Method for the preparation of drug administration units

Abstract

The invention relates to a method for the preparation of drug administration units, comprising the steps of: - arranging a plurality of blister packs (BL) inside respective compartments (5) housing a storage structure (4); - picking up the blister packs (BL) with automatic handling means; - positioning the blister packs (BL) near optical shape and size detection means (1); - detecting the structural conformation of a blister pack (BL) of a drug, containing a plurality of cavities (A); - bringing the blister packs (BL) and said automatic cutting means (2) closer together, by means of the automatic handling means; - separating a first cavity (A1) containing a dose of drug from said blister pack (BL), by means of automatic cutting means (2); - placing blister packs (BL) in the respective housing compartments (5) of the structure (4), with the automatic handling means; - repeating the two preceding steps for a number of blister packs (BL) and a number of cavities (A) necessary to complete a unit of intake of a patient's treatment plan; - collecting the cavities (A1) in sealed containers (C), each containing an intake unit based on the treatment plans of individual patients, with automatic packaging means (3), where such steps are carried out on a plurality of blister packs (BL) of drugs to obtain a plurality of sealed containers (C) belonging to a treatment plan of a single patient.

Description

[0001] METHOD FOR THE PREPARATION OF DRUG ADMINISTRATION UNITS

[0002] Technical field of application

[0003] The invention relates to the field of methods for the partitioning and repackaging of drugs according to treatment plans intended for patients in hospital or at home.

[0004] More in detail, the invention relates to a method for the preparation of drug administration units, also obtained from the composition of different preparations, in particular of the type in the form of pills, tablets, capsules or the like.

[0005] In the following description, the term "blister pack" refers to a type of packaging, especially for pharmaceutical products, generally consisting of a thin metal foil heat-sealed to a thin rectangle of plastic material, transparent or not, on which bubble-shaped compartments are neatly distributed, designed for the sanitary containment of pills, tablets, capsules or the like.

[0006] In the following description, the term "cavities" refers to said bubble-shaped compartments neatly distributed on said "blister packs".

[0007] Prior art

[0008] The management of therapies, for both hospital patients (acute, sub-chronic or chronic) and for home patients, is a highly critical element for regional and national healthcare systems.

[0009] In fact, failure to adhere to therapies is a phenomenon capable of producing alarming economic and social repercussions on the healthcare systems themselves.

[0010] Non-adherence to therapies is linked to multiple causes which not only involve patients but a broader surrounding system, which can comprise:

[0011] - factors linked to shortcomings in healthcare systems;

[0012] - factors linked to patients' health conditions;

[0013] - economic and social factors;

[0014] - factors linked to the therapies prescribed to patients;

[0015] - factors linked to the personal situations of the patients themselves.

[0016] Such factors can be positively affected by a correct preparation of the drugs which are part of the patients' treatment plans, which often involve taking multiple drugs according to complex patterns (*AIFA states in the OSMED 2020 report that 66% of the Italian population over the age of 65 years - equal to over 9 million individuals - takes polytherapy consisting of 5 or more substances). In particular, it could be beneficial to organize the individual doses of drugs prescribed in a combined and ordered form for each moment of intake and to have their intake accompanied by staff competent in the management of the drugs themselves.

[0017] The known methods for preparing drugs in single doses divided and reorganized by administration unit are carried out manually and generally manifest the following critical elements:

[0018] - they have difficulties in managing blister packs of drugs having different structural conformations in terms of size, shape, number and arrangement of the cavities;

[0019] - they are laborious and repetitive in all their steps;

[0020] - they can only be carried out by qualified professionals;

[0021] - they are extremely burdensome in terms of execution times and costs.

[0022] Added to this is the high risk of errors resulting from repetitive operations, which require constant levels of maximum attention from the professionals responsible for their execution.

