineralocorticoid Receptor Antagonists).
  • ARBs Angiotensin Receptor Blockers
  • 0-blocker/Diuretic 0-blocker/Diuretic
  • MRAs Mineralocorticoid Receptor Antagonists
  • the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg) or Fimasartan (120 mg); the fixed dose of the P-blocker/Diuretic is Bisoprolol (5 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg), or Bisoprolol (10 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg); and the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
  • the calendar blister pack contains a combination of medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD) with a high risk of complications and includes three fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitors, p- blocker/Diuretic and MRAs (Mineralocorticoid Receptor Antagonists).
  • CHD coronary heart disease
  • ACE Angiotensin-Converting Enzyme
  • MRAs Mineralocorticoid Receptor Antagonists
  • the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg);
  • the fixed dose of the p-blocker/Diuretic is Bisoprolol (5 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg), or Bisoprolol (10 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg);
  • the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
  • the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction and includes five fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitors, p -blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin.
  • the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg); the fixed dose of the p-blocker is Metoprolol Ext.
  • the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg); and the fixed dose of Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
  • the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction in patients intolerant of ACE inhibition and includes five fixed-dose combinations: Angiotensin Recep tor-Neprily sin Inhibitors (ARNIs)s, 0- blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin.
  • CCS chronic coronary syndromes
  • HF symptomatic heart failure
  • LV left ventricular
  • systolic dysfunction in patients intolerant of ACE inhibition
  • five fixed-dose combinations Angiotensin Recep tor-Neprily sin Inhibitors (ARNIs)s, 0- blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin.
  • the fixed dose of the Angiotensin Receptor-Neprilysin Inhibitors is Sacubitril (24 mg) and Valsartan (26 mg), or Sacubitril (49 mg) and Valsartan (51 mg), or Sacubitril (97 mg) and Valsartan (103 mg);
  • the fixed dose of the 0-blocker is Metoprolol Ext. release (25 mg);
  • the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg);
  • the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg);
  • the fixed dose of Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
  • the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction in specified conditions and includes five fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), 0-blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin.
  • CCS chronic coronary syndromes
  • HF symptomatic heart failure
  • LV left ventricular
  • ARBs Angiotensin Receptor Blockers
  • Diuretic Diuretic
  • MRAs Mineralocorticoid Receptor Antagonists
  • the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg) or Fimasartan (120 mg); the fixed dose of the 0-blocker is Metoprolol Ext.
  • the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg); and the fixed dose of Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
  • the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndrome in the presence of type 2 diabetes and high-risk hypertensive heart disease and includes four fixed-dose combinations: (Angiotensin-Converting Enzyme) Inhibitor, Diuretic, Statin and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor.
  • the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg);
  • the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg);
  • the fixed dose of Statin is Rosuvastatin (10 mg) or Rosuvastatin (20 mg);
  • the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
  • the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndrome in the presence of type 2 diabetes and hypertensive heart disease and includes four fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), Diuretic, Statin, and SGLT2 (Sodium- Glucose Cotransporter 2) Inhibitor.
  • the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg) or Fimasartan (120 mg);
  • the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg);
  • the fixed dose of Statin is Rosuvastatin (10 mg) or Rosuvastatin (20 mg); and the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
  • the calendar blister pack contains a combination of medications for the treatment of heart failure in the presence of type 2 diabetes, CHD (coronary heart disease) with a high risk of complications and includes four fixed- dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitor, 0-blocker, Acetylsalicylic acid and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor.
  • ACE Angiotensin-Converting Enzyme
  • 0-blocker Acetylsalicylic acid
  • SGLT2 Sodium-Glucose Cotransporter 2
  • the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg);
  • the fixed dose of the -blocker is Metoprolol Ext.
  • Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg); and the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
  • the calendar blister pack contains a combination of medications for the treatment of heart failure in the presence of type 2 diabetes and CHD and includes four fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), 0-blocker, Acetylsalicylic Acid, and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor.
  • ARBs Angiotensin Receptor Blockers
  • 0-blocker 0-blocker
  • Acetylsalicylic Acid acetylsalicylic Acid
  • SGLT2 Sodium-Glucose Cotransporter 2 Inhibitor.
  • the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg) or Fimasartan (120 mg); the fixed dose of the p-blocker is Metoprolol Ext.
  • Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg); and the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
  • the set task is achieved owing to the fact that the proposed method of use of a calendar medication blister pack includes the stages in which: using the user terminal 4 the open special graphic code applied on the information zone of the calendar blister pack 3 is scanned, using the authorization link the user being authorized on the user authentication server 7 by the unique identifier of the calendar blister pack 3, for this purpose using the authorization link a user authorization request is sent to the redirect server 2, on the redirect server 2, the unique identifier of the calendar blister pack 3 is derived from the authorization link, the validity of the unique identifier of the calendar blister pack 3 is verified and the user authorization parameters are stored on the redirect server 2, on the redirect server 2, a request is sent to the logic server 1 and it is verified whether such unique identifier of the calendar blister pack 3 has previously been registered, wherein in the event that such unique identifier of the calendar blister pack 3 has already been registered previously, the user is offered to perform authentication and on the user authentication server 7 the entered user’s authentication data are verified with the user’s authentication data stored in the user database 7.1, in the event that such unique
  • consumer information on the calendar blister pack 3 can include information on the appearance and contents of the calendar blister pack 3, text and/or multimedia content, instructions for use and programs of medication schedule, etc.
  • verifying the identification data of the calendar blister pack 3 in the blister pack database 1.1 can include verification of the expiration date of the calendar blister pack 3, verification of the region of origin, verification of the reusability of the calendar blister pack 3.
  • mandatory confirmation of the user’s familiarization with the message is carried out in the form of a "question-answer” where the user is asked to confirm his/her actions, for example, "Have you taken it after a meal? Yes/No", "Have you drunk it with water? Yes/No", etc.
  • special restrictions on taking medications are restrictions specified by the manufacturer of medications in the instructions, for example, prohibition of driving vehicles and mechanisms, prohibition of eating food and/or drinking alcoholic beverages, the need to drink liquid after taking a medication, etc.
  • a medical information system is a hardware and software solution that includes various components that provide processing and exchange of medical data either at the level of commercial institutions or at the national level, under the management of various organizations, including commercial and government structures.
  • Interaction with the information system of electronic prescriptions at the stage of prescribing medications is described, in particular, in patent UA 124828 C2 (PCT application No. PCT/UA2021/000093).
  • the user Before taking medications, the user registers the calendar blister pack 3 in the electronic system of management of interaction with the calendar blister pack.
  • all the necessary identification information is located directly on the calendar blister pack 3 itself, in particular, in the open special graphic code.
  • the identification data of the calendar blister pack 3 can include, in particular, data on the composition, the date of manufacture and the expiration date of the calendar blister pack.
  • the user For registering the calendar blister pack 3, the user points the camera of the user terminal 4 at the machine-readable code or enters the alphanumeric code of the pack 3 manually in the web application 4.2 or the mobile application 4.1, following opening of a web page or a section of the application with additional interactive content, where the user sees the appearance of the calendar blister pack 3 that he/she registers.
  • information on the appearance of the calendar blister pack 3 can include a 3D model of its appearance with the possibility of changing the viewing point, and it is offered to register or log in to the electronic system using the most popular services, such as social networks, messengers, etc. or, also, by e-mail or by phone.
  • the user can be given the possibility to choose a form of interaction convenient for him/her, for example, to continue work through the website (application) 4.2, in particular, to use a web chat, transfer the interaction to a chatbot 4.5 of the selected messenger, install the mobile application 4.1, etc.
  • the user terminal 4 can be any known device with the possibility of accessing the Internet, in particular, a phone, smartphone, personal computer, laptop, smart watch, etc.
  • the installation of the applications 4.1-4.4 is carried out from official stores and/or application platforms, for example, such as the App Store, Google Play, Huawei AppGallery, Huawei GetApps or other official sources, after that the user is given the possibility to get authorizesd either in the usual ways or by using a simplified authorization system, by means of following the authorization link from the web page that is accessible by opening a special graphic code applied on the information zone of the calendar blister pack 3.
  • official stores and/or application platforms for example, such as the App Store, Google Play, Huawei AppGallery, Huawei GetApps or other official sources
  • the user terminal 4 receives an authorization link from the open graphic code and if such calendar blister pack 3 has already been registered previously, the user is offered to perform authentication and on the user authentication server 7, the user’s entered authentication data are verified with the user’s authentication data that were entered previously and are stored in the user database 7.1. If the calendar blister pack 3 has not been registered previously, the user is offered to carry out registration and authentication on the user authentication server 7 and the user’s authentication data are stored in the user database 7.1.
  • the user’s authentication data may include the data on the user terminal 4, the user location, the tcurrent authorization time, the software used, the user’s ID, the user’s personal data, electronic medical record cache, and the data on existing electronic prescriptions associated with the user.
  • the authorization of the user in the medical information system can be carried out simultaneously through the interface of interaction 1.3, where the medical information system can be either a state or a commercial medical information system that contains data on the user’s medical history, all appointments, existing electronic prescriptions, etc. and can be used as an additional mechanism for risk control, adjusting the treatment program and generation of analytical reports.
  • the authorization in the medical information system is carried out as follows.
  • the users When authorizing a user on the authentication server 7 the users are asked for the user’s phone number and/or e-mail, by means of which he/she is registered in the medical information system, and an SMS message and/or an e-mail with an authorization code and/or an authorization link is sent and/or an electronic digital signature is requested.
  • the authorization code for entering the system is entered and/or the authorization link is followed to enter into the system and, using the logic server 1, a connection with the server of the medical information system is established through the interface of interaction 1.3 and the data associated with the user’s electronic medical records (EMR) and the data on the user’s active and redeemed electronic prescriptions (EP) are retrieved.
  • EMR electronic medical records
  • EP electronic prescriptions
  • the user for authorizing the user in the medical information system, the user is provided with a terminal in a graphical form or an interface for authorization, the user’s authorization is carried out by any acceptable method of authorization, for example, using an electronic digital signature, using the logic server 1 the connection with the server of the medical information system is established through the interface of interaction 1.3 and the data associated with the user’s electronic medical records and the data on the user’s active and redeemed electronic prescriptions are retrieved.
  • the logic server 1 monitors and uploads, through the interface of interaction 1.3, available information on the user’s electronic medical records and electronic prescriptions from the server of medical information system with storing all changes in the user database 7.1.
  • Data from electronic medical records can be used in the following cases:
  • the user is given the possibility to choose a taking program based on electronic prescriptions uploaded from the server of the medical information system or from the list of popular ones, or, if there is no corresponding program, to configure it manually, depending on the doctor’s appointment;
  • the service provides a simple process of changing the schedule at the request of a doctor, either on the basis of an issued electronic prescription, or the started parallel treatment of a disease not related to the medication, either by means of interaction with a visual interface or by means of voice commands;
  • the system can automatically change the medication schedule at the request of a doctor, either on the basis of an issued electronic prescription or the started parallel treatment of a disease not related to the medication, with a mandatory notification of the user and with his/her consent;
  • the system offers to replenish the stock from the partners.
  • the system collects BigData on patients and their activities that includes depersonalized incomplete data from electronic medical records and electronic prescriptions for further analysis of the estimated demand for the presented products and forecasting the profitability of the introduction of new products, improvement of risk analysis systems, improvement of service quality, optimization of user scenarios, etc.
  • the mechanism for suggesting the calendar blister packs 3 with medications suitable for the treatment of concomitant or current diseases is that, based on electronic medical records and electronic prescriptions, the system makes assumptions about the need and potential usefulness of a particular product and suggests it/them to order.
  • the mechanism works as follows:
  • the system receives data on the patient’s electronic medical record and electronic prescriptions; - the system compares the received data on the user’s chronic or current diseases, as well as the content of electronic prescriptions with indications for the use of products;
  • the system displays the relevant products in pop-up windows or in the recommendations section of the catalog with the possibility of online ordering or displaying points of sale or their addresses; - the system informs on the possibility or need to purchase necessary or potentially useful products through the notification system.
  • the user needs to remove the tear-off section from the calendar blister pack 3 and open its tab, or take the medications themselves from the taking section. Either way, depending on the embodiment of the calendar blister pack
  • the user gets access to a hidden special graphic code.
  • the user notes the fact of taking the medication by scanning a machine-readable hidden special graphic code that identifies a unique single dosing section by the user terminal 4 containing a video camera, using the web application 4.2 or the mobile application 4.1.
  • an additional verification of the user’s adherence to the medication schedule is carried out.
