JP2005115787A - Method and device for managing biologic product - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method and a device for managing biologic products that can properly keep records of use of the biologic products and that can quickly recover related products and communicate hospitals and patients if infections occur. <P>SOLUTION: The method and the device 4 for managing biologic products store and save information about blood sampled from a donor D, information about the raw materials and/or standards of blood products, and information about the use of the blood products in a computer readable storage media. Even after a biologic product has been used for a patient P, a process for specifying at least either the patient P who used the biologic product or the raw materials of blood products used can be performed. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a management method and management apparatus for a biological product that manages the usage status and the like after the biological product or the specific biological product is used for a patient or the like.

  The revised Pharmaceutical Affairs Law (Act No. 96 dated July 31, 2002) was enforced from July 30, 2003, and new regulations regarding measures to “ensure the safety of biological products by medical personnel” were to be followed. . Due to this new regulation, medical personnel need to strictly ensure the safety of biological products (see Non-Patent Document 1).

FIG. 16 is a diagram published in Non-Patent Document 1 and shows the concept of a biological product / specific biological product.
In this revision of the Pharmaceutical Affairs Law, as shown in Fig. 16, the concepts of "biological products" and "specific biological products" are newly defined, and medical personnel should take safety measures according to their characteristics. Became. By the way, based on the risk for infectious diseases when using each product, products that use raw materials or materials mainly derived from animals are positioned as `` biological products ''. Position product. Here, as shown in FIG. 16, “biological products are products using raw materials or materials mainly derived from animals, and“ specific biological products ”are mainly derived from human blood and tissues. It is a product using raw materials or materials.

  In addition, Article 2, Paragraph 5 of the revised Pharmaceutical Affairs Law states that “biological products are pharmaceuticals and pharmaceuticals manufactured (including subdivisions) using raw materials or materials derived from humans and other living organisms (excluding plants). "Regarding quasi-drugs, cosmetics, or medical devices, those designated by the Minister of Health, Labor and Welfare after listening to the opinions of the Pharmaceutical Affairs and Food Sanitation Council" Specific examples of “biological products” include vaccines / toxoids, gene recombinant preparations, animal component-derived preparations, animal-derived heart valves, and the like.

  In addition, Article 2, Paragraph 6 of the revised Pharmaceutical Affairs Law states that “a specified biological product refers to the occurrence of health hazards caused by the biological product after it has been sold, leased or conferred. Or it is necessary to take measures to prevent the spread, and the Minister of Health, Labor and Welfare shall designate it after hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council. " Specific examples of “special organism-derived products” include blood products for blood transfusions, blood coagulation factors, blood products such as human serum albumin, human immunoglobulin, etc., occurrence of infectious diseases such as drugs derived from human tissues such as human placenta extract There are high-risk products.

As a result of this revision of the Pharmaceutical Affairs Law, pharmaceutical manufacturers, etc. should ensure the safety of raw materials such as selection criteria for donors at the time of manufacture, and appropriate labeling on products and package inserts after marketing and storage of donor records and sales records. Regular reporting of infectious diseases was required.
On the other hand, in medical institutions, when an infectious disease or the like suspected to be derived from a biological product occurs, a report to the Ministry of Health, Labor and Welfare is required. In addition, for specific biological products, stricter safety measures will be imposed than for other products, and medical institutions and pharmacies are concerned about risks and benefits (profits and disadvantages) when using specific biological products. Appropriate explanations are required for patients (or their families).

In addition, for specific biological products, medical institutions and pharmacies should record patients who use specific biological products in order to easily identify patients who are subject to use in the event of an infection. Created and stored. In other words, the blood product management book (current storage period 10 years) shown in the previous guidelines has been legislated, and the record storage period will be 20 years (Article 68-9 of the Pharmaceutical Affairs Law [Creation and storage of records] ).
In addition, pharmaceutical manufacturers, etc. are obligated to keep donor records and sales records. For example, when a lot of biological products (products) is associated with a source product (eg, plasma pool), the lots are shipped. It was obliged to manage the information of medical institutions for 30 years.

  That is, a medical institution or the like is obliged to record information when using a specific biological product and store it at the medical institution for at least 20 years from the date of use. This system is used in order to easily identify patients who have been subject to use in the event of an infection. Specifically, a management book or the like for patient information recording is created. When creating this management book, a product seal provided by a pharmaceutical manufacturer or the like can be used (see FIG. 17, Non-Patent Document 1). As the contents of the record, that is, the contents of the management book, (1) product name, (2) production number (lot number, production symbol), (3) patient name, address, (4) use date, etc. are recorded. It will be. Similarly, pharmaceutical manufacturers need to keep records over a long period of time.

Regarding the management of biological products and chemicals, there are techniques described in the following documents. That is, when managing blood products for transfusion for each blood product pack, blood products are managed using a blood product management form that describes patient information and blood product information. System "(Patent Document 1). In addition, there is a “medicine use management system” in which drug management is performed using a database in which information on use such as a drug ID and a drug use site is managed (Patent Document 2). In addition, there is a “pharmaceutical logistics system” in which a medicine name and amount of medicine stored in a warehouse of a logistics company are recorded in an inventory management database and inventory management is performed (Patent Document 3).
Japanese Patent Laid-Open No. 10-201826 (0009, 0011, abstract, etc.) JP 2002-117144 A (0052 etc.) JP 2003-95439 A (0019, 0033, abstract, etc.) “Providing safer medical care through appropriate use of pharmaceuticals and medical institutions” [online], Ministry of Health, Labor and Welfare, [Search Date] September 1, 2003, Internet <URL; http: //www.mhlw. go.jp/qa/iyaku/yakujihou/point1.html>

  However, these Patent Documents 1 to 3 do not store the records after using blood products or drugs for 20 years or 30 years. In addition, the product seal published in Non-Patent Document 1 in FIG. 17 has a product name of “XXOO Injection 100” and a standard capacity of “100 IU / 0.5 mL” as a manufacturing number (lot number). ) “MHLW07” is described. However, based on this description, even if the record is stored in a medical institution, it is not possible to smoothly identify a patient who has used a specific biological product when an infection occurs.

For example, FIG. 18 is a diagram showing problems associated with the enforcement of the revised Pharmaceutical Affairs Law. The pharmaceutical manufacturer 102 has not surely grasped to which medical institution 103 the product of which product number and which product name has been delivered. On the other hand, the medical institution 103 is generally divided in the management system (entrance / exit management) of the drug management unit and the management system (management of usage history) of the ward (upper diagram in FIG. 18). Further, the medical institution 103 does not surely know to which patient the product of a specific lot has been used.
For this reason, when an infectious disease or the like due to a specific organism-derived product occurs (accident occurrence), the pharmaceutical manufacturer 102 has a wholesale 105 in order to collect the product related to the infectious disease and to determine the patient used. The hospital (medical institution 103) to which the related medicine is shipped is checked by using a paper slip and electronic data, etc., and a survey is requested from the hospital to which the drug is shipped. At hospitals, paper charts are checked by cooperating with surveys. The number of medical charts is more than 1 million a year depending on the hospital. For this reason, it is first impossible to completely find a patient in which a related product (a product of a specific lot [product serial number]) is used (the lower diagram in FIG. 18).
Further, the pharmaceutical wholesale 105 wants to be involved in the new regulation by the revision of the Pharmaceutical Affairs Law as an industry, but it is difficult to get involved because the system cost is not met.
Furthermore, the pharmaceutical manufacturer 102 may be merged or closed, and the hospital (medical institution 103) may be closed or consolidated. For this reason, it is extremely difficult to retain information on the delivery destination hospital and information on used patients for 20 to 30 years.

