Patent Description:
The invention also concerns a system implementing said method.

The invention can find a useful application in several medical settings, both for the supply of therapies in hospital recovery wards and for the intraoperative administration of drugs during surgery.

In the above-identified fields, the need to prepare a drug transferring it in containers of different nature intended for the final administration to the patient, such as for example syringes, syringe pumps, infusion bags, bottles, etc, is known.

In these cases, it is naturally imperative to avoid drug exchanges having potentially life-threatening consequences. For this reason, it is customary to put a label on the container being used, to identify the drug contained therein at the time of the actual administration.

Traditionally, the label is manually filled in by the operator that is working to transfer the drug. But this solution still involves a high risk of human error, mainly linked to the possible misunderstandings in interpreting the handwriting.

Moreover, the whole tracking system of the administered drugs is based on manual filling operations referred to the operator, with possible incidental, when not malicious, errors.

In this context, the use of pre-printed labels that facilitate the reading, but do not improve the tracking of drugs, nor remove the risk of human error in consideration of the possible confusion of the operator at the time of label selection, has been recently suggested.

A further contribution to the safety of hospital procedures came from the introduction of real-time label printing systems, that allow the operator to obtain the label required to identify the specific drug to be employed. But these printing systems, although ensuring great advantages in terms of safety and tracking, significantly slow down the procedures for preparing the drugs by the operators.

In fact, it must be considered that, in the hospital standard practice, it is normally required to prepare at the same time different drugs to be administered to the patient in the context of a therapy or a surgery protocol. The operator has thus to create and print a plurality of labels, to be individually put on different containers, repeatedly shifting the attention between the system terminal and the containers themselves, with non-negligible data entry times.

Moreover, the above systems have a residual risk of error when transferring the labels, in particular when an operator - to accelerate process times - decides to put the labels at a later time after printing operations. In this case, he has to distinguish among a plurality of printed labels, directed to different drugs to be administered to different patients, and the possibility of confusion is high.

For the above reasons, the real-time printing systems did not experience a widespread distribution, at least in European hospitals.

A method for processing a multiple prescription order and pre-packaging the multiple medications in a single container at the production facility, comprising the step of printing an instruction leaflet, is disclosed in prior art document <CIT>.

<CIT> concerns pre-cut adhesive multi-dose pharmacy labels suitable for point-of-sale printing of information thereon. This document discloses a label comprising information about the different drugs to be administered to a specific patient and the label content comprising a printing field for each drug to be administered to the patient and each of said printing fields comprising at least one identifier of the respective drug.

The technical problem underlying the present invention is therefore to provide a method and a related labelling system for identifying drugs to be administered to a patient in a hospital or surgical setting which solve the above-reported drawbacks, and which allow in particular a safe and fast labelling.

The scope of the invention is defined by the appended claims <NUM>-<NUM>. The examples, aspects and embodiments, if any, disclosed in the following description that do not fall within the scope of the claims are for reference only and are to be interpreted as examples useful for understanding various embodiments of the invention.

The above-identified technical problem is solved by a labelling method for identifying drugs to be administered to a patient in a hospital or surgical setting, as defined by the appended claim <NUM>.

The method of claim <NUM> advantageously allows the information about the whole therapy to be administered to the patient to be obtained on a single support; the operator is thus facilitated in identifying and preparing in sequence the different drugs, putting where appropriate the respective label on the respective container.

The risks of error and confusion are therefore considerably reduced, by suggesting a linear and rational labelling method that leads the operator avoiding process ambiguities.

The method, by grouping the selection and printing operations related to the different drugs of a single therapy together, considerably reduces process times, being also compatible with the working rates of the most frantic wards, such as emergency room ones.

Said support strip is unwound from an endless feeding strip, said method comprising a step of automatically size-cutting said endless feeding strip.

The above automatic cutting operation ensures that the strips related to different patients are separated from each other, avoiding any risk of confusion for the operator.

Preferably, the generated and printed printing content further comprises a header printing field, comprising the name and/or an ID of the patient. This header field clearly identifies the patient which the therapy described in the following drug list refers to, warding off replacements and increasing the process safety.

In said step of printing the label content, each printing field is printed on a different adhesive label, said adhesive labels being individually detachable from the common support strip.