  • the appearance of the calendar blister pack 3 is scanned in the form of a digital image and it is transferred to the visual recognition service 10, where recognition and analysis of the digital image are performed based on machine vision algorithms identifying both the opened and unopened dosing sections of the calendar blister pack 3.
  • the logic server 1 an additional automated verification of compliance with taking identified medications by the user is carried out in accordance with the rules for taking medications.
  • the electronic system of management of interaction with the calendar blister pack identifies the medications of the open dosing section and unobtrusively visually reminds the user of the rules for taking the identified medications and causes the user to verify the correctness of his/her actions by asking questions and demanding answers in the format of "question-answer", for example "Have you taken it after a meal? Yes/No", "Have you drunk it with water? Yes/No” etc.
  • the electronic system can display instant recommendations for further actions and restrictions, for example, do not drive vehicles and mechanisms, do not consume alcoholic beverages, etc.
  • the electronic system detects a disruption of the medication schedule by the user, for example, the user did not confirm the taking medications or took the medications out of the schedule (took an evening dose during the day), etc., it adjusts the medication schedule or gives a recommendation for further taking or missing taking certain dosing sections.
  • the user For adjusting the medication schedule using the logic server 1, the user’s actual medication schedule is compared with the prescribed medication schedule. If discrepancies are detected, using the logic server 1, the degree of disruption of the medication schedule is classified based on the possible side effects and risks contained in the content database 1.2 and associated with each medication contained in the calendar blister pack 3 and their combination, and using the logic server 1, messages about possible risks and the need to take the necessary measures are sent to the user terminal 4 and the further medication schedule is changed based on the data on the medications contained in the calendar blister pack 3.
  • a risk control mechanism is provided.
  • a smart system of reminders informs the user about possible risks and also, in special cases, notifies the trusted persons and the doctor about the fact of disruption of the medication schedule by sending a message to terminal 5 of the trusted person or to the terminal 6 of the doctor.
  • the task of ensuring the functioning of the method of use of the calendar medication blister pack with all the possibilities described above is achieved by creating an electronic system of management of interaction with the calendar medication blister pack, the system including: the logic server 1 including the blister pack database 1.1 , the content database 1.2 and the interface 1.3 of interaction with the server of the medical information system and the interface 1.4 of interaction with external services, the logic server being configured to verify the unique identifier of the calendar blister pack 3, extract the unique identifier of the taking section, identify the medications of the open dosing section and make an entry in the blister pack database 1.1 that a single taking medications of the dosing section has been carried out, send messages to the user terminal 4, the terminal 5 of the user’s trusted person and the terminal 6 of the user’s doctor, establish a connection with the server of the medical information system and receive data associated with the user’s electronic medical records and the data on the user’s active and redeemed electronic prescriptions, adjust the medication schedule based on data on the user’s actual medication schedule, the redirect server 2 connected to the logic server 1 and
  • the service 8 of validation of special graphic codes connected to the logic server 1 and configured to verify the authenticity of the open special graphic code when upon its scanning, at least one user terminal 4 configured to install the mobile application 4.1 and/or use the web version of the application 4.2 scan the open special graphic code and the hidden special graphic code, receive and send messages from/to the logic server 1, confirm compliance with taking identified medications, at least one terminal 5 of the user’s trusted person and at least one terminal 6 of the user’s doctor configured to receive event notifications from the logic server 1.
  • a smart watch with the application 4.3 as a user terminal 4 either individually or in combination with a smartphone, it is additionally possible to monitor certain biological indicators of the user, such as blood pressure, pulse, temperature, oxygenation, etc. in real time.
  • Biological indicators are limited only by the capabilities of the device used, instead of a smart watch any other medical device with the application 4.4 capable of connecting to the electronic system and/or to the user terminal 4 can be used.
  • the proposed electronic system is capable of real-time monitoring and detection of undesirable side reactions of the user’s body to taking medications.
  • deviations from normal indicators recorded by the system in automated mode can initiate a message for the user, for example, with a recommendation to stop taking medications that caused an adverse reaction before consulting a doctor, or initiate a message about the deterioration of the user’s condition to the doctor and/or trusted persons, or in some cases, in an automated mode, call emergency assistance for the user.
  • Application 4.3 for smartwatches - software that partially executes user scenarios can work together with the mobile application 4.1, allows to monitor and control certain biological indicators of the user, such as blood pressure, pulse, temperature, oxygenation, etc. in real time.
  • the logic server 1 is the central component of the electronic system that ensures the implementation of all necessary user scenarios, interacts with software applications, databases and external services and also carries out risk control in the case of disruption of the medication schedule based on possible side effects. Additionally, the logic server 1 can include an analytics database 1.5 that is designed to store information associated with the data on the calendar blister pack 3, the user terminal 4, the user location, the current authorization time, the software used, the user’s ID, and the medication schedule. Also, the database 1.5 can store BigData on patients and their activities.
  • the user authentication server 7 is a component that provides security upon user registration and authentication, performs verification of authentication data, and also provides an additional option for the user’s authorization in the medical information system.
  • the redirect server 2 is the main component of the electronic system that generates authorization links that are encoded in special graphic codes applied on the calendar blister pack 3, recognizes transitions to authorization links, with distribution by content sections and collection of analytics of incoming users.
  • the electronic system can additionally include a server 9 of partner programs, a component of interaction with organizations and partners.
  • This server 9 provides interaction with external partner services and the web application 9.3 installed on the partner’s terminal 9.1 for creating, editing and monitoring the passage of partner motivational programs.
  • the server 9 of partner programs can include a database 9.2 of partners and motivational programs configured to store information on partners and motivational programs.
  • the electronic system can additionally include a service 10 of visual recognition 1 that facilitates the recognition and analysis of digital images of the calendar blister pack 3 based on machine vision algorithms and identification of open and unopen dosing sections of the calendar blister pack 3.
  • a service 10 of visual recognition 1 that facilitates the recognition and analysis of digital images of the calendar blister pack 3 based on machine vision algorithms and identification of open and unopen dosing sections of the calendar blister pack 3.
  • This service an additional verification of the user’s adherence to the medication schedule is carried out, it is verified that the user has opened the correct sections of the medications and taken the required medications.
  • This type of verification can be used either in addition to the verification using hidden special graphic codes or individually.
  • the user database 7.1 is a component of the electronic system that stores personal, authentication data of users, a cache of electronic medical records, electronic prescriptions, as well as service data generated in the process of interaction with the system.
  • the blister pack database 1.1 is a component of the electronic system that stores information on the released calendar blister packs 3, their composition, date of issue, expiration date, and other production and consumer parameters of the products. Consumer information on the calendar blister pack 3 can include information on the appearance and contents of the calendar blister pack 3, text and/or multimedia content, instructions for use and medication taking programs.
  • the content database 1.2 is a component of the electronic system that stores all information on the calendar blister packs 3, including text and multimedia content, as well as instructions for using the calendar blister packs 3, programs and medication schedules and other necessary information.
  • the electronic system can additionally include an analytics database 1.5, a component that stores the information necessary for the formation of analytical reports, including data on the calendar blister pack 3, the user terminal 4, the user’s location, the current time of authorization, the software used, the user ID and the medication schedule.
  • an analytics database 1.5 a component that stores the information necessary for the formation of analytical reports, including data on the calendar blister pack 3, the user terminal 4, the user’s location, the current time of authorization, the software used, the user ID and the medication schedule.
  • the service 8 of validation of special graphic codes is an external service that allows to determine the authenticity of an open special graphic code upon its scanning by the user terminal 4.
  • it can be used to verify third-party graphic security elements, such as, for example, security elements with special protection against counterfeiting.
  • the electronic system can include a voice recognition service 11, an external service that allows recognition of voice control commands.
  • This service 11 can be used by users with limited capabilities, for example, visually impaired, who find it difficult to interact with the user terminal 4 in the usual way.
  • the electronic system can include a service of 12 calls and sending messages, an external service that carries out e-mail and SMS-distributions, distribution of messages, calls with reminders about the need to take the next dose and adhere to the medication schedule.
  • the electronic system can include a service 13 for accounting for the movement of the calendar blister packs 3, an external service using cloud technologies that stores and processes information on changes in the status, movement and location of the calendar blister packs during their passage through the electronic system. Owing to this service, the circulation of calendar blister packs can be controlled, for example, tracking of regional restrictions, and the possibility of substitution and counterfeiting of the calendar blister packs 3 is excluded.
  • Administering the electronic system of management of interaction with the calendar medication blister pack is carried out using the administering interface 14, a hardware and software containing the administrator account with all the necessary tools.
  • the proposed invention is not limited to a calendar blister pack, but also implements a full complex of care about a user and support of his/her treatment, including complete information on the user’s health, the history of his/her current and chronic diseases.
  • the main object of the claimed invention namely the possibility of significant improving the quality of rendering medical services, reducing the risks associated with adverse reactions upon taking certain medications, selecting relevant pharmaceutical products for a specific user, namely medications, medical products and biologically active supplements, and even increase in the market efficiency of suppliers of pharmaceutical products, is achieved.

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Abstract

The invention relates to the field of medicine, namely to "smart" blister packs of medications, a set of actions, technologies and measures used in providing treatment to a patient and related to automated electronic systems for monitoring the user's adherence to a medication schedule and monitoring a patient's condition connected with taking the prescribed medications. The proposed calendar medication blister pack, the method of use of the calendar medication blister pack and the electronic system of management of interaction with the calendar medication blister pack together implement a complete set of user care and treatment support, including complete information on the user's health, the history of his/her current and chronic diseases and, thus, the possibility of significantly improving the quality of rendering medical services, reducing the risks associated with adverse reactions upon taking certain medications, selecting relevant pharmaceutical products or medical devices for a specific user, and increase in market efficiency of medication suppliers is achieved.

Description

CALENDAR MEDICATION BLISTER PACK, METHOD OF USING THEREOF AND ELECTRONIC SYSTEM OF MANAGEMENT OF INTERACTION WITH CALENDAR MEDICATION BLISTER PACK
FIELD OF THE INVENTION
The invention relates to the field of medicine, namely to “smart” medication blister packs, a set of actions, technologies and measures used in providing treatment to a patient and related to automated electronic systems for monitoring user adherence to a prescribed medication regimen and patient condition associated with the intake of prescribed medications.
BACKGROUND OF THE INVENTION
A smart medication blister pack comprising cavities for storing medicine and a cover is known from the prior art (US application No. US 2021121366 Al, 04/29/2021). The smart medication blister pack also includes an RFID tag, a circuit, a chip, a communication module for communicating with one or more devices, a reminding module comprising audio/visual means for reminding a patient about medication, receiving module for receiving instructions from a server and/or an authorized means, self-programming module for adjusting the instructions automatically based on one or more events, and a chip for storing the instructions and information about medicine, the tablets, a manufacturer of the medicine, dosage, diseases, side effects, usage, expiration date, manufacturing date, and batch information. The smart medication blister pack is configured to receive instructions from an authorized person regarding the tablets stored in the blister pack and to store the instructions in the chip of the blister pack. The smart blister pack can remind a user, such as a patient, about time, dosage, etc. based on the stored instructions. Furthermore, the smart blister pack can exchange data with a central server to determine the authenticity of the tablets and, accordingly, inform the user about the authenticity of the tablets. The smart medication blister pack also includes a feedback module or a reminding module for providing a feedback or reminder to a user, such as a patient. The feedback or reminder can include at least one of an audio reminder, a video/visual reminder, and displaying a text message on an associated mobile device that communicates with the smart medication blister pack. In some embodiments, the blister pack provides a visual indication based on LEDs or a luminescent coating/ink on the layout of the smart medication blister pack. Furthermore, a smart medication blister pack can contain batteries that power the LEDs. The batteries can be solar cells. The reminding module is configured to inform the user whether the blister pack is authentic or not based on at least one piece of information from the smart medication blister pack and communication with the server.
The disadvantages of the known smart medication blister packs include their manufacturing complexity and increased cost due to integrated technical components such as electronic circuits, batteries, sensors, and means of communication therein. Also, a particular disadvantage is the need for special conditions for the disposal of the used smart blister pack due to the presence of electronic components and power cells therein.
A blister pack station for use with smart blister packs is known from the prior art (US Application No. US 2021125710 Al, 04/29/2021). The blister pack station includes at least one slot for receiving at least one blister pack containing one or more tablets. The blister pack station further includes an input module to receive a plurality of instructions from a third party including at least one of an authorized person, a server, a blister pack, and another blister pack station. The blister pack station also includes a chip configured to communicate the plurality of instructions to at least one of a central server, a device based in a cloud network, the blister pack, and another blister pack station.