  Therefore, the present invention can appropriately store usage records of biological products (specific biological products) and, for example, when an infectious disease develops, quickly collect related products, hospitals, It is a main object to provide a management method and a management device for biological products that can contact a patient.

  The management method and management device for a specific biological product of the present invention that has solved the above problems, information on raw materials collected from biological materials, information on raw materials and specifications of biological products, information on the use of biological products, Is stored in a computer-readable storage medium, and after the biological product is used for the patient, at least the patient used or the raw material of the used biological product can be identified. -Claim 2-Claim 10).

  In addition, when the hospital using the biological product manufactured from a certain raw material / patient used is specified, and the first lot number unique to the raw material is known, the computer uses the first lot number. Biological products made from the raw material of the lot number are individually identified, and hospitals and patients who use the biological products are identified (claims 4 and 12). In addition, the first lot number unique to the raw material is unknown, but when the information for specifying the raw material is known, the computer identifies the first lot number from the information for specifying the raw material, and specifies this A biological product made from the raw material of the first lot number is specified, and a hospital and a patient who has used the specified biological product are specified (claims 5 and 13).

  In addition, the computer identifies the biological product used from the information that identifies the patient, identifies other biological products that use the same raw material from the identified raw material of the biological product, and this other biological product. The hospital used and the patient used were specified (claims 6 and 14). In addition, when the biological product in question is known, the raw material of this biological product is specified by a computer (biological product management device), and the raw material is the same (partially matched). The product is specified, and the hospital / patient who uses this other biological product is specified (claim 15).

  According to the present invention, it is possible to appropriately store usage records of biological products, and for example, when an infection occurs, quickly collect related biological products and contact hospitals and patients. Can be done.

  Hereinafter, the best mode for carrying out the present invention (hereinafter referred to as “embodiment” as appropriate) will be described with reference to the drawings.

(Management of specified biological products)
FIG. 1 is a diagram showing a flow of management work for a specific organism-derived product in the present embodiment. In FIG. 1, the left side is the upstream side (raw material side), and the right side is the downstream side (patient side). In the following description, it is assumed that the raw material is blood.
As shown in this figure, the management work of a specific biological product is a pharmaceutical manufacturer (pharmaceutical company) that manufactures a specific biological product based on a biological material (blood) collected from a person (donor) D as a living organism. (Manufacturer 2), Medical provider 2 that provides raw materials such as blood to the pharmaceutical manufacturer 2 (special corporation Japan Red Cross), etc. It is implemented including a medical institution (hospital / pharmacy) 3 as a person, a distributor 5 such as a wholesaler that purchases a product of a specific organism from the pharmaceutical manufacturer 2 and delivers it to the medical institution 3. Incidentally, reference numeral 1 ′ denotes a raw material importer that imports biological materials such as humans and animals and sells them to the pharmaceutical manufacturer 2. Reference sign D ′ is an animal such as a cow or a rabbit. For products derived from animals, it is not the management of specific biological products, but the management of biological products.
Reference numeral 4 denotes a data center. The data center 4 will be described in detail later. The specific biological product / biological product is abbreviated as a product as appropriate.

Here, the specific biological product and the biological product include the following.
In other words, the products derived from specific organisms are pH4-treated acidic human immunoglobulin, thrombin (limited to human origin), histamine-added immunoglobulin (dried), human plasma-derived dry blood coagulation factor XIII, dry concentrated human blood coagulation factor Factor XIII, fibrinogen-added factor XIII, fibrinogen combination agent, polyethylene glycol-treated anti-HBs human immunoglobulin, polyethylene glycol-treated human immunoglobulin, polyethylene glycol-treated anti-tetanus human immunoglobulin, heated human plasma protein (Limited to use), thawed human erythrocyte concentrate, activated prothrombin complex, human immunoglobulin treated with dry pH 4, human immunoglobulin treated with dry ion exchange resin, dry sulphated human immunoglobulin, ..., dry concentrated human blood coagulation factor VIII , Dry concentrated human blood coagulation factor IX, anti-HBs Immunoglobulin, anti-tetanus human immunoglobulin, synthetic blood, fresh frozen human plasma, human haptoglobin, human platelet concentrate, human platelet concentrate HLA, human serum albumin (but only for use as a main component), human red blood cell concentrate , Preparations containing components such as human whole blood, human immunoglobulin, washed human erythrocyte suspension, and the like.

On the other hand, galactosyl serum albumin diethyltriaminepentaacetic acid technetium (99mTc) technetium large aggregate human serum albumin (99mTc), technetium human serum albumin, iodide human serum albumin (131I), human serum albumin diethyltriaminepentaacetic acid Technetium (99mTc), large aggregate human serum albumin, urokinase, ulinastatin, allergen extract (for treatment) (limited to bacteria and human urine), pituitary gonadotropin, somatotrelin acetate, placental gonadotropin, A “Pharmaceuticals” containing components such as type botulinum toxin, millimostim, and the like.
Biological products include secretin, bovine blood extract, calf blood extract, serum gonadotropin, isophene insulin, insulin zinc, insulin (excluding bacterially-derived genetically modified products), kalidinogenase, protamine Insulin zinc, crystalline insulin zinc, amorphous insulin zinc, conjugated estrogens, danaparoid sodium, dalteparin sodium, heparin calcium, heparin sodium, leviparin sodium, chondroitin sulfate sodium (except those derived from sputum), porphy "Medicines (excluding those used for oral and transdermal administration) containing ingredients such as mer sodium, rabbit testicle / skin extract combination drug, vaccinia virus inoculated rabbit inflammation skin extract, sterilized lyophilized pig dermis, etc. ".
Although different from the preparation, biological products include urokinase, human serum albumin, sheep antibody, mouse antibody, equine pericardium, porcine heart valve, porcine aortic valve, bovine pericardium, juvenile porcine teeth Examples include “medical devices” containing components such as embryonic tissue-derived enamel matrix derivatives, heparin,.

  Next, referring to FIG. 1, blood as a raw material is collected (component donation / whole blood donation), a product of a specific biological origin (blood product, etc.) is manufactured and used for a patient P. Explain the flow of information (management work for specific biological products).

  As shown in FIG. 1, blood is collected from the donor D by the raw material provider 1 (S11). At this time, the donor number, name, date of birth, current address of donor D, and donor screening result are informed to donor D. The donor screening result is a test result such as negative hepatitis B, for example. The raw material provider 1 has the following items (1) to (6), that is, (1) so that the information necessary for ensuring safety can be confirmed in the blood of a person who is a raw material or a material such as a blood product. Blood collection site, (2) Date of blood collection, (3) Questionnaire for blood donor, status of diagnosis by examination and examination, (4) Progress of work to collect the blood, (5) Blood donor (6) Other records necessary for ensuring the quality, effectiveness and safety of blood-derived products must be maintained and stored (donor = donor D). Therefore, the raw material provider 1 creates and stores a blood collection record (S12). In FIG. 1, the collection record is stored in association with the raw material ID (Lot1 = first lot number). Information transmitted (up) to the data center 4 will be described in detail later.

