Description
PRESCRIPTION COMPLIANCE DEVICE AND METHOD OF USING DEVICE
Full benefit of the filing date of U.S. Provisional Application Serial No. 60/000,232, filed June 15, 1995, is claimed pursuant to the provisions of 35 U.S.C. § 119(e) .
BACKGROUND OF THE INVENTION Field of the Invention
This invention relates to an apparatus which aids patients in complying with instructions given by a physician for taking prescription medication, and more particularly, to a device which is programmable in accordance with the physician's instructions.
Discussion of the Background Art
A variety of machines and devices have been proposed for recording intervals at which patients, especially those under the care of an attendant, take medication at periodic intervals prescribed by a physician. If the patient or his medical care provider ignores the proper instructions and repeats the dose too frequently or fails to administer or take medication at the proper time, the concentration of medication in the patient's body may become too high or too low. In order to ensure that medications are taken at the proper time, a variety of devices, such as the one disclosed in U.S. Patent No. 4,361,408, have been devised to generate audible and/or visible prompting or alarm signals that remind a patient or his caretaker to administer the correct dosages at the correct time. Such devices have been complex and costly, inconvenient to program, and have not been flexible enough in establishing varying time intervals at which the medication needs to be administered. It is desirable to have a prescription compliance device which is easily programmable by the patient or his medical care provider and which helps the patient to comply with the physician's instructions by
reminding the patient when the next dose of medication is to be taken, and by indicating whether the patient has taken a specified dose.
Accordingly, one object of this invention is to provide a low cost, easy to use prescription compliance device that has the flexibility of operating in accordance with various different medication-taking intervals.
Another object of this invention is to provide a prescription compliance device which is easily programmable either by activating a programmer on the device itself or by remotely programming the device via a wireless link. Multiple programming regimens which correspond to different medication-taking intervals are programmed into the device.
Another object of this invention is to provide a prescription compliance device of a size such that it may be attached to a container which stores the prescription medication.
Another object of this invention is to provide a prescription compliance device which records the event of taking a dose of medication and displays the time at which the next dose of medication is to be taken.
Another object of this invention is to provide a prescription compliance device having a timer which measures the time that has elapsed since the patient last took a dose of the medication and an alarm which is activated at times when the patient is to take the next dose of medication.
Another object of this invention is to provide a simple, effective method of using a prescription compliance device.
Another object of this invention is to provide a prescription compliance device that maintains a count of the number of doses remaining in a patient's prescription and displays the count so that a patient will know when to have the prescription refilled.
Another object of this invention is to provide a prescription compliance device that alerts a patient when
the patient has missed a scheduled dose of medication or has taken a dose of medication at a non-scheduled time.
Another object of this invention is to provide a prescription compliance device which records the times at which a patient takes each dose of medication in a format that can be easily accessed via a wireless interface.
SUMMARY OF THE INVENTION
A prescription compliance device of a size such that it may be attached directly to a medication container is provided. The device aids patients in complying with the instructions given by a physician for taking prescription medications by displaying a time when the next dose of medication is to be taken, by indicating that the patient has taken a specified dose by advancing the displayed time to the next time at which the patient is to take a dose of the medication, and by displaying a number of doses remaining in a patient's prescription so that the patient will know when to refill the prescription.
To carry out the above-stated functions, the prescription compliance device includes a microcontroller, a program memory which stores data representing a plurality of pre-programmed medication-taking regimens, an oscillator which controls timing functions of the device, a selector selecting one of the regimens and programming the device in accordance with the selected regimen, a display which alternately displays the current time, the time at which a next dose of medication is to be taken in accordance with the regimen selected by the selector, and the number of doses remaining in a prescription, and an alarm which alerts the patient at times when the patient is scheduled to take a dose of medication. The device may also include a memory which records the times at which a patient takes each dose of medication in a format that can be easily accessed via a wireless interface.
The selector includes an event switch which is activated by the patient after taking a dose of medication
to record the taking of the medication, the event switch causing the microcontroller to effect the display of the next time at which a dose of the medication is scheduled to be taken, in accordance with the regimen selected by the selector.
