Method for monitoring a medication prescription.

Abstract

Title: Algorithm for monitoring a medication prescription. The invention relates to a therapeutic monitoring method 100 comprising: - a step 101 for recording data from a prescription 201; - a step 102 for administering a questionnaire and recording data 202 based on the answers to said questionnaire; - a step 101T for generating a table T based on the recorded data and deducing a monitoring score; - a step 103 for generating an alert 204 based on this score; - a step 104M, 104F for processing the alert 204; and, - a step 105 for returning to the questionnaire 102 when the alert has been lifted. Figure for the abstract: Figure 1

Description

Title of the invention: Method for monitoring a drug prescription.

[0001] The present invention relates to the field of drug prescriptions, in particular to devices or methods for ensuring proper follow-up of such a prescription.

[0002] The World Health Organization (WHO) defined polypharmacy in 2004 as "the administration of many drugs simultaneously or the administration of an excessive number of drugs".

[0003] For patients taking multiple medications, that is, whose treatment includes numerous drugs, the risks associated with the treatment may be increased, beyond the risks inherent to each individual drug. These risks are multiplied when there is multiple prescription, that is, prescriptions from several doctors, possibly in several medical specialties. Polypharmacy is a public health issue. Polypharmacy in chronic patients is a risk factor for drug-induced illness; it exposes each patient to a greater number of medications and higher doses, which can also compromise patient adherence to treatment.

[0004] Thus, in France, 6.7 million people aged 65 and over are taking multiple medications (source SNDS 2022). The annual number of hospitalizations related to adverse drug reactions is 212,500, with 2,760 subsequent deaths (source Latrostat study 2018).

[0005] Among people taking multiple medications in France, approximately 1.8 million use digital services in their daily lives, of whom 1.2 million have difficulty adhering to their prescription (source: Médissimo / Opinion Way 2023 study report, medissimo.fr).

[0006] The aim of the invention is to provide means to limit polypharmacy, support a de-escalation of prescriptions, prevent iatrogenic events, and improve patient adherence to their treatments. In particular, one aim is to detect the risk of medication misuse in order to improve patient care and prevent iatrogenic events.

[0007] The invention relates to a therapeutic monitoring method which comprises:

[0008] - a provision of a database;

[0009] - a first step to record data from a prescription;

[0010] - a second step to submit a questionnaire and record data established based on the answers to the questionnaire;

[0011] - a step to generate a table based on the recorded data, and calculate a tracking score based on data in the database;

[0012] - a third step to generate an alert based on the calculated score;

[0013] - a fourth step for handling the alert; and,

[0014] - a fifth step to check to return to the second step when The alert has been closed.

[0015] The questionnaire submission may be recurrent and the process may further include a step to control a recurrence interval.

[0016] The fifth step may return the alert if it has not been closed.

[0017] The method advantageously includes providing access for several operators, in this case for a doctor, a pharmacist and a patient, in particular to enter data and / or access the data table in a shared manner.

[0018] The method may further include calculating several types of scores and issuing several types of alerts conditioned on these scores. The fourth step may include redirecting an alert to a specific operator based on its type, typically to the physician or pharmacist, for processing by that operator.

[0019] The invention also relates to a computer program comprising instructions which, when executed by a processor, implement a process according to the invention. The invention further relates to a computer medium comprising all or part of such a computer program. The invention also relates to a computer machine for implementing a process according to the invention and comprising such a computer medium.

[0020] In the illustrated example, adherence is assessed according to the so-called "Girerd Score" model, a score from 0 to 6 calculated based on the answers to the following six questions:

[0021] 1. This morning, did you forget to take your medicine?

[0022] 2. Since the last consultation, have you run out of medication?

[0023] 3. Have you ever taken your medication late? usual?

[0024] 4. Have you ever missed taking your medication because, on some days, Is your memory failing you?

[0025] 5. Have you ever missed taking your medication because, on some days, you Do you feel that your treatment is doing you more harm than good?

[0026] 6. Do you think you have too many tablets to take?

[0027] A score of 0 (zero) "yes" answers corresponds to very good compliance. A score of 6 (six) "yes" answers corresponds to very poor compliance.