The disadvantages of the known blister pack station are the limitation in its functional capabilities, since the station must be used as a separate device to monitor the user’s adherence to the medication schedule, the requirement to use only specially designed standardized blister packs in conjunction with it containing an integrated electronic circuit, the complexity of its manufacture and the incompatibility of the station with blister packs of different sizes and formats, as well as of different manufacturers. Also, a particular disadvantage is the need for special conditions for the disposal of the used smart blister pack due to the presence of electronic components and power cells therein.
A system and method for managing medication is known from the prior art (US application No. US 2012166216 Al, 06/28/2012), where a user terminal notifies a user of taking medicine and recognizes whether the medicine has been taken by receiving a medication schedule corresponding to an identification code of prescription from a medication management server or generating the medication schedule for itself to thereby interoperate with a medication support device, or the user terminal recognizes whether the medicine has been taken by using a medicine packet and a medicine content area without depending on the medication support device so that a user may easily take a medicine according to the medication schedule and a medication management service may be provided through the user terminal even when the user goes out or moves.
The disadvantage of known technical solutions is the lack of the possibility of adjusting the medication schedule depending on the user’s behaviour model in the process of taking medications, as well as the lack of a mechanism for verifying the originality of the origin of medications and obtaining and displaying detailed information on the contents of the packet on the user terminal.
A method and system for packaging and dispensing medication including at least one prescription package are known from the prior art (US application No. US 2004148054 Al, 07/29/2004). The package has a plurality of discrete spatially distinct locations containing the medication arranged in a two dimensional matrix. The matrix includes data corresponding to time of day information and select number of days of a week information. A heading region is disposed on a portion of the package. The heading region contains prescription instruction data having the patient’s name, medication name, medication dosages and usage schedule. A scheduling code is placed on an end of the prescription package. The scheduling code corresponds to the same time of day information as in the matrix. The medication is disposed in discrete spatially distinct locations to correspond to the medication dosages and usage schedule of the prescription instruction data. The known method begins with the fact that the pharmacy receives a prescription, enters the data into a computerized database, followed by packaging medications. The medications are packaged by units of use, i.e., dose, with one dose in each blister cavity, and only a single medication is packaged in each blister pack. If, for example, a patient is scheduled five oral medications, five blister packs will be filled each week. The medications maybe distributed via pick up, direct delivery to patient, indirect delivery to an agency or clinic, and mail. The most common side effects for each medication will be included on the prescription information indicia of each blister pack. Color- coded cards for patients who cannot read may be provided. Icons such as the sun in the morning and the moon in the evening may be added. The invention additionally contemplates the possibility of providing more than one type of medication in single blister cavities on the same blister pack cards as appropriate for the patient.
The disadvantages of the known system for packaging are that the proposed blister packs are filled with medications according to the needs and prescriptions of each specific patient that may lead to errors when filling and providing the wrong medications, the lack of a mechanism for verifying the originality of the origin of medications, the lack of the possibility of monitoring the user’s taking medications, the lack of possibility of communicating, using a graphic code, the blister pack with the electronic system that can provide additional information on the medications contained in the blister packs to the user terminal.
SUMMARY OF THE INVENTION
The main idea that formed the basis of the creation of the proposed invention is that, in accordance with nosology, nosological units or forms are distinguished, that is, one or another particular disease with its typical combination of symptoms and functional-morphological changes that are their basis, as well as a certain etiology and pathogenesis. In particular, such nosological units are cardiology, diabetes, gastroenterology and others, in the treatment of which protocol methods of complex therapy are used. For each form of nosology, combinations of several medications (drugs) of one or more classes of the ATC system (Anatomical Therapeutic Chemical classification system) are used for the specific profile of the patient being treated. Thus, there was a need to create a calendar blister pack that would contain the entire set of medications necessary for the treatment of one or another disease.
The 2013 ESH/ESC Guidelines encouraged the use of two-drug single-pill antihypertensive combinations, as reducing the number of pills to be taken daily improves adherence and increases the rate of blood pressure control. This recommendation is also endorsed by the current 2018 ESEFESC Guidelines.
Although currently the availability of two-drug FDCs is largely limited to RAS blocker with CCBs or diuretic, there is a need to develop an expanded range of low- cost calendar blister packs with a combination of different dosage forms adapted to different clinical requirements.
A combination of medications in calendar blister packs is intended to provide better effectiveness by increasing the effect of one indicator or by treating more than one indicator, as opposed to any drug used alone, or by that one active ingredient increases the safety or effectiveness of another active ingredient.
A calendar blister pack with a combination of medications can be targeted to treat multiple diseases, can increase effectiveness and can potentially save resources for patients and the healthcare system. Bioequivalence studies show that different medications retain their effectiveness when combined.
The aim of the invention is to create a calendar medication blister pack, a method of use of a calendar blister pack and an electronic system of management of interaction with a calendar blister pack that would provide improved patient disease management, reduce the risk of non-taking the prescribed medications by a user and the probability that a patient will miss taking the prescribed doses of medications, which is especially important in patients with chronic diseases such as hypertension or diabetes, improvement of secondary prevention of diseases, especially in patients with a previous myocardial infarction, facilitation of the routine of taking several medications In addition in single taking, facilitation of monitoring of compliance with the medication schedule and patient’s adherence to treatment on a long-term basis, improving the effectiveness of management of patient treatment results from a longterm care perspective by using a combination of active ingredients that are effective over a long period of time, improving patient safety through the introduction of calendar blister packs with preset combinations and doses that correspond to established international treatment protocols, as well as increasing the convenience of taking medications and facilitating compliance with the proposed treatment regime.
The technical effect of the proposed invention is in the creation of a calendar medication blister pack that provides inclusion of fixed combinations of medications in accordance with international treatment protocols owing to the presence of blister cells adapted for placing a plurality of medications therein; providing information on the scheme of taking medications, the time of taking and recommendations owing to the presence of an information zone; verifying the originality of its origin and receiving all information on the contents of the calendar blister pack on the user terminal, as well as associating a specific pack with the user owing to the presence of a unique identifier of the calendar blister pack; control of opening and control of taking medications by the user owing to equipping the dosing sections with a hidden special graphic code.
Another technical effect is in the creation of a method of use of a calendar medication blister pack that ensures user protection against counterfeit medications and the inadvertent use of counterfeit or falsified drugs by verifying the originality of origin of the calendar blister pack using its unique identifier; control of taking the prescribed medications by the user and reducing the probability that the patient will miss taking the prescribed doses of medications owing to the proposed mechanisms of reminders about the necessity to take medications and control of opening of the cells by a hidden special graphic code; providing the user with details regarding potential adverse side effects or reactions owing to the mechanism for sending messages to the user terminal; modification of the medication schedule if it's detected that the user has missed a dosage.
Another technical effect is the creation of an electronic system of management of interaction with the calendar medication blister pack that, through the utilization of proposed servers, services, and their interaction mechanisms, facilitates the monitoring of compliance with the medication schedule and the patient adherence to treatment on a long-term basis; improving the effectiveness of management of patient treatment results by monitoring and adjusting the medication schedule; increasing the patient safety through introduction of a mechanism for verifying calendar blister packs for the originality of their origin; integration with electronic medical information systems to obtain up-to-date and archival information on the user’s electronic prescriptions, his/her state of health, and based on this information, adjusting the treatment program and controlling risks upon taking medications.
BRIEF DESCRIPTION OF DRAWINGS
The claimed invention is explained by the drawings:
FIG. 1 shows a block diagram of an electronic system of management of interaction with a calendar medication blister pack.
In addition to FIG. 1, for an explanation of the essence of the invention and a better understanding of the embodiments of the calendar blister pack, additional illustrative materials are also provided.
FIG. 2A-2U show possible embodiments of the proposed calendar blister pack according to the proposed invention that illustrate only, but do not limit the essence of the proposed invention.
DETAILED DESCRIPTION OF THE INVENTION The objectives are achieved owing to the fact that the proposed calendar medication blister pack contains an upper layer and a lower layer, between which a blister layer is placed, wherein the upper layer contains an information zone with a special graphic code applied thereon and a section zone equipped with a marking and/or perforation forming one or more dosing sections defining a single taking medications, each dosing section being equipped with an opening tab configured to provide access upon its opening to a hidden special graphic code, the open special graphic code including a unique identifier of the calendar blister pack and an authorization link, and the hidden special graphic code including a unique identifier of the taking section, the lower layer contains an information zone and a section zone equipped with a marking and/or perforation forming one or more dosing sections defining a single taking medications, the information zone and the dosing sections of the lower layer corresponding to the information zone and the dosing sections of the upper layer, the blister layer includes one or more blister cells, each blister cell being configured to contain one or more medications therein, the blister cells of the blister layer being placed correspondingly to the dosing sections of the upper layer and the lower layer so that upon opening of the opening tab of the upper layer, access to the blister cell is provided, the upper layer, the lower layer and the blister layer being fastened together so as to form one or more tear-off dosing sections with medications configured to be tom-off by the marking and/or perforation, each tear-off dosing section being equipped with a hidden special graphic code that is unique for each tear-off taking section.
The open special graphic code is applied on the information zone of the pack in an open form and is used to register the calendar medication blister pack in the electronic system of management of interaction with the calendar blister pack and to launch the scenarios for taking medications contained in the pack in association with a specific user who has scanned the special graphic code from the pack or entered it manually. In addition, the open special graphic code contains a unique identifier of the calendar blister pack that can be verified by the user, and an authorization link for registering the pack in the electronic system and verifying the originality of its origin. In addition, the open special graphic code can contain additional information, for example, regarding regional restrictions on the use of the calendar blister pack, if it contains medications approved for circulation only in certain countries or regions. Also, the open special graphics code is used to access additional interactive content.
The authorization link of the open special graphic code is, in a preferred embodiment, a direct link that includes a unique identifier of the calendar blister pack in an open form or an indirect link that includes an encrypted or open unique identifier of the calendar blister pack that leads to a redirect server of the electronic system of management of interaction with the calendar blister pack. The authorization link can be formed with the possibility of collecting information on the hardware of the user terminal, requesting additional user data including meta or direct data on the operating system of the user terminal, geodata, system settings and other parameters.
In a preferred embodiment, the open special graphic code is a two-dimensional graphic code such as a QR code, or a bar code, or a DataMatrix code, or a code with special anti-counterfeiting protection - with integrated security elements. Also, as a special graphic code, an alphanumeric sequence or a combination of an alphanumeric sequence with a two-dimensional graphic code can be used.
Codes with embedded security elements, such as unique identifiers, are designed to protect products from counterfeiting and unauthorized distribution across multiple sectors, notably in the pharmaceutical industry, and they are an alternative to traditional means of protection such as special paints, materials and holograms. These unique identifiers are implemented as unique graphic elements, underpinned by cryptographic methods, used in codes that exclude the possibility of their copying or duplicating. Each unique graphic element is generated individually for each product or a batch of products which ensures the uniqueness of a product identifier. Unique graphic elements can be presented in various formats, including QR codes, onedimensional barcodes and codes that use existing product design elements of the product and are integrated into it in the form of a periodic machine-readable signal. Applying codes with integrated security elements on goods can be done using special printing or marking technologies which makes them difficult to copy or reproduce on a large scale. Recognition and analysis of codes with integrated security elements can be carried out using terminals and specialized hardware and software, such as smartphones with high-resolution cameras and mobile applications. During the analysis of images of codes with integrated security elements, a number of parameters are taken into account which allows to determine the originality of the code or its possible copy, and also, if necessary, to verify with the centralized database of released codes. To expand functionality, unique graphic elements can be integrated with common code standards that are read by terminal cameras. This facilitates the process of recognition and provides additional opportunities for presenting content and creating a convenient interface for displaying data and interacting with a user.
Such codes with special protection against couterfeiting, in particular, can be, for example, the code "CipherME" (https://cipherme.com/) or Digimarc Barcode (https://wvxw.digimarc.com). or SICPA REVEO
(https://brandprotection.sicpa.com/products-sicpa/reveo/), or other codes with integrated security elements.
The hidden special graphic code remains inaccessible until the calendar blister pack is opened and it is used to confirm that the user has taken the appropriate medications. The hidden special graphic code is unique to each medication dosing section for the calendar blister pack which allows unmistakably identifying the blister cell and/or the taking section. Depending on the design of the calendar blister pack, the hidden special graphic code can be applied on the inner side of the opening tab of the pack or applied on the inner portion of the blister cell, or can be applied on an insert or a sticker that is placed inside, for example, at the bottom of the blister cell together with medications. Thus, the hidden special graphic code becomes accessible for scanning/entering only upon opening of the necessary blister cell. Since each hidden special graphic code is unique, it is possible to accurately identify the open blister cell that the user has opened, as well as its contents that he has taken. Thus, the correctness of taking medications is controlled, the miss or disruption of the medication schedule is identified, as well as the mechanism for adjusting the medication schedule is launched in the case of disruption being detected.