The event switch and a function button are provided for programming the regimens by which the medication is to be taken daily, the day of the week on which the first dose is to be taken, the time at which the first dose is to be taken or the designation of meals during which the first dose is to be taken, and the number of doses in a patient's prescription.
Programming may be done either directly by using the function button and the event switch or remotely via a wireless link. To program from a remote location, the device is provided with a wireless transmitter/receiver and an external wireless transmitter/receiver configured to be connected to an input device. The external wireless transmitter/receiver communicates with the wireless transmitter/receiver via a wireless link to select one of the regimens and to program the device in accordance with the selected regimen.
The display includes a first display area which displays a number of the regimen selected by the selector, a second display area which alternately displays the current day of the week and a day of the week on which a next dose of medication is to be taken, a third display area which alternately displays the current time, the time or meal at which the next dose of medication is to be taken, and the number of doses remaining in a prescription, a fourth display area which alternately displays AM or PM designations for the current time and the time at which a next dose of medication is to be taken, and a fifth display area which displays an icon indicating the nature of the information currently displayed in the first through fourth display areas.
Brief Description of the Drawings
A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:
Figure 1 is an illustration of a prescription compliance device in accordance with a first embodiment of the present invention;
Figure 2 is a block diagram of a prescription compliance device of Figure 1;
Figures 3A-3E are flow diagrams illustrating the steps a patient follows in operating the prescription compliance device;
Figure 4 is a table listing examples of common medication-taking regimens which may be programmed into the prescription compliance device; and
Figure 5 is a block diagram of a prescription compliance device including a memory for recording the takings of medication and wireless programming capabilities.
DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views, and more particularly to Figure 1 thereof, a prescription compliance device 1 according to a first embodiment of the present invention includes a function button 2a, a reset button 2b, and an event switch 4 for programming the device, and a digital display 3 for displaying the programmed information. The event switch 4 is activated by the patient upon the taking of a dose of medication.
The prescription compliance device according to this invention may be attached to medication containers by adhesives, straps, velcro, mechanical attachment, integration as a component of the container itself, or by
any other manner of attachment. The device also operates freestanding, and need not be attached to a medication container.
Figure 2 illustrates a block diagram of the prescription compliance device according to one embodiment of the invention. An 8-bit microcontroller 9 (Microchip Part No. PIC 16C54) which controls the overall functions of the device includes a program memory 20 for storing pre¬ programmed medication-taking regimens. A 32 KHz crystal oscillator 7 controls all timings of the device. The program memory 20 is preferably a dedicated chip mask read only memory (ROM) . The specific parameters of the microcontroller, program memory, and the oscillator are set forth here solely for illustrative purposes and are not intended to limit the scope of the invention. The use of equivalent elements is contemplated within the scope of this invention.
The microcontroller receives inputs from the function and reset buttons 2a,2b and from the event switch 4 and controls the device functions in accordance with the pre¬ programmed regimens stored in program memory 20. The microcontroller 9 is connected via an 8-bit bus 21 to display driver 11 which drives the display 3 to display relevant information in display areas 31-35. The display 3 is preferably a liquid crystal display (LCD) and display driver 11 an ASIC LCD driver, however equivalents are also within the scope of the invention.
Battery 12 is preferably a 3 volt battery and alarm circuit 8 may visually and/or audibly prompt the patient to take medication.
The operation of the prescription compliance device according to this embodiment of this invention will now be described with reference to Figures 3A-3E. Patients who are under the care of an attendant are instructed to take medication at periodic intervals as prescribed by a physician. Upon receiving the prescription, the patient or his medical care provider employs the prescription
compliance device to aid the patient in complying with the instructions given by the physician.
First, the device must be switched from an OFF state to an ON state by pressing the reset button (Step Sl) . A "SET" icon is displayed in display area 35 to indicate that the device is in setup mode. The patient first sets the current time (Steps S2 and S3) as follows.
The event switch 4 is pressed and the microcontroller 9 directs the display area 33 to blink hour digits "12". Hours "1" through "12" are scanned through by pressing the event switch and the appropriate hour is selected by pressing the function button when that hour is displayed.
