阅读说明：本技术 对患者重复服用药物的支持 (Support for repeated administration of medication to a patient ) 是由 H.特吕贝尔 P.P.伯梅 M.范艾克尔斯 W.丁 F.克拉默 C.卡斯特龙 于 2018-03-16 设计创作，主要内容包括：本发明涉及在治疗处置的范围中在患者重复服用药物时给予支持的技术领域。本发明的主题是一种方法、一种系统和一种计算机程序产品,它们监视患者服用药物并且在应当禁止服用药物部分时通知患者或医师或其他人,以从而优化所述处置的有效性或降低风险。(The invention relates to the technical field of providing support in the context of therapeutic treatment when a patient takes a drug repeatedly. The subject of the invention is a method, a system and a computer program product that monitors the patient taking medication and informs the patient or a physician or other person when the taking of a medication fraction should be prohibited, to thereby optimize the effectiveness of the treatment or reduce the risk.)

1. A method comprising the steps of:

automatically monitoring the patient for repeated administrations of the medication,

recording events that cause the administration of the medication to result in adverse consequences,

determining a break-off time after which the medication should not be taken anymore due to the adverse consequence,

recording attempted or completed administration of the medication after the suspension time,

in case of attempted administration: communicating a warning to the patient that the medication should not be taken,

in case of complete administration: communicating a notification to the patient and/or others related to the event regarding the completion of the administration.

2. The method of claim 1, wherein the monitoring unit records

When a preparation for taking the pharmaceutical portion is to take place, and/or

-when the patient actually takes a medication portion.

3. The method according to any of claims 1 or 2, wherein the patient carries the monitoring unit as a mobile device or an integral part of a mobile device together with a medication portion to improve adherence.

4. The method according to any one of claims 1 to 3, wherein the event is an event planned for the future and the suspension time is temporally located before or coincides with the time of the event planned for the future.

5. The method of any of claims 1-4, wherein the suspension time instant is calculated according to the following equation:

the suspension time = time of the planned future time-the expiration of the drug part.

6. The method of any one of claims 1 to 5, wherein the event is a medical intervention into the patient's body, the intervention being associated with bleeding or a bleeding risk, and the drug is an anticoagulant or an inhibitor of platelet function.

7. The method according to any one of claims 1 to 6, wherein the actual taking is recorded and the planned event for the future is postponed or cancelled due to the taking, or measures are taken to prevent or reduce or compensate for the effect of the drug present at the moment of the event.

8. The method according to any one of claims 1 to 7, wherein the event is characterized by a parameter within the body of the patient or within a body product of the patient taking a defined value or reaching a value above or below a threshold value.

9. A system comprising

Apparatus for automatically monitoring repeated administrations of a drug by a patient,

means for recording events that cause the administration of said medication to result in adverse consequences,

means for determining a break time after which the medication should no longer be taken due to the adverse outcome,

means for recording attempted or completed administrations of the medication after the suspension moment,

means for communicating an alert to the patient that the medication should not be taken and/or a notification to the patient and/or others related to the event that the taking is complete.

10. The system of claim 9, comprising a monitoring unit and a computer unit,

wherein the monitoring unit is configured such that it identifies an intake attempt or an actual intake of a medication portion by a person and transmits information about the intake attempt or the actual intake to the computer unit,

wherein the computer unit is configured such that it receives information about the intake attempt or the actual intake from the monitoring unit and transmits a signal to a user of the computer unit if the intake attempt or the actual intake time is completed after the suspension moment in time.

11. The system of claim 10, wherein the monitoring unit and the computer unit are two separate mobile devices.

12. The system of claim 11, wherein the monitoring unit and the computer unit are two components of a unique mobile device.

13. The system according to any one of claims 10 to 12, further comprising a sensor that measures a parameter in or on the body of the patient and/or measures a parameter in a body product and is configured such that the sensor transmits the measurement to the monitoring unit or the computer unit.

14. System according to any of claims 10 to 13, characterized in that the system has a blocking function which is activated as soon as an intake attempt after the suspension moment is recorded, wherein the blocking function prevents the removal of the medication portion by the person.

15. A computer program product comprising a data carrier and program code stored on the data carrier, which program code is loaded into a working memory of a computer unit and which program code causes the computer unit to carry out the following steps:

receiving an event time for an event that causes the taking of the medication to result in an adverse outcome,

determining a break-off time from which the medication should no longer be taken due to the adverse consequence,

recording patient attempts to take or complete the taking of the portion of the medication,

communicating an alert to the patient that the medication portion should not be taken and/or communicating a notification to others related to the event that the taking is complete.