  A part of the blood collected by the raw material provider 1 in S11 is sent as it is to the medical institution 3 (S13), and is used for blood transfusion at the time of surgery, for example. The remainder is sent to the pharmaceutical manufacturer 2 (S14), and a specific biological product such as a blood product is manufactured using this as a raw material. The manufactured product of a specific biological product as a pharmaceutical product is sent from the pharmaceutical manufacturer 2 to a distributor 5 such as a wholesaler (S15). This specific organism-derived product is sorted for each destination and sent from the dealer 5 to the medical institution 3 (S16). The dealer 5 records the delivery destination for each product (sales results by item, manufacturer, product, delivery medical institution ID) (S17). The dealer 5 feeds back this information to the pharmaceutical manufacturer 2 (S18). The pharmaceutical manufacturer 2 takes into account the information fed back from the dealer 5, and the product ID and lot number (local lot number = product number [product manufacturing number]), delivery dealer ID, delivery medical institution ID, etc. Are recorded in association with each other and stored (S19). Thereby, the pharmaceutical manufacturer 2 fulfills the obligation to keep the donor record / sales record. Note that the product ID is the second lot number, and the specific biological product to be managed is individually specified.

  The medical institution 3 that has received the medicine (specific biological product) in S16 uses the specific biological product appropriately selected according to the symptoms for the patient P (S20). A record of the specific biological product used is stored in the medical institution 3 (S21, S22). That is, the medical institution 3 creates and stores a record of a patient who uses a specific biological product in order to easily identify a patient who is a target of use in the event of an infection.

  In addition, some of the raw materials derived from organisms are imported by S31, and the raw materials related to this import are left with a record of collection as shown in FIG. (S33). In addition, a bio-derived raw material (manufactured / imported in Japan) collected from the animal D 'is also left with a collection record as shown in FIG. 1 (S35) and sent to the pharmaceutical manufacturer 2 (S36).

(Information handled by pharmaceutical manufacturers / dealers / medical institutions)
FIG. 2 is a diagram showing an example of information handled by each department of the pharmaceutical manufacturer / dealer / medical institution in the present embodiment together with the flow of information.
As shown in FIG. 2, the pharmaceutical manufacturer 2 has a material department 21, a manufacturing department 22, and a sales department 23. The medical institution 3 has a material department (pharmaceutical department) 31, a medical department 32, and a medical department 33. Further, a wholesale agent 5 such as a wholesaler located between the pharmaceutical manufacturer 2 and the medical institution 3 has a distribution department 51, an inventory management department 52, and a sales department 53.

  The material department 21 of the pharmaceutical manufacturer 2 purchases the raw material with LotNo. From the raw material provider 1 (see FIG. 1), and supplies the raw material according to the name of the supplier company, the supplier LotNo, the sampling record, and the unique ID. Management operations related to In addition, the manufacturing department 22 is supplied with the raw material assigned with the unique ID by the material department 21, and performs a management operation related to the production based on the unique ID, the production record, and the product-specific LotNo. The sales department 23 performs management operations related to sales of the product of the specific biological origin manufactured by the manufacturing department 22 using the product-specific LotNo and the name of the distributor. The sales department 23 also performs management work related to sales by item-by-item information, lot-by-lot information, and delivery facility name (delivery medical institution name) fed back from the sales department 53 of the dealer 2.

  The distribution department 51 of the dealer 5 purchases a specific biological product with a product name and LotNo. From the pharmaceutical manufacturer 2, and for the purchased specific biological product, the pharmaceutical manufacturer's name, product-specific LotNo, unique ID Management operations related to logistics. The inventory management department 52 receives the unique ID assigned by the logistics department 51, and performs a management operation related to inventory by using a unique ID different from the unique ID. The sales department 53 receives the unique ID assigned by the inventory management department 52, and performs management related to sales by using the unique ID and the delivery facility name (delivery medical institution name). In addition, the sales department 53 feeds back the information for each item related to sales, the information for each lot, and the delivery facility name to the sales department 23 of the pharmaceutical manufacturer 2.

  The material department (pharmaceutical department) 31 of the medical institution 3 includes the name of the distributor, the Lot No. of each purchased product, the medical care, together with the information obtained from the medical department 32 regarding the product of a specific organism with a pharmaceutical manufacturer name, product name and LotNo. Management operations related to materials are performed based on the medication history by product fed back from the department 32. In addition, the medical department 32 performs management work related to medical care based on the medication history, medical record, personal identification ID, and the like based on information on medical treatment / treatment / medication. In addition, the medical department 33 performs management operations related to medical care based on the medical record, personal identification ID, personal identification information, and the like based on information obtained from the medical department. Incidentally, in this embodiment, it is assumed that the medical institution 3 records which lot (product serial number) of a biological product is used for which patient P.

  As will be described later, the pharmaceutical manufacturer 2 uploads (uploads) information on the raw materials and specifications of the specific biological product to the data center 4. In addition, the medical institution 3 uploads information related to the use of the specific biological product to the data center 4. These points, information uploaded by the raw material provider 1 (see FIG. 1), and information stored in the data center 4 will be described in detail later.

(Manufacture of blood products)
FIG. 3 is a diagram illustrating an example of a manufacturing process of a blood product as a specific organism-derived product in the present embodiment. An example of a blood product manufacturing process will be described with reference to FIG. 3 (see FIG. 1 and the like as appropriate).
The raw material provider 1 collects blood as biological material from the donor D by donating blood. Blood donation includes whole blood donation (S51) and component blood donation (S53). Whole blood donation is a method of donating all blood components and includes 400 mL donation and 200 mL donation. Component blood donation is a method of collecting only plasma and platelets in blood using a dedicated device. The whole blood donation of S51 (part thereof) is collected for 10 to 15 persons (specimen), centrifuged, and treated as fractionated plasma (with 3 L / bag) (S52). The component blood donation of S53 is handled as a unit of 80 mL of FFP (Fresh Frozen Plasma) or 200 mL of plasma, and a part thereof is further handled as plasma for fractionation (S54).

  Information on the donor D at the time of blood donation is given to the donor D by a unique donor number and is managed by the raw material provider 1 such as Sun Red (S91). The contents of the collection record at the time of blood donation are as described with reference to FIG. Moreover, the red blood ID is attached to the bag of the plasma for fractionation (S92). Incidentally, when a certain donor D donates blood after ** month ** day and half a year after that, it is different from the specimen and is given a different Lot 1 (first lot number). For this reason, if the bag is made by mixing blood for 15 people, Lot 1 for 15 samples is attached to the bag, or Lot 1 for 15 samples is recorded in association with the red-red ID.

  The plasma for fractionation by S52 and S54 is provided (sold) from the raw material provider 1 to the pharmaceutical manufacturer 2. At this time, the flexible disk in which Lot 1 (first lot number) and the donor number are stored in association with each other is sent from the raw material provider 1 to the pharmaceutical manufacturer 2 (S93).

  In the pharmaceutical manufacturer 2, the plasma for fractionation is put into a large pool for thousands to 10,000 people to obtain pooled plasma (S55). Pooled plasma is 1 lot, for example 2,750L. For example, a lot number of K6100 is assigned to the 1 lot of pooled plasma (S94). The lot number (first lot) corresponding to the sample corresponding to the pooled plasma (several thousands to 10,000) is recorded in association with the lot number of K6100.

