ES2609515B1 - Method and system of monitoring and control of drug temperature stability - Google Patents

Description

DESCRIPTION

Method and system for monitoring and controlling the temperature stability of drugs.

Object of the invention.

The object of the present invention relates to a method and system for monitoring and controlling the stability and temperature of drugs, in particular of drugs dispensed to patients.

The system presents constructive particularities aimed at maintaining the stability and temperature of the drugs at an established storage temperature since they have been dispensed in the outpatient services of the hospital pharmacies until their consumption by the patient, including this time control. drug transport and storage time at the patient's home.

The method of the invention also includes features aimed at allowing batch control, expiration, location, validity periods, established temperature ranges, conservation precautions and special circumstances, such as specific conditions in already reconstituted drugs.

State of the art

At present, the drugs dispensed to patients are transported by them to their home, it being usual that once finished the treatment they remain without using a part of these drugs that are stored in the patient's home for later uses without any control of their expiration or conservation conditions.

This inconvenience is exacerbated when physical stability needs to be maintained. and chemistry of the drugs and facilitate their storage conditions, both in the temperature range indicated in the established conservation precautions and in the batch control and storage times associated with their expiration.

The applicant of the present invention is unaware of the existence in the market of monitoring and control systems of the drugs dispensed both in regard to the cold chain, especially during transport by the patient to his home, as the batch control and the storage times associated with its expiration.

Description of the invention

This invention has characteristics oriented to solve the exposed problem and that allow to record the physical and chemical stability of the drugs and to facilitate their storage conditions both in the indicated temperature range and in the batch control and the storage times associated with their expiration.

These characteristics contribute to maintaining the safety and therapeutic efficacy conditions, preserving the relationship between risk and benefit of each drug, and provide potential efficiencies in the reuse of drugs previously stored in the patient's home.

In addition to fully controlling the entire cold chain of drugs with high economic impact, this system allows controlling: batch, expiration, location, validity periods, established temperature ranges, conservation precautions and special circumstances, such as specific conditions in already reconstituted drugs .

According to the invention, the control and monitoring method comprises:

A method of monitoring and controlling medications; in particular of drugs dispensed to patients; characterized in that it comprises:

- incorporate the medication assigned to a patient into a remote monitoring and control center,

- communicate to a medication dispensing center the medication assigned to the patient,

- incorporate in the remote center the data (lot, expiration, storage temperature) related to the medicines to be dispensed,

- supply the medication assigned to the patient in a refrigerated container box.

- continuously capture inside the container box supplied to the patient, the presence of the medications and their storage temperature, - periodically send to the remote center, through a communication network, the data related to the medications, to the presence and storage temperature of said medications inside the container box, together with the geolocation of said medications;

- record and compare the data received at the remote center with the data previously incorporated and related to those medicines,

- generate alarms in case the received data is not within acceptable parameters and

-communicate alarms to the patient.

This method allows to perform a series of functions detailed below:

- cold chain traceability: temperature control at all times;

- batch control and expiration: the logistic process designed for activation includes remote batch management and expiration of the medication, which allows controlling a lot of risk for patients involved and geographical areas for withdrawal.

- Geolocation: The modem of the communications box in addition to the sensor information provides the location of the medications by triangulation of the radio network of the mobile operator. The system manages patients / medications on a virtual map that facilitates planning and logistic control for maintenance and user support (cash changes or implementation of collection-delivery routes).

- Help the user and remote control of patient adherence to medication: The sensor that controls the entry and exit of the medication inside the box is crossed with a database of the prescribed pattern to the patient in order to control the prescription. The platform of the remote control center sends the patient taking alerts to improve adherence and avoid forgetting; as well as warnings of battery status or subsequent appointments for medication collection.

This invention provides a series of advantages for the health system, specifically allowing the maintenance of the conditions of efficacy and safety of medicines, as well as the improvement of the control of the efficiency in the management of medicines and their impact on health outcomes. . Household stock control, through the management of geolocated remote warehouses, the patients' own refrigerator acting as virtual warehouses, also provides significant economic savings by allowing the assignment to other medication patients who have not broken the cold chain and management Immediate and efficient withdrawal of medication from a critical or expired lot.

Other advantages of the invention is that it provides powerful information tools for the pharmacy service about the patient's adherence to the medication and its behavior as well as automatic communication services for pharmacy citation.

This system also offers the opportunity to triple the days of treatment in the dispensation, for example going from 30 to 90 days, thus decongesting the in-person units of the external patient unit.

To achieve the proposed objectives, the system of the invention comprises a container box usable by the patient consisting of a box for the storage of the medicine, said container box comprising a sensor for detecting the presence of the drug or drugs inside, a sensor for temperature, an active RFID module that reads the characteristics of the drug (such as name, expiration, or batch, among others), and a wireless transceiver that transmits the information to a communications box; a power battery and a microprocessor with memory that manages communications and stores measurements not communicated due to a lack of connection to the communications box.