This printing mode is particularly advantageous when the labels must be individually put on a plurality of different containers, for example syringes.

As an alternative, not being part of the present invention, in said step of printing the label content, all the printing fields can be printed one after the other on a single adhesive label.

This printing mode allows a single label to be put on a drug bottle containing all the drugs of a specific therapy to be prepared.

In both cases, the labels on which at least one drug printing field is printed are put on containers for the administration of the respective drug to the patient.

The method can advantageously comprise a step of recording the occurred administration of the drug by means of a remote device, that is able to read a graphic identifier of the drug printing field.

This step is particularly advantageous since it suggests a check of the actual administration, allowing reliable statistics on drug consumption to be generated, detecting waste and potential abusive behaviours.

Preferably, the above remote device is located near a hospital bed or otherwise dedicated to a given patient. The device can be for example a tablet attached in close proximity to the bed, or a display screen of any kind located inside the operating room.

Said remote device can thus advantageously notify the operator when the read graphic identifier does not match with a drug comprised in the drug list of the respective patient, warding off possible cases of mistaken identity having harmful outcomes.

Said step of associating a drug list with the patient can advantageously provide a possible sub-step of recalling a drug list previously used for the same patient, with the possibility to modify said drug list by the operator.

Said step of associating a drug list with the patient can also or otherwise provide a possible sub-step of importing the drug list from a preset protocol file, with the possibility to modify said drug list by the operator.

The two above-discussed possibilities advantageously allow the times for generating the drug list by the operator to be reduced.

Preferably the method further comprises a preliminary step of recognizing the operator by the labelling system, that is necessary to enable the following steps of associating a drug list with the patient and/or of printing the generated label content.

Said preliminary step of recognizing can advantageously occur through optical reading of a graphic code printed in advance by the same system after a first identification of the operator through secret credentials.

The operator must thus enter his secret credentials only a first time, and then he can print an identifying label that will contain the graphic code (preferably a barcode, for example a bidimensional barcode) identifying him. The next logins to the system fastly occur by scanning the graphic code through an optical reader associated with the system.

It must be noted that printing a graphic code for identifying the user to log in the printing system itself is an innovative aspect of the system not depending on label printing modes.

A possible divisional application of the present application can therefore be directed to a labelling method comprising the steps of:.

The step of recognizing the qualified operator thus occurs through optical reading of a graphic code printed in advance by the labelling system after a first identification of the operator through secret credentials.

In this way, it is possible to use the labelling system to generate a label that allows the operator to be fastly identified, both by the system itself and by other limited-access systems. The label can be put on a personal accessory (for example: plate or bracelet) that allows the operator to fastly identify himself if necessary.

In an embodiment of the invention, the step of printing the label content is allowed, at least for some drugs, only if two different qualified operators approve the drug list in advance.

The drug printing fields comprise at least one colour-painted background identifying the type of drug. Yet preferably, the drug printing fields further comprise a graphic code for colour-blind persons that identifies the colour of said painted background.

The above-defined technical problem is further solved by a labelling system for identifying drugs to be administered to a patient in a hospital and/or surgical setting, as defined by the appended claim <NUM>.

The above system is arranged to implement the method of claim <NUM>.

Further features and advantages will become more apparent from the following detailed description of a preferred, but not exclusive, embodiment of the present invention, with reference to the attached figures given by way of non-limiting example.

With reference to the attached <FIG>, a labelling system for identifying drugs to be administered to a patient in a hospital or surgical setting is generally identified with S.

As stated beforehand in the above introduction, said system can be advantageously employed in several hospital contexts, where the labelling of intermediate containers (for example: syringes, syringe pumps, infusion bags, bottles, and the like) for the administration of drugs of any nature to a patient is to be arranged.

The system comprises at least one data processing unit U, connected to a plurality of input/output peripheral units.

The data processing unit U is arranged to execute a computer program that allows the automated operations of the method according to the present invention to be performed.

It must be noted that the program can be partially or totally executed on one or more remote units that interface with the rest of the system S comprising the peripheral units. These remote units can be general-purpose devices not specifically directed to the aim, for example smartphones on which a specific application was installed.