  Next, the pooled plasma is fractionated with alcohol to produce a Fr-I paste (S56). Further, Fr-II + III paste is produced from this Fr-I paste (S57), Fr-IV paste is produced from Fr-II + III paste (S58), and Fr-V is further produced from Fr-IV paste. A paste is manufactured (S59).

  In this manufacturing process, a part of the Fr-I paste is extracted and used as an original fraction of blood product called XXXXX product (S60). The original fraction is subjected to various treatments and purifications, converted into a blood product (product) called a XX preparation (S61), shipped to the factory, and sent to, for example, the distribution center of the dealer 5 (S62). In addition, the product number + Lot number (E10 + K6100) is given to the original fraction of the XX formulation in S60 (S95). In addition, another product number + Lot number (E20 + K6100) is assigned to the blood product called SOO product of S61 (S96). Incidentally, the product number E20 here corresponds to, for example, a pharmaceutical manufacturer name + product name. The lot number K6100 corresponds to, for example, a product manufacturing number, and is associated with lots 1 to 1000 to 10,000 people (samples) as described above.

  The blood product as a specific biological product produced by the pharmaceutical manufacturer 2 is delivered from the distribution center to the medical institution 3, where sufficient informed consent is given to the patient P, and the patient P is informed of the benefits and disadvantages. And then used by patient P. Although the used record is left as shown in FIG. 1, the information stored in the data center 4 in the figure showing an example of the manufacturing process in FIG. 3 will be described later.

(Data center)
FIG. 4 is an overall configuration diagram in which the management method and the management apparatus for a specific organism-derived product according to this embodiment including a data center are implemented.
As shown in FIG. 4, the management method of the specific biological product (biological product) of the present embodiment is performed by the raw material provider 1, the pharmaceutical manufacturer 2, and the medical institution 3 that have already been described with the data center 4 as the core. . In addition, in the management method of the product derived from a specific organism in this embodiment, since the presence of the special agent 5 is not particularly required, it is omitted from FIG.

  As shown in FIG. 4, the data center 4 includes a management device (a management device for a specific biological product) 40. The configuration of the management device 40 will be described in detail later with reference to FIG. Moreover, in order to communicate with the management apparatus 40 via a network, the raw material provider 1 includes the terminal device 10, the pharmaceutical manufacturer 2 includes the terminal device 20, and the medical institution 3 includes the terminal device 30. Each of the terminal devices 10, 20, and 30 includes a communication device, a browser, and the like (not shown) and has a function of transmitting and receiving information using http (hyper text transfer protocol) or ftp (file transfer protocol). In FIG. 4, only one raw material provider 1, pharmaceutical manufacturer 2, and medical institution 3 are shown, but there are a plurality of them.

(Information registration / storage)
First, a part related to information registration / storage in the data center 4 of FIG. 4 will be described with reference to FIG.
FIG. 5 is a diagram illustrating a configuration of a part related to registration / storage of information in a management apparatus that manages a product of a specific organism.
As shown in FIG. 5, the management device 40 includes a CPU (Central Processing Unit), a RAM (Random Access Memory), a processing device 41 including other electric / electronic circuits, a hard disk device, and a controller thereof. A configuration in which a storage device 42 as a storage medium, an input / output device (input device) 43 including a keyboard / mouse / monitor / I / O device, a communication device (NIC: Network Interface Card) 44, and the like are connected to a bus. I am doing. The management device 40 is connected to a network via a router (not shown), and communicates with each terminal device via http or ftp.

  The processing device 41 classifies and arranges information received from the terminal devices 10, 20, and 30 via the communication device 44 as a software configuration, and the first to third databases 42 c and 42 b stored in the storage device 42. , 42c. Specifically, a function of receiving “information about raw materials collected from living organisms” transmitted from the terminal device 10 via the network via the NIC 44 and registering it in the first database 42a, via the network A function for receiving “information on raw materials and specifications of specific biological product” transmitted from the terminal device 20 via the terminal device 44 and registering it in the second database 42b, and transmitting from the terminal device 30 via the network The “information regarding the use of the specific biological product” is received via the communication device and registered in the third database 42c.

With reference to FIGS. 6-8, the three databases 42a, 42b, 42c memorize | stored in the memory | storage device 42 in this embodiment are demonstrated (refer FIGS. 1-5 suitably).
FIG. 6 is a diagram showing the configuration of the first database (raw material management DB) of the present embodiment.
The first database 42a is a so-called raw material management DB that is stored to manage information related to raw materials collected from living organisms (for example, blood). This information stores information for individually managing each specimen called a collected biological material (blood collected as an example). The serial number is registered in the No item of the first database 42a. In the item of raw material / biological identification information, for example, information for uniquely identifying the donor D is registered (name, date of birth, current address). The collection date is, for example, the day of blood donation. Thereby, even if it is the same donor D, if a blood collection day differs, it will be handled as another sample (different raw material). Test results such as HIV negative and hepatitis B negative are registered as screening results. For example, the name of the raw material provider 1 such as Japan Red is registered in the raw material provider name item. In Lot 1 (first lot number), an identifier uniquely indicating the raw material / biological identification information, the collection date, the raw material provider name,..., For example, Lot (m1), Lot (m2), or the like is registered. One Lot1 is given to one specimen.

  Incidentally, in the present embodiment, the first database 42a classifies, registers, and stores information transmitted (up) from the terminal device 10 to the management device 40 by the raw material provider 1, but stores the raw material. Information that the provider 1 transmits in the format shown in FIG. 6 may be registered and stored in the first database 42a as it is. In addition, it is assumed that the raw material provider 1 and the data center 4 are in discussion about how to assign Lot1. Of course, the data center 4 may lead the way of assigning Lot1.

FIG. 7 is a diagram showing a configuration of a second database (product-raw material / standard correspondence DB) of the present embodiment.
The second database 42b manages information on the raw materials and specifications of the specific biological product for the specific biological product manufactured by the pharmaceutical manufacturer 2 using the biological raw material provided from the raw material provider 1. This is a product-raw material / standard correspondence DB that is stored. The serial number is registered in the item No in the second database 42b. In the Lot 1 item, all the Lot 1 of biological materials included in the product are registered. For example, if the aforementioned pooled plasma is a mixture of 8000 samples of blood, Lot1 (for example, Lot1 (m1) to Lot1 (m8000)) of all the blood of 8000 samples is registered. Lot2 (second lot number) is an identifier that uniquely indicates a product. In this embodiment, Lot2 uniquely indicates a pharmaceutical manufacturer name (pharmaceutical manufacturer number), a product name (product number), a product manufacturing number (product individual lot number), and a product standard (standard capacity, etc.). is there. Among the components of Lot 2, the pharmaceutical manufacturer name identifies the pharmaceutical manufacturer 2, such as A Pharmaceutical and B Pharmaceutical, and the company name is registered, but can be replaced with a stock code, other symbols, numbers, or the like. A product name such as A-long or B-nin is registered as the product name, but it can be replaced with a product code or the like. The product manufacturing number is a lot number (local lot number), a manufacturing number, or the like. As the product standard, standard capacities such as 50 tablet candy and 100 IU 0.5 mL are registered. By this Lot 2, each product (specific biological product) is uniquely identified. In FIG. 7, No1 and No2 use the same raw material, and different products are manufactured by another pharmaceutical manufacturer 2 (when part of the pooled plasma is provided to another company). In addition, the products No. 1 and No. 4 are manufactured with different Lot 1 raw materials and different pharmaceutical manufacturers 2 with the same product name. Moreover, the product of No5 is manufactured from the single raw material.