The minutes tenth digit then blinks "0" and the digits "0" through "5" are scanned through by pressing the event switch. The appropriate digit is selected by pressing the function button when that digit is displayed.
The minutes unit digit then blinks "0" and the digits "0" through "9" are scanned through by pressing the event switch. The appropriate digit is selected by pressing the function button when that digit is displayed.
The display area 34 then blinks "A" and the patient selects AM or PM time designations using the event switch to toggle between the two and the function button to select. This completes the setting of the current time.
The patient now selects the regimen by which the prescription medication is to be taken. Upon depressing the event switch 4, the display area 35 displays "RGMN" and the display area 31 blinks "0", prompting the patient to scan through and select a desired regimen using the event switch 4 (Step S4) . Figure 4 lists examples of common programming regimens which may be pre-programmed into program memory 20. These regimens are listed only by way of example and other regimens are possible.
In Figure 4, regimens are provided for taking the medication 1, 2, 3, 4, or 6 times daily, taking the medication with breakfast and dinner, breakfast, lunch, and dinner, or breakfast, lunch, dinner, and at bedtime, and
for taking the medication once every 48 hours.
The patient presses the event switch 4 to advance through the programming regimens until the desired regimen is displayed. During scanning, regimen numbers appear in display area 31 and descriptions of the regimens appear in display area 35 so that the patient knows which regimen each number corresponds to. For example, when "8" appears in display area 31, "3:D" appears in display area 35 to indicate to the patient that programming regimen 8 corresponds to taking medication three times daily.
When the desired regimen is displayed, the function key is pressed (Step S5) and the display 3 prompts the patient to choose between standard, pre-programmed default times corresponding to the selected regimen or setting a specific time at which the first dose is to be taken. If the default times for taking the medication are acceptable, the patient presses the event switch and is then prompted to enter the number of doses in the prescription (Step S21) .
If the patient instead wants to set the time at which the first dose is to be taken, the microcontroller 9 directs the display area 33 to blink hour digits "12". Unless the patient selects one of the meal regimens, the time of day at which the first dose of the medication is to be taken is next programmed (Steps S6 and S7) . Hours "1" through "12" are scanned through by pressing the event switch and the appropriate hour is selected by pressing the function button when that hour is displayed.
The minutes tenth digit then blinks "0" and the digits "0" through "5" are scanned through by pressing the event switch. The appropriate digit is selected by pressing the function button when that digit is displayed.
The minutes unit digit then blinks "0" and the digits "0" through "9" are scanned through by pressing the event switch. The appropriate digit is selected by pressing the function button when that digit is displayed.
The display area 34 then blinks "A" and the patient
selects AM or PM time designations using the event switch to toggle between the two and the function button to select. This completes the setting of the time at which a first dose of medication is to be taken by the patient.
If one of the meal regimens is selected, the medication is to be taken with meals the times of which will vary from person to person. The program memory 20 has pre-programmed therein standard meal times (breakfast, lunch, dinner) during which most persons normally eat. However, the device is flexible enough to allow for different meal times, as will now be explained.
After a meal regimen is selected, display area 33 blinks "D" for default meal times. If the patient eats meals at the standard times programmed into the program memory 20, then the function button is pressed when "D" is displayed (Step S8) . If the patient eats at different times, then pressing the event switch (Step S9) allows the patient to toggle between "D" and "S" (indicating 'set') . Pressing the function key when "S" is displayed (Step S10) allows the user to set his breakfast, lunch, dinner, and bedtimes as follows. After the function key is pressed, "BRKF" appears in display area 35 and "12" blinks in display area 33. The patient's breakfast time (hour, minute, AM/PM) is entered as described above (Steps Sll and S12) .
After programming the breakfast time, the operation varies according to the specific regimen selected. For explanatory purposes, regimens 1, 2, and 3 refer to the meal designations listed in Figure 4. If regimen 2 or 3 has been selected, "LNCH" appears in display area 35 and the time setting process is repeated to set the patient's lunch time (Steps S13 and S14) . "DINR" then appears in display area 35 under regimens 1, 2, and 3 and the patient's dinner time is similarly set (Steps S15 and S16) . Finally, "BDTM" appears in display area 35 if regimen 3 is selected and the patient's bedtime is set as described above (Steps S17 and S18) .