[0023] If the divided and reorganized individual doses are obtained by extracting the drugs from their primary packaging (blister packs), the following critical issues may be added to those mentioned above:

[0024] - risks of hygienic compromise of the drugs extracted from the blister packs;

[0025] - unknown issues related to the maintenance of the durability of drugs extracted from the blister packs;

[0026] - difficulty recognizing the drugs extracted from the blister packs.

[0027] Such methods, essentially of a hospital type, would require being carried out in sterile rooms and denote an overall lack of the requirements of execution simplicity and cost-effectiveness. Such limits, if resolved, would make it possible to adopt practices for preparing personalized therapies in unit doses by community pharmacies, which due to their institutional role, qualifications and skills, as well as their widespread presence in the territories, are the outposts of reference for taking charge of the therapies of home- based patients, both chronic and non-chronic.

[0028] Presentation of the invention

[0029] The object of the invention is to overcome the problems previously illustrated by means of a method for the preparation of drug administration units capable of:

[0030] - automatically processing all types of blister packs present on the market, recognizing the shape, arrangement and size of the cavities containing the individual drug doses, even when the blister packs themselves are incomplete;

[0031] - separating, by means of automatic cutting, the individual cavities containing the drug doses from the blister packs, without extracting the drug therefrom;

[0032] - packaging the individual doses thus obtained, reorganizing them by intake unit based on the patient's treatment plan.

[0033] It is also an object of the invention to propose a method for the preparation of drug administration units which, due to simplicity, size and execution costs, can be adopted by community pharmacies.

[0034] The objects of the invention are achieved with a method for the preparation of drug administration units according to the independent main claim 1 .

[0035] Further characteristics of the invention are described in the dependent claims.

[0036] A method for the preparation of drug administration units, according to the invention, produces the following important advantages: - it allows to recognize the different types of blister packs on the market as well as the shape, size and arrangement of the drug containment cavities arranged thereon, even if the blister packs are incomplete;

[0037] - it allows the drugs to be kept in the respective cavities and to obtain the single-dose volumes by cutting said blister packs, according to cutting lines capable of preserving the integrity of the individual cut cavities and those remaining on the blister packs themselves;

[0038] - it is capable of automatically carry out all the repetitive steps of choosing the medicine, reducing it into single doses, reorganizing and packaging the medicines;

[0039] - it allows to obtain high results of simplicity, cost-effectiveness, efficiency, effectiveness and safety in all operating steps, making its use possible in the context of community pharmacies.

[0040] A method for the preparation of drug administration units, according to the invention, produces the further important advantage of simplifying patients' adherence to therapies, avoiding administration errors thereof, preparing the drugs in single or multi-dose units consisting of drugs, even different ones, organized according to pre- established intake plans.

[0041] Brief description of the drawings

[0042] Further characteristics and advantages of the invention will be more evident from the more detailed description set out below, with the help of the drawing in figure 1 which shows a preferred embodiment, illustrated by way of non-limiting example in which the different and main steps of the workflow of a method for the preparation of drug administration units, according to the invention, are schematically illustrated.

[0043] Detailed description of the invention

[0044] With reference to the details of figure 1 , a method for the preparation of drug administration units, according to the invention, substantially comprises the steps of:

[0045] - detecting the structural conformation of a blister pack BL of a drug, containing a plurality of cavities A, by means of optical shape and size detection means 1 ;

[0046] - separating a first cavity A1 containing a dose of drug from said blister pack BL, by means of automatic cutting means 2;

[0047] - repeating the two preceding steps for a number of blister packs BL and a number of cavities A1 necessary to complete an intake unit;

[0048] - organizing said cavities A1 into intake units based on treatment plans of individual patients, by means of automatic packaging means 3.

[0049] The step of detecting the structural conformation of the blister packs BL of drugs comprises the further steps of:

[0050] - observing the arrangement, the shape and the size of the cavities A of the blister pack BL;

[0051] - determining coordinates X, Y identifying the position of the first cavity A1 available on the blister pack BL.

