CA1273323A - Contingent dosing device - Google Patents

Contingent dosing device

Info

Publication number
CA1273323A
CA1273323A CA000544750A CA544750A CA1273323A CA 1273323 A CA1273323 A CA 1273323A CA 000544750 A CA000544750 A CA 000544750A CA 544750 A CA544750 A CA 544750A CA 1273323 A CA1273323 A CA 1273323A
Authority
CA
Canada
Prior art keywords
patient
regimen
dose
informing
deviation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA000544750A
Other languages
French (fr)
Inventor
John Urquhart
Harold R. Elgie
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aprex Corp
Original Assignee
Aprex Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aprex Corp filed Critical Aprex Corp
Application granted granted Critical
Publication of CA1273323A publication Critical patent/CA1273323A/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0445Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system for preventing drug dispensing during a predetermined time period
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076Medicament distribution means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0418Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with electronic history memory
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0436Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system resulting from removing a drug from, or opening, a container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0481Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis
    • A61J7/049Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis automatically changing in response to a schedule deviation by the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/30Compliance analysis for taking medication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00General identification or selection means
    • A61J2205/70Audible labels, e.g. for pre-recorded info or messages

Abstract

CONTINGENT DOSING DEVICE

Abstract of the Disclosure A contingent dosing device which actively controls the pattern in which doses of one or more pharmaceutical preparations are administered to a patient. The device is programmed with information concerning an initial dosing regimen, and monitors deviations from that regimen. Based on the acceptability of the calculated deviations, the device may dispense or withhold medication. The invention also includes an automatic drug dosage compliance method using the contingent dosing device.

Description

CONTINGENT DOSING DEVICE

Backqround of the Invention 1. Field of the Invention This invention relates to the dis~ensing of eharmaceutical preparations. More particulally, the invention relates to a device for actively controlling ~
the pattern in which doses of one or more pharmaceutical preparations are administered to a patient.
2. Description of Backaround Art When a ehysician prescribes medication in a nonhospital setting or when an over-the-counter medication is sold, substantial reliance is placed on the patient to comply with the dosing instructions.
Unfortunately, even in the case of acute illness, `~ `` pa~ient compliance with the prescribed dosing regimen is often casual or negligent. This problem, as it is exhibited even among maximally motivated patients suffering from a disease as serious as glaucoma with associated loss of sight, has recently been discussed by M.~. Kass and associates in two papers appearing in Volume 101 of the AMERICAN JOURN~L OF OPHTHAMOLOGY at pages 515 and 5Z4. These papers pointed out that a substantial fraction of the patients took less than one half their required doses of sight-saving medication, that viLtually all of the patients reported that they took all of their doses and that the prescribing physicians were completely unable to accurately identify those patients who were not taking their medication.
This failure to properly self-medicate can lead to inaccurate feedback to persons monitoring the patient's progress and misinformation regarding t~le effectiveness ( ~3~

of the drug. Similarly, the dosing regimen initially set i~ o~ten inflexible and not designed to be easily modified to correspond to change~ in the patient'~
condition.
A number of devices have been proposed heretofore as aids to reliable se~f-medication. Th~se include:
- passive medication containers that segregate~
medicines according to the times they should be taken-(for example, the dispensing packages in which birth control pills are marketed):
- medication dispensers that provide clock-actuated alarms (see, for example, U.S. Pat. No.
3,651,984 to Redenbach);
- medication disp~ensers from which the patient can receive medication only within certain time intervals (see, for example: U.S. Pat. Nos. 3,722,739 to Blumberg: 3,762,601 to McLaughlin; and 3,815,780 to Bauer);
- medication dispensers designed for general use in therapeutics, lacking specifications peculiar to particular pharmaceuticals (see, for exam~le, U.S. Pat.
No. 3,911,856 to Ewing); and - medication dispensers that record the times at which the patient ~emoves medication (see, for example: U.S. Pat. No. 4,034,757 to Glove~; 4,360,125 to Martindale et al. 4,419,016 to Zoltan; and 4,504,153 to Schollmeyer e~ al.).
Other references relating to this general subject include the following: U.S. Pat. Nos. 3,369,697 to Glucksman et al.; 3,395,829 to Cogdell et al.:
3,917,045 to Williams; 3,968,900 to Stambuk; 3,998,356 to Christensen; 4,207,992 to Brown: 4,223,801 to Carlson; 4,258,354 to Carmon et al.; 4,275,384 to ~licks et al.; 4,361,40~ to Wirtschafter; 4,367,955 to Balle~
4,382,638 to Machamer 4,4~8,541 to Wirtscha~ter;
4,473,884 to Behl; 4,483,626 to Noble: 4,~so,711 to Johnston: and 4,526,~74 to Simon.
These prio~ art devices are sometimes helpful aids for improving the reliability of self-medication.
~owever, implicit in these devices is the assumption that dosage regimen and patient condition are unchanging. In the reality of everyday therapeutics,-however, both the prescription of drugs and the self-administration of drugs are subject to many contingencies, including, but not limited to:
- changes in the course or nature of the patient's disease:
- changes in the overall reliability with whi~h the patient takes a given medication:
- particular circumstances that may arise which will prevent the patient from faithfully following the prescribed regimen ~e.g., having no access to water, being preoccupied by other business, having previously exhausted the medication supply, or being in a social situation where self-administration of drugs would be embarrassing):
- changes in the patient~s physiological mechanisms of drug absorption, metabolism or excretion that necessitate changes in the dosing regimen and occurrences of acute nausea or vomiting that preclude the oral self-administration of a particular medication.
Summarv of the Invent_ Accordingly, it is an object o~ the present invention to provide a drug-dispensing device which facilitates the accurate self-administration of drugs.