Once the time/meal designations have been programmed, the display area 32 then blinks "SU", prompting the patient to program the day of the week on which the first dose is to be taken. The days "SU" through "SA" are scanned through by pressing the event switch (Step S19) and the appropriate day is selected by pressing the function button (Step S20) .
The display area 35 then displays "CNT", prompting the patient to enter the number of doses in the current prescription. Display area 33 blinks "0" and the patient scans up using the event switch until the desired number is displayed (Step S21) . The function button is then pressed to select this number (Step S22) .
The display area 35 then prompts the patient to enter the number of days that the current prescription is scheduled to last. Display area 33 blinks "0" and the patient can scan up using the event switch until the desired number is displayed (Step S23) . The function button is then pressed to select this number (Step S24) .
This completes the setup process. Display area 35 next displays "STRT" and display area 33 displays a question mark ("?") . When the user presses the event switch, the device is in operation mode (Step S25) . Display 3 continuously alternates between displaying the current time, the time at which the next dose is to be taken, and the number of doses and days remaining in the prescription. When the current time is displayed, display area 35 displays "TIME", display area 31 displays the number of the regimen selected by the patient, display areas 33 and 34 display the current time of day, and display area 32 displays the current day of the week. When the time of taking the next dose of medication is displayed, display areas 33 and 34 display the time at which the next dose is to be taken, display area 32 displays the day of the week on which the next dose is to be taken, display area 31 continues to display the number of the selected regimen, and display area 35 displays
"NEXT" .
After the device is programmed and the event switch 4 is pressed to enter operation mode, the patient is aware of the day and time at which the first dose of the medication must be taken. At the time for taking the first dose, the microcontroller 9 directs the alarm circuit 8 to emit an audible and/or visible signal to alert the patient that the first dose must be taken at this time (Step S26) . The alerting signal continues to be emitted intermittently until the patient takes the dose and presses the event switch or until a prescribed time has elapsed (Step S27) . During this time, display area 35 displays "TAKE" indicating that it is time to take the next dose. If the patient takes the dose more than a prescribed time before the scheduled time and presses the event switch 4, the alarm circuit 8 is activated (Step S28) and the display area 35 indicates "ERR" (Step S29) to indicate that the patient has not properly followed the selected regimen. The display then indicates the time that the dose was scheduled to be taken (Step S30) and prompts the patient to direct the device as to how to proceed (Step S31) . At this point the patient may press the event switch 4 to maintain the current regimen (Step S32) or may select a new regimen (Step S33) since the current regimen was interrupted.
If the patient fails to take the dose within a prescribed time after the scheduled time while the alarm circuit 8 is activated, display area 35 displays "MISS" (Step S34) indicating that the patient has missed taking the scheduled dose. The display then indicates the time that the missed dose was scheduled to be taken (Step S35) and prompts the patient to direct the device as to how to proceed (Step S36) . At this point the patient may press the event switch 4 to maintain the current regimen (Step S37) or may select a new regimen (Step S38) .
Upon taking the first dose, the patient presses the event switch 4 which records the taking of the medication and causes the microcontroller to automatically calculate
the time/meal at which the next dose of medication must be taken according to the selected regimen and to effect the display of this time on the digital display 3 (Step S39) . The microcontroller also subtracts the dose taken from the total number of doses in the prescription to update the count of remaining doses. This number is displayed in display area 33 while "LEFT" is displayed in display area 35 to indicate the number of doses remaining (Step S40) .
Likewise, at the end of each day the microcontroller subtracts one from the total number of days in the prescription to update the count of remaining days. This number is displayed in display area 33 to indicate the number of days remaining (Step S41) .