In one of the embodiments, along with the hidden special graphic code, additional information on the content of the dosing section can also be applied, for example, instructions for taking, a list of contained medications, day of the week and/or taking time, etc. The amount of such additional information can depend on the size of the dosing section or vice versa - the size of the section is chosen depending on the amount of information placed thereon, and the location of additional information can be chosen depending on the option of applying the hidden special graphic code. For example, the instructions for taking can be applied on the inner side of the opening tab of the pack and the hidden special graphic code can be applied on the inner side of the blister cell (FIG. 2L, 2M) or the instructions for taking can be applied on the inner side of the blister cell and the hidden special graphic code can be applied on the inner side of the opening tab of the pack (FIG. 2K), or the instructions for taking and the hidden special graphic code can be applied on one insert or sticker from different sides (FIG. 2N), or on one side with subsequent folding of the sticker, or in the form of a mini-book, etc. Any other options of location and their combinations can be used.
In one of the embodiments, information on the contained medications, a visual representation of the contained medications, in particular the shape and color of the tablet or capsule, the day and time of taking the medications, the quantity and composition of the contained medications and other information can be additionally applied on the outer side of opening tab.
In a preferred embodiment, the hidden special graphic code is a two-dimensional graphic code such as a QR code, or a bar code, or a DataMatrix code, or a code with special anti-counterfeiting protection - with integrated security elements. Also, as a special graphic code, an alphanumeric sequence or a combination of an alphanumeric sequence with a two-dimensional graphic code can be used. In a preferred embodiment, the upper layer and the lower layer of the calendar blister pack are made of cardboard.
The information zone of the upper layer of the calendar blister pack can contain information on the general medication schedule, for example, days of the week, a breakdown by the time of taking medications, for example, morning, afternoon and evening, and information on the medications contained in the pack. In addition, information on the contained medications can, if necessary, include information on the visual representation of the contained medications, in particular, the shape, colour of the tablet or capsule, etc., the composition of the contained medications, their dosage and quantity (FIG. 2A, 2C, 2D).
In one of the embodiments, the information zone of the upper layer of the calendar blister pack can be divided into four separate zones. The first zone contains an open special graphic code, the name of the calendar blister pack and information on the number of days for which the calendar blister pack is designed. The second zone contains a general division by type of taking, namely, information on the general medication schedule, breakdown by time of taking, information on contained medications, visual graphic presentation of medications, composition of one or more components, dosage and number of medications. The third zone contains text information on the time of day of taking, visual presentation of information on days of taking, for example, using day/night icons in the form of the sun and moon, serial number of taking. The fourth zone contains an indication of the day of taking, in two formats: the serial number of the day of taking and the name of the day of the week. The information zone is intended for placing the main content and can be folded according to the additionally made perforation, and it is also made in the form of an extended element of the structure. If it is necessary to place additional content, the size of the information zone can be increased.
In one of the embodiments, at least part of the information applied on the information zone of the upper layer of the calendar blister pack can be duplicated in Braille. In a particular embodiment, color coding of the calendar blister pack may be employed to simplify user interaction, especially for those with visual impairments or reading difficulties with limited capabilities, low vision, or reading difficulties. In this case, the dosing sections or the blister cells can be additionally marked with color marking, for example, a coloured outline around the perimeter of the dosing section or the blister cell and the information zone can be provided with a legend explaining the meaning of the colors, for example, the taking days of the week can be marked with colors of a rainbow, etc.
In one of the embodiments, the information and section zones of the lower layer of the calendar blister pack can contain duplicate information, including the number of days of taking for which the calendar medication blister pack is designed, as well as information on the content, dosage and other information.
In one of the embodiments, the information zone of the lower layer of the calendar blister pack can be divided into two separate zones. The first zone explicitly denotes the number of days covered by a single calendar blister pack. The second zone contains information on the manufacturer of the calendar blister pack.
In one of the embodiments, the section zone of the lower layer can contain a tear-off dosing section with duplication of information on the time of taking, the day of taking, a set of medications, a visual graphic representation of medications, the composition of one or more components, dosage and the number of medications. The set of presented information can be optimized for certain tasks and the size of dosing sections (FIG. 2B).
According to the proposed invention, the blister layer can be one continuous blister containing a plurality of blister cells (FIG. 2P, 2R), or it can be made in the form of a plurality of separate blister cells that are not attached to each other (FIG. 20, 2Q). In addition, if the blister layer is made in the form of one continuous blister, it can additionally be equipped with a marking and/or perforation that corresponds to the marking and/or perforation of the section zones of the upper layer and the lower layer so that one blister cell corresponds to one taking section. Thus, if necessary, the user can tear off or separate in another way, for example, cut off, from the entire pack a separate dosing section for one or more days, as well as for one or more takings (FIG. 2F). For ease of separation, dosing sections can be rectangular or square.
In one of the embodiments, for placing a plurality of the blister cells, the calendar blister pack can contain an additional layer with formed tear-off cavities in the form of tear-off sections (FIG. 2U), the addiotnal layer being located between the lower layer and the blister layer and equipped with a marking and/or perforation to ensure the possibility of separation of separate tear-off sections (FIG. 2S, 2T). This additional layer can be made of transparent or opaque material.
As can be seen from the description, the calendar blister pack is made with an intuitive arrangement of elements which allows to use it effectively even without any additional hardware and software, such as a user terminal with installed applications. Consequently, the calendar blister pack encompasses a visually segmented regimen or a portion of the medication intake schedule broken down into sections (zones) of single taking. It is possible to make calendar blister pack either with sets of medications that repeat every day and every time of the day of taking or with sets of medications that differ, or both. The calendar blister pack can be scaled either in height that provides the possibility of placing a greater number of takings per day or in width that provides the possibility of increasing the number of days of taking in one pack or vice versa, or both (FIG. 2E).
According to the periods of taking, the calendar blister pack provides several embodiments, in particular, a pack for a week, a pack for a day, or a pack for a full course or for an indefinite period of use, for example, in the case of the need for lifelong taking medications. Each dosing section contains a separate blister or blister cell for single taking with one or more medications of different release forms. The dosing sections can be of different sizes depending on the set of medications and their sizes as well as release forms. In particular, medications can be made in the form of a round tablet, oblong capsule or in other release forms. In addition, the dosing section can contain a combination of different medications of different shapes and types, for example, a round tablet with another round tablet, a round tablet with an oblong capsule, two oblong capsules, etc.
In various embodiments, the pack can be made with an open visible part and closed on both sides. The pack with an open visible part allows to visually show the medications inside the visible blisters (FIG. 2H). The pack of a closed type allows to apply more information on its both sides (FIG. 2G). For example, the calendar blister pack of a closed type can contain additional information with instructions for taking duplicated, if necessary, in Braille applied on the pack itself. Thus, users with visual impairments will be able to take medication without outside help which increases the convenience and safety of using the calendar blister pack. In addition, the risk of taking a wrong medication by a user with disabilities is reduced, as the instructions are applied directly on the corresponding calendar blister pack.
In a preferred embodiment, the calendar blister pack is a matrix of dosing sections that includes columns and rows. Preferably, the columns define the days of taking medications, for example, days of the week, and the rows define the time of a day for taking, for example, morning, afternoon, evening, night (FIG. 2J). However, depending on the layout and contents of the calendar blister pack, the layout can be done in any other way, in particular, the columns can define the time of day, and the rows can define the days of taking (FIG. 21). In addition, a different order of taking can be used, indicated, for example, by a line showing the sequence of taking of medications. The line can be supplemented with an arrow that defines the beginning of taking. The line, in particular, can be made in the form of a “snake” or a circle. Also, for calendar blister packs that are not referred to the days of the week, or those that imply a long course of use, numerical ordinal numbering of the days of taking that does not depend on the days of the week can be used. For example, a course of two calendar blister packs for two weeks can have consecutive numbering so that the first pack has days 1 to 7 and the second pack has days 8 to 14. Also, a combination of the said indications can be used, in particular, numbering of dosing sections and a line showing the sequence of taking. Thus, the taking can be started on any day of the week.
Depending on the duration of the course of treatment, the number of medications, the medication schedule, etc., several calendar blister packs can be combined into one box or pack. For example, a box can contain seven calendar blister packs per week of taking, each of the seven calendar blister packs containing medications for a day, the dosing sections of which are divided by time of a day. Otherwise, the box can contain several identical calendar blister packs that can be used for a long course of treatment.
Given the task, the proposed calendar medication blister pack can be used for convenient and controlled protocol methods of complex therapy in the treatment of, in particular, cardiac and diabetic diseases. The following are embodiments of a calendar blister pack that contains certain combinations of medications with prescribed doses for the treatment that can be used for certain diseases.
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of hypertension in patients with high and very high risk of cardiovascular complications and includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers)/CCBs (Calcium Channel Blockers)/Diuretic, Acetylsalicylic acid and Statin. In this case, the fixed dose of ARBs/CCBs/Diuretic is Olmesartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Olmesartan (40 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (320 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (160 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Losartan (50 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Losartan (100 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Eprosartan (600 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Eprosartan (600 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (150 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (300 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Candesartan (8 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Candesartan (16 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Telmisartan (80 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Telmisartan (80 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (80 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Fimasartan (60 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Fimasartan (60 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg); the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg); and the fixed dose of Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of uncomplicated hypertension in patients with high and very high risk of cardiovascular complications and includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers)/Diuretic, Acetylsalicylic Acid and Statin.In this case, the fixed dose of ARBs/Diuretic is Losartan (50 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Losartan (100 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (160 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Valsartan (320 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Eprosartan (600 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Eprosartan (600 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (150 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Irbesartan (300 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Candesartan (8 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Candesartan (16 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Telmisartan (80 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Telmisartan (80 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Olmesartan (20 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Olmesartan (40 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (40 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Azilsartan (80 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Fimasartan (60 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Fimasartan (120 mg) and
Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of Acetylsalicylic acid is
Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg); and the fixed dose of Statin is
Atorvastatin (20 mg) or Atorvastatin (40 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the prevention of atherosclerotic cardiovascular disease (ASCVD) and includes two fixed-dose combinations: Statin and Acetylsalicylic acid. In this case, the fixed dose of Statin is Atorvastatin (20 mg), or Atorvastatin (40 mg), or Rosuvastatin (10 mg), or Rosuvastatin (20 mg); and the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of uncomplicated resistant hypertension and includes two fixed-dose combinations of ARBs (Angiotensin Receptor Blockers)/CCBs (Calcium Channel Blockers)/Diuretic and MRAs (Mineralocorticoid Receptor Antagonists). In this case, the fixed dose of ARBs/CCBs/Diuretic is Olmesartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Olmesartan (40 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (320 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (160 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Losartan (50 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Losartan (100 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Eprosartan (600 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Eprosartan (600 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (150 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (300 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Candesartan (8 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Candesartan (16 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Telmisartan (80 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Telmisartan (80 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (80 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Fimasartan (60 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Fimasartan (60 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg); and the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD) and/or chronic kidney disease (CKD) and includes three fixed- dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitor/Diuretic, CCBs (Calcium Channel Blockers) and MRAs (Mineralocorticoid Receptor Antagonists). In this case, the fixed dose of the ACE Inhibitor/Diuretic is Lisinopril (20 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Lisinopril (20 mg) and Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of CCBs is Amlodipine (5 mg); and the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD) and includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), 0-blocker/Diuretic, and MRAs (Mineralocorticoid Receptor Antagonists). In this case, the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg) or Fimasartan (120 mg); the fixed dose of the P-blocker/Diuretic is Bisoprolol (5 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg), or Bisoprolol (10 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg); and the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD) with a high risk of complications and includes three fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitors, p- blocker/Diuretic and MRAs (Mineralocorticoid Receptor Antagonists). In addition, the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg); the fixed dose of the p-blocker/Diuretic is Bisoprolol (5 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg), or Bisoprolol (10 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg); and the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction and includes five fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitors, p -blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin. In this case, the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg); the fixed dose of the p-blocker is Metoprolol Ext. release (25 mg); the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg); and the fixed dose of Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction in patients intolerant of ACE inhibition and includes five fixed-dose combinations: Angiotensin Recep tor-Neprily sin Inhibitors (ARNIs)s, 0- blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin. In this case, the fixed dose of the Angiotensin Receptor-Neprilysin Inhibitors (ARNIs) is Sacubitril (24 mg) and Valsartan (26 mg), or Sacubitril (49 mg) and Valsartan (51 mg), or Sacubitril (97 mg) and Valsartan (103 mg); the fixed dose of the 0-blocker is Metoprolol Ext. release (25 mg); the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg); and the fixed dose of Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction in specified conditions and includes five fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), 0-blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin. In this case, the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg) or Fimasartan (120 mg); the fixed dose of the 0-blocker is Metoprolol Ext. release (25 mg); the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg); and the fixed dose of Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndrome in the presence of type 2 diabetes and high-risk hypertensive heart disease and includes four fixed-dose combinations: (Angiotensin-Converting Enzyme) Inhibitor, Diuretic, Statin and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor. In this case, the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg); the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of Statin is Rosuvastatin (10 mg) or Rosuvastatin (20 mg); and the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of chronic coronary syndrome in the presence of type 2 diabetes and hypertensive heart disease and includes four fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), Diuretic, Statin, and SGLT2 (Sodium- Glucose Cotransporter 2) Inhibitor. In addition, the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg) or Fimasartan (120 mg); the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg); the fixed dose of Statin is Rosuvastatin (10 mg) or Rosuvastatin (20 mg); and the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of heart failure in the presence of type 2 diabetes, CHD (coronary heart disease) with a high risk of complications and includes four fixed- dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitor, 0-blocker, Acetylsalicylic acid and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor. In this case, the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg); the fixed dose of the -blocker is Metoprolol Ext. release (25 mg); the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg); and the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg). In one of the embodiments, the calendar blister pack contains a combination of medications for the treatment of heart failure in the presence of type 2 diabetes and CHD and includes four fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), 0-blocker, Acetylsalicylic Acid, and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor. In this case, the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg) or Fimasartan (120 mg); the fixed dose of the p-blocker is Metoprolol Ext. release (25 mg); the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg); and the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
Regular monitoring of the user’s taking medications is critical to the success of most methods of treatment. Various studies have shown that irregular taking medications gradually progresses and eventually, in many cases, users stop taking medications at all, especially in the case of long-term therapy. In addition, if the therapy is not successful, new methods of treatment that would not be necessary if the medications were taken regularly are often used. Therefore, if the irregular taking medications is detected during the monitoring, the regularity of their taking can be significantly improved owing to the motivation of the user.