~d33~3 It is another objeet of the present invention to provide a eontingen~ dosing deviee that can aeeommodate foreseeable eontingeneies which may acise during the medication-taking period.
It is still another obiect of the present invention to provide a contingent dosing deviee which includes an initial programmed dosing regimen, records deviations from that regimen, and instructs the patient~
as to whether a dose is proper at a given time.
It is yet another objeet of the present invention to provide a eontingent dosing device as above, in whieh the initial dosing regimen is later modifiable either automatically or by the patient.
It is a further object of the present invention to provide an automat;e drug dosage eompliance method.
It is still a further object of the present invention to provide an automatic drug do6age compliance `''` method, which method includes providing an automated dispensing deviee programmed with a dosing regimen, automatically computing a patient's deviation fcom the regimen, and informing the patient whether a medication dose is eroper at a particular time.
It is a general object of this invention to provide a device that can overcome the shortcomings of the prior art discussed above.
Additional objeets, advantages and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art on examination of the following, or may be learned by eraetiee of the invention.
In one aspeet of the present invention, a deviee is pcovided whieh is eapable of eontrolling in an !
~ ,~73~3 interactive or contingent sense the dispensing of a sequence of pharmaceutical doses to a pati~nt.
In another aspect this invention provides a device to correct at least partially the errors and deviations from the pharmacokinetic and pharmacodynamic ideal as encountered in self-m~dication in which device information regarding the ideal regimen is stored, deviations from this ideal are detected and pharmacokinetically and pharmacodynamically appropriate regimen modifications based on the deviations are selected and communicated to the patient.
The device includes a time counter capable of recording one or more starting times and of measuring at least one elapsed time period from the one or more starting times. The device also includes an electronic memory in which can be recorded an initial dispensing regimen (including information concerning the times for taking doses and information regarding acceptable deviations from the programmed times). The device is provided with a means for recording the times that the patient requests a dose of the drug and a means for determining therefrom the actual deviation from the prescribed regimen. The device compares the actual deviation with the preprogrammed, acceptable deviation and informs the patient whether the originally programmed dose may be taken, i.e., if the actual deviation is less than or equal to the acceptable deviation, the device will indicate to the patient that the originally programmed dose may be taken but if the actual deviation is greater than the acceptable deviation, the device will indicate that the originally programmed dose should not be taken or should be modified in some manner.

. .
.