The peripheral units comprise at least one printing device P, arranged in particular to print adhesive labels <NUM>; <NUM>h; <NUM>d.

The peripheral units further comprise a plurality of data input units I<NUM>; I<NUM>; V that, as it will better come out below in the present description, allow in particular to the operator all those operations allowing a printing content to be generated.

The data input units can comprise a keyboard I<NUM> and an optical reader I<NUM>. Naturally, other data input units of a known type, such as for example a mouse, can be used as an alternative to or in combination with the previous ones.

A display screen V, whose primary function is to provide a visual support to the operations for generating the printing content, can be of the touch-sensitive type defining an input interface as well.

Moreover, one or more memories M, of the fixed or volatile type, are connected to the data processing unit U. It must be observed that these memory units M can also be remotely located with respect to the data processing unit U. Preferably, said memories are at least partially located on a cloud that can be accessed by the different processing units U interfacing the system S.

The labelling system S can further provide a plurality of fixed remote devices Ri, for example tablets, that are able to exchange data with the data processing unit U. Preferably, for some reasons that will become more apparent below, said remote devices Ri are located in a non-removable manner in close proximity to as many beds. In this way, a single remote device Ri is univocally associated with a recovering patient Pi in the neighbouring bed.

The above-described labelling system S is arranged to generate, upon indication by one or more designated operators, a label content that is printed in colours by the printing device S on an appropriate strip support.

Each label content is directed to a specific patient pi and it describes a drug list ti approved for said patient pi. The drug list ti comprises one or more drugs to be administered to the patient pi: these drugs can define a therapy identified by the designated practitioner or a series of drugs to be taken in an intraoperative setting, for example in the context of a surgical anaesthesia.

The label content comprises a plurality of successive printing fields fh, fd that are printed on a strip of label/ s.

A first printing field fh, preferably the first of the strip of label/s, is a header field that identifies the patient that is the recipient of the drug list ti.

The header printing field fh, an example of which is individually represented in <FIG>, preferably comprises the patient name n accompanied by his nosocomial code c.

The field can further comprise the printing date di<NUM> and time tii and an identifying code of the operator op<NUM> in charge of this printing, in order to facilitate an immediate tracking.

The header printing field fh can also comprise other information being useful to identify the patient, for example the recovery ward, bed number, date of birth, age, weight.

The printing fields fd after the first one are instead drug printing fields; each of them concerns a single drug di of the drug list ti assigned to the patient.

The drug printing field fa, an example of which is individually represented in <FIG>, comprises a verbal identifier w of the drug (preferably: the general drug name) and a graphic identifier g thereof.

The latter is preferably a barcode, for example a dimensional barcode. This barcode can contain information of various type about the drug, and it allows in particular the drug to be identified by means of optical reading devices.

In a specific embodiment of the label, the graphic identifier g or the barcode is arranged to be read by a machinery (for example: a syringe pump) arranged to interact with the container which the label will be put on.

The drug printing field fd has a colour-painted background co, that chromatically identifies the type of drug according to the A. D4774-<NUM> international identification code and the DIVI extension thereof. Preferably, in addition to the colour-painted background co a graphic code dco is provided to make the same information about the type of drug immediately available to colour-blind users.

The drug printing field fd can also advantageously indicate different information inf being useful to lead the operator in the preparation of the drug itself, for example: posology, dilution liquid, concentration and dosage.

A graphic and/or verbal identifier of the route of administration of the drug ra can be further provided.

Other information indicated on the drug printing field fd can be once again the printing date di<NUM> and time tii and an identifying code of the operator opi in charge of this printing.

At least for given drugs, the system S can provide the need of approval by a second authorized operator in addition to the one performing printing. In this case, the drug printing field fd can comprise the date di<NUM> and time ti<NUM> of this approval, as well as an ID of the second designated operator op<NUM>.

Moreover, the name n and the nosocomial code c of the patient can be also indicated on the drug printing field fd, - preferably in a smaller typeface.

The label content comprising the different printing fields fh, fd can be printed on two printing media of a different type, as needed.

Both printing media comprise an endless support strip <NUM>, preferably unwound from a roll.

In the invention, said support strip <NUM> has a plurality of separate labels <NUM>h; <NUM>d, equally spaced from each other, that can be individually detached from the strip itself. In an example not being part of the invention, the support strip <NUM> is instead overhung by an endless adhesive label <NUM>.

