Patent Application
20080027291
The present invention relates to the field of administering medicine. Specifically, the present invention relates to monitoring patient compliance with a prescribed treatment regarding the time of consumption, frequency and amount of medicine taken.
Patient compliance is critical in the effective use of pharmaceuticals. The term “patient compliance” within the pharmaceutical industry refers to taking the proper type and amount of a medication at the proper time interval.
When new drugs are tested, compliance is extremely important in determining the effectiveness and side effects of drugs being tested. If patients skip doses, an effective drug may be mistakenly determined to be ineffective because it was not taken properly. Thus, millions of dollars of developmental costs as well as FDA approval may be lost by an otherwise effective drug due to lack of patient compliance. Conversely, negative side effects may not become evident during testing if patients do not take medication regularly enough to produce the negative side effect. The result could be that a potentially dangerous drug will be approved for use by the public. Drug recalls, negative publicity and lawsuits are all potential detriments which could be suffered by the companies involved in marketing a drug, as a result of lack of patient compliance.
Patient compliance is an important factor in determining effectiveness and side effects of new drugs, it also critical in the determination of proper dosage of a new drug. When patients don't take the prescribed amount of medication at the proper time, a new drug could be released into the market with recommendations for an improper dose. This may lead to lack of effectiveness, greater occurrence of side effects, and increased drug interactions.
While most interested parties would agree that compliance is extremely important, there are not many widely used systems for insuring patient compliance. Pre-printed fold-over blister cards are common in the clinical trial industry. Cards are printed with easy to understand graphics and text instructing the patient exactly what medication to take at the designated time. Slowly, such pre-printed cards are making their way into the commercial/retail marketplace with great success.
Easy to read instructions are a critical first step, yet they do little to provide actual patient compliance information back to the physician, clinician, or other involved party. Despite the fact that cards may have an area to write-in information about the time of dosing, patients often forget or may write false information in order to avoid criticism from the health care provider. It is possible that many individuals will skew information to show greater compliance as a means to achieve acceptance and avoid disapproval as well as possible termination as a participant in a clinical trial.
While there are some materials which pertain to the field of medication disbursement and recording information, such devices generally involve elaborate systems for dispensing the medication. Existing products attempt to control the dispensing of medication. Such systems are too complex to be cost effective, are too limiting with regard to the type of medications dispensed, may require repackaging of product into their dispensing system, tend to provide unreliable data, may not be child resistant, and can be perceived as too controlling by the patient.
U.S. Pat. No. 6,529,446 B1 to de la Huerga provides a good example of an elaborate system for dispensing medication. Exact time of dispensing is recorded via doors that open in the top of a system. While such a system has the potential of working, it is not portable, and is too large, awkward and expensive to be cost effective and convenient. Furthermore, any system such as this that controls or overtly monitors medication by opening doors or compartments can be perceived as overly controlling.
Attempts to include circuitry into blister cards can have two major drawbacks. First the cost of such a system is high. Each card may need to be manufactured with radio frequency ID chips, batteries or extensive circuitry wiring. Such high tech systems are delicate and may malfunction in normal conditions. Bending such a card could result in the computer recording doses taken when only a wire has been broken inside the card. False data will be an inevitability involved in such a systems and quickly invalidate patient data from a clinical trial. Thus, there is a need for a device which can monitor patients' adherence to medication regimens and is inexpensive. There is also a need for a device that is far less complex than other devices currently available.
The present invention is an apparatus for monitoring patient compliance in the administration of medication. The apparatus includes a recording device for recording data related to administration of said medication to a patient, a collecting device and an electronic transmitting device for transmitting, via an electronic link, data to the collecting device. The data is related to administration of the medication and includes time and date of administration. The data may consist of many types of data such as patient identification information, medication identification information, dose consumed, reported side effects, severity of reported side effects, delays in consumption of said medication, text notes by said patient, and text notes by any other individual.
The medication and the apparatus are attached to a blister card and the device alerts a patient to the time of the next dosage of the medication.
Other objects, features and characteristics of the present invention, as well as the methods of operation and functions of the related elements of the structure, and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following detailed description with reference to the accompanying drawings, all of which form a part of this specification.
A further understanding of the present invention can be obtained by reference to a preferred embodiment set forth in the illustrations of the accompanying drawings. Although the illustrated embodiment is merely exemplary of systems for carrying out the present invention, both the organization and method of operation of the invention, in general, together with further objectives and advantages thereof, may be more easily understood by reference to the drawings and the following description. The drawings are not intended to limit the scope of this invention, which is set forth with particularity in the claims as appended or as subsequently amended, but merely to clarify and exemplify the invention.
A detailed illustrative embodiment of the present invention is disclosed herein. However, techniques, systems and operating structures in accordance with the present invention may be embodied in a wide variety of forms and modes, some of which may be quite different from those in the disclosed embodiment. Consequently, the specific functional details disclosed herein are merely representative, yet in that regard, they are deemed to afford the best embodiment for purposes of disclosure and to provide a basis for the claims herein which define the scope of the present invention.