Technical Field

The invention relates to the technical field of supporting patients in the context of therapeutic treatment when repeatedly taking medication. The subject of the invention is a method, a system and a computer program product that monitors the taking of a medication by a patient and informs the patient or a physician or other person when the taking of a medication portion should be prohibited, in order to thereby optimize the effectiveness of the treatment or reduce the risk.

Background

Many people have to take medication for long periods of time or for a prolonged period of time.

For example, patients suffering from heart diseases (e.g. in the case of prosthetic heart valve replacements, heart malformations, cardiac arrhythmias, cardiac insufficiency) and patients with recurrent thrombosis and pulmonary embolism should receive long-term anticoagulant therapy, also colloquially referred to as "hemodilution".

Adherence refers to the extent to which a person's behavior in terms of taking medication, diet maintenance and/or lifestyle changes is consistent with the negotiated recommendations of the medical handler.

There are various methods of determining adherence, which are used in clinical studies and for therapy control. They can be classified into direct methods and indirect methods. Examples of direct methods are: direct observation (taking, e.g. by a physician), measurement of drug concentration in body fluids and measurement of marker substances in blood, urine or exhaled air. Examples of indirect methods are: medication consumption measurements ("pill counts"), patient diaries, and electronic monitoring.

Patient surveys are the most common method for determining adherence. However, patients clearly overestimate their adherence and the longer time period of the description quickly becomes inaccurate. More accurate values can be achieved by determining the drug in the blood. However, this method is costly and can only draw conclusions about the time period during which the administered substance has not been metabolized or excreted.

The device for electronic monitoring is also summarized under the term "MEMS (pharmaceutical event monitoring system)". There are various MEMS on the market. Such as the "Helping Hand" of Bang & Olufsen Medicom and the smartphone application of AiCure, for visually confirming the administration of the medication portion by means of a camera built into the smartphone.

These systems on the market give support when the patient repeatedly takes portions of the medication according to the respective treatment.

However, there may be events in which the otherwise repeatedly administered medication should not be taken, and continued administration may even be life threatening for the patient. For example, surgery or similar interventional intervention (e.g., biopsy, puncture, etc.) is performed on a patient treated with an anticoagulant or platelet inhibitor. In this case, the risk of a higher bleeding tendency must be taken care not only in the surgical intervention but also in the choice of anesthesia methods (e.g. local methods in the vicinity of the spinal cord).

Therefore, there is a need to remind patients not only to take medication portions on a regular basis, but also to support patients in the event of a planned event in which taking medication portions conflicts with an effective treatment or represents a risk.

Disclosure of Invention

This technical task is solved by the subject matter of the independent claims 1, 10 and 15. Preferred embodiments can be found in the dependent claims and in the present description.

A first subject of the invention is therefore a method comprising the following steps:

automatic monitoring of repeated patient administrations of drugs

Recording events that cause the taking of said drugs to lead to adverse consequences

Determining a break moment after which the medication should not be taken any more due to the adverse consequence

Recording the attempted or completed administration of the drug after the suspension moment

In case of attempted administration: communicating to the patient a warning that the medication should not be taken

Upon completion of the administration: communicating a notification to the patient and/or others related to the event regarding completion of the taking.

Another subject of the invention is a system comprising:

device for automatically monitoring repeated administration of medication to a patient

Means for recording events causing adverse consequences for the administration of said drugs

Means for determining a break moment after which the medication should not be taken any more due to the adverse consequence

Means for recording attempted or completed administration of said medicament after said suspension moment

Means for transmitting an alert to the patient that the medication should not be taken and/or a notification to the patient and/or others related to the event that the taking is complete.

A further subject matter of the invention is a computer program product comprising a data carrier and a program code stored on the data carrier, which program code is loaded into a working memory of a computer unit and which program code causes the computer unit to carry out the following steps:

receiving an event moment for an event causing the taking of a drug to cause an adverse outcome

Determining a break moment from which no further administration of the drug should be performed due to the adverse consequence

Recording patient attempts to take or complete taking of the portion of the medication

Transmitting an alert to the patient that the medication portion should not be taken and/or transmitting a notification to the patient and/or others related to the event that the taking is complete.

The present invention is explained in more detail below without distinguishing between the inventive subject matter (method, system, computer program product). Rather, the following explanations should apply in a similar manner to all subject matter of the present disclosure, regardless of the context (method, system, computer program product) in which they are implemented.

If steps are mentioned in this specification or claims in a certain order, this does not necessarily mean that the invention is limited to the order mentioned. But it is contemplated that these steps may also be performed in a different order or in parallel with each other; this necessitates subsequent execution of dependent steps unless one step builds on another (although this will be apparent in individual cases). The mentioned sequence therefore represents a preferred embodiment of the method according to the invention.