-- ( ~
~733~3 This device, with its preselected d~via~ion ~windows~, doe~ not impose upon the patient an overly fussy precision in do~ing but rather maintains and adjusts where needed a schedule of self-medication so as to maintain levels or concentrations of drugs within the body within pharmacod~namically recognized upper and lower limits.
It is understood by those engaged in the science of pharmacodynamics that there is a certain imprecision in the definition of the upper and lower limits of drug levels or concentrations within the body. It is also known that there is a degree of imprecision in the defined relation between dosing and the ensuing time course of drug levels or concentrations within the body. Regimen adjustments made against these somewhat imprecise criteeia may, in general, be made in three ways:
1) by adjusting the time intervals between doses, 2) by adjusting the size of a dose given at one or more designated times, and 3) by a combination of adjusting time intervals and adjusting the size of the dose. However, this third method is potentially very complicated and confusing ~o the patient - time can be varied continuously but dose size generally can only be modified stepwise since drugs are most commonly formulated in unit dosage forms such as 100 mg or 250 mg tablets or the like. The present invention provides a device which can carry out such 3Q complex changes in regimen and facilitate the dosing in accord with the new regimen with a minimum of confusion.
In cectain embodiments of this invention, the device can additionally include a gate or valve or the like for controlling the dispen6ing of the dose. When - ( ~3 ( so configured, the device can carry out its informing~of the patient function by either dispensing a dose of the drug, refusing to dispense a dose, or altering the dose of ~he drug which i~ dispenses.
If desired, the dispensing regimen may be modified in response to contingencies beyond deviations in the patient~s drug requests such as changes in the patient's condition. In such cases the embodiment of the device includes means for inputting information regarding these additional contingencies.
In certain other embodiments the device of this invention can additionally include means for recording when drug doses are requested and/or dispensed. This permits healthcare professionals upon reviewing this reco~d to identi~y self-medication noncompliance and thus to correctly correlate the course of the patient's condition with the ~rue dosing of the drug.
In an additional aspect of the invention, an automatic drug dosage compliance method is provided.
The method entails providing a contingent dosing device as above, which device has a patient-portable memory unit, entering into the memory unit an initial dosing regimen capable of later modification, and controlling, based on either the initial or the modified dosing regimen, the dispensing of medication to a patient.

Brief Description of the Drawinqs In this specification and appended claims, reference will be made to the accompanying drawings in which FIG. 1 is a partially cross sectional, top plan view of a contingent dosing device according to an embodiment of the invention;

-3~ 3 ~3 FIG. 2 is a bot~om plan view of a eontingent dosing deviee shown in FIG. 1:
FIG. 3 is a peespective view of a eontingent dosing deviee shown in FIG. l;
5FIG. 4 i8 a top plan vi~w of the deviee shown in FIG. i with the earousel assembly cemoved.
FIG. S is a bottom plan view of the earousel assembly of the deviee shown in FIG. 1.
FIG. 6 is a funetional bloek diagram of the eireuitry within the eontingent dosing deviee aeeording to embodiments of the invention:
FIG. 7 is a sehematie showing an eleetrieal eireuit following the bloek diagram of FIG. 6;
FIGs. 8, 9, lo and 11 ace flow diagrams lS illustrating examples of dosing regimens as eontrolled by the contingent dosing deviee.