[0028] In the illustrated example, iatrogenesis is assessed according to the so-called "Urbina Score" model, calculated as follows:

[0029] - Patient age > 60 years: 1 point

[0030] - Charlson index 2: 1 point

[0031] - Number of medications > 10: 3 points

[0032] - type of organ or system involved, according to diagnostic categories major diagnostic categories (MDC):

[0033] MDC 0 - relating to transplants: 1 point

[0034] MDC 1 - relating to the nervous system: 1 point

[0035] MDC 5 - relating to the circulatory system: 1 point

[0036] MDC 6 - relating to the digestive system: 1 point

[0037] MDC 8 - relating to the musculoskeletal system: 1 point

[0038] MDC 11 - relating to the renal and urinary system: 1 point

[0039] - type of medicine:

[0040] ATC C: 1 point

[0041] ATC H: 1 point

[0042] ATC J: 1 point

[0043] ATC S: 1 point

[0044] ATC V: 1 point

[0045] The iatrogenic score is calculated by adding the points. An iatrogenic score of 1 or 2 points corresponds to a low risk for the patient. An iatrogenic score of 3 to 7 corresponds to a moderate risk for the patient. An iatrogenic score of 8 or more corresponds to a high risk for the patient.

[0046] According to a second object, the invention relates to a computer program comprising instructions which, when executed by a processor, implement a process according to the invention.

[0047] According to a third object, the invention relates to a medium comprising all or part of a computer program according to the invention.

[0048] According to a second object, the invention relates to a machine or computer system for implementing a process according to the invention and comprising a support according to the invention.

[0049] Embodiments and variants will be described below by way of non-limiting examples, with reference to the accompanying drawings in which:

[0050] [Fig-1] illustrates a flowchart describing steps of a process according to the invention allowing for therapeutic monitoring, including monitoring of a medication prescription.

[0051] Figure 1 illustrates, in the form of a flowchart, a method 100 according to the invention. This method is intended to monitor how a drug treatment is taken. by patient P, specifically by assessing the patient's adherence to this treatment and the associated iatrogenic effects. This process is carried out using a remote server and terminals; the terminals may be located at a physician M and / or a pharmacist F and / or at patient P's home.

[0052] In a first preliminary step 1, the doctor M establishes 2 a prescription 201 to the patient P, then the patient goes to the pharmacist F equipped with a terminal for the implementation of the process 100.

[0053] In a first step 101 of the initialization of the process 1, a first substep 101S consists of recording the prescription 201, i.e. for the pharmacist F to enter the prescription 201 and additional data 201C; Some of the additional data may come from answers to a questionnaire submitted to the patient P. A second substep 101T of step 101 consists of the automatic generation of a monitoring table T.

[0054] In a second step 102 recurring according to a recurrence period R, the patient enters data 202, including adherence data 202A and iatrogenic data 202B. Each of the adherence and side effect data, i.e. iatrogenic data, are collected from patient P using a specific questionnaire.

[0055] The questionnaire can be completed at each dose, at the end of the day, or at the end of the week. It is completed independently by patient P using a device, such as a tablet or mobile phone. This questionnaire allows for the collection of data concerning adherence, side effects, and self-medication.

[0056] A self-medication alert can be triggered in the event of an inadvisable combination of medications. For example, the patient may receive an alert message such as: "Caution: seek advice from a healthcare professional before taking any medication that has not been prescribed to you."

[0057] In the case of one or more side effects, the questionnaire may allow patient P to note:

[0058] - the organ that appears to be affected; the organ can be checked by patient P in a list automatically generated based on the prescribed medications;

[0059] - the type of effect: for example nausea, vomiting, diarrhea, constipation, bleeding, urinary tract infection, hypoglycemia, insomnia, dizziness, fever, itching, rash, shortness of breath, fall, tension, edema, fatigue, erectile dysfunction, or other;

[0060] - the frequency;

[0061] - the intensity and evolution of gravity, for example on a scale that can be 1 at 10; and,

[0062] - the impact on his daily life.

[0063] An example of a questionnaire may be the following. The questions are designated by the letter Q, followed by an index. Thus, question no. 1 is designated Q1. Each question advantageously includes several more precise "sub-questions," which are not detailed in this description.

[0064] Start of questionnaire.

[0065] Ql. Did you take your medication correctly? If not, which medication and why?

[0066] Q2. Do you experience any side effects, if so, which ones?

[0067] Q3. Do you practice self-medication, if so, which one?

[0068] End of questionnaire.