The invention is mainly used for patients who take medicines repeatedly. The term "repeated administration" is to be understood as meaning that the patient, within the scope of the therapeutic or prophylactic measure, must take the drug over a period of time, which typically lasts for days, weeks, months or even years. It can be said that there is a repeated administration within the meaning of the present invention if the patient has to take more than five, preferably more than ten, particularly preferably more than twenty medicament portions of a particular medicament at different times. The administration of these drug portions may be done periodically or aperiodically. Typically, administration is done periodically, which means at regular intervals.

By drug is meant a substance or mixture of substances that achieves a therapeutic effect. Synonymous with the term "drug" is the term "Medikant" (drug).

The term "taking" should not be construed restrictively as it only means oral administration of a drug. Rather, the term "administered" shall encompass every application form contemplated, such as otic, buccal, inhaled, intra-arterial, intra-articular, intra-gluteal, intradermal, intramuscular, intraocular, intrauterine, intravenous, intravitreal, intranasal, transdermal, rectal, sublingual, subcutaneous, topical, transdermal, vaginal, and the like. Preferably, the medicament is self-administered by the patient; that is, no specialist knowledge is required to administer the drug to the patient. The medicament is preferably a medicament orally taken by said patient.

Typically, the drug is in the form of a defined portion, wherein the patient should take a defined amount (one portion, two portions, half portions, etc.) at a defined time or within a defined time interval.

The medicament may be in solid form (e.g. in the form of a tablet) or in liquid form (e.g. in the form of a juice) or in gaseous form or in mixed form (e.g. as a gel capsule or aerosol or ointment). It may be a pure substance, a solid mixture, a solution, a suspension (e.g., an emulsion or aerosol), etc.

In a particularly preferred embodiment, the drug is an anticoagulant or an inhibitor of platelet function.

Examples of anticoagulants are, for example, rivaroxaban, dabigatran, apixaban, edoxaban, coumarins (e.g., coumarins, warfarin), heparins (e.g., dalteparin sodium, enoxaparin, tinzaparin, fondaparinux, etc.), factor XIa, and factor XI inhibitors.

Examples of platelet function inhibitors are aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, eligrelor, abciximab, eptifibatide, tirofiban, vorapasha, atoxa, tissue factor pathway inhibitors, NAPc 2.

The first step of the method according to the invention is to automatically monitor the patient's repeated administration of the medication. In this case, the term "monitoring the administration" means controlling whether the patient has at least taken preventive measures to take the medication portion and/or whether the patient has actually taken the medication portion.

The progress of the administration is monitored to improve adherence. By "adherence" is meant the extent to which the patient's behavior in taking medication complies with recommendations negotiated with the attending physician.

The term "automatic monitoring" means that support is provided by a technical monitoring unit for drug handling (abbreviated MEMS = drug event monitoring system) when a patient takes a drug repeatedly. The monitoring unit is an integral part of the system according to the invention. The monitoring unit is preferably a portable device that the patient can carry around (e.g. in a trouser pocket or a purse).

The term "monitoring unit" is understood to mean any electronic system that identifies a person's attempt to take and/or actually take a portion of a medication.

The term "attempt to take" is to be understood as a measure taken by a person to prepare to take a pharmaceutical portion. A typical example is the removal of a pharmaceutical part from a package, for example the removal of a tablet from a blister pack.

It is conceivable that the provision of the medication portion is not made by the patient himself, but for example by a physician or a care-giver or a relative. It is irrelevant for the invention whether the preparation is carried out by the patient himself or by someone else; the present invention should detect all of these possibilities. For reasons of simplicity of presentation, the invention will be described mainly based on the first option (the patient takes the preparatory measures), but it is not intended to limit the invention to this option.

In one embodiment of the invention, the monitoring unit records whether and when the patient is ready to remove a drug portion from the device for keeping the drug and/or whether and when the patient has removed a drug portion. It is contemplated that before the patient can remove the drug portion from the escrow device, the patient must be notified, for example, by pressing a button or by presenting a biometric (e.g., presenting a finger within the scope of fingerprint recognition to detect a fingerprint): the patient wants to remove the drug portion. In this case, the monitoring unit records the patient's action, which should result in the removal of the drug portion. It is also conceivable, however, for the monitoring unit to record the actual removal of the medicament portion. For example, it is conceivable to interrupt the electrically conductive conductor line by extruding a medicament portion from a blister pack; the interruption can be detected, for example, by electronic circuits (see, for example, WO9604881a1 or DE19516076a 1).

