EP0563100A1

EP0563100A1 - Instructions or analogous element for medicaments.

Info

Publication number: EP0563100A1
Application number: EP92900725A
Authority: EP
Inventors: Joep Winters; Wim Winters
Original assignee: Individual
Current assignee: PATIENT COMPLIANCE BV
Priority date: 1990-12-21
Filing date: 1991-12-14
Publication date: 1993-10-06
Anticipated expiration: 2011-12-14
Also published as: JP2964426B2; EP0563100B1; DE69107628D1; ES2070624T3; JPH06504122A; WO1992011587A1; DE69107628T2

Abstract

Dispositif donnant des indications ou analogue concernant l'administration d'un médicament. Il comporte un émetteur (9) destiné à émettre un signal sonore à des momemts prédéterminés qui correspondent aux moments auxquels l'on doit utiliser le médicament.Device giving indications or the like concerning the administration of a medicament. It comprises a transmitter (9) intended to emit an audible signal at predetermined times which correspond to the moments at which the drug must be used.

Description

"Instructions or analogous element for medicaments"

The invention relates to a new type of instructions or analogous element for medicaments which preferably give a.o. indications for the use of the concerned medicaments, and which comprise means for producing a signal, such as a sound and/or light signal, on predetermined points of time which correspond to those on which the medicaments should be used.

A very great number of factors and circumstances determine the activity and the therapeutical effect of a medicament, on the one hand, the pharmacological properties and, on the other hand, the biological availability and the pharmaco-kinetics.

The pharmaceutical industry takes care that the medicaments are brought at the disposal of the patient in optimal shape and condition- However, the effect of a medicament therapy depends from the dosage and timing of consumption of the medicament. Searches have proven that the effect of medicaments is about 40 • lower than should be, because of the fact that a lot of patients do not take care of the timing and dosage.

With the use of medecines, it is of the utmost importance that the medecine is taken at the right point of time. Take for instance an antibiotic cure, for which the antibiotic should be taken every six hours to keep the concentration of the antibiotic in the blood at such an effective level that the pathogenic micro-organisms will not survive. If the - 2

antibiotic is not taken in time or if a dose is skipped, one runs the risk of a revival of the micro¬ organism, after which the chance of success of the therapy can strongly decrease.

When a medicament should be administrated several times a day, the number of administrations a day can be different, while the intervals of time between two successive administrations can also vary during the day. Moreover, for certain medicaments, the number of administrations and/or the intervals of time between two successive administrations can also vary from day to day. It is for instance possible that the number of administrations decreases day after day and inversely the intervals of time between two successive administrations increase day after day. It has further to be emphasized that the cycles of administration of a specific medicament can also depend from the patient himself.

The phenomenon of not keeping a measurement schedule, one calls in the technical jargon "nonco pliance".

Research has shown that 40 % of the patients do not keep a measurement schedule entirely. This percentage can be higher, the less the patient feels ill. Thus, it is known that, also because of possible side-effects, a patient with hypertension, who notices little of this, will be inclined to forget his medication.

Now, it is tried to remedy this important problem substantially by providing better and more understandable information to the patient about the medecine to be used, a.o. by simplifying the language in the instructions in connection with the indications concerning the use of the medecine.

Another often more efficient method is that the dispenser, who gives the medecine, files the medication data per patient in the memory of a computer, which calculates the consumption period and gives a signal if the patient comes too early for a new amount of the concerned medecine.

Further experience has shown that if a medecine has to be taken orally at a relatively low frequency a day, this also has a positive influence on the correct use. This has had the effect that one tries to reduce the intake-frequency per day as well by changed administration methods, as by medecines, which are taken in gradually in the body, if possible to only once. Since however this is only possible for a limited number of medecines, the problem remains of the erroneously using or not at the right point of time using of most medecines. Furthermore, the consequences of forgetting a once-a-day intake are of course more important than when one omits an intake of a prescribed frequency of four times a day.

In the document US-A-4,490,711 a- solution has already been proposed to overcome this problem. Use has been made of an electronic clock which cooperates with a programmable timer by means of which each point of time of a cycle of 24 hours on which a medicament should be taken can separately be adjusted by means of separate switches. On this way, a signal is given to the clock by means of the timer which at each preselected point of time activates the alarm of the clock.