According to the type of media being used, label strips of different types are obtained.

In the invention, illustrated by the example strips of <FIG>, the different printing fields fh, fd are printed on separate adhesive labels <NUM>h; <NUM>d. The header label <NUM>h indicates the header printing field fh, and it only serves to identify the rest of the strip. The following drug labels <NUM>d indicate the drug fields fd, and they must be put on the different containers into which the operator will introduce the drugs di of the drug list ti.

In the example not being part of the invention, illustrated by the example strips of <FIG>, the different printing fields fh, fd fall in a single label <NUM>, to be put on a drug capsule housing all the drugs di of the drug list ti.

It is observed that the printing device P provides automated means for cutting the support strip <NUM>: the strip is thus size-cut upon reaching the length required to contain the different printing fields fh, fd. In this way, it is avoided that successive strips intended for different patients pi are adjacent, which would generate potential errors.

In the examples of <FIG> and <FIG>, it is observed how the number of fields affects the final length of the support strip <NUM>.

With reference to the attached <FIG>, the method through which the system S generates and prints the label strips will now be analysed.

A preliminary step <NUM> provides for the identification of the operator that interfaces with the system S by requiring the printing.

The identification can traditionally occur by entering identifying credentials through the keyboard I<NUM>.

Once a first recognition by the system S is performed, an auxiliary step of the method can provide for the printing, through the printing device P, of a recognition label for the operator. The recognition label comprises a graphic code, preferably a barcode that is recognizable by the optical reader I<NUM>, to log in the system S without manually entering the above credentials. The operator can thus stick the label to a personal accessory, for example a plate or a bracelet, through which he performs the fast identification for the next logins to the system S.

A following step <NUM> of the method concerns the identification of the patient.

If the patient is a new patient, an appropriate record must be created (step <NUM>) on a patient database Bp that is present in the memory M. The patient can be fastly identified also by inserting only the nosocomial code c, that can be read by passing the optical reader I<NUM> on an identification code indicated for example on a bracelet put on the wrist of the patient.

If on the contrary the patient record has already been created, it must be selected or imported (step <NUM>) by the operator to pursue with the definition of the drug list ti.

The following step provides for the association <NUM> of a drug list ti with the patient pi.

To do this, the operator has naturally the possibility to create from scratch this drug list ti (step <NUM>). This can be advantageously done by displaying on the display screen V the drugs stored in a drug file Ld, and selecting them for example by means of a drag and drop interface by using the touch-sensitive screen of the display screen V itself.

As an alternative, the operator can retrieve a therapy (step <NUM>) from a database of the previous drug lists Bt, that contains the therapies previously administered for which the system has printed the related labels. Preferably, in this case the system S automatically recalls the drug lists ti previously intended for the same patient pi. The operator can then decide to keep or modify the drug list ti before the final approval.

The operator can also recall a protocol (step <NUM>) from a protocol file Lp, that comprises therapeutic protocols used in the concerned ward or drug lists applied during given surgeries. In this case too, the drug list ti from the protocol can be modified in case before the approval.

It must be noted that the entry and/or approval of a drug list do not involve an immediate printing. When a surgery on the patient is planned, for example, the drug list ti can be entered and/or approved before the actual surgery. In this case, in a next login to the system the entered and/or approved drug list is recalled (step <NUM>) to proceed then to the printing.

It must be noted that the operators qualified to approve a drug list can belong to a narrower group or anyhow different from the one of the operators qualified to print. Moreover, as hinted above, for some or all the types of drug a double approval can be required before the final printing.

A step <NUM> following the above-described ones is printing the label content comprising the approved drug list ti, that generates a strip of adhesive labels <NUM>; <NUM>h; <NUM>d of the above-described type. These labels must thus be suitably stuck on the related containers.

At the time of printing a label content comprising an approved drug list ti, this list is stored by the system S, so as to keep track of the administered drugs.

Moreover, after printing, a display of the drug list ti can be sent to a local device in close proximity to the place where the drugs must be administered. In the case of a recovering patient pi, the drug list ti is sent to the remote device Ri near the bed assigned to the patient pi himself; in the case of a patient pi waiting for surgery, the drug list ti is sent to a display screen located in the operating room.