In another embodiment, the monitoring unit is implemented such that it records the actual taking of a medication portion by the patient. By way of example, mention may be made here of the abovementioned systems from AiCure, Inc. In the case of the AiCure system, the smartphone application tracks the actual taking of the medication portion by means of the camera of the smartphone. Image analysis and image recognition algorithms are responsible for identifying the drug portion and the patient's face. The patient is also identified as placing the drug moiety in the mouth and swallowing.

In a preferred embodiment, the monitoring unit is implemented such that it alerts the patient (or a caregiver or other person) of an impending drug portion taking; for example acoustically (e.g. by means of a tone or voice message), visually (e.g. by flashing of a light or text message) and/or tactilely (e.g. by means of vibration).

In a further step of the method according to the invention, an event is recorded. This event leads to adverse consequences for the administration of the drug. This means that there is reason to object to taking the drug at a time when it exhibits an effect that persists also at the time of the event.

It is contemplated that the administration of the drug portion is "incompatible" with the event. The action of the drug results in an effect that is "not matched to" the event or "not expected" in connection with the event.

Thus, under normal circumstances, the patient continues to take repeated doses of medication; however, due to the event, the patient should avoid (continue) taking the medication.

In a preferred embodiment, the event is an event planned for the future.

Preferably, the event is a medical intervention, particularly preferably a measure accompanying or possibly leading to bleeding.

In medicine, intervention refers to any aggressive form of treatment if one wants to distinguish it from mere waiting. This includes similar therapeutic and prophylactic measures. In a narrow sense, intervention means urgent and urgent intervention in the disease process.

Examples of interventions that may be related to bleeding are surgical interventions (surgery), punctures, biopsies, tooth extractions, catheter examinations and the like.

For example, it is conceivable that the effect of the drug represents an (increased) risk (e.g. a safety risk) for the event. For example, it is conceivable that the drug effects a "blood dilution" effect, whereas the event planned for the future is an invasive measure. By the "blood-diluting" action of the drug, the risk of bleeding that occurs during and/or after the invasive procedure and that may not be stopped or may be difficult to stop is increased.

However, it is also conceivable that the medication must be stopped periodically. Examples are contraceptives, which are typically taken on a 21 day cycle; administration will be suspended for a period of 7 days thereafter. Thus, the female patient should take the drug portion for up to 21 days, preferably also be reminded to take it. However, if the female patient attempts to continue taking the medication portion on day 22, such an attempt will be identified and corresponding action taken in accordance with the present invention.

It is also contemplated that the event is an effective level being reached in the patient. By "effective level" is understood the concentration of a drug in the body (or a defined body area) of a patient that is necessary to achieve the desired effect of the drug. It is contemplated that the effective level will be reached by repeated administration of the medicament. It is contemplated that the drug may or should be discontinued after the effective level is reached in order to reduce or avoid side effects. This measure is useful, for example, in the case of antibody therapy.

It is however also conceivable that the event occurs as a result of a parameter in the patient's body taking a defined value or reaching a value above or below a threshold value. The parameter may be, for example, the concentration of a drug within the body or within a region of the body; for example, the concentration of the drug in the blood or other body fluids. The parameter may also be a biomarker or other concentration of a substance measurable in the body or in bodily excretion products. The parameter may also be body temperature, blood pressure or other physiological parameter. Preferably, the parameter is measured on or in the patient's body or in a human body product (blood, saliva, urine, etc.) by means of a sensor.

In a further step of the method according to the invention, a pause time is determined. In a preferred embodiment of the invention, the pause instant is temporally preceding the (preferably future planned) event.

It is well known that drugs exhibit their effects over a period of time. After taking the drug, the effect of the drug will last for a certain period of time, which is usually patient specific.

The break moment is defined as the moment after which the medication should not be taken any more, in order to avoid an (undesired) effect of the medication at the moment of the event, or to ensure that the effect is below an allowable threshold.

It is conceivable to calculate the pause time by means of a validity period. In this case, for example, an average validity period or a security validity period may be used.

The expiration date usually begins with the administration of the drug. The average expiration date ends when, on average, the effect of the drug can no longer be observed/measured in the patient. The safety-effective period ends at a point where it can be assumed with a probability close to safety that the drug no longer exhibits an effect. However, it is also contemplated to define other validity periods; for example, it is contemplated that the expiration period may be defined as the period of time in which the concentration of the drug drops to a certain component (e.g., 1% or 5% or 10%, etc.) such as a maximum. The definition of the validity period thus involves first defining the pharmaceutical effect that can still be tolerated at the occurrence of the (preferably future planned) event. The time elapsed until the drug reaches a tolerable effect after the patient takes the drug is then measured.