  Incidentally, in the present embodiment, the second database 42b classifies, registers, and stores information that the pharmaceutical manufacturer 2 transmits (ups) from the terminal device 20 to the management device 40, but stores the information. The information to be transmitted in the format shown in FIG. 7 may be registered and stored in the second database 42b as it is. In addition, about the method of granting Lot2, it is assumed that the pharmaceutical manufacturer 2 and the data center 4 (and the medical institution 3) are in discussion. Of course, the data center 4 may lead the way of assigning Lot2. A JAN code (Japanese Article Number Code) or the like may be used as a component of Lot2.

FIG. 8 is a diagram showing the configuration of the third database (product usage information DB) of the present embodiment.
The third database 42c is stored so that the medical institution 3 manages information related to the use of the specific biological product for the patient P regarding the specific biological product such as a blood product manufactured by the pharmaceutical manufacturer 2. This is a product usage information DB. The serial number is registered in the item No in the third database 42c. In the Lot 2 item, Lot 2 uniquely indicating a product used for the patient P is registered. Further, product information (pharmaceutical manufacturer name + product name), product manufacturing number, and product standard (standard capacity, etc.), which are constituent elements of Lot2, are also registered information items. Furthermore, the personal identification information of the patient P (patient ID, current address shown in FIG. 1) and the date of use at the medical institution 3 are registered. In addition, in order to grasp which medical institution used the product, the name of the medical institution used is set as an item. Note that, as shown in FIG. 8, the product of the same Lot 2 (Lot 2 (1)) may be used (administered) to different patients P. The same patient P may use a plurality of products. Further, although not shown in FIG. 8, the same patient P may be used by different medical institutions but with different Lot 2 but the same product.

  Incidentally, in the present embodiment, the third database 42c categorizes, registers, and stores information that the medical institution 3 transmits (ups) from the terminal device 30 to the management device 40. The information transmitted by 3 in the format shown in FIG. 8 may be registered and stored in the third database 42c as it is. Note that the pharmaceutical manufacturer 2 and the data center 4 are in discussion about how to assign Lot2.

Each information is stored as each database 42a, 42b, 42c in a storage device 42 as a computer-readable storage medium. Each database 42a, 42b, 42c is stored in a magnetic tape, a DVD (Digital Versatile Disc) or the like. You may make it memorize | store in a portable storage medium (it is preferable to preserve | save a portable storage medium in a cool dark place). For each information, the contents of the first database 42a and the second database 42b are stored by the data center 4 for 30 years after the medicine is used. The contents of the third database 42c are stored by the data center 4 for 20 years after the product is used. By storing the information in this manner, it is possible to immediately specify the related product, raw material, patient P, and medical institution 3 when an accident such as an infection occurs. This point will be described later in detail as tracking information at the time of the accident. Further, by storing information in the data center 4 in this way, the cost required for record storage in the raw material provider 1, the pharmaceutical manufacturer 2, and the medical institution 3 can be kept low. In addition, it is possible to flexibly deal with mergers and integrations of companies and hospitals, business closures, abolitions, and organizational changes.
If a product is uniquely specified by a pharmaceutical manufacturer name, a product name, etc., the object can be achieved without using Lot 2 for the second database 42b and the third database 42c.

(Tracking information at the time of an accident; tracking from upstream to downstream)
Next, a description will be given of a part of the data center 4 in FIG. 4 relating to tracking of information when an accident occurs (from upstream to downstream).
FIG. 9 is a diagram illustrating a configuration of a part related to tracking of information at the time of an accident (from upstream to downstream) of a management apparatus that manages a product of a specific organism. Note that description of portions common to FIG. 5 is omitted.

  The processing device 41 has a function (Lot1 acquisition function) of acquiring Lot1 of this raw material from the first database 42a based on information specifying the raw material such as the name of the donor D as a software configuration. In addition, based on the acquired Lot 1, the second database 42 b has a function (product information acquisition function) for acquiring information (Lot 2) that individually identifies a product manufactured based on the acquired raw material of Lot 1. . Further, based on the information (Lot2) for individually identifying the product, information for identifying the medical institution 3 that uses the product corresponding to the information (Lot2) for individually identifying the product from the third database 42c, And a function (patient / medical institution information acquisition function) for acquiring both information for specifying the patient P in which the product is used. Further, it has a function (communication function) for transmitting / receiving information to / from the terminal devices 10, 20, and 30 via the communication device 44.

Next, the operation of the management device 40 in FIG. 9 will be described.
FIG. 10 is a sequence diagram illustrating a case where information is tracked from upstream (raw material side) to downstream (product use side) when an accident occurs in the present embodiment.
The operation of the management device 40 (biological product management method) will be described with reference to the sequence diagram of FIG. 10 (see FIG. 9 and the like as appropriate).

In the example of FIG. 10, when donor D develops an infection (for example, donor D develops an infection after blood donation and there is a possibility that a virus or the like is mixed in the raw material), the fact that the infection has developed A communication is sent via the medical institution 3 to the raw material provider 1 such as Japan Red. The raw material provider 1 transmits information (name, current address, etc.) specifying the donor D to the management device 40 of the data center 4 using the terminal device 10 (S101). The management apparatus 40 acquires Lot 1 (first lot number) from the first database 42a (see FIG. 6) based on the received information specifying the donor D (S102). Next, the management apparatus 40 acquires Lot 2 (second lot number) of the product including the same Lot 1 material from the second database 42b (see FIG. 7) (S103). Furthermore, the management apparatus 40 acquires information specifying the patient P and information specifying the medical institution 3 from the third database 42c (see FIG. 8) based on the Lot 2 (S104). Then, the management device 40 sequentially contacts the terminal device 20 of the pharmaceutical manufacturer 2 and the terminal device 30 of the medical institution 3 (S105, S106), and if the e-mail address or the like is known, the terminal device of the patient P (Not shown) is contacted (S107).
If the raw material provider knows Lot 1, the Lot 1 may be transmitted to the management device 40, and the management device may start processing from S103.

FIG. 11 is a flowchart corresponding to the sequence diagram of FIG.
With reference to the flowchart of FIG. 11, a case where information is tracked from upstream to downstream when an accident occurs will be supplementarily described.

  When the donor D develops an infectious disease, a notification that the infectious disease has developed is sent to the raw material provider 1 such as the Japanese Red Cross via a medical institution (S111). The raw material provider 1 notifies the pharmaceutical manufacturer 2 of Lot 1 of the raw material (S112). The pharmaceutical manufacturer 2 identifies the product Lot2 derived from the raw material Lot1 (S113). In addition, the pharmaceutical manufacturer 2 performs processing such as notification of an accident to the medical institution 3 (S114). In addition, all medical institutions 3 are notified of accidents that clearly indicate Lot2. The medical institution 3 confirms the usage history of the product corresponding to the specified Lot 2 (S115). Then, notification / confirmation to the patient P using the Lot 2 product is performed (S116).