The operation of such a device and also the adjustment of the points of time on which the alarm should be activated is very complicated and need in fact a certain technical background and dexterity, which the user does not necessarily dispose of. This is for instance generally the case for unskilled people - •

and also for old or sick persons.

If a person should be using different medicaments, the possibility exists that each of these medicaments should be administrated at different points of time. Moreover, as already mentioned hereinabove, the possibility also exists that the daily dose for a same medicament varies from day to day, more particularly decreases after each day. All this makes it still more difficult for the patients using such medicaments.

The invention mainly has as purpose to give a solution to all the above cited situations and to remedy the shortcomings of the different above described methods not only on an economically sound manner but also on a very simple way so that all possible mistakes in the administration times will be excluded.

To this aim, instructions or an analogous element, according to the invention is presented in which the means for emitting or producing a signal on predetermined periods or points of time corresponding to those on which the medicament should be used comprise an electronic timer connected to a signal producing device for activating said signal, which timer being preprogrammed in such a way as to be able to activate said signal after successive intervals of time of one or more cycles of such intervals, said intervals being identical or different, the latter being further defined with respect to a starting reference point of time for said cycles, an operating organ being provided for setting up, by means of said timer, a specific cycle at a starting reference point of time which preferably corresponds to the point of time that the medicament has to be used for the first time, the end of each interval corresponding to the point of time a next dose of the medicament should be used when starting the cycle at the reference point of time.

In a specific embodiment of the invention, these means include also a "reset" switch which permits to erase the possibly already regulated points of time and to define a new first point of time on which all the subsequent points depend automatically.

In a preferred embodiment of the invention, the instructions or the analogous element is made out of a relatively stiff little plate, for example of plastificized or not plastificized cardboard, onto which possibly certain inscriptions are made and which e.g. can be ranged in detachable fashion in a packing of the medicaments.

Other details and advantages of the invention will become apparent in the description following hereafter of a specific embodiment of instructions according to the invention ; this description is only provided as an example and does not limit the invention; the reference numbers used hereafter refer to the figures added thereto.

Figure 1 is a frontal view of instructions made of a stiff rectangular card according to the invention.

Figure 2 is a rear view of the same instructions.

Figure 3 represents a block diagram of the in this instruction built in electronic circuit according to the invention.

Figure 4a represents a portion of more detailed- block diagram of an electronic part of a specific embodiment of the instructions according to the invention.

Figure 4b represents the other portion z f the same block diagram, as referred to in figure 4a.

The general idea on which the present invention is based is to draw the attention of the patient, each time he has to use a medecine, to this fact in an active manner, such that the factor forgetfullness is entirely eliminated.

Besides this, it is of the utmost importance that this idea is worked out in a practical and very simple economically sound method for everybody's use.

These criteria have lead then, according to the invention, to instructions (or instruction enclosure) , or analogous element which includes means for generating a sound signal on points of time which in a simple manner can be regulated beforehand and correspond to those on which the concerned medicament should be used.

Hence in the accompanying figures a specific embodiment of instructions was presented, according to the invention, which a.o. includes such means.

This instruction enclosure is made out of a cardboard card of very limited dimension such that it can be enclosed into the packing of the medecines. It is, for example, a rectangular card which has the standardized dimensions of a bank card or a credit card and, therefore, can be taken along in the same manner as such a bank card or credit card in a 'wallet or diary, such that one always carries the instructions about.

It is for example a card with a length of 85.5 mm, a width of 54 mm and a thickness which can vary between 2 and 5 mm.

In the embodiment of the instructions represented according to the invention, a sound signal is generated by means of a piezo-electπc buzzer provided with a so-called "Helmholz resonator ("piezo- buzzer") 10 as represented schematically in figure 3.

The instructions include further a so-called "reset" switch 4, which in practice is made up by a small push button sunk in the left top corner of the front side 1a of this card 1 and which can be operated via a small circular hole in the upper carboard layer by means of a pointed object. In this manner, it is avoided that by an accidental touch this switch 4 would be operated.

This switch 4 enables to stop the possible cycle of successive points of time and if necessary to start again on another moment a new cycle.