Moreover, well known methods and procedures for both carrying out the objectives of the present invention and illustrating the preferred embodiment are incorporated herein but have not been described in detail as not to unnecessarily obscure novel aspects of the present invention.
The present invention is a device for recording data (i.e. time, date and type of medication taken) related to patient compliance with drug regiments. Under clinical testing condition or when medication is administered to a patient in a hospital, the container in which the medicine is administered would contain an electronic device capable of recording the date and time when the device is activated, as well as any other relevant information, and transmitting such data to a central computer (i.e. server).
When a patient is given a drug the patient would activate the data recording device when taking the drug, by pressing a button on the device, the device would then record the time and date at which the patient consumed the medication and transmit this data to a data storing server. Such data can be reviewed by any relevant medical professional (i.e. doctor, testing technician, etc.) from a computer to ensure that a patient is compliant with medication regimens designed to either treat a patient or test a medication.
Referring to
Rather than writing the time of dispensing the medication on the blister card 101, the patient will simply press the button 102 to record this event. Because the patient has no ability to alter the time/date on the device 103, they can not record information other than the actual time and date of each event.
Compliance with a schedule can be further increased with the addition of a reminder signal. The lighting of LED 104 with the speaker 106 emitting an audible alarm would remind the patient that it is time to take the medication. For example, a LED 104 that glows green 10 minutes before the exact prescribed time of dosing, indicating that it is now OK to take the medication, this could be combined with three audible beeps to attract attention.
If the patient has not already pressed the button 102 to record the event at the time of the dose, the speaker 106 would beep 5 times. The LED 104 would then turn to blinking orange 15 minutes after the recommended time of dosing. After a certain time period, when the dose should be skipped, the LED 104 would blink red. Printed instructions 105 on the card would direct the patient to respond to different colors of LED 104 and different audible signals emitted by speaker 106. One example would be that the patient would press the button 102 to reset the device and skip the dose and leave the dose in the card 101. Each medication or clinical trial could have its own customized design as to the precise compliance requirements. The signaling methods could be adjusted to cater to the needs of a particular study, without departing from the spirit of the present invention.
Shown in
The time and date recording device 103 is adhered to the blister card as in
Instead of the LED 104, a liquid crystal screen 201 could be used to display the exact amount of time until the next dose, or the amount of time until the dose is overdue. Only the device 103 adhered to the card would have the time/date recording button 102. This would reduce the ability of the patient to record an event unless they have the blister card 101 with the medication in their hand. The two devices synchronize with each other by means of radio frequency communication, or the reminder device 200 could simply have an alarm reset button 202 which would not record any actual time/date information.
The device 103 has a simple wire socket 301 to hook up wiring to the device 103. The patient downloads the information on device 103 to a computer for analysis by an electronic means such as radio frequency communication means 301, optical signal transmission means 303 (i.e. infrared LED), or by wire connection 302 to wire socket 301. Because the device 103 is not hidden inside the blister card 101, the data can be recovered by any conventional means. Other devices must rely on RFID transmission because they have been designed with no means to connect wires. Any other conceivable method of data transfer may be used without departing from the spirit of the present invention.
In yet another embodiment of the invention, as depicted in
Any other data input means maybe used without departing from the spirit of the present invention. It is possible that the computerized device 500 could be existing technology such an existing Personal Digital Assistant (PDA).
This device 500 could be configured to record multiple medication regimens. In such a scenario, it is preferred that the device 500 not be adhered to the container, whether it is a blister package 101 or a pill bottle 509. A method for reliably recording that the medication was present at the time of the event recording may be used. This could be established by the use of RFID tags 503 on or in each medicine container, the printing of barcodes 504 on the container, such as blister card 101 or pill bottle 509, wire socket 301, or the use of an alphanumeric code system 506.
With the RFID system, the card 101 containing the RFID tags 503 would need to be within the reading range of the computerized device 500, for the device 500 to acknowledge the medication and to record the event of the dispensing of that medication. With printed barcodes 504, the computerized device 500 would be equipped with a LED barcode reader 507 or a camera system to read the barcode 504. Wire hookup would entail a simple chip 508 possessing a socket 301 attached to the pill bottle 509 or blister package 101, and the data recording device to have a socket 301 capable of receiving the same type of wire connection 302 as the chip 508, thus verifying the presence and type of medication as well as identifying the medication.
In an alphanumeric system, the container would have information on it such as alpha numeric code 506 or the prescription number. The user would key in the number from the package in order to verify that they are indeed looking at the package. In this scenario, patients would be instructed not to copy down the alphanumeric code 506 elsewhere.