Monitoring of taking, reminders and motivation of users can significantly increase the success of therapy and thus, lead to lower costs. All such solutions on the market today disclose opening a medication pack which is also considered to be one of the means of successful treatment. However, most of the solutions presented on the market do not allow determining whether the medications are actually taken after opening the pack, since, as a rule, the patient burdens himself with opening the pack only if he/she really wants to take medications. Thus, there is a need for a convenient and reliable method to ensure and monitor the regular taking medications by the user. The set task is achieved owing to the fact that the proposed method of use of a calendar medication blister pack includes the stages in which: using the user terminal 4 the open special graphic code applied on the information zone of the calendar blister pack 3 is scanned, using the authorization link the user being authorized on the user authentication server 7 by the unique identifier of the calendar blister pack 3, for this purpose using the authorization link a user authorization request is sent to the redirect server 2, on the redirect server 2, the unique identifier of the calendar blister pack 3 is derived from the authorization link, the validity of the unique identifier of the calendar blister pack 3 is verified and the user authorization parameters are stored on the redirect server 2, on the redirect server 2, a request is sent to the logic server 1 and it is verified whether such unique identifier of the calendar blister pack 3 has previously been registered, wherein in the event that such unique identifier of the calendar blister pack 3 has already been registered previously, the user is offered to perform authentication and on the user authentication server 7 the entered user’s authentication data are verified with the user’s authentication data stored in the user database 7.1, in the event that such unique identifier of the calendar blister pack 3 has not been registered previously, the user is offered to carry out registration and authentication on the user authentication server 7 and the user’s authentication data are stored in the user database 7.1, using the unique identifier of the calendar blister pack 3, the identification data of the calendar blister pack 3 are verified in the blister pack database 1.1 and the originality of its origin is verified, and in the case of a successful verification, the user terminal 4 is provided with access to the content database 1.2 and is provided with consumer information on the calendar blister pack 3, and in the case of an unsuccessful verification a message about the impossibility of using the calendar blister pack 3 is sent to the user terminal 4 and a corresponding entry is made in the blister pack database 1.1, or a message with a warning that an unverified calendar blister pack 3 is being used is sent to the user terminal 4, about which a corresponding entry is made in the blister pack database 1.1, the opening tab of the dosing section of the calendar blister pack 3 is open and the access to the hidden special graphic code is granted, using the user terminal 4, the hidden special graphic code is scanned, from which, using the logic server 1, the unique identifier of the dosing section is extracted, the medications of the open dosing section are identified and an entry that a single taking medications of the dosing section has been carried out is made in the blister pack database 1.1, wherein using the logic server 1 , a message with the rules for taking identified medications of the dosing section is sent to the user terminal 4 and it is offered to confirm, using the user terminal 4, compliance of taking the identified medications by the user with the sent rules for taking, in the event that the user takes identified medications that may cause undesirable side effects or reactions, a message about such undesirable side effects or reactions is additionally sent from the logic server 1 to the user terminal 4, following sending a mandatory confirmation from the user terminal 4 to the logic server 1 that the user has familiarized with the message, and in the event that the user takes the identified medications with special taking restrictions, a message about the need to comply with the established restrictions is additionally sent from the logic server 1 to the user terminal 4 following sending a mandatory confirmation from the user terminal 4 to the logic server 1 that the user has familiarized with the message, in the case of disruption of the medication schedule and/or opening of the wrong taking section, using the logic server 1, a corresponding message and recommendations regarding further actions are sent to the user terminal 4, and the medication schedule is adjusted, wherein, in the case of a repeated disruption of the medication schedule and/or lack of confirmation from the user terminal 4 regarding a single taking medication of the taking section, the logic server 1 sends a message about the event to the terminal 5 of the user’s trusted person and/or the terminal 6 of the user’s doctor.
In one of the embodiments, consumer information on the calendar blister pack 3 can include information on the appearance and contents of the calendar blister pack 3, text and/or multimedia content, instructions for use and programs of medication schedule, etc.
In one of the embodiments, verifying the identification data of the calendar blister pack 3 in the blister pack database 1.1 can include verification of the expiration date of the calendar blister pack 3, verification of the region of origin, verification of the reusability of the calendar blister pack 3.
In one of the embodiments, mandatory confirmation of the user’s familiarization with the message is carried out in the form of a "question-answer" where the user is asked to confirm his/her actions, for example, "Have you taken it after a meal? Yes/No", "Have you drunk it with water? Yes/No", etc.
In one of the embodiments, special restrictions on taking medications are restrictions specified by the manufacturer of medications in the instructions, for example, prohibition of driving vehicles and mechanisms, prohibition of eating food and/or drinking alcoholic beverages, the need to drink liquid after taking a medication, etc.
Interaction with the calendar blister pack 3 begins with an appointment made by a doctor, this can be done either in the classic form or electronically in the medical information system using electronic medical records and electronic prescriptions. In the context of this disclosure, a medical information system is a hardware and software solution that includes various components that provide processing and exchange of medical data either at the level of commercial institutions or at the national level, under the management of various organizations, including commercial and government structures. Interaction with the information system of electronic prescriptions at the stage of prescribing medications is described, in particular, in patent UA 124828 C2 (PCT application No. PCT/UA2021/000093).
Before taking medications, the user registers the calendar blister pack 3 in the electronic system of management of interaction with the calendar blister pack. In this case, all the necessary identification information is located directly on the calendar blister pack 3 itself, in particular, in the open special graphic code. The identification data of the calendar blister pack 3 can include, in particular, data on the composition, the date of manufacture and the expiration date of the calendar blister pack.
For registering the calendar blister pack 3, the user points the camera of the user terminal 4 at the machine-readable code or enters the alphanumeric code of the pack 3 manually in the web application 4.2 or the mobile application 4.1, following opening of a web page or a section of the application with additional interactive content, where the user sees the appearance of the calendar blister pack 3 that he/she registers. In this case, information on the appearance of the calendar blister pack 3 can include a 3D model of its appearance with the possibility of changing the viewing point, and it is offered to register or log in to the electronic system using the most popular services, such as social networks, messengers, etc. or, also, by e-mail or by phone. Also, the user can be given the possibility to choose a form of interaction convenient for him/her, for example, to continue work through the website (application) 4.2, in particular, to use a web chat, transfer the interaction to a chatbot 4.5 of the selected messenger, install the mobile application 4.1, etc. The user terminal 4 can be any known device with the possibility of accessing the Internet, in particular, a phone, smartphone, personal computer, laptop, smart watch, etc.
In one of the embodiments, when scanning the open special graphic code, its authenticity is additionally verified using the service 8 of validation of special graphic codes to detect fake and/or counterfeit calendar blister packs 3.
The installation of the applications 4.1-4.4 is carried out from official stores and/or application platforms, for example, such as the App Store, Google Play, Huawei AppGallery, Xiaomi GetApps or other official sources, after that the user is given the possibility to get authorizesd either in the usual ways or by using a simplified authorization system, by means of following the authorization link from the web page that is accessible by opening a special graphic code applied on the information zone of the calendar blister pack 3.
In one of the embodiments, the user terminal 4 receives an authorization link from the open graphic code and if such calendar blister pack 3 has already been registered previously, the user is offered to perform authentication and on the user authentication server 7, the user’s entered authentication data are verified with the user’s authentication data that were entered previously and are stored in the user database 7.1. If the calendar blister pack 3 has not been registered previously, the user is offered to carry out registration and authentication on the user authentication server 7 and the user’s authentication data are stored in the user database 7.1. The user’s authentication data may include the data on the user terminal 4, the user location, the tcurrent authorization time, the software used, the user’s ID, the user’s personal data, electronic medical record cache, and the data on existing electronic prescriptions associated with the user.
In one of the embodiments, together with the registration of the calendar blister pack 3, the authorization of the user in the medical information system can be carried out simultaneously through the interface of interaction 1.3, where the medical information system can be either a state or a commercial medical information system that contains data on the user’s medical history, all appointments, existing electronic prescriptions, etc. and can be used as an additional mechanism for risk control, adjusting the treatment program and generation of analytical reports. The authorization in the medical information system is carried out as follows.
When authorizing a user on the authentication server 7 the users are asked for the user’s phone number and/or e-mail, by means of which he/she is registered in the medical information system, and an SMS message and/or an e-mail with an authorization code and/or an authorization link is sent and/or an electronic digital signature is requested. Next, the authorization code for entering the system is entered and/or the authorization link is followed to enter into the system and, using the logic server 1, a connection with the server of the medical information system is established through the interface of interaction 1.3 and the data associated with the user’s electronic medical records (EMR) and the data on the user’s active and redeemed electronic prescriptions (EP) are retrieved.
In one of the embodiments, for authorizing the user in the medical information system, the user is provided with a terminal in a graphical form or an interface for authorization, the user’s authorization is carried out by any acceptable method of authorization, for example, using an electronic digital signature, using the logic server 1 the connection with the server of the medical information system is established through the interface of interaction 1.3 and the data associated with the user’s electronic medical records and the data on the user’s active and redeemed electronic prescriptions are retrieved. Upon registration of the user, as well as during the entire life cycle of the software, starting from the moment of the user’s registration and gaining access to the user’s data, the logic server 1 monitors and uploads, through the interface of interaction 1.3, available information on the user’s electronic medical records and electronic prescriptions from the server of medical information system with storing all changes in the user database 7.1.
Data from electronic medical records can be used in the following cases:
- to propose a medication administration program: the user is given the possibility to choose a taking program based on electronic prescriptions uploaded from the server of the medical information system or from the list of popular ones, or, if there is no corresponding program, to configure it manually, depending on the doctor’s appointment;
- to offer to change the medication schedule; the service provides a simple process of changing the schedule at the request of a doctor, either on the basis of an issued electronic prescription, or the started parallel treatment of a disease not related to the medication, either by means of interaction with a visual interface or by means of voice commands;
- to automatically change the medication schedule: the system can automatically change the medication schedule at the request of a doctor, either on the basis of an issued electronic prescription or the started parallel treatment of a disease not related to the medication, with a mandatory notification of the user and with his/her consent;
- to control risks: in the case when the user stops noting taking medications or misses taking, as well as in situations where the medication schedule must be forcibly adjusted at the request of a doctor, either on the basis of an issued electronic prescription or started treatment related to a disease not associated with the medications, a smart system of reminders (depending on the degree of the user’s risk or depending on the diligence of using the application) notifies the user of possible risks, and also, in special cases, notifies the trusted persons and the doctor;
- to implement the replenishment service: in the event that the calendar blister pack runs out or is insufficient for the treatment based on the information of the patient’s electronic prescriptions, or its expiration date expires, the system offers to replenish the stock from the partners.