Detailed Deseription o~ the Invention FIGs. 1 through 5 illustcate one possible embodiment of the eontingent dosing device. The device is shown generally at 10, and ineludes housing 12 in whieh both the medieation and the eleetronie eireuitry of the invention ae eontained. In the embodiment shown, the housing 12 eacries a battecy aecess cover 11 and a key pad 13 which carries a numbec of pushbutton switehes whieh ean secve as on-off switches and also was a eort for the patient to input infocmation into the device, if ealled for. Housing 12 also is shown eaccying a data aeeess poct 57 through whieh pcogramming information ean be fed into the contcol ciceuit of the deviee oc ~hrough whieh data stored within the deviee ean be aeeessed by healthcare professionals.
~ nit doses of medieation 1~ sueh as tablets or eapsulffs are provided within dose apertuces 16 loeated 33~;3 _9_ within and disposed around the circumference of rotatable circular base 18 of carousel assembly 20.
- Cacousel assembly 20 also includes cotatable lid 22 coaxially aligned with and affixed to ciccular base 18
5 at a central ~lange 24 by means of retaininy collars 25 on centcal flange 24 protruding through central aperture 26 of base 18 and rotatably gripping the inner lower edge of apertuce 26. Flange 24 is sized to extend downward into the housing 12 of device 10 and has an inner diameter which will frictionally engage a center post 48 in housing 12 when carousel assembly 20 is in place on the device. Lid Z2 is provided with dispensing eort 30 which is adapted to align wi~h apertures 16.
The lowec surface of lid ZZ and apertures 16 ace essentially in contact so as to define a series of closed compartments. As base 18 is independently rotatable relative to lid ZZ, dispensing port 30 may be aligned with any one of compartments 16 upon rotation of base 18 relative to the lid 22. Thus, access to individual dosing compartments and the pharmaceuticals they contained may be gained thcough port 30.
Carousel assembly 20 is a sepacate integral unit or cartridge which is adapted to fit within recess 32 of housing 12. ~'hese carousels can be separately filled or refilled and marketed as called foc by the marketplace. The carousel is a fciction press fit onto center post 48 and may be cemoved thecefcom by lifting up on knob 34. When cacousel assembly 20 is fitted within cecess 32, pecimetec 36 of lid 22 rests on peripheral wall 38 of housing 12.
As is most clearly shown in FIGs. 5 and 4, the underneath surface of rotatable base 18 neac the flange surrounding aperture 26 carries an outwacdly extending wedge 40. When the cacousel assembly 20 is fitted 3%~
, within recess 32, wedge 40 is adapted to engage inwardly protruding end 42 of spring 44 coiled within circular enclosure 46 in recess 32 in housiny 12. The other outer end 45 of coil spring 44 is attached to fixed housing 12. When the coiling of~coil spring 44 is tightened, energy is stored which can apply a force against wedge 40 and thereby supply a driving force to cause carousel base 18 to rotate about center post 48 lo relative to housing 12 and lid 22.
Carousel base 18 is provided with a plurality of spaced apart ribs 51 disposed around the edge of the base's pe~imeter. Typically, the number and spacing of these ribs 51 corresponds to the number and spacing o~
the apertures 16 in the base 18. Each of these ribs is designed to co-operatively engage latch 52. When latch s2 engages a rib, it prevents rotation of the base 18 as dri~en by spring 44. Latch 52 is connected to lever 54. When lever 54 is depressed, it causes latch 52 to release its engagement with rib 51 and permits the base to rotate until the next rib 51 comes in contact with the latch. Thus, a single dose storage aperture is permitted access to port 30. Lever 54 can also serve as a sensor designed to signal to the device when a patient is requesting a medication dose (i.e., requesting access to one or more compartments 16 through dispensing port 30). This can be done by having lever 54 change a switch when the patient requests a dose by pressing it.
Lever 54 and latch 52 can also be equipped with a stop tnot shown) which can block the full movement of the lever and the subsequent release of the latch unless or until the device has determined that the requested dose is proper to dispense. In this case, the lever 54 sends the request signal to the device as previously described. In addition to signalling the cequest of a ~.2~