[0069] In particular to answer question Q2, in order to identify the organ involved, the method advantageously presents the patient with images and / or a map of the human body, so that the patient can indicate or locate the organ, without having any particular knowledge of anatomy.

[0070] In a joint step 102 T to step 102, the follow-up table T is updated from the data 202 provided by patient P.

[0071] Table T, which is regularly updated, allows for the establishment of a medication review shared between the doctor M, the pharmacist F and the patient P.

[0072] In the illustrated example, this report, notably established from the data 201, 201C entered by pharmacist F and the responses to the questionnaire, may include all or part of the following data:

[0073] - the number of prescribing physicians;

[0074] - the patient's age;

[0075] - the number of medications prescribed;

[0076] - the ATC classes (Anatomical, Therapeutic and Classification System) chemical);

[0077] - a possible non-response to the questionnaire for more than three weeks;

[0078] - a shortage of one or more drugs;

[0079] - information indicating whether the order has expired, for example in the case of a prescription given for a period of 28 days and which would have expired more than seven days ago;

[0080] - a possible combination of drugs is formally discouraged;

[0081] - a reference compliance score;

[0082] - a need for a pill organizer prepared in a pharmacy, which can be determined based on the patient's age, the number of medications prescribed and / or any memory problems the patient may have;

[0083] - an Urbina score;

[0084] - general observance and its evolution;

[0085] - adherence specific to each drug and its evolution;

[0086] - a side effect and its details; and / or,

[0087] - self-medication and its details.

[0088] In a third step 103, a score 203 is calculated, based on the data entered 201-202, in particular the data 202 entered by the patient.

[0089] In the illustrated example: - an adherence score 203A is calculated from the adherence data 202A, according to the methods of the Girerd score described previously; and, - an iatrogenic score 203B is calculated from the iatrogenic data 202B, according to the modalities of the Urban score previously described.

[0090] In the third step 103, according to the calculated score, it is determined whether an alert should be triggered "O" or not "N". In the illustrated example, an alert is triggered when the calculated score 203 is outside a predefined interval considered safe for patient P.

[0091] In this third step 103, if no alert is issued "N", a recurrence interval control step D allows patient P to be questioned "O" when a pre-programmed interval has elapsed; for example, several recurrence intervals R can be programmed according to each type of medication, for example, and another to monitor side effects. If no recurrence interval R has elapsed "N", the questioning is put on hold. An alert can be issued if the score is below or above a threshold value.

[0092] Alerts are issued automatically.

[0093] In a fourth step 104, a redirection 104R first directs the alert to the doctor M or the pharmacist F. Thus, if it is an alert called "iatrogenic alert 204M" the alert is sent to the doctor M; if it is an alert called "drug alert 204F" it is sent to the pharmacist F. The information collected in the third step 103 can trigger both an iatrogenic alert 204M and a drug alert 204F.

[0094] A control step 104C ensures that the alert is acknowledged by its recipient, for example, Dr. M. If the alert is not acknowledged "N" within a given timeframe, an emergency procedure U is initiated. This emergency procedure may include an automated telephone call to Dr. M; it may also include notification by an emergency operator, who takes charge of the emergency and may contact the doctor, or another doctor, directly to ensure that the alert is addressed.

[0095] The effective handling “O” fourth step 104 then allows the 104M processing of the alert by the doctor or the 104F processing of the alert by the pharmacist.

[0096] In the case of an iatrogenic alert, the physician receives alerts based on data entered by the patient and the pharmacist: iatrogenic risk, non-compliance In general, a serious or worsening side effect, or a substantial deterioration of the shared medication record, the physician opens the shared medication record with the pharmacist and the patient to gather more information and make a treatment decision. Thus, in the case of an iatrogenic alert (204M), the physician can revise their prescription (201), which is then re-entered into process 1 at the first step (101).

[0097] Thus, the doctor or pharmacist processes and reports whether or not they were able to close alert 204M.

[0098] At a fifth step 105, if the alert is not closed "N", it is redirected according to branch 204C to both the doctor M and the pharmacist F, until it is closed.

[0099] When each alert is closed “O”, the process proceeds to step D of recurrence time control, pending return to the second step 102, at the end of a recurrence time R, at which new data 202-204 are required and collected from patient P.