- to offer the calendar blister packs with medications suitable for the treatment of concomitant or current diseases revealed on the basis of electronic prescriptions or electronic medical records;
- to collect and use BigData for analytical purposes: the system collects BigData on patients and their activities that includes depersonalized incomplete data from electronic medical records and electronic prescriptions for further analysis of the estimated demand for the presented products and forecasting the profitability of the introduction of new products, improvement of risk analysis systems, improvement of service quality, optimization of user scenarios, etc.
The mechanism for suggesting the calendar blister packs 3 with medications suitable for the treatment of concomitant or current diseases is that, based on electronic medical records and electronic prescriptions, the system makes assumptions about the need and potential usefulness of a particular product and suggests it/them to order. The mechanism works as follows:
- after the user’s authorization in the medical information system, the system receives data on the patient’s electronic medical record and electronic prescriptions; - the system compares the received data on the user’s chronic or current diseases, as well as the content of electronic prescriptions with indications for the use of products;
- the system displays the relevant products in pop-up windows or in the recommendations section of the catalog with the possibility of online ordering or displaying points of sale or their addresses; - the system informs on the possibility or need to purchase necessary or potentially useful products through the notification system.
For taking medications, the user needs to remove the tear-off section from the calendar blister pack 3 and open its tab, or take the medications themselves from the taking section. Either way, depending on the embodiment of the calendar blister pack
3, the user gets access to a hidden special graphic code. The user notes the fact of taking the medication by scanning a machine-readable hidden special graphic code that identifies a unique single dosing section by the user terminal 4 containing a video camera, using the web application 4.2 or the mobile application 4.1.
In one of the embodiments, an additional verification of the user’s adherence to the medication schedule is carried out. For this purpose, using the camera of the user terminal 4, the appearance of the calendar blister pack 3 is scanned in the form of a digital image and it is transferred to the visual recognition service 10, where recognition and analysis of the digital image are performed based on machine vision algorithms identifying both the opened and unopened dosing sections of the calendar blister pack 3. Using the logic server 1, an additional automated verification of compliance with taking identified medications by the user is carried out in accordance with the rules for taking medications.
At the same time, the electronic system of management of interaction with the calendar blister pack identifies the medications of the open dosing section and unobtrusively visually reminds the user of the rules for taking the identified medications and causes the user to verify the correctness of his/her actions by asking questions and demanding answers in the format of "question-answer", for example "Have you taken it after a meal? Yes/No", "Have you drunk it with water? Yes/No" etc. In addition, the electronic system can display instant recommendations for further actions and restrictions, for example, do not drive vehicles and mechanisms, do not consume alcoholic beverages, etc.
In the event that the electronic system detects a disruption of the medication schedule by the user, for example, the user did not confirm the taking medications or took the medications out of the schedule (took an evening dose during the day), etc., it adjusts the medication schedule or gives a recommendation for further taking or missing taking certain dosing sections.
For adjusting the medication schedule using the logic server 1, the user’s actual medication schedule is compared with the prescribed medication schedule. If discrepancies are detected, using the logic server 1, the degree of disruption of the medication schedule is classified based on the possible side effects and risks contained in the content database 1.2 and associated with each medication contained in the calendar blister pack 3 and their combination, and using the logic server 1, messages about possible risks and the need to take the necessary measures are sent to the user terminal 4 and the further medication schedule is changed based on the data on the medications contained in the calendar blister pack 3.
In one of the embodiments, a risk control mechanism is provided. In the event that the user stops noting taking medications or misses the medication schedule, as well as in situations where the medication schedule must be forcibly adjusted at the request of a doctor, either on the basis of an issued electronic prescription or started treatment related to the disease not associated with the medications, a smart system of reminders, depending on the degree of risk of the user or depending on the diligence of using the application 4.1-4.4, informs the user about possible risks and also, in special cases, notifies the trusted persons and the doctor about the fact of disruption of the medication schedule by sending a message to terminal 5 of the trusted person or to the terminal 6 of the doctor.
The task of ensuring the functioning of the method of use of the calendar medication blister pack with all the possibilities described above is achieved by creating an electronic system of management of interaction with the calendar medication blister pack, the system including: the logic server 1 including the blister pack database 1.1 , the content database 1.2 and the interface 1.3 of interaction with the server of the medical information system and the interface 1.4 of interaction with external services, the logic server being configured to verify the unique identifier of the calendar blister pack 3, extract the unique identifier of the taking section, identify the medications of the open dosing section and make an entry in the blister pack database 1.1 that a single taking medications of the dosing section has been carried out, send messages to the user terminal 4, the terminal 5 of the user’s trusted person and the terminal 6 of the user’s doctor, establish a connection with the server of the medical information system and receive data associated with the user’s electronic medical records and the data on the user’s active and redeemed electronic prescriptions, adjust the medication schedule based on data on the user’s actual medication schedule, the redirect server 2 connected to the logic server 1 and configured to receive a user authorization request using an authorization link, extract the unique identifier of the calendar blister pack 3 from the authorization link, verify the validity of the unique identifier of the calendar blister pack 3 and store the user authorization parameters, send a request to the logic server 1 and verifying whether the unique identifier of the calendar blister pack 3 has not previously been registered, the user authentication server 7 containing the user database 7.1 connected to the logic server 1 and configured to carry out authorization and registration of users verify the entered user’s authentication data with the user’s authentication data stored in the user database 7.1, save the user’s authentication data in the user database 7.1, carry out the user’s authorization in the medical information system,
The service 8 of validation of special graphic codes connected to the logic server 1 and configured to verify the authenticity of the open special graphic code when upon its scanning, at least one user terminal 4 configured to install the mobile application 4.1 and/or use the web version of the application 4.2 scan the open special graphic code and the hidden special graphic code, receive and send messages from/to the logic server 1, confirm compliance with taking identified medications, at least one terminal 5 of the user’s trusted person and at least one terminal 6 of the user’s doctor configured to receive event notifications from the logic server 1. In one of the embodiments, in particular, when using a smart watch with the application 4.3 as a user terminal 4, either individually or in combination with a smartphone, it is additionally possible to monitor certain biological indicators of the user, such as blood pressure, pulse, temperature, oxygenation, etc. in real time. Biological indicators are limited only by the capabilities of the device used, instead of a smart watch any other medical device with the application 4.4 capable of connecting to the electronic system and/or to the user terminal 4 can be used. Thus, the proposed electronic system is capable of real-time monitoring and detection of undesirable side reactions of the user’s body to taking medications. Depending on user scenarios, deviations from normal indicators recorded by the system in automated mode can initiate a message for the user, for example, with a recommendation to stop taking medications that caused an adverse reaction before consulting a doctor, or initiate a message about the deterioration of the user’s condition to the doctor and/or trusted persons, or in some cases, in an automated mode, call emergency assistance for the user.
Application 4.3 for smartwatches - software that partially executes user scenarios, can work together with the mobile application 4.1, allows to monitor and control certain biological indicators of the user, such as blood pressure, pulse, temperature, oxygenation, etc. in real time.
The logic server 1 is the central component of the electronic system that ensures the implementation of all necessary user scenarios, interacts with software applications, databases and external services and also carries out risk control in the case of disruption of the medication schedule based on possible side effects. Additionally, the logic server 1 can include an analytics database 1.5 that is designed to store information associated with the data on the calendar blister pack 3, the user terminal 4, the user location, the current authorization time, the software used, the user’s ID, and the medication schedule. Also, the database 1.5 can store BigData on patients and their activities. The user authentication server 7 is a component that provides security upon user registration and authentication, performs verification of authentication data, and also provides an additional option for the user’s authorization in the medical information system.
The redirect server 2 is the main component of the electronic system that generates authorization links that are encoded in special graphic codes applied on the calendar blister pack 3, recognizes transitions to authorization links, with distribution by content sections and collection of analytics of incoming users.
In one of the embodiments, the electronic system can additionally include a server 9 of partner programs, a component of interaction with organizations and partners. This server 9 provides interaction with external partner services and the web application 9.3 installed on the partner’s terminal 9.1 for creating, editing and monitoring the passage of partner motivational programs. In addition, the server 9 of partner programs can include a database 9.2 of partners and motivational programs configured to store information on partners and motivational programs.
In one of the embodiments, the electronic system can additionally include a service 10 of visual recognition 1 that facilitates the recognition and analysis of digital images of the calendar blister pack 3 based on machine vision algorithms and identification of open and unopen dosing sections of the calendar blister pack 3. Using this service an additional verification of the user’s adherence to the medication schedule is carried out, it is verified that the user has opened the correct sections of the medications and taken the required medications. This type of verification can be used either in addition to the verification using hidden special graphic codes or individually.
The user database 7.1 is a component of the electronic system that stores personal, authentication data of users, a cache of electronic medical records, electronic prescriptions, as well as service data generated in the process of interaction with the system. The blister pack database 1.1 is a component of the electronic system that stores information on the released calendar blister packs 3, their composition, date of issue, expiration date, and other production and consumer parameters of the products. Consumer information on the calendar blister pack 3 can include information on the appearance and contents of the calendar blister pack 3, text and/or multimedia content, instructions for use and medication taking programs.
The content database 1.2 is a component of the electronic system that stores all information on the calendar blister packs 3, including text and multimedia content, as well as instructions for using the calendar blister packs 3, programs and medication schedules and other necessary information.
In one of the embodiments, the electronic system can additionally include an analytics database 1.5, a component that stores the information necessary for the formation of analytical reports, including data on the calendar blister pack 3, the user terminal 4, the user’s location, the current time of authorization, the software used, the user ID and the medication schedule.
The service 8 of validation of special graphic codes is an external service that allows to determine the authenticity of an open special graphic code upon its scanning by the user terminal 4. In particular, it can be used to verify third-party graphic security elements, such as, for example, security elements with special protection against counterfeiting.
In one of the embodiments, the electronic system can include a voice recognition service 11, an external service that allows recognition of voice control commands. This service 11 can be used by users with limited capabilities, for example, visually impaired, who find it difficult to interact with the user terminal 4 in the usual way.
In one of the embodiments, the electronic system can include a service of 12 calls and sending messages, an external service that carries out e-mail and SMS-distributions, distribution of messages, calls with reminders about the need to take the next dose and adhere to the medication schedule.
In one of the embodiments, the electronic system can include a service 13 for accounting for the movement of the calendar blister packs 3, an external service using cloud technologies that stores and processes information on changes in the status, movement and location of the calendar blister packs during their passage through the electronic system. Owing to this service, the circulation of calendar blister packs can be controlled, for example, tracking of regional restrictions, and the possibility of substitution and counterfeiting of the calendar blister packs 3 is excluded.
Administering the electronic system of management of interaction with the calendar medication blister pack is carried out using the administering interface 14, a hardware and software containing the administrator account with all the necessary tools.
Thus, the proposed invention is not limited to a calendar blister pack, but also implements a full complex of care about a user and support of his/her treatment, including complete information on the user’s health, the history of his/her current and chronic diseases. Thus, the main object of the claimed invention, namely the possibility of significant improving the quality of rendering medical services, reducing the risks associated with adverse reactions upon taking certain medications, selecting relevant pharmaceutical products for a specific user, namely medications, medical products and biologically active supplements, and even increase in the market efficiency of suppliers of pharmaceutical products, is achieved.

Claims

1. A calendar medication blister pack comprising an upper layer and a lower layer, between which a blister layer is placed, characterized in that the upper layer contains an information zone with a special graphic code applied thereon and a section zone equipped with a marking and/or perforation forming one or more dosing sections defining a single taking medications, each dosing section being equipped with an opening tab configured to provide access upon its opening to a hidden special graphic code, the open special graphic code including a unique identifier of the calendar blister pack and an authorization link, and the hidden special graphic code including a unique identifier of the taking section, the lower layer contains an information zone and a section zone equipped with a marking and/or perforation forming one or more dosing sections defining a single taking medications, the information zone and the dosing sections of the lower layer corresponding to the information zone and the dosing sections of the upper layer, the blister layer includes one or more blister cells, each blister cell being configured to contain one or more medications therein, the blister cells of the blister layer being placed correspondingly to the dosing sections of the upper layer and the lower layer so that upon opening of the opening tab of the upper layer, access to the blister cell is provided, the upper layer, the lower layer and the blister layer being fastened together so as to form one or more tear-off dosing sections with medications configured to be tom-off by the marking and/or perforation, each tear-off dosing section being equipped with a hidden special graphic code unique for each tear-off taking section.
2. The pack according to claim 1 characterized in that the hidden special graphic code is applied on the inner side of the opening tab.
3. The pack according to claim 1 characterized in that the hidden special graphic code is applied on the blister cell.
4. The pack according to claim 1 characterized in that the hidden special graphic code is applied on an insert or a sticker placed under the opening tab.