The validity period can be determined, for example, in a clinical study.

Preferably, the suspension time is calculated by subtracting the validity period from an event time:

abort time = time of an event planned for the future-validity period.

In this case, the effect of the medication taken at the moment of suspension will decline over the period of validity and still have a tolerable effect at the moment of the event. The medication taken after the break moment still has the effect of exceeding the tolerance threshold at the moment of the event.

The validity period may be stored in a database. It is contemplated that a system according to the present invention can access such a database to determine the expiration date of the corresponding medication. It is conceivable that the system according to the invention has a storage unit in which the validity period is stored.

In a preferred embodiment, the expiration date is calculated for the respective patient based on patient-specific information. The calculation may be done at the time of recording an event planned for the future; but the calculation may also be done early or later. Said calculation can be done by means of the system according to the invention.

Patient-specific information that can be entered into the validity period calculation is for example sex, age, weight, height, blood values, genetic characteristics, etc.

It is contemplated that a pharmacokinetic metabolic model, such as PKSim (http:// www.systems-biological.com/products/pk-sim.html) may be used to calculate the patient-specific expiration date.

However, it is also conceivable for the pause time to coincide in time with the event time. For example, it is conceivable that the parameter in the patient reaches a defined value or assumes a value above or below a threshold value. This may be a triggering event for (at least temporarily) discontinuing the drug. Therefore, after this event time (= suspension time), the medication should not be taken any more.

In one embodiment of the invention, the system according to the invention records an attempt to take the medication portion after the suspension moment. A person (typically a patient, but also possibly a physician, caregiver or other person) takes action that typically causes the patient to take a medication portion. The person may e.g. remove a drug portion from the container, wherein the removal is recorded. It is also conceivable that the person must operate a switch or present a biometric feature in order to remove the medicament portion from the container. In this case, the operation of the switch or the presentation of the biometric feature is recorded as a removal attempt. The switch may also be a virtual switch on the display screen of the computer unit.

According to the invention, in response to said administration attempt, a warning is issued to prevent actual administration. The warning is typically directed to the person who has made the attempt to take the medication. However, it is also contemplated that one or more warnings may be issued to others or one or more others.

Such a warning may be audible (e.g. by means of a signal tone or voice message), visual (e.g. by means of a flashing light or text message) and/or tactile (e.g. by means of a vibration).

It is also contemplated that an electronic message (e-mail, SMS, etc.) indicating the administration attempt is sent to the physician or caregiver.

In one embodiment of the invention the system according to the invention records the actual administration of the medication portion after said suspension moment. According to the invention, a notification is transmitted in response to completion of the administration. The notification may be to the patient, physician and/or the caregiver and/or to others related to the event planned for the future. The notification may indicate that the patient has taken a medication portion after the suspension time. The scheduled event for the future may be cancelled or deferred in response to completion of the taking. It is also contemplated that cancellation or deferral may not be possible or desirable. The notification may then be used to take (other) measures to prevent or reduce or compensate for the effect caused by the (undesired) action of the drug at the planned future event moment.

The system according to the invention may be the only device; it is also contemplated that the functionality implemented by the system according to the invention may be distributed over two or more devices.

In one embodiment, there is a unique device. In the device according to the invention, the various functions necessary for implementing the invention are combined in a single device. The device has means for accommodating a plurality of medicament portions. The device may comprise, for example, a container in which a plurality of medicament portions may be filled. It is also contemplated that the device may accommodate replaceable containers (e.g., blister strips) for the medicament portions. The device according to the invention may have means to register the removal attempt or the actual removal of the drug portion. Alternatively, the device according to the invention may have means to record the actual administration of the medication portion by the patient. The device comprises a computer unit configured such that it can record the event, i.e. keep the date and, if necessary, the time of the event. It is conceivable, for example, that the device comprises a calendar function in which the time of the event can be entered. However, it is also conceivable for the device to be connected in communication with the sensor. It is conceivable that the sensor measures a parameter on or in the body of the patient and transmits the measured value to the device according to the invention. As soon as the transmitted measured value reaches a defined value or assumes a value above or below a defined threshold value, the computer unit records the corresponding event. A logged event typically includes the time of the event (event time) and information about what the event is. The computer unit is further configured such that it can determine, preferably calculate, a moment of suspension based on the event. If a person makes a taking attempt or an actual taking, the computer unit determines whether the taking attempt or the actual taking is completed before or after the suspension time. If the administration attempt or the actual administration time is completed after the suspension moment, the computer unit transmits a notification to the person that an administration attempt or an actual administration has been made. To this end, the device according to the invention has corresponding means, for example a display screen (for text or image messages), a lamp (for optical warning signals), a loudspeaker (for voice messages or warning sounds) and/or a vibrating alarm. The computer unit may also be configured such that it transmits notifications to another person or to others, e.g. e-mail or SMS or the like to a physician and/or a caregiver or the like.