In the middle part of the front side 1a of the cardlike instruction 1, four keys or buttons 2 are represented with diaphragm switches S , S , S and S

1 2 3 4 for regulation of the desired number of points of time per day on which a sound signal should be emitted.

These keys or buttons are numbered from 1 to

4. The switches S to S are linked up mutually and

1 4 with the "reset" switch 4 such that, when one of the switches S to S is pressed after the reset switch was

1 4 operated, all the keys 2 will automatically be switched off, as a result of which it is of course no longer possible to influence the position of one of these switches 1 to 4.

In a specific embodiment of the invention, the sound signal can be combined or replaced by a spoken short text in connection with the use of the medecine. This specific embodiment was not represented in the figures but the technique for this is known in itself e.g. in certain postcards.

Besides means for generating a sound signal, in an advantageous embodiment of the invention, means are provided to give together with this sound signal a light signal. To this aim use can be made in an advantageous manner of a light-emitting diode, known by the name "LED" 3 (see figure 3).

This can be of importance if the patient has to use several different medecines and therefore has disposal of several information enclosures according to the invention. In this manner, the patient can determine therefore at the hearing of a sound signal from which card it is emitted and so he knows automatically which medecine should be used at this point of time.

All functions described above are operated via a built-in electronic circuit 9, as represented in figure 3. This circuit is thus completely built-in in the card 1 between the cardboard layer forming the top side 1a and the one forming the underside 1b.

This electronic circuit 9 includes a programmed time regulator or timer 11, which is made up of a so-called "customised CMOS timer". On this time regulator 11 the different functions to be operated, such as the sound signal, the light signal and the

"reset" switch, are connected in parallel. Via the in parallel mounted switches S to S this time regulator

1 4 11 is further connected to a battery 12 which provides the necessary energy supply, the battery in turn being in a series with the "reset" switch 4.

The embodiment of the instructions represented in the figures according to the invention shows four different push buttons 2 which each permits to operate one of the switches S , S , S or S . These

1 2 3 4 buttons are numbered from 1 to 4. The key with number

1 has to be pressed when the concerned medicament has to be used only once a day. The key number 2 relates to a medicament which has to be used twice a day. For the key with number 3 it is three times a day and for the key with number 4 it is four times a day. If, for example for a diuretic, a dose of one table once a day at 8 o'clock in the morning is prescribed, it suffices at the first use at 8 o'clock in the morning to press first the reset switch 4 and next the push button with number 1. In this manner, after an interval of time of 24 hours, so each time at 8 o'clock in the morning, a sound signal will be made by buzzer 10 and at the same time the "LED" diode 3 will flash.

The time regulator 11 can be regulated so that the sound signal and the light signal remain working for a specific number of seconds after which they are automatically switched off. Possibly an extra button could be provided to switch off these signals within this period of time. If for example it is provided that these signals can be sustained for ten seconds, this extra button could thus take care that these signals are switched off sooner, the aim being not to disturb possible persons in the neighbourhood.

For a use of twice a day, the signals will be emitted for one medicament f.i. at 9 o'clock (9 a.m.) and at 21 o'clock (9 p.m.) and for another medicament f.i. at 9 o'clock (9 a.m.) and at 18 o'clock (6 p.m.).

With the use of three times a day one must take into account the sleeping period. If it is accepted that the period of sleeping amounts on average to ten hours, including making one's toilet before and after sleeping, then it is for example possible to give a signal every seven hours. If one sets the first signal at 8 o'clcock then a signal will be given also at 15 o'clock and 23 o'clock. With the use of four times a day the interval of time will preferably amount to five hours, which implies that the signals are given at the following points of time : 8 o'clock, 13 o'clock, 18 o'clock and 23 o'clock. The benefit of the "reset" switch is that it allows to change the time for the first use. If for example one wants to move the first intake from 8 o'clock to 9 o'clock, it suffices to press the reset switch 4 first and then one of the four press buttons 2, depending on whether the dose is once, twice, three or four times a day. Also at the beginning of summer or winter time it can be desirable to take into account the time change.