These operating procedures are repeated for as long as the patient's prescription is valid. When the number of doses in the prescription has been nearly exhausted (i.e., six doses or less remaining) , the display indicates "FILL" and the alarm circuit is activated (Step S42) . If the patient has the prescription refilled at the direction of a physician, the operating procedures are resumed at Step S21. Otherwise, if the patient has completed his prescription and needs no further medication, the device is turned off by pressing the reset button 2b (Step S43) .
Provision may also be made to accommodate multiple prescriptions by assigning to each prescription a unique identification number and following the foregoing procedures to program the device for each prescription.
The present device informs the patient of the fact that a dose has been taken, the time at which the next dose is to be taken, and the number of doses and days remaining in the prescription.
The event switch 4 should be of a size such that activation by an elderly person would not be difficult while at the same time safeguarding against accidental activation. The reset button 2b is of a size such that activation thereof requires a thin, needle-shaped object so as to safeguard against the accidental turning off of the
device. Accidental depression of the function button is harmless since this button has no effect when the device is not is setup mode except to de-activate the alarm circuit.
Provision is also made for a low battery indication. After the passage of a certain number of days from when the battery was last replaced, display area 35 displays "BAT" to indicate that the battery 12 should soon be replaced.
The programming effected by the patient or his medical care provider is simpler to carry out than programming methods known in the prior art. Additionally, the present device ensures that the taking of a dose of medication will be recorded and that the time for taking the next dose will be displayed so as to ensure proper compliance with a physician' s instructions.
Figure 5 illustrates another embodiment of the present invention, wherein like reference numerals designate identical elements from the first embodiment. Since the programming and operation of the prescription compliance device according to this embodiment are identical in most aspects to those of the first embodiment, a description of the identical features will be omitted. Referring to Figure 5, the prescription compliance device further includes a wireless transmitter/receiver 40 (Microchip Part No. SFH485) which communicates with an external wireless transmitter/receiver 41 via a wireless link 44. The external wireless transmitter/receiver 41 includes a wireless transmitter/receiver 42 and an interface 43 for connection to an input device, such as a personal computer. The interface is preferably a standard RS-232 serial interface, and infrared technology is employed in the preferred embodiment to transmit and receive information. The personal computer runs software by which the device is programmed via the personal computer in lieu of direct programming using the function button 2a and the reset switch 4. The above-described programming procedures (Steps S1-S25) are carried out in this embodiment on a personal computer running software that assigns certain
keystrokes the functions that the reset button, function button, and the event switch perform in the first embodiment. Programming the device is thus made more convenient by simply inputting the above-described parameters (time, meals, number of pills, etc.) via a personal computer keyboard.
The information input by the patient or his medical care provider via a personal computer is transmitted by the wireless transmitter/receiver 42 and received by the wireless transmitter/receiver 40 and processed just as if it were directly input via the function button, reset button, and the event switch 4. The wireless transmitter/receiver 40 transmits back to the external device the current status of the device and the information displayed on display 3.
The device of Figure 5 also includes a non-volatile memory 10 which records the taking of each dose of medication by the patient when the event switch 4 is pressed. Information as to which doses have been taken is accessible via the wireless link so that a physician can examine the patient's compliance in taking the medication. The non-volatile memory 10 of the preferred embodiment is an 8 KB serial EEPROM (Microchip Part No. 24LC08B) , however equivalent memories may be employed without departing from the scope of this invention.
After programming the device on a personal computer, the patient's operation of the device is identical to that described above (Steps S26-S43) .
The wireless transmitter/receiver 40 preferably utilizes Amplitude Shift Keying (ASK) modulation to transmit/receive infrared energy to/from the external wireless transmitter/receiver. Infrared technology has been disclosed merely for illustrative purposes; other wireless technologies and modulation methods are contemplated to be within the scope of the invention.
Each prescription compliance device has a unique identification number assigned thereto and stored in its
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program memory 20 for the purpose of identifying a particular device when programming from a remote location.
Obviously, numerous modifications and variations of the present invention are possible in light of the above teachings. The specific parameters mentioned in conjunction with the description of the invention have been set forth solely for illustrative purposes and are not limiting of the scope of the invention in any way. It is therefore to be understood that within the scope of appended claims, the invention may be practiced otherwise than as specifically described herein.