It is also contemplated that the various functions necessary to implement the present invention may be distributed across multiple separate devices. For example, it is conceivable that a separate monitoring unit is present, which monitoring unit can maintain a communication connection with a separate computer unit. For example, it is conceivable that the monitoring unit is configured such that it can transmit information about the taking attempt or the actual taking to the separate computer unit (e.g. via bluetooth, ZigBee, mobile wireless network, etc.). In this case, the monitoring unit may be configured such that it communicates any attempt to take or any actual taking; however, it is also conceivable for the monitoring unit to transmit only the intake attempt or intake after the pause time. The separate computer unit, preferably embodied as a smartphone, a smart watch or a tablet computer, is configured such that it can receive information from the monitoring unit about a taking attempt or actual taking and can issue one or more notifications.

In addition, it is conceivable that the device or the monitoring unit according to the invention has a blocking function which is activated as soon as an administration attempt after the suspension moment is registered. The blocking function for example prevents the removal of the medicament portion in such a way that the blocking function for example prevents access to the container in which the medicament portion is stored.

The term "computer unit" or simply "computer" is preferably understood to mean a general-purpose program-controlled machine for processing information. The computer unit has at least one input unit via which data and control commands can be input (mouse, touch pad, keyboard, scanner, webcam, joystick, microphone, bar code reader, etc.), a processing unit comprising a working memory and a processor for processing data and commands, and an output unit (e.g. display screen, printer, loudspeaker, etc.) which transmits data from the system. Modern computers are generally divided into desktop computers, portable computers, laptop computers, notebook computers, netbook and tablet computers and so-called handheld devices (e.g. smart phones, smart watches).

Detailed Description

The invention is explained in more detail below on the basis of the figures and preferred embodiments, without however being restricted to these examples.

Fig. 1 schematically shows an embodiment of the system according to the invention.

The system (1) according to the invention comprises a monitoring unit (10), a device (20) for accommodating a drug portion and a computer unit (30).

Fig. 2 schematically shows another embodiment of the system according to the invention.

The system (1) according to the invention comprises two separate components. One component is a monitoring unit (10) and the other component is a computer unit (30). The monitoring unit (10) has a sensor unit (15) and a container (25) for accommodating the medicament portion. The sensor unit (15) is designed such that it registers a withdrawal and/or a withdrawal attempt of a medicament portion from the container (25) and transmits corresponding information about said withdrawal and/or said withdrawal attempt to the monitoring unit (30) via the transmitting unit (16). The monitoring unit (30) has a receiving unit (36), with which the monitoring unit (30) can receive the information from the transmitting unit (16).

Fig. 3 schematically shows another embodiment of the system according to the invention.

The monitoring unit (10) and the computer unit (30) are integrated in a single device (1) (according to the invention). With the monitoring unit (10), removal and/or removal attempts of the drug portions from the separate containers (25) may be detected.

Fig. 4 schematically shows an example of the structure of the computer unit of the system according to the invention, which system is shown schematically in fig. 1, 2 and 3.

The computer unit (30) comprises an input unit (35) with which a user can input data and control commands. The computer unit (30) comprises a processing unit (31) for processing data and control commands. The processing unit (31) has a working memory (32) and a processor (33). The processor (33) includes a control unit (33 a) and a calculation unit (33 b). The computer unit (30) also comprises an output unit (37) with which data can be output. The computer unit (30) further comprises a data memory (39), a receiving unit (36) which may be used for receiving signals and/or data from an external device, and a transmitting unit (39) which may be used for transmitting signals and/or data to an external device.

Fig. 5 shows an example of a system (1) according to the invention in which a computer unit, a monitoring unit and a container for containing a drug portion are integrated in a single device. The system (1) according to the invention is implemented as a portable handheld device. All components are housed in a housing (40). There is an interior space in the housing in which a medicament portion (not explicitly identified in fig. 5) may be stored. The drug portions can be individually removed through an opening closed by a lid (41). The lid (41) is moved upward to be opened. The system according to the invention has an output unit embodied as a display screen (42). In order to input data and control commands, buttons (43, 44) are used as input units. A calendar (45) is schematically shown on the display screen (42). An event (46) is entered in a calendar (45) that causes the taking of the medication to result in an adverse outcome. However, it is also possible that the event (46) entered in the calendar (45) is a pause time from which the medication should no longer be taken.