On the free space both at the front side 1a and at the back side 1b of the card, 1 use can be made in an advantageous way for inserting useful information. Hence it is for example possible to print in section 5 at the front side 1a of the card the directions for the use of the medecine. In section 6, at the top of the back side 1b of the card, the trade name of the medecine can be printed, while in the bigger middle part 7 of this side 1b all information in connection with the composition and possible side effects, way of storing the medecine, etc. can be put. Finally, in the lower section 8, it is for example possible to provide name and address of the manufacturer of the medecine. Hence these instructions can generally replace entirely the classic instructions which in general are added under form of a leaflet to each medecine.

As it results from the description given hereinabove the time regulator or timer 11 has two different states : a state of rest and an active state.

The manufacturer of the medicament and. or the pharmacist add to the medicament a programmed instruction enclosure in state of rest. The patient brings the timer 11 in active state at the moment the first dose of the medicament has to be taken bv acting on the corresponding operating organ 2 comprising switches S , S , S and S , depending from the

1 2 3 4 prescribed cycle of points of time on which a dose of the medicament has to be taken. At that moment the timer 11 will activate the buzzer 10 and possibly simultaneously the light producing device indicating that the active state and thus the cycle of successive intervals of time has started.

In another particular embodiment of the instructions, according to the invention, in this active state, all the operating organs 2, except the "reset" switch 4, will automatically obtain another function, i.e. to stop the sound signal. In this way, it will be possible to interrupt very easily the alarm without requiring the extra button as mentioned hereinbefore. Moreover, a much more important advantage is that it will not be possible to disturb by inadvertence the cycle of the programmed successive intervals of time.

Also in another particular embodiment of the instructions, according to the invention, the switches S , S , S , S which are f.i. diaphragm switches, can be replaced by detectors from a quite different type, as long as they have the same function as these switches.

In the embodiment of the instructions represented in figures 1 to 3, a choice can be made by the patient between four different cycles of programmed successive intervals of time depending from the prescription of manufacturer, pharmcist or physician. However, in practice, instructions with at the most two and generally with only one operating organ 2 will be sufficient so that it will still be easier for the patient to use such instructions.

Various methods can be found to realize the electronic circuits 9 required. One of these methods is to build the circuits using digital integrated circuits with basic functions, like gates and memory circuits. An example solution has been given in figure 4a and 4b.

The circuit can be energized by a switch 21. This switch connects a small battery to the integrated oscillator and frequency divider 22. This frequency divider 22 is connected to the quartz cristal 23. The result will be an oscillation at the frequency determined by the quartz cristal 23. This method of providing a stable and reliable time base is also used in so-called "quartz clocks". A second frequency divider 24 divides the output frequency of frequency divider 22 to the time base required for a certain medicine. As soon as this time base times out, the flip-flop circuits 25 and 26 will be set. The output of flip-flop 25 will enable the AND gate 27 which AND's the enable signal from flip-flop 25 with a short repeated pulse generated by the first divider 22 and a differentiating network 28. The output of gate 27 drives an emitter-follower which switches the energy stored in capacitor 30 to the LED 29.

This LED will flash as long as the flip-flop 25 is set. After approximately 90 seconds, flip-flop

25 will be reset by the timer/divider circuit 24 and the LED will stop flashing.

A similar circuit is build around flip-flop

26 and gate 31. The output from flip-flop 26 is AND gated with a 4 kHz tone generated by the frequency divider 22, inverted and again AND gated by gates 32 and 33 with a pulse to make the 4 kHz tone intermittent. The signal is inverted by two parallel inverters 33 and 34 in order to generate sufficient drive for a oiezo-electric audible transducer 10. The flip-flop 26 is reset after approximately 10 seconds, so that audible signal will only be heard during that time.

As long as the circuits are energized, the audible signal and the optical signal will be present, as described above, every time the second frequency divider 24 is timed out. Hence, the signalling will be repeated at very exact time intervals. By adding more outputs from the frequency divider chain and enabling these outputs to set the flip-flops 25 and 26, several time intervals can be programmed. In the example circuit this is realized by switch 37.

The circuits are build using C-MDS logic circuits. This ensures an extremly low power consumption. The circuit will operate at a set of batteries as used in electronic watches from one month to more than a year, depending from the frequency and the circuit used.