The communication box comprises a minicomputer provided with a wireless transceiver for the collection of the data provided by the sensors of the container box; a display display and a communications module, preferably GPRS, said communication box managing communication with a remote control center provided with a management platform responsible for patient management, global, historical statistics, technical alarms for example due to communications failures, the detection of a risk temperature for drugs stored in any container or low battery box.

In order to avoid breaking the cold chain of the drug during the time that passes in the transfer from the pharmacy until the patient's home and this enters it in the refrigerator, this system incorporates appropriate transport bags to accommodate the container box and keep medications at a stable temperature for a sufficient time. This cold transport bag comprises grip handles and flexible ice plates that adapt to the inside of the bag and keep the medicines cold,

Description of the figures.

To complement the description that is being made and in order to facilitate the understanding of the characteristics of the invention, a set of drawings is attached to the present specification in which, for illustrative and non-limiting purposes, the following has been represented:

- Figure 1 shows a schematic view of the different elements that make up the system of the invention.

- Figures 2 and 3 show two block diagrams of a container box and a communication box.

- Figure 4 shows an exemplary embodiment of a refrigerated bag for cold transport of the container box.

Preferred embodiment of the invention.

In figure 1 several plastic container boxes (1) have been shown for containing one or more drugs to be controlled; communication boxes (2) linked to the corresponding container boxes (1) and a remote center (3) for monitoring and controlling the medications contained in a plurality of container boxes (1).

The container box (1) has adequate dimensions to allow manual transport and placement in a refrigerator for domestic use, in this case the corresponding patient.

In the example of figure 2, each container box has: a sensor (11) to detect the presence of the drug or drugs inside, a temperature sensor (12), an active RFID module (13), a battery of power supply (14), a wireless transceiver (15) and a microprocessor (16) with memory that manages data communications and stores the measurements provided by the sensors until they are sent to the communications box (2). These elements allow monitoring of the medications supplied to each patient and knowing if the cold chain has been maintained under the recommended conditions.

The communication box (2), associated with the corresponding container box (1), comprises a minicomputer (21) provided with a wireless transceiver (22) for receiving the data provided by the wireless transceiver (15) of the corresponding box container (1); a display display (23) and a communications module (24) GPRS; said communication box (2) managing communication with the remote control center (3).

Said remote control center (3) is provided with a management platform responsible for patient management, global statistics, historical, alarms techniques for example due to communications failures, the detection of a risk temperature for drugs stored in any container or low battery box.

A bag (4) for cold transport of the container box (1) is schematically shown in Figure 4. This bag (4) comprises grip handles (41) and flexible ice plates (42) that adapt to the inside of the bag.

Once the nature of the invention has been sufficiently described, as well as a preferred embodiment, it is stated for the appropriate purposes that the materials, shape, size and arrangement of the described elements may be modified, provided that this does not imply an alteration. of the essential features of the invention that are claimed below.

Claims (3)

re iv in d ic ac io nes 1. - Method of monitoring and control of medicines; in particular of dispensed drugs; characterized in that it comprises: - incorporate the medication assigned to a patient into a remote monitoring and control center, - communicate to a medication dispensing center the medication assigned to the patient, - incorporate in the remote center the data (lot, expiration, storage temperature) related to the medicines to be dispensed, - supply the medication assigned to the patient in a refrigerated container box. - continuously capture inside the container box supplied to the patient, the presence of the medications and their storage temperature, - periodically send to the remote center, through a communication network, the data related to the medications, to the presence and storage temperature of said medications inside the container box, together with the geolocation of said medications; - record and compare the data received at the remote center with the data previously incorporated and related to those medicines, - generate alarms in case the received data is not within acceptable parameters and; - communicate alarms to the patient. 2. - System for monitoring and control of drugs, in particular of dispensed drugs; characterized in that it comprises at least: - a container box (1) usable by the patient, intended to contain one or more drugs to be controlled and comprising, at least: a sensor (11) to detect the presence of the drug or drugs therein; a temperature sensor (12) inside the box; an active RFID module (13), a power battery (14), a wireless transceiver (15) and a microprocessor (16) with memory that manages data communications and stores measurements provided by the sensors until they are sent to a communications box (2); - a communication box (2) linked to the corresponding container box (1) and comprising: a minicomputer (21) provided with a wireless transceiver (22) for receiving the data provided by the container box (1); a display display (23) and a communications module (24) GPRS; managing communication with a remote control center (3) and; - a remote center (3) for monitoring and controlling the medicines contained in each container box; said remote center (3) comprising a management platform in charge of patient management, global, historical statistics, technical alarms, detection of a risk temperature for drugs stored in any container or low battery box. 3. System according to claim 2, characterized in that it comprises a cold transport bag (4) of the container box (1), whose bag comprises grip handles (41) and flexible flexible ice plates (42) inside of it.