dose via the lever 5~, the movement of the latch and , movement of the rotatable base can also be used to drive a switch to signal that a dose has in fact been dispensed.
The device~s response to the patient request again varies witil the particular~embodiment of the invention. As just noted, one response can be to allow latch 52 to disengage and permit base 18 to rota~e and administer a dose of druy. Another response can be to not permit base 18 to rotate and thus to withhold the requested dose. The decision as to which action to take can be carried out as will be described hereinafter with reference to FIGs. 6-11. The response can also be a patient-detectable message such as an audio signal i.e an inte~nally generated audio signal (heard through gLating 56), a visual signal (message in~orming patient appearing on display screen 58) or a combination thereof.
FIG. 6 is a functional block diagram of the control circuitry of the device. In FIG. ~ a microprocessor unit 60 is provided which is the central logic unit of the device. A clock, or time counter 6Z, is also provided which is capable of recording one or more regimen starting times and of measuring elapsed time periods therefrom. Information concerning an initial dosage regimen is entered by a pharmacist or physician through the data communications interface 64 and stored in the PROM 66. (An initial dosage regimen might be, e.g., four 50-mg doses at once, ~ollowed by one dose every three hours.) The initial dosage regimen includes information relating to acceptable deviations from the programmed dosage times. When a patient requests a dose as outlined above, the dosage request sensor 68 is activated, and the fact and time of the request may, if desired, be stored in the event storage -3~3 --l.Z--RAM 70. Based on the foregoing information, the microprocessor will calculate the actual deviation of the time of the patient~s request from the acceptable deviation as initially recorded. If the actual deviation is less than or equal to the acceptable deviation, a dose will be dispen~èd but, if the ac~ual deviation is greater than the acceptable deviation, a do~e will be withheld. If the dose is dispensed, a dispensing means 72 will activate, e.g. in the embodiment described in FIGs. 1-5 above, base 18 would automatically rotate so as to align dispen~ing port 30 with a dosing compartment 16, thereby allowing the patient access to the drug.
Whether or not the actual deviation exceeds the lS acceptable deviation, the device can inform the patient as to the results of the comparison. An informing means 74 such as an audio or visual signal (o~ combination thereof), or a time lock, will instruct the patient as to whether a dose may be taken at the time requested.
For example, the device may be provided with either an alpha-numeric display or an electronically synthesized voice, or both, to permit communication with the patient. In addition, the device may include a responding means 76 such as a buzzer or the like to alert the patient when a dose is due to be taken.
In an alternative embodiment of the device, the informing means further includes: (1) a means for instructing the patient, e.g. with instructions regarding special conditions for taking the delivered medication, with instructions to to the patient to contact the patient's health care professional or to convey diagnostic information to that professional: and (2) a means for interrogating the patient as to the patient's condition. For e~ample, if the initially ~ r~l173~3 prescribed regimen requires one dose every four hours~
with an acceptable deviation, or window, of one-half hour on either side of the dose time, and a patient requests a dose two hours early, the device will interrogate the patient as to the reason for the early request such as through the informing means 7~. The patient then responds through the data communications interface 64, and if, for example, the dose has been requested early because of pain or a worsening of the patient~s disease state, the device may take additional action such as to alert the patient to contact the patient's health care professional. If the patient has re~uested an early dose accidentally, the patient may so inform the device through the data communications interface 64 and wait for the recorded dose time. If a patient has requested a dose two hours late, the device may inquire, for e~ample, if a pill was dropped or lost, or if undesirable side effects warranted putting off of the medication, etc. Ayain, the patient may respond through the data communications interface, either by suitable electrical switches-and/or by electronic speech recognition, and the device may either modify the regimen accordingly (e.g., in the case of an accidental late dose, modifying the entire regimen so as to shift all doses by two hours) or instruct the pa~ient to contact his health care professional (e.g., in the case of severe side effects) with, optionally, diagnostic information ascertained by the device.
The informing means may be tailored to the amount of detail desired or needed by the patient, which may deeend on the patient's understanding of the nature of his or her disease, on the nature and rationale of the various medications prescribed therefor, and on changes in the patient's familiarity with the content ~ ~733~

and style of the instruetions. The informing means may also be designed 60 as to avoid eonsistently identical phrasing or otherwise cepetitive instructions.
The instructing means may be in the form of an audio or visual message to the patient to call his or her health eare professional. ~lternativelY, the instrueting means may be such that the device ean eontaet the health care professional directly, sueh as , by means of a eordless phone.
The device is additionally provided with a means for modifying the initial regimen,-either automatically or by the patient, physician or pharmacist. For example, if a patient has requested a dose late, i.e. outside the acceptable deviation from the ~ecorded dosing time, the device may be programmed to shift the entire dosing regimen by the actual time deviation. Alternatively, the patient or pharmaeist may ,~ ~ repcogram the device to aeeommodate ehanges in the reglmen. This eapability of modifying the initial dosage cegimen entails receipt by the device and its contained logic unit of eneoded radio signals, direeting a change in regimen. To this end, the dispenser includes a means for reeeiving and deeoding radio signals that have been especially coded to maintain confidentiality and avoid mistaken aetivation due to receipt of unrelated radio signals.
The device is also capable of operating as above based on the modified regimen. That is, the modified regimen will inelude information based on aeeeptable deviations from the dosing times as modified, so that dispensing of medieation will be eontrolled by the deviee as above foc the initial dosing regimen.
The device may also allow for the type and strength of drug loaded into the di~pensec, whieh r information could be included as part of the initial recorded dosing regimen. If a patient were to request an additional dose of a drug, or an early dose, the device would thus take into account any difficulties that might arise as a result of a higher dose.
The time counter in the device of the present invention may, if desired, record the times at which a patient received each dose throughout a dosing regimen.
Thus, a dosing record is created which is useful for later examination of patient compliance. Such a com~liance monitoring system is clearly useful to confirm drug efficacy and the like.
FIG. 7 is a schematic illustrating a circuit embodying the circuitry diagrammed in FIG. 6. The same identifying numbers are used in each of these figures for the same parts. In this schematic, microprocessor 60 is a type 8085 unit. Clock 62 is a MM58167A clock circuit controlled by crystal 63. Data interface 64 includes a data reception port and a data transmission port. These ports operate in RS232 format and the interface includes a circuit to convert these signals into a voltage usable in the microprocessor 60. The program storage 66 is a 32K ROM and the évent storage 70 is an 8K RAM. The dose request sensor 68 is an electrical switch. In FIG.s 1-5, this switch is shown as 50. The circuit shown in FIG. 7 has provision for data input from the patient. This is in the form of numeric keyboard 78.
The circuit of FIG. 7 also provides a variety of output signals. These signals include a drug dispensing event. This event is provided by solenoid 72 controlled off of pin Q3 of central status register 80.
This register is in turn controlled by microprocessor 60. Solenoid 72 can release the latch 52 as shown in ~

