Patent Application
20120053437
This invention is directed to a low cost, highly informative and effective method of medically prescribing drugs or foods and food supplements to patients. It permits tracking of the patient's consumption of the prescribed drug, food and/or food supplement and enables cost effective supervision and evaluation by a physician or other qualified medical supervisor of the use of the prescription through the use of software and/or the internet. One focus of these disclosed inventions is to facilitate low cost, effective, documented compliance with the medical food guidelines and provisions of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) as well as the guidelines of the Office of Orphan Products Development (OOPF) within the Federal Food and Drug Administration of the U.S. Department of Health and Human Services. Requirements of those guidelines include evaluation and ongoing medical supervision of a specifically formulated and processed food product that is intended for the dietary management of the patient with special medical needs.
The stated requirement of “medical supervision” for the use of a prescribed medical food raises the immediate fears and concerns of high cost, expensive methods and procedures with exasperating, long term preventative healthcare services. This requirement also implies the usual delays and impediments of continuous, high cost visitations with physicians, of laboratory tests, of delayed evaluations, of delayed communications from busy physicians, together with undesirable waiting for information of the effectiveness of the use of the prescription. The present inventions are directed towards the elimination of these problems and the implementation of cost effective “medical supervision” of medical foods. Both patients and medical providers will find the instant inventions effective in prescribing drugs and/or medical foods, in tracking consumption, providing discipline and certainty in consumption, evaluating clinical therapeutic effects and providing early identification of potential adverse effects and enabling effective medical provider supervision in instances extending beyond medical foods.
On belief, the prior art contains teachings of Electronic Medical Records (EMR) for patient's that are maintained on computer servers providing access to the medical providers including treating physicians as well as clinic and hospital staffs, and in some cases to billing offices. As a general rule, however, most of the data contained in those EMR's are entered and used by the Clinic and hospital staff such as the laboratory, nursing staff, physicians, etc. In some instances, patient portals may be provided, but, on belief, such portals are not intended as a means of physician supervision, disciplined consumption and evaluation. Indeed, as a general practice, it seems that the physician examines the patient, determines the needs of the patient, prescribes medications and schedules follow-up examinations to evaluate the effectiveness of the prescriptions and exercises primary control over the EMR. Such follow-up exams require time of the patient and the physician, are spaced apart to minimize time and dollar costs and provide little, if any, intervening patient supervision and/or encouragement. Indeed, in many instances, a physician may well prescribe a medication, a dietary procedure, a daily blood sugar or heart rate determination of the patient—and, without adequate supervision or discipline, the patient forgets, or ignores the prescription and/or the instruction and, consequently, the adverse patient condition continues with cost to the patient, the insurance company, the medical providers, etc. The present inventions are constructed to deal with the patient problems of forgetfulness, of lack of discipline, and when needed, lower costs of ongoing supervision and evaluation, etc.
There is also movement in the public to provide a more patient-centric electronic health record. A number of companies now offer web-based electronic medical record completely in the control of the patient. The more prominent of these companies are Google and Microsoft with Google Health (http://www.google.com/health/) and Microsoft Healthvault (http://www.healthvault.com), respectively. Both products allow the patient to organize and maintain medical information on-line and such may include information relating to prescriptions, immunizations, history of surgeries, etc. On belief, they also allow the patient to control who can access the information. Though the products allow for patient data input and information sharing, they do not intend to facilitate supervision, medical compliance by the patient, evaluation of clinical therapeutic effects and/or early identification of potential adverse effects from the medical food prescription. They largely reflect an electronic version of a filing cabinet similar to what a patient may use at home to maintain records together with limited accessibility by others.
The present inventions comprise methods that provide and facilitate assurance of effective compliance with the physician's instructions and prescriptions and with the “medical food” provisions of the Orphan Drug Act and the related Code of Federal Regulations (21 CFR 101.9(j)(8). Moreover, these inventions go further and confirm compliance by the patient with the physician's instructions pertaining to the prescription, provide daily communication of that compliance to the physician or other medical provider's, facilitate continued medical supervision and further provide continuous, ongoing feedback of information pertaining to the effectiveness of the prescription—all with the intended purpose of insuring patient compliance and effective results and lack of adverse effects—while and eliminating the patient's lack of understanding, forgetfulness and/or, lack of discipline on a daily basis. These methods begin with a physician's medical examination and evaluation of the patient's needs, his prescription responding to those needs, computer program access for the patient through a patient portal as well as access by the physician and/or other medical supervisory medical providers (an Online Patient Supervisory Group), the laboratory and the pharmacy or other distribution facility which provides the medical foods.