[0100] The method 100 includes the provision of a database supplied with data 201, 201C, 202; it may further include the provision of computing means, in particular for calculating scores 203 and / or determining alerts 204. It further includes the provision of means for generating table T.

[0101] Preferably, method 100 is implemented on a network platform, preferably an Internet platform. The questionnaire may be designed to be accessible via a mobile terminal; for example, a mobile phone or an electronic tablet.

[0102] Furthermore, even if the description mentions only one physician, one pharmacist, and one patient, the method is advantageously designed to be used by several physicians, several pharmacists, and several patients, through a network comprising one or more servers and numerous terminals for access by the physicians, pharmacists, and patients. Applications may be provided and downloaded onto some or all of the terminals, or the terminals may allow access to the server(s) via a portal on a network such as the Internet.

[0103] In addition, the process may include steps for remote communication, for example tele-expertise or teleconsultation.

[0104] Of course, the invention is not limited to the examples just described. On the contrary, the invention is defined by the following claims.

[0105] It will indeed appear to the person skilled in the art that various modifications can be made to the embodiments described above, in the light of the teaching which has just been disclosed to him.

[0106] Thus, other types of scores can be calculated, from identical or different questionnaires, to collect identical and / or different data, particularly with the doctor, pharmacist or patient. An adherence score can be calculated according to a model known as "EvalObs®" and a treatment adherence score calculated according to a model known as "Morisky" can be used.

[0107] Also, the prescription can be entered directly by a physician during the patient consultation, then checked and validated by the associated pharmacist when the prescription is dispensed. A system can also be in place to route an alert to another physician whom the initial physician deems more competent or specialized to handle that specific alert.

[0108] Also, several recurrence periods can be used in the same process according to the invention, depending on the data and scores calculated. In particular, iatrogenic data can be collected and an iatrogenic score calculated in real time, in order to trigger an alert in the event of an iatrogenic emergency. An iatrogenic score can notably be calculated at the start of the process, when a drug is added or removed, or at regular intervals, for example, every three months.

[0109] Also, a method according to the invention may provide only iatrogenic alerts, only sent to a doctor, and no alert sent to a pharmacist.

[0110] Faced with the challenge of polypharmacy, physicians and pharmacists play a key role in supporting patients taking multiple medications, and monthly interventions by pharmacists increase adherence to medication regimens. At the same time, remote patient monitoring allows a physician to remotely interpret data for patient follow-up and even adjust treatment. A remote patient monitoring device according to the invention makes it possible to limit polypharmacy and prevent iatrogenic effects, thus preserving patients' overall health and quality of life.

Claims

Demands

1. A therapeutic monitoring method (100) characterized in that it comprises: - providing a database; - a first step (101) for recording data (201) from a prescription; - a second step (102) for submitting a questionnaire and recording data (202) based on the answers to said questionnaire using a terminal, preferably a tablet or a mobile phone; - a step (101T) for providing means to generate a table (T) and generating said table (T) based on the recorded data, and providing means to calculate a monitoring score (203) and calculating said score based on data in said database; - a third step (103) for generating an alert (204) based on said calculated score; - a fourth step (104M, 104F) for processing said alert (204); and, - a fifth step (105) to return to the second step (102) when said alert has been closed.

2. Method according to claim 1, characterized in that the submission of the questionnaire is recurrent and includes a step (D) to control a recurrence delay.

3. A method according to claim 1 or 2, characterized in that the fifth step (105) is provided to refer the alert back to the fourth step (104M, 104F) for processing if the alert (204) is not closed.

4. A method according to any one of claims 1 to 3, characterized in that it comprises providing access for several operators (M, P, F) in particular to enter data and / or access the data table (T) in a shared manner.

5. A method according to any one of claims 1 to 4, characterized in that it comprises the calculation of several types of scores (203) and the issuance of alerts (204M, 204F) of several types conditioned on said scores.

6. A method according to claim 5, characterized in that the fourth step (105) comprises redirecting an alert to an access point for a specific operator depending on its type (204M, 204F) for processing by that operator.

7. A method according to any one of claims 6, characterized in that it comprises a step for identifying an organ from an organ image bank and / or a map of the human body.

8. A computer program comprising instructions which, when executed by a processor, implement a method according to any one of claims 1 to 7.

9. Support comprising all or part of a computer program according to claim 8.

10. Machine or computer system for carrying out a process according to any one of claims 1 to 7 comprising a support according to claim 9.

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