5. The pack according to any one of claims 1 to 4 characterized in that the plurality of cells of the blister layer are made in the form of individual blisters.
6. The pack according to any one of claims 1 to 4 characterized in that the blister cells of the blister layer are made in the form of one continuous blister equipped with a marking and/or perforation corresponding to the marking and/or perforation of the section zones of the upper layer and the lower layer so that one blister cell corresponds to one taking section.
7. The pack according to any one of claims 1 to 6 characterized in that it contains an additional layer with formed tear-off cavities, which is located between the lower layer and the blister layer and is equipped with a marking and/or perforation, the tear- off cavities being specially adapted for placing separate blisters with medications therein.
8. The pack according to claim 7 characterized in that the hidden special graphic code is applied on an insert or a sticker placed at the bottom of the tear-off cavity.
9. The pack according to any one of claims 7 to 8 characterized in that the additional layer with formed tear-off cavities is made of a transparent material.
10. The pack according to any one of claims 1 to 9 characterized in that the upper layer and the lower layer are made of cardboard.
11. The pack according to any one of claims 1 to 10 characterized in that the dosing sections are of a rectangular or square shape.
12. The pack according to any one of claims 1 to 11 characterized in that the information zone of the upper layer contains information on the general medication schedule, a breakdown by the time of taking medications and information on the contained medications.
13. The pack according to claim 12 characterized in that the information on the contained medications includes information on the visual representation of the contained medications, the composition of the contained medications, their dosage and quantity.
14. The pack according to any one of claims 1 to 13 characterized in that the information zone of the lower layer contains information on the number of days of taking for which the calendar medication blister pack is designed.
15. The pack according to any one of claims 1 to 14 characterized in that the outer side of the opening tab is additionally marked with information on the contained medications, a visual representation of the contained medications, the day and time of taking the medications, the quantity and composition of the contained medications.
16. The pack according to any one of claims 1 to 15 characterized in that the special graphic code is a QR code, or a bar code, or a DataMatrix code, or an alphanumeric sequence, or a code with special protection against counterfeiting.
17. The pack according to claim 16 characterized in that the code with special protection against counterfeiting is a code with integrated security elements.
18. The pack according to any one of claims 1-17 characterized in that the authorization link is a direct link that includes a unique identifier of the calendar blister pack in open form, or an indirect link that includes an encrypted or open unique identifier of the calendar blister pack, which leads to a redirect server and is formed to collect information on the hardware of the user terminal, request additional user data including meta or direct data on the operating system of the user terminal, geodata and system settings.
19. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of hypertension in patients with a high and very high risk of cardiovascular complications.
20. The pack according to claim 19 characterized in that it includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers)/CCBs (Calcium Channel Blockers)/Diuretic, Acetylsalicylic acid and Statin.
21. The pack according to claim 19 characterized in that the fixed dose of ARBs/CCBs/Diuretic is Olmesartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Olmesartan (40 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (320 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (160 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), orLosartan (50 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Losartan (100 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Eprosartan (600 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Eprosartan (600 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (150 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (300 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Candesartan (8 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Candesartan (16 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Telmisartan (80 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Telmisartan (80 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (80 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Fimasartan (60 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Fimasartan (60 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg).
22. The pack according to any one of claims 20 to 21 characterized in that the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg).
23. The pack according to any one of claims 20 to 22 characterized in that the fixed dose of Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
24. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of uncomplicated hypertension in patients with high and very high risk of cardiovascular complications.
25. The pack according to claim 24 characterized in that it includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers)/Diuretic, Acetylsalicylic acid and Statin.
26. The pack according to claim 25 characterized in that the fixed dose of
ARBs/Diuretic is Losartan (50 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Losartan (100 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (160 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Valsartan (320 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Eprosartan (600 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Eprosartan (600 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (150 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Irbesartan (300 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Candesartan (8 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Candesartan (16 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Telmisartan (80 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Telmisartan (80 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Olmesartan (20 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Olmesartan (40 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (40 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Azilsartan (80 mg) and
Hydrochlorothiazide (HCTZ) (25 mg), or Fimasartan (60 mg) and
Hydrochlorothiazide (HCTZ) (12.5 mg), or Fimasartan (120 mg) and
Hydrochlorothiazide (HCTZ) (25 mg).
27. The pack according to any one of claims 24 to 26 characterized in that the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide
(15.2 mg).
28. The pack according to any one of claims 24 to 27 characterized in that the fixed dose of the Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
29. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the prevention of atherosclerotic cardiovascular disease (ASCVD).
30. The pack according to claim 29 characterized in that it includes two fixed-dose combinations: Statin and Acetylsalicylic acid.
31. The pack according to claim 30 characterized in that the fixed dose of the Statin is Atorvastatin (20 mg), or Atorvastatin (40 mg), or Rosuvastatin (10 mg), or Rosuvastatin (20 mg).
32. The pack according to any one of claims 30 to 31 characterized in that the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg).
33. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of uncomplicated resistant hypertension.
34. The pack according to claim 33 characterized in that it includes two fixed-dose combinations of ARBs (Angiotensin Receptor Blockers)/CCBs (Calcium Channel Blockers)/Diuretic and MRAs (Mineralocorticoid Receptor Antagonists).
35. The pack according to claim 34 characterized in that the fixed dose of ARBs/CCBs/Diuretic is Olmesartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Olmesartan (40 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (320 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Valsartan (160 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Losartan (50 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Losartan (100 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Eprosartan (600 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Eprosartan (600 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (150 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Irbesartan (300 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Candesartan (8 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Candesartan (16 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Telmisartan (80 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Telmisartan (80 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (40 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Azilsartan (80 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Fimasartan (60 mg) and Amlodipine (10 mg) and Hydrochlorothiazide (HCTZ) (25 mg), or Fimasartan (60 mg) and Amlodipine (5 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg).
36. The pack according to any one of claims 34 to 35 characterized in that the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
37. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD) and/or chronic kidney disease (CKD).
38. The pack according to claim 37 characterized in that it includes three fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitor/Diuretic, CCBs (Calcium Channel Blockers) and MRAs (Mineralocorticoid Receptor Antagonists).
39. The pack according to claim 38 characterized in that the fixed dose of the ACE Inhibitor/Diuretic is Lisinopril (20 mg) and Hydrochlorothiazide (HCTZ) (12.5 mg), or Lisinopril (20 mg) and Hydrochlorothiazide (HCTZ) (25 mg).
40. The pack according to any one of claims 38 to 39 characterized in that the fixed dose of CCBs is Amlodipine (5 mg).
41. The pack according to any one of claims 38 to 40 characterized in that the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
42. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD).
43. The pack according to claim 42 characterized in that it includes three fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), 0-blocker/Diuretic and MRAs (Mineralocorticoid Receptor Antagonists).
44. The pack according to claim 43 characterized in that the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg), or Fimasartan (120 mg).
45. The pack according to any of the claims 43 to 44 characterized in that the fixed dose of the -bloeker/Diuretic is Bisoprolol (5 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg), or Bisoprolol (10 mg) and Hydrochlorothiazide (GHTZ) (6.25 mg).
46. The pack according to any one of claims 43 to 45 characterized in that the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
47. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of resistant hypertension accompanied by coronary heart disease (CHD) with a high risk of complications.
48. The pack according to claim 47 characterized in that it includes three fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitors, 0- blocker/Diuretic and MRAs (Mineralocorticoid Receptor Antagonists).
49. The pack according to claim 48 characterized in that the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg).
50. The pack according to any of the claims 48 to 49 characterized in that the fixed dose of the 0-blocker/Diuretic is Bisoprolol (5 mg) and Hydrochlorothiazide (HCTZ) (6.25 mg), or Bisoprolol (10 mg) and Hydrochlorothiazide (GHTZ) (6.25 mg).
51. The pack according to any one of claims 48 to 50 characterized in that the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
52. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction.
53. The pack according to claim 52 characterized in that it includes five fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitors, 0-blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin.
54. The pack according to claim 53 characterized in that the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg).
55. The pack according to any one of claims 53 to 54 characterized in that the fixed dose of the 0-blocker is Metoprolol Ext. release (25 mg).
56. The pack according to any one of claims 53 to 55 characterized in that the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg).
57. The pack according to any one of claims 53 to 56 characterized in that the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
58. The pack according to any one of claims 53 to 57 characterized in that the fixed dose Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
59. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction in patients, which do not tolerate ACE inhibition.
60. The pack according to claim 59 characterized in that it includes five fixed-dose combinations: Angiotensin Receptor-Neprilysin Inhibitors (ARNIs), P-blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin.
61. The pack according to claim 60 characterized in that the fixed dose of the Angiotensin Receptor-Neprilysin Inhibitors (ARNIs) is Sacubitril (24 mg) and
Valsartan (26 mg), or Sacubitril (49 mg) and Valsartan (51 mg), or Sacubitril (97 mg) and Valsartan (103 mg).
62. The pack according to any one of claims 60 to 61 characterized in that the fixed dose of the p-blocker is Metoprolol Ext. release (25 mg).
63. The pack according to any one of claims 60 to 62 characterized in that the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg).
64. The pack according to any one of claims 60 to 63 characterized in that the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
65. The pack according to any one of claims 60 to 64 characterized in that the fixed dose of the Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
66. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of chronic coronary syndromes (CCS) with symptomatic heart failure (HF) due to ischemic cardiomyopathy and left ventricular (LV) systolic dysfunction in the specified conditions.
67. The pack according to claim 66 characterized in that it includes five fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), P-blocker, Diuretic, MRAs (Mineralocorticoid Receptor Antagonists) and Statin.
68. The pack according to claim 67 characterized in that the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg), or Fimasartan (120 mg).
69. The pack according to any one of claims 67 to 68 characterized in that the fixed dose of the P-blocker is Metoprolol Ext. release (25 mg).
70. The pack according to any one of claims 67 to 69 characterized in that the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg).
71. The pack according to any one of claims 67 to 70 characterized in that the fixed dose of MRAs is Spironolactone (25 mg) or Spironolactone (50 mg).
72. The pack according to any one of claims 67 to 71 characterized in that the fixed dose Statin is Atorvastatin (20 mg) or Atorvastatin (40 mg).
73. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of chronic coronary syndrome in the presence of type 2 diabetes and hypertensive heart disease with a high risk of complications.
74. The pack according to claim 73 characterized in that it includes four fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitor, Diuretic, Statin and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor.
75. The pack according to claim 74 characterized in that the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg).
76. The pack according to any one of claims 74 to 75 characterized in that the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg).
77. The pack according to any one of claims 74 to 76 characterized in that the fixed dose of the Statin is Rosuvastatin (10 mg) or Rosuvastatin (20 mg).
78. The pack according to any one of claims 74 to 77 characterized in that the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
79. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of chronic coronary syndrome in the presence of type 2 diabetes and hypertensive heart disease.
80. The pack according to claim 79 characterized in that it includes four fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), Diuretic, Statin, and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor.
81. The pack according to claim 80 characterized in that the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg), or Fimasartan (120 mg).
82. The pack according to any one of claims 80 to 81 characterized in that the fixed dose of the Diuretic is Hydrochlorothiazide (HCTZ) (25 mg).
83. The pack according to any one of claims 80 to 82 characterized in that the fixed dose of the Statin is Rosuvastatin (10 mg) or Rosuvastatin (20 mg).
84. The pack according to any one of claims 80 to 83 characterized in that the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
85. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of heart failure in the presence of type 2 diabetes, CHD (coronary heart disease) with a high risk of complications.
86. The pack according to claim 85 characterized in that it includes four fixed-dose combinations: ACE (Angiotensin-Converting Enzyme) Inhibitor, p-blocker, Acetylsalicylic Acid and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor.
87. The pack according to claim 86 characterized in that the fixed dose of the ACE Inhibitor is Lisinopril (10 mg), or Lisinopril (20 mg), or Lisinopril (40 mg).
88. The pack according to any one of claims 86 to 87 characterized in that the fixed dose of the P-blocker is Metoprolol Ext. release (25 mg).
89. The pack according to any of the claims 86 to 88 characterized in that the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium hydroxide (15.2 mg).
90. The pack according to any one of claims 86 to 89 characterized in that the fixed dose of the SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
91. The pack according to any one of claims 1 to 18 characterized in that it contains medications for the treatment of heart failure in the presence of type 2 diabetes, CHD (coronary heart disease).
92. The pack according to claim 91 characterized in that it includes four fixed-dose combinations: ARBs (Angiotensin Receptor Blockers), p-blocker, Acetylsalicylic Acid and SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor.