Subject to the privacy rules of HIPPA, the methods of this invention includes entry of the lab work into the patient's portal, entry of the physician's prescriptions, the date of supply of the prescription and regular daily entry thereafter of physiological information by the patient and/or the laboratory. For example, if a physician examines an obese individual and identifies the condition of insulin resistance or pre-diabetes and prescribes a special dietary food that may also assist in preventing progression of this condition to type II diabetes, the physician may enter the prescription on the patient's medical record which is accessible by the portal, or directly into the patient portal. In addition, the laboratory might enter the blood sugar level while the pharmacist would enter the date on which the prescription was filled together with the quantity. Thereafter, the patient might confirm his consumption of the dietary medical food by date and time and also ascertain such physiological factors as weight, heart rate, blood pressures and blood sugar level as indicated by standard scales, blood pressure cuffs and blood glucose monitoring units. The patient would then regularly enter such physiological data into his patient portal for review by his physician and/or the Online Patient Supervisory/Compliance Group which is competent to routinely access the patient's portal, review the entries and ascertain the effectiveness of the prescription. Moreover, if the data is not properly entered, the physician or the staff of the Online Patient Supervisory Group may telephone the patient to provide reminders to take the prescription, and/or enter data pertaining to the physiological factors. Alternatively, the computer program may be written so as to immediately forward an email to the patient and/or the physician should the patient fail to input the desired information. Because medical foods have the risk of adverse consequences (e.g, dangerously low blood sugar, electrolyte abnormalities, and many others), the supervising physician may find it necessary to discontinue the ongoing fulfillment of the medical food prescription for noncompliant patients who do not facilitate continual medical supervision.
There are numerous medical conditions which may be identified by a physician in the process of medical evaluation which require specific dietary management due to distinctive nutritional requirements. The widespread use of specifically formulated products to treat these medically determined needs has been greatly hindered due to the absence of the invention that is the subject of this patent, an online supervisory system to satisfy the requirements of active and ongoing medical supervision. Three examples will help to elucidate the problem requiring a solution.
Deficient levels of “good” cholesterol, HDL, is a common condition in this country. Medical literature establishes that deficient levels of HDL contribute greatly to the epidemic levels of heart attacks and strokes, causing the death of about ½ of all Americans. One of the most effective means of raising the levels of good cholesterol is to use a nutritional supplement, vitamin B3, also known as niacin. However, when used at doses sufficient to achieve this highly desired effect, there are risks of liver failure and muscle degeneration. Therefore, if the nutrient supplement, niacin, is to be used to the appropriate therapeutic endpoint of elevated HDL, ongoing medical supervision for the risk of adverse effects should also be provided.
Supplements of omega-3 fatty acids have been shown to decrease the risk of heart attacks and strokes. However, these same supplements have also been associated with the increased risk of bleeding complications. Therefore, ongoing medical supervision of compliance with the appropriate dose and monitoring of the absence of adverse effects such as easy bruising are desired.
The condition of vitamin D deficiency has been associated with cardiovascular disease and its complications. Supplementation has been shown to be effective in raising levels. However, vitamin D is a fat soluble vitamin and therefore the body retains levels for prolonged periods of time in the fat depots of the body. Over exuberant vitamin D supplementation has been shown to cause toxic levels with the potential for severe consequences in the extreme including irreversible kidney failure which may result in death. Therefore, this supplement may be used to treat deficient levels, but ongoing medical supervision is needed to ensure safety.
Accordingly, the inventions of this application are intended to achieve, among other things, one or more of the following goals and objectives:
The manner in which the foregoing goals and objectives are achieved is disclosed in the following specification and drawings in which:
Numerous individuals of our society have unique nutrient needs and requirements because of a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs. To encourage the development of foods to meet the needs of these people, Congress enacted the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) and the FDA has established further criteria relating to such foods (See for example 21 CFR 101.9(J)(8). Such foods are defined as foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in its natural state) for the patient who is seriously ill or who requires the product as a major treatment modality. Medical foods are to be prescribed by a physician as a result of a medical evaluation and are intended to be used under ongoing and active medical supervision of the patient. Such patients may include those who are or have substantial obesity, incipient type II diabetes, arthrosclerosis, Vitamin D deficiency, etc. Moreover, many patients not only suffer from one of these conditions, but often they are plagued with a combination of these conditions. For example, patients with substantial obesity often suffer from type II diabetes and/or arthrosclerosis, etc.