~æ733~3 FIG. 4 and thus deliver a dose of drug as described in reference to FIG. ~. Pin Ql of status regi~ter ~0 eontrols a flashing LCD which funetions as responding means 76 to signal when a dose should be taken. Pin ~4 of register 80 can control an audible beeper to also signal when a dose is to be taken~ Output signals can also take the form of visible alpha-numeric messages dis~layed on an LCD such as 58 in FIG. 3. This LCD is not directly shown in FIG. 7 but 74 is an interface to which a standard display can be connected. ~he circuit of FIG. 7 additionally contains audible output stage 82. This stage includes a speaker 84 which can enunciate a variety of audible messages stoced in digital form in the device's memory.
The pLesent invention also encompasses an automatic drug dosage compliance method u~ing the contingent dosing device as described above. The method includes recocding in a patient-eoctable memory unit, such as the program storage ROM 66 of FIG. 7, information concerning an initial dosage regimen, the initial regimen compcising times for taking doses in a specified sequence as well as information regacding deviations thecefcom. After this recocding step, and after the stact of the dosing cegimen, the device determines when a patient is requesting a dose by noting signals fron dose request switch 68, and calculates the actual deviation of the request times from the cecorded dose times. The actual deviation is compared in microerocessor 60 to the acceptable deviation set forth in the regimen, and the time difference therebetween is derived. Based on the derived time difference, a dose may or may not be dispensed such as by the action of solenoid 72. The method may include optional steps, i.e. modifying the initial regimen, informing the ~ ( !

patient as to the time a dose should bff taken (e.g., by audio or visual means or both), and instructing the patient to call his or her health care professional with, oetionally, diagnostic information.
The contingent dosing device and me~hod of the present invention thus accommodat~e a wide variety of contingencies which may arise during a drug adminis~ration sequence. The device of this invention will thus can be set up to accommodate situations such as: (l) when a patient seeks to remove more than the scheduled quantity of a drug; (2) when a patient drops or otherwise loses a unit of dispensed medication; (3) circumstances in which it is not possible for the patient to take the dispenser with him or her and so lS seeks to remove sufficient medication to cover the anticipated interval away from the dispenser; (4) when the patient seeks additional medication for a worsening condition; and/or (S) when the patient seeks lower dosage because of undesirable side effects or an improvement in condition.
While the invention has been described in conjunction with the preferred specific embodiments thereof, the foregoing description as well as the examples which follow are intended to illustrate and not limi~ the scope of t~le invention, which is defined by the scope of the appended claims. The following examples illustrate representative dosing regimens and contingencies which may arise during the regimens. They also ill~strate how the dosing device of the invention ~0 responds to and accommodates these contingencies.
Reference will be had in these examples to the flow charts of Figures 7-lO.

~ ~ 3 3~

ExamPle 1 Administration of Diaoxin Pursuant to a Mandated Reaimen Beainninq with a Complex Sequence of Initial Loadinq Doses A mandated digoxin regimen as ac~ommodated by the device o~ the present invention is illustrated in the flow chart of FI~. 9. With this drug an initial loading regimen is provided for the first N doses ~ollowed by a maintenance regimen for later dosings. To achieve the propec maintenance levels succes6ive doses must be separated by at least 20 hours but by less than 54 hours. In the initial regimen the number of tablets dispensed is a function of N and time (t), FI(N,t).
In the steady state regimen the number of tablets dispensed is F(N,t). After the initial request, the device detecmines whether the number of the cequested dose is less than or equal to N; if this is the case, FI(N,t) tablets are dispensed, and the device issues a message to the patient to take the dispensed dose with a full glass of water. If the number of the requested dose is greater than N, the device goes on to analyze whether the elapsed time since the previous dose (t) is less than twenty hours. If so, the patient is instructed to wait 20-t hours before taking a dose. If more than 20 hours have passed, but less than 54 hours, F(N,t) tablets are dispensed, and the patient is again instructed to take the dose with water. If more than 54 hours have elapsed since the previous dose, the patient is instructed to call his or her physician, as the actual deviation has exceeded the programmed acceptable deviation.