  In this flow, the management device 40 can be used to determine the Lot 1 to be notified to the pharmaceutical manufacturer 2 in S112. Further, in S113, the management device 40 can be used for the process of washing out Lot1 to Lot2. In S114, the management device 40 can be used for the process of specifying the medical institution 3 to be notified. In S115, the management device 40 can be used for the process of confirming the usage history. In S116, the management device 40 can be used for notification to the patient P or the like.

  According to this, it is possible to reliably determine the patient P while eliminating the impossible work such as investigating the medical record exceeding 1 million cases / year for many years and determining the patient P. It can be carried out. Moreover, the notification to the patient P and the notification to the medical institution 3 can be reliably performed.

(Tracking information when an accident occurs; case of tracking from downstream to upstream)
Next, a description will be given of a portion of the data center 4 in FIG. 4 related to tracking of information at the time of occurrence of an accident (from downstream to upstream (and further downstream)).
FIG. 12 is a diagram illustrating a configuration of a part related to tracking of information at the time of occurrence of an accident (from downstream to upstream) of the management apparatus that manages the product of a specific organism. Note that description of portions common to FIG. 5 is omitted.

  The processing device 41 has a function of acquiring, as a software configuration, information (Lot2) for individually identifying the product used for the patient P from the third database 42c based on the information for identifying the patient P ( Used product information acquisition function). In addition, based on the information (Lot2) for individually identifying the product, it has a function (raw material information acquisition function) for acquiring Lot 1 (first lot number) unique to the raw material of this product from the second database 42b. . Further, based on Lot 1, a function for acquiring information (Lot 2) for individually identifying other products manufactured based on the raw material corresponding to Lot 1 from the second database 42 b (other product information specifying function) Have Further, based on the information (Lot2) for specifying other products individually, information for specifying the medical institution 3 that uses the other products for the patient P from the third database 42c, and the other products used. A function of acquiring information identifying the patient P (patient / medical institution information acquisition function). Further, it has a function (communication function) for transmitting / receiving information to / from the terminal devices 10, 20, and 30 via the communication device 44.

Next, the operation of the management device 40 in FIG. 13 will be described.
FIG. 13 is a sequence diagram illustrating a case in which information is tracked from downstream to upstream (further downstream) when an accident occurs in the present embodiment.
The operation of the management apparatus 40 (biological product management method) will be described with reference to the sequence diagram of FIG. 13 (see FIG. 12 and the like as appropriate).

In the example of FIG. 13, when the patient P develops an infectious disease, a notification that the infectious disease has developed is sent to the medical institution 3. The medical institution 3 transmits information (name, current address, etc.) specifying the patient P using the terminal device 30 to the management device 40 of the data center 4 (S141). The management apparatus 40 acquires Lot2 (second lot number) from the third database 42c (see FIG. 8) based on the received information specifying the patient P (S142). Next, the management apparatus 40 acquires the Lot 1 of the raw material of the product from the Lot 2 from the second database 42b (see FIG. 7) (S143). Furthermore, the management apparatus 40 acquires Lot 2 of other products having the same raw material (including the same Lot 1) from the second database 42b based on Lot 1 (S144). Next, the management device 40 acquires information for specifying the patient P who has used the other product and information for specifying the medical institution 3 from the Lot 2 of the other product (S145). Then, the management device 40 sequentially contacts the terminal device 20 of the pharmaceutical manufacturer 2 and the terminal device 30 of the medical institution 3 (S146, S147), and if the e-mail address is known, the terminal device of the patient P (Not shown) is contacted (S148).
When Lot 2 is found in the medical institution 3 by the contact of the patient P, the Lot 2 may be transmitted to the data center 4 and S142 may be omitted. When the number of raw material types (Lot1) of other products is small, the donor D may be specified by the first database 42a and contacted with the donor D.

FIG. 14 is a flowchart corresponding to the sequence diagram of FIG.
With reference to the flowchart of FIG. 14, a supplementary description will be given of a case where information is traced from downstream to upstream (and again upstream) when an accident occurs.

  The patient P who has used (administered) the product from the medical institution 3 may develop an infection with a time lag of 10 years or more (S151). When the patient P develops an infection (S152), the medical institution 3 is contacted (S153, the patient P visits). In some cases, another medical institution 3 is contacted or the patient P visits. The medical institution 3 confirms the usage history and grasps the lot of the pharmaceutical (S154). Also, voluntarily report to the Ministry of Health, Labor and Welfare (S155). In addition, a suspicion report is spontaneously made to the pharmaceutical manufacturer 2. The medical institution 3 may be published in the literature (S154a). In addition, the pharmaceutical manufacturer 2 may conduct a literature survey (S154b). Furthermore, the pharmaceutical manufacturer 2 reports the literature to the Ministry of Health, Labor and Welfare (S154c). The Ministry of Health, Labor and Welfare makes a survey request to the pharmaceutical manufacturer 2 in response to the report of S155 or S154c (S156).

  The pharmaceutical manufacturer 2 conducts an investigation and identifies a product having the same Lot1 as the Lot2 product in question (S157). And the notification etc. to the medical institution 2 based on a survey result are performed (S158). If a virus is found in the raw material, the raw material supplier 1 is notified, and in the case of blood transfusion, the donor D is notified.

  The pharmaceutical manufacturer 2 that has completed the survey notifies all the medical institutions 3 of information on the product in question (S158), but the medical institution 3 investigates the use history of the product (S159). When the use history is found, the patient P is informed of a different patient P from the patients P in S151 and S152.

  In this flow, in S154, the management apparatus 40 can be used to grasp the problematic Lot2. In S157, the management apparatus 40 can be used to identify other products having the same Lot1 as the product in question. In S158, the management apparatus 40 can be used for washing out the medical institution 3 to which other products are delivered. Moreover, the management apparatus 40 can be used for the process of reaching the raw material provider 1 from the pharmaceutical manufacturer 2 and further reaching the donor D. In S159, the management apparatus 40 can be used to investigate the usage history of other products. In S160, the management device 40 can be used for notification / confirmation to other patients P.

  According to this, as in the case of tracing from upstream to downstream, while abolishing impossible work such as examining patient charts over many years over 1 million cases / year, The patient P can be reliably determined. Moreover, the notification to the patient P and the notification to the medical institution 3 can be reliably performed.

  FIG. 15 is a diagram schematically showing the overall flow, but the data center 4 stores information from the raw material provider 1, information from the pharmaceutical manufacturer 2, and information from the medical institution 3, and when necessary. Or track information from upstream to downstream, or track information from downstream to upstream. As shown in FIG. 15, Lot 2 may be attached to or described in a product container or the like, attached to a package, or described. Note that Lot 1 and Lot 2 may be a one-dimensional code (bar code) or a two-dimensional code (a computer-readable code may be used). In addition, an IC tag (also referred to as an RFID tag) storing Lot1 or Lot2 directly or indirectly may be attached to a raw material or a biological product.

  According to the present invention described above, it is possible to appropriately store usage records of biological products (specific biological products), and to quickly collect related products when an infection occurs, for example. Can contact hospitals and patients.

  The present invention is not limited to the above-described embodiment, and can be modified in various forms within the scope of the technical idea of the present invention. Moreover, although the distribution route including the dealer 5 has been described, the distribution route may be further complicated. In addition, it is possible to appropriately cope with grasping of a raw material that becomes a carry-over.