The invention is of course in no way limited to the specific embodiments of the instructions described above, but within the framework of the invention and the protection claimed, several changes can be considered, a.o. concerning the relative arrangement of the component parts of the card, such as in relation to the push buttons 2, the light-emitting diode 3, the reset switch 4, the composition and the units of the electronic circuit 9, etc. Also the shape of the instructions can be very different.

In fact, the instructions or analogous element according to the invention should comprise an electronic timer or time regulator 11 connected to a sound signal producing device, such as a piezo-buzzer 10, and possibly to a light signal producing device, such as a LED 3 for activating said signal. This timer should further be programmed on beforehand in such a - M -

way as to be able to activate said signal after well defined successive intervals of time of a time cycle, in such a way that the end of each interval should correspond to a point of time, prescribed by the manufacturer, pharmacist or physician, on which the medicament to which the instruction disclosure is relating to, should be administered. An operating organ 2 should be provided for starting this cycle of intervals of time at such moment of the day so that the end of each of these intervals will automatically correspond to a point of time of the day on which the medicament should be taken.

The intervals of time of a cycle are thus defined with respect to a starting reference point of time. This starting reference point of time corresponds preferably to the moment of the day the medicament has to be administered for the first time. The length of a specific interval of time should correspond to a corresponding space of time between two successive points of time so that when the timer is activated on the right moment, the end of each interval of time will automatically correspond to a point of time of the day on which the medicament should be taken.

In practice, it will be sufficient to act at this moment on the "reset" switch 4 of the instructions and on the selected operating organ 2 corresponding to the chosen cycle of intervals of time.

As the "reset" switch 4 is not always absolutely necessary, in case such switch is not present, it will be sufficient to act directly on the selected operating organ 2.

By "analogous element" is meant every bearer, suitable for housing means which allows for the emission of a sound signal and possibly a light signal and which is such that it can play a role substantially similar to the above described and in the figures represented card. Hence this means that the patient must be able to carry along this bearer in a simple and discrete manner such that when a sound signal is generated this is easily audible to him. Hence it follows that for example could be thought of a bracelet, a necklace, etc.

When use is made of a card, the latter could for example be provided with a sticker or stick-on surface, thanks to which the card can be fixed in a detachable way e.g. inside a garment, such as a shirt or blouse.

From these additional considerations, it also follows that the instructions or analogous element, according to the invention, could be introduced on the market possibly totally separated from the medecine to be used, because of the different regulation possibilities which it offers and hence it is made suitable for a very broad range of medecines. In the packing of the medecines for example, a sticker could be provided with the necessary information which can be attached to the back side of the card 1 in a detachable way.

Thanks to the fact that, contrarily as in the known device of U.S patent No. 4,490,711 referred to hereinabove, the intervals of time are not determined with respect to a clock, a cycle of intervals ran be defined independently from the day time so that a ycie of intervals can be longer than 24 hours. This cculd be important if the number of dose changes from _av to day as mentioned hereinabove. If the intervals are connected to a clock as in the device according to tnis U.S. patent, a cycle could never be longer tnan 24 hours. As to the operating organ 2 instead of push buttons, as in figure 1, it can be made of a lip which should be drawn away for bringing the timer in said active state.

Claims

17CLAIMS

1. Instructions or analogous element for medicaments comprising means (9) for producing a signal, such as a sound and/or light signal, on predetermined points of time which correspond to those on which the medicaments should be used, characterized in that said means (9) comprise an electronic timer (11) connected to a signal producing device (3,10) for activating said signal, which timer (11) being preprogrammed in such a way as to be able to activate said signal on intervals of time of one or more cycles of such intervals of time, said intervals of time being identical or different, the latter being further defined with respect to a starting reference point of time for said cycles, an operating organ (2) being provided for setting up, by means of said timer (11), a specific cycle at a starting reference point of time which preferably corresponds to the point of time that the medicament has to be used for the first time, the end of each interval corresponding to the point of time a next dose of the medicament should be used when starting the cycle at the reference point of time.

2. Instructions or analogous element according to claim 1 , characterized in that these means (9) include a "reset" switch (4) which permits to switch off the possible already regulated points of time and to define a new first point of time.

3. Instructions or analogous element according to claim 1 or 2, characterized in that a separate operating organ (2) is provided for each cycle of intervals of time to be chosen.