~33~

Example 2 Codeine ~ As-Needed~ Reqimen Refecence is now had to the flow chart of FIG.
8. In the codeine regimen shown there, one pill is to be taken no more often than every fouc hours as needed for pain. In the flow chart of F~IG. 8, "t" is an elapsed time recorded in a re~ifiter which resets t to 0 each time a dose is dispensed. Initial]y, t is set to 4 hours (t=~) so that the first dose will automatically be delivered upon demand. Thereafter, when the patient requests a dose, the device determines whether t is greater than or equal to 4. If not, the dose is refused, and the patient is instructed to wait for 4-t hours until taking a dose. If t is greater than or equal to 4, a dose is diseensed and the timer is reset to 0 (t=0).

Example 3 . ~ ~, , .
Warfarin -- Mandated Reqimen with a Lonq Half-life, RoutinelY
and FrequentlY Monitored Druq A warfarin, mandated regimen is illustrated in the flow chart of FIG. 10. A preprogrammed first dose is administered followed by dosages determined by a function F which calculates the current dose based on the east n dosing times and amounts. No dose is dispensed if the patient has taken a dose within 20 hours or if more than 54 hours have elapsed since the patient took the last dose. In the latter case, the patient is informed to call his or her doctor. The function F allows the dispensed dose to be increased to compensate for the patient's having gone, e.g. 48 hours without having taken a dose. The function F ifi subject to fortnightly to monthly revision in light of tests per~ormed at those intervals to determine the maginitude of warfarin~s anticoagulant ef~ect in the patient. Such periodic revision is easily programmed into the device~
o~ this invention but is confusing for patients to master independently.

~ ple 4 Tetracycline -- A Mandated Reqimen _ith a Druq Havinq a Co~lex Interaction with Food The flow chart of FIG. 11 illustcates a tetracycline regimen. One capsule is to be taken four times a day. If a patient misses a dose, then two caesules are to be taken at the next dosing time. Two capsules are also to be taken at bedtime in order to compensate for the greater than six hour interval between the bedtime and awakening doses. It will be appreciated that such within-day variations in dose are usually not prescribed in current practice, even though they may be pharmacokinetically preferable, because they ` `tend to confuse eatients. In no case should more than two pills ever be taken at one time. The regimen allows for a two hour window around the scheduled dosing time.
Tetracycline should only be taken on an empty stomach.
Therefore the regimen provides ~hat the device will interrogate the patient as to when he or she last ate.
If at least two hours have passed since eating, and the other conditions are met, a dose will be administered.
If two hours has not elapsed since eating the dose will be denied and the device instructs the patient to wait at least two hours after eating before taking a dose.
When a dose is administered, the patient receives instructions to take the medication with a full glass of water and further instructed to not eat for 1/2 hour after taking the dose. The device can recocd whether a dose is a bedtime dose and whether the previous dose was taken or missed.

Claims (30)

WHAT IS CLAIMED IS:
1. A contingent dosing device for controlling the dispensing of a drug to a patient, comprising:
a time counter capable of recording one or more starting times and of measuring at least one elapsed time period from the one or more starting times:
means for recording an initial dispensing regimen, said regimen including information concerning the times for taking doses in a specified sequence and information regarding acceptable deviations therefrom;
means for relating the start of said dispensing regimen to a time recorded or measured by the time counter;