The following may be considered:

-the user repeatedly takes medication portions using the system (1) according to the invention.

-the user has entered in a calendar (45) by means of a button (43, 44) an event (46) that causes the taking of the medication to be of adverse consequence.

The system according to the invention is configured such that it calculates a suspension moment from which the user should not take any more medication portions due to an upcoming event.

The system according to the invention is configured such that it records administration attempts.

-if the administration attempt is completed after the suspension moment and before the event, displaying a warning prompt on a display screen (42), i.e. the user should not take the medication portion due to the upcoming event.

For example, the cover (41) may be locked and only allow the lock to be released by operating a button, such as button (43). The warning prompt may be displayed if the user operates a button (43) to unlock the lid after the suspension time and before the event.

The system according to the invention may be configured to remind the user to take a medication portion repeatedly as long as the suspension moment has not been reached.

The system according to the invention may be configured to transmit a notification to a physician if said user has removed a drug portion after said suspension moment.

Fig. 6 shows another embodiment of the present invention. In the context of treatment, the patient (50) must repeatedly take the medicament (60) in the form of individual medicament portions (here represented by three capsules). The system according to the invention is implemented as a smartphone (1) on which a computer program according to the invention is installed. It is contemplated that the smartphone (1) is configured such that it reminds the patient to take a medication portion (or portions) at a defined moment. The smartphone (1) is also configured such that it records, by means of the sensor (70), the occurrence of an event that causes adverse consequences for the continued taking of said medication (60). For this purpose, the sensor (70) has a transmitting unit, while the smartphone (1) has a receiving unit (represented by a radio symbol). For example, it is conceivable that the sensor measures an in-or on-body parameter of the patient (50) or a parameter in a body fluid (blood, saliva, urine, etc.) of the patient (50). It is conceivable that the sensor (70) transmits the measured values at defined times to the smartphone (1), or that the smartphone requests the measured values at defined times from the sensor (70). It is also conceivable that the sensor is configured such that it transmits data to the smartphone (1) only when a defined limit value is exceeded or fallen below. It is contemplated that the smartphone (1) is configured such that it compares data received from the sensor (70) with reference data stored (stored) in the smartphone (1) in a memory unit, and transmits a warning prompt to the patient (50) and/or other person (e.g. a physician) when a defined state is reached. The warning indication should then be used to prevent the patient (50) from continuing to take the medication (60).

Fig. 7 shows an exemplary embodiment of the method (100) according to the invention, comprising steps (101), (102), (103), (104) and (105). The first step (101) is indicative of repeated administration of the drug portion by the patient in the therapeutic context. In the process, support is provided to the patient by the monitoring unit; the monitoring unit records the removal of the medicament portion from its container. In a further step (102), events are recorded which cause adverse consequences for the continued administration of the drug. It is for example conceivable that the drug is an anticoagulant or an inhibitor of platelet function and that the patient is informed about an impending intervention, which may be related to bleeding. It is contemplated that the patient enters the event in a virtual calendar, which may be an integral part of the monitoring unit or computer unit. To reduce the risk of uncontrolled bleeding, the "blood diluent" should be discontinued in time, i.e. not taken, before the event (intervention). In a further step (103), a pause time is accordingly determined, after which the medication is paused, i.e. should not be taken any more, due to the adverse consequences. It is conceivable that the physician informs the patient about the moment of pause. It is also conceivable for the monitoring unit or the computer unit to calculate the pause times. It is possible to take account of the entry of the suspension time into a virtual calendar of the monitoring unit or of the computer unit. In a further step (104), the monitoring unit records an administration attempt after the suspension moment. In a further step (105), the monitoring unit or the computer unit communicates to the patient a warning prompt that the medication should not be taken any more.

Fig. 8 shows an exemplary embodiment of a method (200) according to the present invention, comprising steps (201), (202), (203), (204) and (205). In a first step (201), an event is set that causes adverse consequences for taking medication, and a suspension time is set. In this example it is assumed that the break moment coincides in time with the event, i.e. the medication portion should not be taken again after the event has occurred. Setting the event includes defining one or more conditions that must be satisfied before the event is considered to have occurred. For example, it is conceivable that a parameter has exceeded or fallen below a defined limit value. The parameter may be a physiological parameter of the patient, such as the concentration of a substance in the body of the patient. In a further step (202), the patient is automatically monitored by the monitoring unit for repeated administration of the medication portion in the context of the treatment; that is, the monitoring unit identifies whether the patient has taken a medication portion or whether the patient has made an attempt to take. In another step (203), the occurrence of an event is recorded. Thus, the condition defined in step (201) occurs. By means of the monitoring unit, in a further step (204), an attempt of administration of the medication portion by the patient after the suspension moment is recorded. In a further step (205), the monitoring unit or computer unit communicates an alert to the patient that the medication should not be taken any more.