The possibility to check the actual administration of the drugs di to the patient can be provided. The check occurs by means of the operator by interfacing the above local device. The check can advantageously occur through optical scanning of the graphic identifier g of the drug di printed on the drug adhesive label <NUM>d.

Advantageously, in these cases the system can also carry out a consistency check about the drug list ti approved for the patient pi, so as to notify the operator if the drug di to be administered is dedicated to another patient pi.

The above-described system S allows a telematic register to be kept constantly updated with all the operations performed by the operators, concerning in particular the printing of drugs lists ti for related patients pi. Starting from these data, it is possible to carry out statistics on the use of drugs, detecting waste and possible thefts.

The above-described system S can further allow miscellaneous labels to be printed, that are different from the above-hinted ones, customizable with date, time, operators, patient name and record data. Moreover, it is possible to create miscellaneous labels to label containers or the like, for example sterilization containers or milk bottles, or drugs, or even customized labels of a different kind. The printing of these custom labels can be enriched with the printing date and time and the operator reference; however, the printing operation is still stored in the telematic register of the system S.

The above-described system S can also provide a module for filling and managing the patient data and therapy.

The patient data and therapy (the so-called therapy sheets), filled in by a qualified operator, contain the treatment plan for each patient with the indication of the drugs to be taken at the different times of the day. Starting from said therapy sheet, the system S can automatically generate a drug list ti to be printed comprising the drugs to be taken in a given time-slot that require a labelling.

In this case, the operator that logs in the labelling system S recalls this drug list ti and proceeds to the printing.

Advantageously, the terminal arranged to fill in the therapy sheets can be unique, for example located in an office dedicated to the medial staff, while the printing terminals can be deployed in the hospital and also accessed by the other healthcare operators.

The labelling system S can also interface with another system for filling in medical records, for example a management software of the known type, automatically importing the data of the medical records required for the generation of the drug lists ti for the various patients pi.

The labelling system S can also comprise appropriate functions for managing a local drug warehouse of the ward.

In this case, the system stores an inventory of the drug packages that are present in the local warehouse: each field comprises the expiry date and the residual package content.

Moreover, the system S generates a label to be put on each package. The label comprises at least one recognition code that is readable through optical scanning (for example: a bidimensional barcode).

When an operator collects one or more drugs from the warehouse, he uses the system optical reader I<NUM> to scan the label on the package, pointing out the number of collected doses. The system S then automatically updates the inventory.

Moreover, the system S can notify the user in case the same drug is available in a package having an earlier expiry date.

The system can further display and/or print a summary report of the drugs that are present in the local warehouse with the related expiry dates.

Claim 1:
Labelling method for identifying drugs to be administered to a patient in a hospital or surgical setting, comprising the steps of:
arranging a labelling system (S) comprising at least one data input unit (I<NUM>; I<NUM>; V), one data processing unit (U) and one printing device (P);
identifying (<NUM>) a patient (pi) through the data input unit (I<NUM>; I<NUM>; I<NUM>);
associating (<NUM>) a drug list (ti) with said patient, said drug list (ti) comprising a set of drugs (di) to be administered to the patient;
generating, through the data processing unit (U), a label content comprising at least one printing field (fd) for each drug (di) of the drug list (ti), each of said printing fields (fd) comprising at least one identifier of the respective drug (di);
printing (<NUM>), through the printing device (P) of said labelling system (S),
the generated label content on one or more adhesive labels (<NUM>h; <NUM>d) located on a common support strip (<NUM>), so that the identifiers (w; g) of all the drugs (di) of the drug list (ti) are indicated on said support strip (<NUM>); each printing field (fh, fd) being printed on a different adhesive label (<NUM>h, <NUM>d), said adhesive labels (<NUM>h, <NUM>d) being individually detachable from the common support strip (<NUM>), characterized in that:
said support strip (<NUM>) is unwound from an endless feeding strip, said method further comprising a step of automatically size-cutting said endless feeding strip which ensures that the strips related to different patients are separated from each other; and
the drug printing fields (fd) comprise at least one colour-painted background (co) identifying the type of drug (fd).