93. The pack according to claim 92 characterized in that the fixed dose of ARBs is Losartan (50 mg), or Losartan (100 mg), or Valsartan (80 mg), or Valsartan (160 mg), or Eprosartan (600 mg), or Irbesartan (150 mg), or Irbesartan (300 mg), or Candesartan (8 mg), or Candesartan (16 mg), or Telmisartan (80 mg), or Olmesartan (20 mg), or Olmesartan (40 mg), or Azilsartan (40 mg), or Azilsartan (80 mg), or Fimasartan (60 mg), or Fimasartan (120 mg).
94. The pack according to any one of claims 92 to 93 characterized in that the fixed dose of the P-blocker is Metoprolol Ext. release (25 mg).
95. The pack according to any one of claims 92 to 94 characterized in that the fixed dose of Acetylsalicylic acid is Acetylsalicylic acid (75 mg) and Magnesium Hydroxide (15.2 mg), or Acetylsalicylic acid (81 mg) and Magnesium Hydroxide (15.2 mg).
96. The pack according to any one of claims 92 to 95 characterized in that the fixed dose of SGLT2 (Sodium-Glucose Cotransporter 2) Inhibitor is Empagliflozin (10 mg) or Empagliflozin (25 mg).
97. A method of use of a calendar medication blister pack characterized in that it includes the steps where:
- using the user terminal, the open special graphic code applied on the information zone of the calendar blister pack is scanned, using the authorization link the user being authorized on a user authentication server by the unique identifier of the calendar blister pack, for this purpose using the authorization link a user authorization request is sent to the redirect server, on the redirect server, the unique identifier of the calendar blister pack is extracted from the authorization link, the validity of the unique identifier of the calendar blister pack is verified and the user authorization parameters are stored on the redirect server, on the redirect server, a request is sent to the logic server and it is verified whether such unique identifier of the calendar blister pack has previously been registered, wherein in the event that such unique identifier of the calendar blister pack has already been registered previously, the user is offered to perform authentication and on the user authentication server the entered user’ s authentication data are verified with the user’ s authentication data stored in the user database, in the event that such unique identifier of the calendar blister pack has not been registered previously, the user is offered to carry out registration and authentication on the user authentication server and the user’s authentication data are stored in the user database, - using the unique identifier of the calendar blister pack, the identification data of the calendar blister pack are verified in the blister pack database and the originality of its origin is verified, and
- in the case of a successful verification, the user terminal is provided with access to the content database and consumer information on the calendar blister pack is provided, and in the case of an unsuccessful verification a message about the impossibility of using the calendar blister pack is sent to the user terminal and a corresponding entry is made in the blister pack database, or a message with a warning that an unverified calendar blister pack is being used is sent to the user terminal, and a corresponding entry is made in the blister pack database, - the opening tab of the dosing section of the calendar blister pack is open and the access to the hidden special graphic code is granted,
- using the user terminal, the hidden special graphic code is scanned, from which, using the logic server, the unique identifier of the dosing section is extracted, the medications of the open dosing section are identified and an entry that a single taking medications of the dosing section has been carried out is made in the blister pack database, wherein using the logic server, a message with the rules for taking identified medications of the dosing section is sent to the user terminal and it is offered to confirm, using the user terminal, compliance of taking identified medications by the user with the sent rules for taking,
- in the event that the user takes the identified medications that may cause undesirable side effects or reactions, a message about such undesirable side effects or reactions is additionally sent from the logic server to the user terminal, following sending a mandatory confirmation from the user terminal to the logic server that the user has familiarized with a message, and
- in the event that the user takes the identified medications with special restrictions on taking, a message about the need to observe the established restrictions is additionally sent from the logic server to the user terminal, following sending a mandatory confirmation from the user terminal to the logic server that the user has familiarized with the message,
- in the case of disruption of the medication schedule and/or opening of the wrong taking section, using the logic server, a corresponding message and recommendations regarding further actions are sent to the user terminal, and the medication schedule is adjusted,
- in the case of repeated disruption of the medication schedule and/or lack of confirmation from the user terminal regarding a single taking medications of the taking section, the logic server sends a message about the event to the terminal of the user’s trusted persons and/or the terminal of the user’s doctor.
98. The method according to claim 97 characterized in that the terminals of the user, the user’s trusted persons and the user’s doctor are a telephone, a smartphone, a personal computer, a smart watch.
99. The method according to any one of claims 97 to 98 characterized in that the user’s authentication data include the user’s personal data, a cache of electronic medical records and the data on existing electronic prescriptions associated with the user.
100. The method according to any one of claims 97 to 99 characterized in that the user authorization parameters include data on the user terminal, the user’s location, the current authorization time, the software used, the user’s ID.
101. The method according to any one of claims 97 to 100 characterized in that the identification data of the calendar blister pack includes data on the composition, date of manufacture and expiration date of the calendar blister pack.
102. The method according to any one of claims 97 to 101 characterized in that upon scanning the open special graphic code, its authenticity is additionally verified using the service of validation of special graphic codes.
103. The method according to any one of claims 97 to 102 characterized in that upon authorization of the user on the user authentication server, the user is additionally authorized in the medical information system, for this purpose the user’s phone number and/or e-mail is requested and an SMS message and/or an e-mail with an authorization code and/or an authorization link is sent, the authorization code for entering the system is entered and/or the authorization link for entering the system is followed, using the logic server, the connection with the server of the medical information system is established and the data associated with the user’s electronic medical records and the data on the user’s active and redeemed electronic prescriptions are retrieved.
104. The method according to any one of claims 97 to 102 characterized in that upon authorization of the user on the user authentication server, the user is additionally authorized in the medical information system, for this purpose the user is provided with a terminal in a graphical form or an interface for authorization, user authorization is carried out by any acceptable method of authorization, using the logic server, the connection with the server of the medical information system is established and the data associated with the user’s electronic medical records and the data on the user’s active and redeemed electronic prescriptions are retrieved.
105. The method according to any one of claims 97 to 104 characterized in that during the first scanning of the open special graphic code, the user is offered to install a mobile application on the user terminal or to use a web version of an application.
106. The method according to any one of claims 97 to 102 characterized in that the consumer information on the calendar blister pack includes information on the appearance and contents of the calendar blister pack, text and/or multimedia content, instructions for use and medication taking programs.
107. The method according to claim 106 characterized in that the information on the appearance of the calendar blister pack includes a 3D model of its appearance, with the possibility of changing the viewing point.
108. The method according to any one of claims 97-107 characterized in that the consumer information on the calendar blister pack is provided in a mobile application or in a web application.
109. The method according to any one of claims 97 to 108 characterized in that the verification of identification data of the calendar blister pack in the blister pack database includes the verification of the expiration date of the calendar blister pack, the verification of the region of origin, the verification of reusability of the calendar blister pack.
110. The method according to any of clauses 97 to 109 characterized in that a mandatory confirmation of the user’s familiarization with the message is carried out in the form of "question-answer".
111. The method according to any one of claims 97 to 110 characterized in that the special restrictions on taking are the restrictions indicated by the manufacturer of medications in the instructions.
112. The method according to claim 111 characterized in that the special restrictions on taking are the prohibition of driving vehicles and mechanisms, the prohibition of consuming food and/or alcoholic beverages, the need to drink liquid after taking a medication.
113. The method according to any one of claims 97 to 112 characterized in that for adjusting the medication schedule, steps are carried out where - using the logic server, the patient’s actual medication schedule is compared with the established medication schedule,
- in the case of detection of discrepancies, using the logic server, the degree of disruption of the medication schedule is classified on the basis of possible side effects and risks contained in the content database and associated with each medication contained in the calendar blister pack and their combination,
- using the logic server, messages about possible risks and taking the necessary measures are sent to the user terminal,
- the further medication schedule is changed based on the data on the medications contained in the calendar blister pack.
114. The method according to any one of claims 97 to 112 characterized in that it additionally includes the steps where using the user terminal, the appearance of the calendar blister pack is scanned in the form of a digital image and it is transferred to the visual recognition service, using the visual recognition service, recognition and analysis of the digital image is carried out based on machine vision algorithms, the open and unopen dosing sections of the calendar blister pack are identified and using the logic server, the additional automated verification of compliance of taking identified medications by the user with the sent rules for taking is carried out.
115. An electronic system of management of interaction with a calendar medication blister pack characterized in that it includes:
- a logic server that includes a blister pack database, a user database, a content database and an interface for interaction with a server of the medical information system and an interface for interaction with external services, the logic server being configured to verify the unique identifier of the calendar blister pack, extract the unique identifier of the taking section, identify medications of the open dosing section and make an entry in the blister pack database that a single taking medications of the dosing section has been carried out, send messages to the user terminal, the terminal of the user’s trusted persons and the terminal of the user’s doctor, establish a connection with the server of the medical information system and receive the data associated with the user’s electronic medical records and the data on the user’s active and redeemed electronic prescriptions, adjust the medication schedule based on data on the user’s actual medication schedule,
- a redirect server connected to the logic server and configured to receive a user authorization request using an authorization link, extract the unique identifier of the calendar blister pack from the authorization link, verify the validity of the unique identifier of the calendar blister pack and store the user authorization parameters, send a request to the logic server and verify whether the unique identifier of the calendar blister pack has previously been registered,
- a user authentication server containing a user database, connected to the logic server and configured to carry out authorization and registration of users verify the entered the user’s authentication data with the user’s authentication data stored in the user database, save the user’s authentication data in the user database, carry out the user’s authorization in the medical information system, -the service of validation of special graphic codes connected to the logic server and configured to verify the authenticity of the open special graphic code upon its scanning,
- at least one user terminal configured to install a mobile application and/or use a web version of an application scan the open special graphic code and the hidden special graphic code, receive and send messages from/to the logic server, confirm compliance with taking identified medications,
- at least one terminal of the user’s trusted persons and at least one terminal of the user’s doctor configured to receive event notifications from the logic server.
116. The system according to claim 115 characterized in that the terminals of the user, the user’s trusted persons and the user’s doctor are a phone, a smartphone, a personal computer, a smart watch.
117. The system according to any one of claims 115 to 116 characterized in that the user authentication server is additionally configured to authorize the users in the medical information system.
118. The system according to any one of claims 115 to 117 characterized in that it additionally contains a visual recognition service configured to make recognition and analysis of a digital image based on machine vision algorithms, identify open and unopen dosing sections of the calendar blister pack.
119. The system according to any one of claims 115-118 characterized in that the logic server additionally includes an analytics database configured to store information associated with the data on the calendar blister pack, the user terminal, the user location, the current authorization time, the software used, the user’s ID and the medication schedule.
120. The system according to any one of claims 115 to 119 characterized in that it additionally includes a server of partner programs configured to interact with external partner services and a web application for creating, editing and monitoring the passage of partner motivational programs.
121. The system according to claim 120 characterized in that the server of partner programs includes a database of partners and motivational programs configured to store information on partners and motivational programs.
122. The system according to any one of claims 115 to 121 characterized in that the medical information system is a state and/or commercial medical information system.
EP24729115.6A 2023-04-13 2024-04-12 Calendar medication blister pack, method of using thereof and electronic system of management of interaction with calendar medication blister pack Pending EP4694856A1 (en)

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PCT/UA2024/000024 WO2024215297A1 (en) 2023-04-13 2024-04-12 Calendar medication blister pack, method of using thereof and electronic system of management of interaction with calendar medication blister pack

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KR20120072109A (en) 2010-12-23 2012-07-03 한국전자통신연구원 System and method for managing medication
CA2776111C (en) * 2012-04-26 2019-02-05 Michel Bouthiette Sealing sheet for use to close a container-defining sheet
US20150347712A1 (en) * 2014-05-27 2015-12-03 Amerisourcebergen Specialty Group, Inc. System and method for product distribution and tracking
US20160147976A1 (en) * 2014-11-26 2016-05-26 RxAdvance Corporation Medication Identification, Tracking And Adherence Management
GB2536966A (en) * 2015-04-02 2016-10-05 Teva Nederland Bv Pharmaceutical packaging
GB201810882D0 (en) 2018-07-03 2018-08-15 Tenac Phillip John Blister pack station
GB201810881D0 (en) 2018-07-03 2018-08-15 Tenac Phillip John Smart medication blister pack
US12133830B2 (en) * 2019-02-15 2024-11-05 Sailendra Upendram Pharmaceutical container and method
UA124828C2 (en) 2020-11-16 2021-11-24 Товариство З Обмеженою Відповідальністю "Астум" METHOD OF PATIENT SUPPORT AUTOMATIC ELECTRON prescription for prescription medicines, the method automatically obtain prescription drugs with a unique email id recipes WAY Automatic delivery of prescription medicines the patient with a unique email id recipes and information system electronic recipe

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