4. Instructions or analogous element according to anyone of the claims 1 to 3, characterized in that the operating organ (2) is connected in such a way that, after having acted on said organ (2), it will be switched off, and it will only be possible to switch it on again after acting on said "reset" switch (4).

5. Instructions or analogous element according to anyone of claims 1 to 3, characterized in that the operating organ (2) is connected in such a way that, after having acted on said organ (2), its function will be changed, i.e. to stop or interrupt the signal .

6. Instructions or analogous element according to anyone of the claims 1 to 5, characterized in that said means (9) include a part producing a light signal (3) which operates at the same time as the sound signal .

7. Instructions or analogous element according to anyone of the claims 1 to 6, characterized in that the sound signal is formed by a spoken text.

8. Instructions or analogous element according to anyone of the claims 1 to 7, characterized in that an electronic circuit (9) worked by a battery (12) is provided which allows to control the emission of said sound signal on successive intervals of time regulated ahead.

9. Instructions or analogous element according to claim 8, characterized in that a piezo- buzzer (10) is provided for the emission of said sound signal.

10. Instructions or analogous element according to one of the claims 8 or 9 , characterized in that said light signal is emitted by means of a light- emitting diode ("LED") (3).

11. Instructions or analogous element according to anyone of the claims 8 to 10, characterized in that the electronic circuit (9) includes an adjustable time regulator, in particular a so-called "CMOS timer" (11), onto which the functions to be operated, such as the sound signal, the possible light signal, the "reset" switch, are connected in parallel and links up, via said in parallel mounted operating organs (2) which show switches (S , S , S ,

1 2 3 S ), to a battery (12) which in turn is placed in a

4 series with said "reset" switch (4).

12. Instructions or analogous element according to anyone of the claims 1 to 11, characterized in that it is made of a relatively stiff little plate (1), for example of plasticized or not plasticized hard cardboard, onto which possibly certain inscriptions have been made and that can be fitted in detachable fashion in a package of medicaments.

AMENDED CLAIMS

[received by the International Bureau on 18 May 1992 (18.05.92); original claim 1 amended; remaining claims unchanged (1 page)]

1. Instructions or analogous element for medicaments comprising means (9) for producing a signal, such as a sound and/or light signal, on predetermined points of time which correspond to those on which the medicaments should be used, characterized in that said means (9) comprise an electronic timer (11) connected to a signal producing device (3,10) for activating said signal, which timer (11) being preprogrammed for a specific medicament in such a way as to be able to activate said signal on intervals of time of one or more cycles of such intervals of time, said intervals of time being identical or different, the latter being further defined with respect to a starting reference point of time for said cycles, an operating organ (2) being provided for setting up, by means of said timer (11), a specific cycle at a starting reference point of time which preferably corresponds to the point of time that said medicament has to be used for the first time, the end of each interval corresponding to the point of time a next dose of the medicament should be used when starting the cycle at the reference point of time.

4. Instructions or analogous element according to anyone of the claims 1 to 3, characterized in that the operating organ (2) is connected in such a way that, after havin acted on said or an 2 it wi_l 21

STATEMENTUNDERARTICLE 19

Claim 1 has been amended in order to emphazise the difference between the claimed invention and the contain of the prior art references cited in the search report.

Indeed, contrarily as in the prior art references, according to the invention, there is no intervention at all of the patient for indicating on the instruction leaflet or card enclosed with a specific medicament the intervals at which this medicament should be taken. There is one leaflet or card for each specific medicament which has completely been preprogrammed. The only thing a patient has to do is to activate the timer at the point of time of the first use of the medicament, by acting on an operating organ. This is very important, because this will avoid all risks of programming errors made by the patient, which could have very dangerous consequences.

According to the known devices as disclosed in the prior art references, especially those classified by the examiner in category "X", the patient has to program the intervals at which the medicament should be taken according to the prescriptions of the doctor or of those indicated on a separate leaflet contained in the box of the medicaments, f.i. so that generally these known devices should contain a digital clock. Reference is more particularly made to US-A-4,725,995 and EP0159,306.

Therefore, we presume these references should be cited in the introduction of the specification of this patent application.