Fig. 9 schematically shows another embodiment of the method (300) according to the invention, comprising steps (301), (302), (303), (304) and (305). The first step (301) is to indicate that the patient is repeatedly taking the drug portion in the therapeutic range. During this process, support is provided to the patient by a monitoring unit; the monitoring unit records the actual administration of the medication portion by the patient. In another step (302), events are recorded that cause continued administration of the medication to result in adverse consequences. It is contemplated that the patient enters the event in a virtual calendar. In a further step (303), a break-off time is determined, after which the medication is broken off, i.e. should not be taken any more, due to the adverse outcome. The suspension time may be considered to be entered into a virtual calendar. In a further step (304), the monitoring unit records the actual administration of the medication portion by the patient after the suspension moment. In a further step (304), the monitoring unit or computer unit transmits a notification to the patient and/or other persons associated with the event about the completion of the administration.

Other examples of the invention are:

1. a method comprising the steps of:

automatic monitoring of repeated patient administrations of drugs

Recording events that cause the taking of said drugs to lead to adverse consequences

Determining a break moment after which the medication should not be taken any more due to the adverse consequence

Recording the attempted or completed administration of the drug after the suspension moment

In case of attempted administration: communicating to the patient a warning that the medication should not be taken

Upon completion of the administration: communicating a notification to the patient and/or others related to the event regarding the completion of the administration.

2. The method of example 1, wherein the event is a planned-for-future event and the suspension time is temporally prior to a time of the planned-for-future event.

3. The method of example 2, wherein the suspension time is calculated according to the following formula:

abort time = time of an event planned for the future-validity period.

4. The method of example 3, wherein the expiration date is calculated and used to calculate patient-specific information.

5. The method according to any one of examples 1-4, wherein the event is a medical intervention to the patient's body, the intervention being associated with bleeding or a bleeding risk.

6. The method according to any of examples 1 to 5, wherein the actual taking is recorded and the planned event for the future is postponed or cancelled due to the taking or measures are taken to prevent or reduce or compensate the effect of the drug present at the moment of the event.

7. The method of any one of examples 2 to 6, wherein the drug is an anticoagulant or an inhibitor of platelet function.

8. The method of example 1, wherein the abort time coincides with or is temporally subsequent to a time of the event.

9. The method according to any of examples 1 or 8, wherein the event is characterized by a parameter within the body of the patient taking a defined value or reaching a value above or below a threshold value.

10. An apparatus comprising

Multiple parts of the drug

Device for automatically monitoring repeated administration of medication to a patient

Means for recording events causing adverse consequences for the administration of said drugs

Means for determining a break moment after which the medication should not be taken any more due to the adverse consequence

Means for recording attempted or completed administration of said medicament after said suspension moment

Means for transmitting an alert to the patient that the medication should not be taken and/or a notification to the patient and/or others related to the event that the taking is complete.

11. Device according to example 10, characterized in that the device has a blocking function which is activated as soon as an administration attempt after the suspension moment is recorded, wherein the blocking function prevents the removal of the medication portion by the person.

12. A system comprising a monitoring unit and a computer unit, said computer unit having means for recording events and determining a moment of suspension based on the recorded events,

wherein the monitoring unit is configured such that it identifies an intake attempt or an actual intake of a medication portion by a person and transmits information about the intake attempt or the actual intake to the computer unit,

wherein the computer unit is configured such that it receives information about the intake attempt or the actual intake from the monitoring unit and transmits a signal to a user of the computer unit if the intake attempt or the actual intake time is completed after the suspension moment in time.

13. The system of example 12, wherein the computer unit is implemented in the form of a smartphone or tablet computer.

14. The system of one of example 12 or example 13, further comprising a sensor that measures a parameter in or on the body of the patient and is configured such that it transmits the measurement to the monitoring unit or the computer unit.

15. A computer program product comprising a data carrier and program code stored on the data carrier, which program code is loaded into a working memory of a computer unit and which program code causes the computer unit to carry out the following steps:

receiving an event moment for an event causing the taking of a drug to cause an adverse outcome

Determining a break moment from which no further administration of the drug should be performed due to the adverse consequence

Recording patient attempts to take or complete taking of the portion of the medication

Transmitting an alert to the patient that the medication portion should not be taken and/or transmitting a notification to others related to the event that the taking is complete.