[0052] The step of separating the first cavity A1 containing a dose of drug from the blister pack BL comprises the step of making cuts based on the coordinates X, Y identifying the position of said first cavity A1 on said blister pack BL, so as to preserve the integrity of both the cavity A1 separated from the blister packs BL and of the cavities A remaining on the blister packs BL themselves.

[0053] The step of detecting the structural conformation of the blister pack BL and the step of separating the first cavity A1 containing a dose of drug from the blister pack BL can be carried out both on whole blister packs BL and on blister packs BL already subjected to the preceding steps of separating cavities A1 .

[0054] The step of organizing the cavities A1 into intake units comprises the further steps of:

[0055] - collecting the cavities A1 inside sealed containers C, of the sachet type or the like, by means of the automatic packaging means 3;

[0056] - grouping the sealed containers C in structures S that can be rolled up or folded over on one another, of the reel type or the like, by means of the automatic packaging means 3.

[0057] The method according to the invention includes a preliminary step of:

[0058] - arranging a plurality of blister packs BL of drugs inside respective housing compartments 5 of a storage structure 4, manually or by means of automatic loading means (not illustrated).

[0059] The method according to the invention comprises the further intermediate steps of:

[0060] - individually withdrawing the blister packs BL of drugs from the respective housing compartments 5 of the storage structure 4, by means of automatic handling means;

[0061] - positioning the blister packs BL near the optical shape and size detection means 1 , by means of the automatic handling means;

[0062] - bringing the blister packs BL and said automatic cutting means 2 closer together, by means of the automatic handling means;

[0063] - introducing the cavities A1 separated from the blister packs BL into the automatic packaging means 3, by means of the automatic handling means;

[0064] - placing the blister packs BL in the respective housing compartments 5 of the storage structure 4, from which they had previously been withdrawn, by means of the automatic handling means.

[0065] Such steps are repeated for all the blister packs BL of drugs belonging to a single patient's treatment plan.

[0066] The method according to the invention includes a conclusive step of:

[0067] - displaying on each sealed container C at least the list of the drugs contained therein, the time of intake and the name of the end patient, by means of automatic printing means 6.

[0068] The implementation of a method for the preparation of drug administration units, according to the invention, can be summarized as described below.

[0069] The following are preliminarily carried out with manual or automated methods:

[0070] - arranging a plurality of blister packs BL of drugs belonging to a patient's treatment plan inside respective housing compartments 5 of a storage structure 4.

[0071] With automated methods, based on the intake order of the drugs envisaged by the patient's treatment plan, the following steps are then taken:

[0072] - withdrawing a single blister pack BL of drugs from a respective housing compartment 5 of the storage structure 4, by means of automatic handling means;

[0073] - positioning the blister packs BL near the optical shape and size detection means 1 , by means of the automatic handling means;

[0074] - observing the shape and arrangement of the cavities A and the coordinates X, Y of the first cavity A1 available on the blister pack BL, by means of the optical shape and size detection means 1 ;

[0075] - positioning the blister pack BL near automatic cutting means 2, by means of the automatic handling means;

[0076] - separating the first cavity A1 from the blister pack BL, according to cutting lines based on the coordinates X, Y which identify the position occupied by said cavity A1 on said blister pack BL by means of the automatic cutting means 2, respecting the integrity of both the cavity A1 and of the remaining cavities A of the blister pack BL;

[0077] - introducing the cavity A1 separated from the blister pack BL inside the automatic packaging means 3, by means of the automatic handling means;

[0078] - placing the blister pack BL in the respective housing compartment 5 of the storage structure 4, from which it had previously been withdrawn, by means of the automatic handling means by means of automatic means;

[0079] - repeating the operations listed above for each blister pack BL of drugs reported in the patient's treatment plan.

[0080] With automated methods, then proceeding to:

[0081] - collect the cavities A1 inside sealed containers, of the sachet type or the like, by means of the automatic packaging means 3;

[0082] - grouping the sealed containers C in structures S that can be rolled up or folded over on one another, of the reel type or the like, by means of the automatic packaging means 3.