From an evaluation of these patients, a physician may conclude that medical foods provide an appropriate therapeutic intervention and thus prescribe the medical food that will assist the individual in eliminating, minimizing or living with the medical problem under improved circumstances. Once prescribed, however, the Orphan Drug Act requires use and/or consumption of the drug under supervision on an ongoing, active basis. That supervision raises the image of constant, recurring trips to the physician's offices by the patient. Such involves scheduling, time costs and money costs. Moreover, the physician who prescribed the medical food is left with the responsibility of supervising the use of the drug—and this supervision is dependent upon a prompt, cooperative patient.
Significantly, supervision of such matters may well focus on simple physiological measurements that can be taken at home with home instruments such as scales, blood pressure monitors, O2 saturation meters, blood glucose monitors, etc. Alternatively, such supervision my focus on such matters as laboratory tests such as ascertainment of the patient's lipid profile, the C-Reactive Protein results, Plac2 or other test from the laboratory. Alternatively, the physician may ascertain other specific focal points to measure the effect of the medical food on the patient.
This method may be implemented immediately after the physician conducts an examination of the patient and makes the diagnostic determination that a medical food prescription would ameliorate the patient's condition.
At that point in time, the pertinent information is entered into a program that, preferably, is designed to run as a Patient Portal through a computer server shown in
To the extent necessary and as required by HIPPA, the patient would consent to access of his patient portal by each of the entities shown in
Illustrative of the information that may be maintained on this special Patient Portal is that depicted in the table of
Important to the success of the medical food is proper participation by the patient. His daily interest, daily self-care, and daily data input are supervised and disciplined by the Online Patient Supervisory Group. The inventor believes this is a novel form of Medically Supervised Disciplined Self Care, the type of care which will be the most effective and cost effective of all. This Online Patient Supervisory/Compliance Center is constituted of, preferably, administrators, nurses and/or physicians. Preferably, the administrators of this group would insure compliance with the physician's instructions, the patient's monitoring and entry of data as requested by the physician. For instance, if, by a given time of the day, the patient has failed to enter his blood pressure, weight, O2 saturation level, etc, the Center's personnel calls or emails a reminder to the patient and insists on the data entry. Alternatively, if the patient is not familiar with internet protocols and daily entry, it is anticipated that the Online Patient Supervisory/Compliance Group may operate a kiosk so as to permit those patients unfamiliar with physiological monitors and/or the interne to come to the kiosk daily and have those measurements taken with the data being entered into the form of the Patient Portal.
When the Online Supervisory/Compliance Patient Group is sufficiently large, it is anticipated RN's and MDs will monitor the Patient Portal and, in the event of health problems, they can directly call or email the patient. In addition, algorithms may well be developed to mine the patient data to ascertain those with immediate health problems and, when identified, the Supervisory Group would call the patient and advise him to seek immediate medical attention.
The invention intends to minimize manual input of data. To that end, it complies with various standards of data sharing such as Health Level Seven (HL7) for exchange of patient discrete information between disparate systems, Continuity of Care Record for importing and exporting the patient chart as defined by Healthcare Information and Management Systems Society (HIMSS), and Digital Imaging and Communications in Medicine (DICOM) for sharing medical images between disparate systems. The itemized standards are not exhaustive. They simply serve as examples of standard compliance implemented by the invention. Compliance with industry standards helps insure portability and longevity of the patient's healthcare information.
In summary, the basic functions of the software for the computer and/or server are:
Those skilled in the art will appreciate that this invention can take different forms, that the software to accomplish the functions of the inventions may take various forms, and that the table of
This application is based upon and claims priority and other benefits from U.S. Provisional Patent Application Ser. No. 61/402,180 filed Aug. 25, 2010.
| Number | Date | Country | |
|---|---|---|---|
| 61402180 | Aug 2010 | US |