  By the way, there may be multiple hospitals with the same name for hospitals (medical institutions), etc., so for example, in the third database, in addition to the name of the medical institution, the address, the director's name, etc. You may make it memorize | store. In addition, biological products manufactured in foreign countries may be imported by pharmaceutical companies (importers) and used by patients at medical institutions. Such a case also belongs to the technical scope of the present invention. In the case of this import, pharmaceutical companies include importers who only import. By the way, even when imported, biological products are given information that identifies raw materials or can be linked to information that identifies raw materials.

In the present embodiment, blood (raw component donation / whole blood donation) as a raw material is collected (product donation / whole blood donation), a product of a specific biological origin (blood product, etc.) is manufactured and used for the patient P (specific flow) Explain the management of biological products). It is the figure which showed an example of the information which each department of the pharmaceutical maker / dealer / medical institution in this embodiment handles with the flow of information. It is a figure which shows an example of the manufacturing process of the blood formulation as a specific biological origin product in this embodiment. It is the whole block diagram by which the management method and management device of a specific living thing product of this embodiment including a data center are implemented. It is a figure which shows the structure of the part which concerns on registration / storage of information of the management apparatus which manages the product of specific organism origin. It is a figure which shows the structure of the 1st database (raw material management DB) of this embodiment. It is a figure which shows the structure of the 2nd database (product-raw material and specification corresponding | compatible DB) of this embodiment. It is a figure which shows the structure of the 3rd database (product usage information DB) of this embodiment. It is a figure which shows the structure of the part which concerns on the tracking of the information at the time of the accident occurrence (from upstream to downstream) of the management apparatus which manages specific biological origin products. In this embodiment, it is a sequence diagram explaining the case where information is tracked from the upstream (raw material side) toward the downstream (product use side) when an accident occurs. It is a flowchart corresponding to the sequence diagram of FIG. It is a figure which shows the structure of the part which concerns on the tracking of the information at the time of the accident occurrence (from the downstream to the upstream) of the management apparatus which manages specific biological origin products. In this embodiment, it is a sequence diagram explaining the case where information is tracked from downstream to upstream (further downstream) when an accident occurs. 14 is a flowchart corresponding to the sequence diagram of FIG. 13 of the present embodiment. It is a figure which shows the whole flow typically. It is the figure published in the nonpatent literature 1, and shows the concept of a biological origin product and a specific biological origin product. It is a figure published in the nonpatent literature 1, and shows an example of the seal | sticker of the product provided from a pharmaceutical manufacturer etc. It is the figure which showed the problem accompanying enforcement of the revised Pharmaceutical Affairs Law.

Explanation of symbols

1 Raw material provider 2 Pharmaceutical manufacturer (Pharmaceutical company)
3 Medical institutions (medical providers)
4 Data Center 40 Management Device 41 Processing Device 42 Storage Device 42a First Database 42b Second Database 42c Third Database 43 Input Device 44 Communication Device

Claims (17)