[0083] Lastly, with automated methods, then proceeding to:

[0084] - display on each sealed container C at least the list of the drugs contained therein, the time of intake and the name of the end patient, by means of automatic printing means 6.

[0085] The method for packaging drug administration units, according to the invention, advantageously allows to:

[0086] - reduce the drugs of an entire treatment plan into single administration units, of a single-dose type; - organize the individual administration units according to the order of intake envisaged by the treatment plan;

[0087] - collect the individual administration units in sealed containers, of the sachet type or the like, from which they can be withdrawn at the moment of intake. For example, if the treatment plan envisages three intake moments throughout the day, the patient will have a therapy collected in three daily containers, each of which will contain all and only the doses of the drugs intended for the corresponding intake.

[0088] Furthermore, the method for packaging drug administration units, according to the invention, also advantageously allows to:

[0089] - reduce complex treatment plans into single administration units, of a single-dose type, prepared by competent personnel and in full compliance with the envisaged intake methods;

[0090] - reduce the risks of errors in the preparation by operators and in the intake by patients of individual administration units;

[0091] - optimize the yield of drugs from treatment plans, reducing the dispersion thereof and consequently producing significant economic and social benefits for the benefit of regional and national healthcare systems.

Claims

CLAIMS1 . Method for the preparation of drug administration units to follow a patient's treatment plan, characterized in that it comprises the steps of:- preliminary arranging a plurality of blister packs (BL) of drugs inside respective housing compartments (5) of a storage structure (4), manually or by means of automatic loading means;- individually withdrawing the blister packs (BL) of drugs from the respective housing compartments (5) of the storage structure (4), by means of automatic handling means;- positioning the blister packs (BL) near the optical shape and size detection means (1 ), by means of said automatic handling means;- detecting the structural conformation of a blister pack (BL) of a drug, containing a plurality of cavities (A), by means of said optical shape and size detection means (1 );- bringing the blister packs (BL) and said automatic cutting means (2) closer together, by means of the automatic handling means;- separating a first cavity (A1 ) containing a dose of drug from said blister pack (BL), by means of automatic cutting means (2);- placing the blister packs (BL) in the respective housing compartments (5) of the storage structure (4), from which theyhad previously been withdrawn, by means of the automatic handling means;- repeating the two preceding steps for a number of blister packs (BL) and a number of cavities (A) necessary to complete a unit of intake of a patient's treatment plan;- collecting the cavities (A1 ) inside sealed containers (C), each containing an intake unit based on the treatment plans of individual patients, by means of the automatic packaging means (3), where such steps are carried out on a plurality of blister packs (BL) of drugs to obtain a plurality of sealed containers (C) belonging to a treatment plan of a single patient.

2. Method according to claim 1 , characterized in that the step of detecting the structural conformation of the blister pack (BL) of a drug comprises the further steps of:- observing the arrangement, the shape and the size of the cavities (A) of the blister pack (BL);- determining coordinates (X, Y) identifying the position of the first cavity (A1 ) available on the blister pack (BL).

3. Method according to claim 2, characterized in that the step of separating the first cavity (A1 ) containing a dose of drug from the blister pack (BL) comprises the step of making cut lines based on the coordinates (X, Y) that identify the position of said first cavity (A1 ) on said blister pack (BL).

4. Method according to claim 1 , characterized in that the step ofdetecting the structural conformation of the blister pack (BL) and the step of separating the first cavity (A1 ) containing a dose of drug from the blister pack (BL) are adapted to be carried out both on whole blister packs (BL) and on blister packs (BL) already subjected to the preceding steps of separating cavities (A1 ).

5. Method according to claim 1 , characterized in that it comprises the further subsequent step of:- grouping said sealed containers (C) in structures (S) that can be rolled up or folded over on one another, by means of said automatic packaging means (3).

6. Method according to claim 5, characterized in that it comprises the further step of:- displaying on each sealed container (C) at least the list of the drugs contained therein, the time of intake and the name of the end patient, by means of automatic printing means (6).

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