As shown in
The portable electronic data recording device 500 will allow more information to be recorded by the patient, and thus increase the amount of information to the healthcare provider. Because of the interactive nature of a PDA or similar device, the patient could be asked questions about their health at regular intervals, such as at the time of dosing of medication. Through software programming, the questions could be adapted to the responses of the patient.
By asking the questions at time of the event, the patient can provide more accurate responses to the questions than if they were to wait until their next doctor's appointment. Furthermore, when necessary, the system would follow-up with more in-depth questions thus providing more feedback to the physician. By having the system ask a number of predetermined questions closer to the event, important questions will be asked. When the information is downloaded to the healthcare provider, problems could be flagged for follow up, thus reducing the possibility that a serious side effect or problem will be overlooked. Recording of the exact time line of positive effects of a drug can be critical information for the physician or clinician.
If the patient overrides the dose in step 804 the patient may choose to inform the system that the medication will be taken later in step 806. This may be done outside of observation. Once the patient returns to the testing facility or observation area the time when the patient ingested the medication is recorded in step 807. Then that particular dose is flagged as an overridden dose in step 808.
Patients with too many dose overrides could be identified and reviewed. In the case of a clinical trial, non-compliant participant's data could be reviewed and/or removed from the drug study. In the general population, physicians would be alerted to the lack of patient compliance as part of their overall assessment of the patient's condition.
This system can also be used to instruct patients how to handle missed or skipped doses. Because the system knows how long it has been since the last dose, it could instruct the patient to take double the medication, skip a dose, or set up an accelerated dosing pattern to get the patient back on the proper schedule. The exact choice for such handing of missed doses would be pre-programmed into the system by the health care provider and can be tailored to the particular medication taken.
It is also contemplated that drug interaction of existing medications could be uploaded into the system, and that all medications would be checked against each other to reduce the possibility of interaction.
Yet another embodiment of the device is depicted in
The system shown in
The system in
Confirmation of dosing can be received via voice recognition. The system would also be able to warn patients of mixed up medicine containers between individuals in a household. Thus a wife would be less likely to take a husband's medication because all medication would be identified by system prior to dispensing.
Additionally, the electronic device which monitors compliance can be read by the doctor at regular check-up intervals. If the device was hooked up to a central computer at the user's home or at the pharmacy, non-compliance could be identified and automatic emails to the physician and/or responsible caregivers (i.e. family) would be generated to alert them that the patient has exceeded some minimum compliance requirement. An example would be that if a patient misses 3 or more doses in a week and their caretaker and the physician are alerted via email, text message or other electronic means. By downloading the compliance data to a home PC or other device with internet access, such non-compliance would be detected quickly, before health consequences occur.
Up to the minute recording of medication is critical to emergency care givers responding to patients in medical crisis. Information about the previous 48 hours of medication is of utmost importance in such cases. In such a scenario, the EMT would simply have to bring the medication computer to the emergency room to read a full record of the patient's current medications, dosing levels and time of dosing.
Elaborate dosing regimens such as AIDS drugs and diabetes medication would be excellent uses of the present invention. It is contemplated that the system could easily interface with blood glucose readers to record critical blood sugar levels as well as to record the medication taken. This could include user input data for injected insulin as well as recoding information about current health conditions.
By recording this data in one device, data analysis would be greatly simplified, with trends and statistical factors more accurately identified. Even though complex regimens would be most important for this system, it could be used by anyone on a drug therapy to help boost compliance and aid in the convenience of medication dispensing.
Once data is downloaded, it can be analyzed by software to determine the compliance rate of a given patient. Coupled with medical records, compliance can be factored into the effectiveness rating of the drug. With this critical information, bad data may be eliminated from drug studies leading to more accurate evaluations of drugs under review.
In the case of the consumer, the physician may encourage stronger adherence to the dosing instructions before changing a medication. The result could be greater effectiveness of preferred medications; thus reducing the reliance on more dangerous medications, surgeries, or other intrusive therapies. In an environment where information is critical to accurate decision making, accurate dosing information and compliance to the prescribed regimen is critical. A simple, low cost, easy to use device can greatly aid in the flow of information back to the health care provider.
While the present invention has been described with reference to the preferred embodiment and alternative embodiments, which have been set forth in considerable detail for the purposes of making a complete disclosure of the invention, such embodiments are merely exemplary and are not intended to be limiting or represent an exhaustive enumeration of all aspects of the invention. The scope of the invention, therefore, shall be defined solely by the following claims. Further, it will be apparent to those of skill in the art that numerous changes may be made in such details without departing from the spirit and the principles of the invention. It should be appreciated that the present invention is capable of being embodied in other forms without departing from its essential characteristics.
This application claims the benefit of application Ser. No. 60/830,049, filed Jul. 11, 2006, which is incorporated herewith.
| Number | Date | Country | |
|---|---|---|---|
| 60830049 | Jul 2006 | US |