A pharmaceutical manufacturer that manufactures biological products based on biological raw materials collected from living organisms, a raw material provider that provides the pharmaceutical raw materials to the pharmaceutical manufacturers, and a biological product manufactured by the pharmaceutical manufacturers. Manufactured based on the above-mentioned biological products manufactured and used, or imported from pharmaceuticals, and used by patients by medical providers. A biological product management method for managing a biological product,
Even after the biological product is used for the patient, at least the patient used, the used medical provider, or the raw material of the used biological product can be identified.
A first procedure for associating information identifying the raw material with a first lot number unique to the raw material and storing the information in a computer-readable storage medium;
A second procedure for associating information for individually identifying the biological product with the first lot number and storing the information in a computer-readable storage medium;
The information for individually identifying the biological product, the information for identifying the patient using the biological product, and the information for identifying the health care provider who has used the biological product for the patient are associated with each other. A third procedure for storing information in a computer readable storage medium;
And storing the information after use of the biological product,
A method for managing biological products characterized by The second procedure includes the name of a pharmacist of the biological product, the product name of the biological product, the product number of the biological product, the form of the biological product, and the first lot number. And storing these information in a computer-readable storage medium,
The third procedure includes the name of the pharmacist of the biological product, the product name of the biological product, the product number of the biological product, the form of the biological product, and the biological product. The third procedure of associating information for identifying a patient with information for identifying a health care provider who has used this biological product for a patient, and storing the information in a computer-readable storage medium ,
The management method of the biological product of Claim 1 characterized by these. The second procedure and the third procedure are performed by attaching a second lot number unique to the biological product to the information stored in the second procedure and the third procedure,
The management method of the biological product of Claim 1 or Claim 2 characterized by these. A pharmaceutical manufacturer that manufactures biological products based on biological raw materials collected from living organisms, a raw material provider that provides the pharmaceutical raw materials to the pharmaceutical manufacturers, and a biological product manufactured by the pharmaceutical manufacturers. Manufactured based on the above-mentioned biological products manufactured and used, or imported from pharmaceuticals, and used by patients by medical providers. A biological product management method for managing a biological product by a computer,
A procedure in which a first lot number unique to the raw material is input or instructed to the computer via an input device;
Biological product manufactured based on the raw material of the first lot number from the second database in which the computer stores information on the raw material / standard of the biological product based on the first lot number To obtain information to identify each individually,
Information for identifying a health care provider who uses the biological product for a patient from a third database in which the computer stores information on the use of the biological product based on information for individually identifying the biological product. , And a procedure for obtaining information including at least one of information for identifying a patient in which the biological product is used,
Performing the
A method for managing biological products characterized by A pharmaceutical manufacturer that manufactures biological products based on biological raw materials collected from living organisms, a raw material provider that provides the pharmaceutical raw materials to the pharmaceutical manufacturers, and a biological product manufactured by the pharmaceutical manufacturers. Manufactured based on the above-mentioned biological products manufactured and used, or imported from pharmaceuticals, and used by patients by medical providers. A biological product management method for managing a biological product by a computer,
A procedure in which information specifying the raw material is input or instructed to the computer via an input device;
Based on the information for identifying the raw material, the computer stores, from a first database in which information for identifying the raw material is associated with a first lot number that uniquely indicates the raw material, a first unique to the raw material The procedure to get the lot number,
Biological product manufactured based on the raw material of the first lot number from the second database in which the computer stores information on the raw material / standard of the biological product based on the first lot number To obtain information to identify each individually,
Information for identifying a health care provider who uses the biological product for a patient from a third database in which the computer stores information on the use of the biological product based on information for individually identifying the biological product. , And a procedure for obtaining information including at least one of information for identifying a patient in which the biological product is used,
Performing the
A method for managing biological products characterized by A pharmaceutical manufacturer that manufactures biological products based on biological raw materials collected from living organisms, a raw material provider that provides the pharmaceutical raw materials to the pharmaceutical manufacturers, and a biological product manufactured by the pharmaceutical manufacturers. Manufactured based on the above-mentioned biological products manufactured and used, or imported from pharmaceuticals, and used by patients by medical providers. A biological product management method for managing a biological product by a computer,
A procedure in which information identifying the patient is input or instructed to the computer via an input device;
A step in which the computer acquires information for individually identifying the biological product used for the patient from the third database storing the usage information of the biological product based on the information for identifying the patient;
The computer is unique to the raw material of the used biological product from the second database storing the information on the raw material / standard of the biological product based on the information for individually identifying the used biological product. A procedure for obtaining a first lot number;
Based on the first lot number, the computer individually identifies information from the second database that identifies other biological products manufactured based on the raw material corresponding to the first lot number. Steps to get,
Based on the information that the computer individually specifies the other biological product, the medical provider using the other biological product and the other biological product are used from the third database. A procedure for obtaining information including at least one of information identifying a patient,
Performing the
A method for managing biological products characterized by In the second database and the third database, information for individually specifying the biological product is replaced with a second lot number unique to the biological product, or the biological product is specified individually. The information is stored in association with a second lot number unique to the biological product;
The method for managing a biological product according to any one of claims 4 to 6, wherein: The second database includes a name of a pharmacist of the biological product, a product name of the biological product, a product number of the biological product, a form of the biological product, and the raw material. 1 associated with the lot number,
In the third database, the name of the pharmacist of the biological product, the product name of the biological product, the product number of the biological product, the form of the biological product, and the biological product are used. Storing information identifying a patient and information identifying a health care provider who used the biological product for the patient in association with each other,
The method for managing a biological product according to any one of claims 4 to 7, wherein: In the case of using the second lot number, the biological product has the second lot number written or attached to the container or package thereof,
The management method of the biological product of Claim 3 or Claim 7 characterized by these. A pharmaceutical manufacturer that manufactures biological products based on biological raw materials collected from living organisms, a raw material provider that provides the pharmaceutical raw materials to the pharmaceutical manufacturers, and a biological product manufactured by the pharmaceutical manufacturers. Manufactured based on the above-mentioned biological products manufactured and used, or imported from pharmaceuticals, and used by patients by medical providers. A biological product management device for managing biological products,
The management device includes a processing device that processes information, a storage device that stores information, and a communication device that communicates information with a terminal device via a network.
The storage device
A first database in which information for specifying the raw material is associated with a first lot number unique to the raw material;
A second name that associates the name of the pharmacist of the biological product, the product name of the biological product, the product number of the biological product, the form of the biological product, and the first lot number. Database,
The name of the pharmacist of the biological product, the product name of the biological product, the product number of the biological product, the form of the biological product, and information identifying the patient in which the biological product was used. , A third database that associates information specifying a medical provider who uses this biological product for the patient,
With
The processor is
A function of receiving information about the raw material collected from the organism transmitted from the terminal device via the network via the communication device and registering it in the first database;
A function of receiving information about the raw materials and standards of the biological product transmitted from the terminal device via the network via the communication device and registering the information in the second database;
A function of receiving information about the use of the biological product transmitted from the terminal device via the network via the communication device and registering the information in the third database;
Providing
Biological product management device characterized by Registration of information in the second database and the third database is performed by assigning a unique second lot number to the biological product,
The biological product management device according to claim 10. A pharmaceutical manufacturer that manufactures biological products based on biological raw materials collected from living organisms, a raw material provider that provides the pharmaceutical raw materials to the pharmaceutical manufacturers, and a biological product manufactured by the pharmaceutical manufacturers. Manufactured based on the above-mentioned biological products manufactured and used, or imported from pharmaceuticals, and used by patients by medical providers. A biological product management device for managing biological products,
The management device includes a processing device that processes information, a storage device that stores information, and a communication device that communicates information with a terminal device via a network.
The storage device
A second database that stores information relating to the raw materials and specifications of biological products, and stores the first lot number uniquely indicating the raw materials and information that individually specifies the biological products in association with each other;
A third database storing information on the use of biological products;
With
The processor is
A function for acquiring information for individually identifying a biological product manufactured based on the raw material of the first lot number from the second database based on the first lot number;
Based on the information for individually identifying the biological product, information for identifying the health care provider who used the biological product for the patient and the patient in which the biological product was used are identified from the third database. A function of acquiring information including at least one of information to be
A function of transmitting and receiving information to and from the terminal device via the communication device;
Having
Biological product management device characterized by The storage device further includes a first database in which information for specifying the raw material is associated with a first lot number that uniquely indicates the raw material,
The processing apparatus further includes a function of acquiring a first lot number of the raw material from the first database based on information specifying the raw material,
The biological product management device according to claim 12. A pharmaceutical manufacturer that manufactures biological products based on biological raw materials collected from living organisms, a raw material provider that provides the pharmaceutical raw materials to the pharmaceutical manufacturers, and a biological product manufactured by the pharmaceutical manufacturers. Manufactured based on the above-mentioned biological products manufactured and used, or imported from pharmaceuticals, and used by patients by medical providers. A biological product management device for managing biological products,
The management device includes a processing device that processes information, a storage device that stores information, and a communication device that communicates information with a terminal device via a network.
The storage device
A second database in which the first lot number uniquely indicating the raw material and information for individually specifying the biological product are stored in association with each other as information on the raw material / standard of the biological product;
A third database storing information on the use of biological products;
With
The processor is
A function for acquiring information for individually identifying the biological product used for the patient from the third database based on the information for identifying the patient;
A function for obtaining a first lot number unique to the raw material of the biological product from the second database based on information for individually identifying the biological product;
A function for acquiring information for individually identifying other biological products manufactured based on the raw material corresponding to the first lot number from the second database based on the first lot number;
Based on the information that individually identifies other biological products, the information that identifies the health care provider who used the other biological products for the patient from the third database and the other biological products are used. A function of acquiring information including at least one of information identifying a patient,
A function of transmitting and receiving information to and from the terminal device via the communication device;
Having
Biological product management device characterized by A pharmaceutical manufacturer that manufactures biological products based on biological raw materials collected from living organisms, a raw material provider that provides the pharmaceutical raw materials to the pharmaceutical manufacturers, and a biological product manufactured by the pharmaceutical manufacturers. Manufactured based on the above-mentioned biological products manufactured and used, or imported from pharmaceuticals, and used by patients by medical providers. A biological product management device for managing biological products,
The management device includes a processing device that processes information, a storage device that stores information, and a communication device that communicates information with a terminal device via a network.
The storage device
A second database in which the first lot number uniquely indicating the raw material and information for individually specifying the biological product are stored in association with each other as information on the raw material / standard of the biological product;
A third database storing information on the use of biological products;
With
The processor is
A function for obtaining a first lot number unique to the raw material of the used biological product from the second database based on information for individually identifying the used biological product;
A function for acquiring information for individually identifying other biological products manufactured based on the raw material corresponding to the first lot number from the second database based on the first lot number;
Based on the information that individually identifies other biological products, the information that identifies the health care provider who used the other biological products for the patient from the third database and the other biological products are used. A function of acquiring information including at least one of information identifying a patient,
A function of transmitting and receiving information to and from the terminal device via the communication device;
Having
Biological product management device characterized by In the second database and the third database, information for individually specifying the biological product is replaced with a second lot number unique to the biological product, or the biological product is specified individually. The information is stored in association with a second lot number unique to the biological product;
The biological product management device according to any one of claims 12 to 15, wherein the device is a biological product management device. The second database includes a name of a pharmacist of the biological product, a product name of the biological product, a product number of the biological product, a form of the biological product, and the raw material. 1 associated with the lot number,
In the third database, the name of the pharmacist of the biological product, the product name of the biological product, the product number of the biological product, the form of the biological product, and the biological product are used. Storing information identifying a patient and information identifying a health care provider who uses this biological product for the patient in association with each other,
The biological product management device according to any one of claims 12 to 16, wherein:

Images