means for determining when the patient requests to take a dose of the drug:
means for calculating the actual deviation of the request from the recorded dosing time of said regimen;
means for comparing the actual deviation with the acceptable deviation set forth in the regimen and deriving the time difference therebetween: and means for informing the patient as to the acceptability of said time difference, whereby if said actual deviation is less than of equal to said acceptable deviation, a dose is dispensed and whereby if said actual deviation is greater than or equal to said acceptable deviation, a dose is refused.
2. The device of claim 1, further including a means for modifying the initial regimen to yield a modified regimen to accommodate the actual deviation.
3. The device of claim 1, further including a means for modifying the initial regimen to yield a modified regimen when the actual deviation is greater than the acceptable deviation.
4. The device of claim 2, wherein the means for determining said actual deviation includes a means for basing this deviation on said modified regimen.
5. The device of claim 1, further including a means for recording the times at which said requests are made.
6. The device of claim 1, additionally comprising a means for controlling the delivery of the dose of the drug to the patient.
7. The device of claim 6, additionally comprising means for recording the times at which a dose is requested.
8. The device of claim 6, additionally comprising a means for recording the times at which a dose is delivered.
9. The device of claim 6, wherein the means for informing the patient includes a means for varying the delivery of the dose of the drug to the patient.
10. The device of claim 6, further including a means for recording the dose that is delivered and the times at which said dose is delivered.
11. The device of claim 10, wherein the means for informing the patient includes visual display means.
12. The device of claim 10, wherein the means for informing the patient includes audible signalling means.
13. The device of claim 1, wherein the means for informing the patient includes a means for instructing the patient.
14. The device of claim 13, wherein the means for instructing the patient includes a means for instructing the patient to contact the patient's health care professional.
15. The device of claim 14 wherein the means for instructing the patient includes a means for instructing the patient to convey diagnostic information to the patient's health care professional.
16. The device of claim 1, additionally comprising a means for informing the patient when to request a dose according to said initial regimen.
17. The device of claim 2, additionally comprising means for informing the patient when to request a dose according to said modified regimen.
18. The device of claim 1, further including a means for interrogating the patient during the dosing regimen.
19. The device of claim 18, further including a means for modifying the regimen based on the results of said interrogation.
20. A contingent dosing device for controlling the dispensing of a drug to a patient, comprising:
a time counter capable of recording one or more starting times and of measuring at least one elapsed time period from the one or more starting times:
means for recording an initial dispensing regimen, said regimen including information concerning the times for taking doses in a specified sequence and information regarding acceptable deviations therefrom:
means for relating the start of said dispensing regimen to a time recorded or measured by the time counter:
means for determining when the patient requests to take a dose of the drug:
means for calculating the actual deviation of said request from the recorded dosing time of said regimen:
means for comparing the actual deviation with the acceptable deviation set forth in the regimen and deriving the time difference therebetween: and means for informing the patient's health care professional as to said time difference.
21. An automatic drug dosage compliance method, comprising the steps of:
(a.) recording in a patient-portable memory unit an initial dispensing regimen, said regimen including information concerning the times for taking doses in a specified sequence and information regarding acceptable deviations therefrom:

(b.) determining the times when a patient requests to take a dose of a drug:
(c.) calculating the actual deviation of the request times from the recorded dosing times;
(d.) comparing the actual deviation with the acceptable deviation set forth in the regimen and deriving the time difference therebetween; and (e.) automatically informing the patient as to the acceptability of said time difference, whereby if said actual deviation is less than or equal to said acceptable deviation, a dose is dispensed and whereby if said actual deviation is greater than or equal to said acceptable deviation, a dose is refused.
22. The method of claim 21, further including modifying the initial regimen to yield a modified regimen when the actual deviation is greater than the acceptable deviation.
23. The method of claim 21, wherein said calculating of the actual deviation is based on the modified regimen.
24. The method of claim 21, additionally comprising controlling the delivering of the dose of the drug to the patient.
25. The method of claim 24, wherein the informing the patient includes varying the delivering of the dose of the drug to the patient.
26. The method of claim 21, wherein the informing the patient includes visual displaying.
27. The method of claim 21, wherein the informing the patient includes audible signalling.
28. The method of claim 21, wherein the informing the patient includes instructing the patient.
29. The device of claim 21, additionally comprising informing the patient when to request a dose.
according to said initial regimen.
30. The device of claim 21, further including informing the patient when to request a dose according to said modified regimen.
CA000544750A 1986-08-22 1987-08-18 Contingent dosing device Expired - Fee Related CA1273323A (en)

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US899,412 1986-08-22
US06/899,412 US4725997A (en) 1986-08-22 1986-08-22 Contingent dosing device

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DE3783430T2 (en) 1993-05-06
JPS63212362A (en) 1988-09-05
EP0265049A2 (en) 1988-04-27
EP0265049A3 (en) 1989-11-29
US4725997A (en) 1988-02-16
ATE84373T1 (en) 1993-01-15
DE3783430D1 (en) 1993-02-18
EP0265049B1 (en) 1993-01-07

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