JP2007133704A - Medicine information collection management system, server, and method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medicine information collection management server capable of efficiently preparing appropriate harmful event information. <P>SOLUTION: The medicine information collection management server 1, which is connected to a user network 4 through networks 2 and 3 and registers or provides medicine information on the basis of an access from a user terminal 4, is provided with: an input person information file 11 including input person information for specifying the input person of the harmful event information on the medicine and the type of his/her job; and a harmful event information file 12 including the input harmful event information. The type of job of the input person is specified by accesses from the user terminals 4a and 4b based on the input person information, entry screens corresponding to the type of job are displayed to the user terminals 4a and 4b, and harmful event information is prepared on the basis of the input information by way of the entry screens. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a drug information collection management system, server, and method for collecting and providing drug information including adverse event information related to drug safety.

  In order to ensure the safety and efficacy of pharmaceuticals, follow-up surveys are required for a certain period after manufacturing approval, and information on side effects is collected. Conventionally, pharmaceutical information including information on adverse events related to the safety of pharmaceutical products has been obtained mainly by obtaining information from doctors by MRs (medical information officers) of pharmaceutical manufacturers visiting medical institutions.

  That is, as shown in FIG. 26, a doctor who has been complained of an adverse event from a patient who has prescribed a drug is through a pharmaceutical wholesaler or a pharmaceutical manufacturer's representative (MS, MR), or in the form of collection of a report. By reporting the occurrence of adverse events to pharmaceutical manufacturers and analyzing and analyzing the information, pharmaceutical manufacturers created reports on side effects, which were the final product. However, such a flow of drug information has problems in the following two points.

1. Problems from the viewpoint of the revised Pharmaceutical Affairs Law
In the revised Pharmaceutical Affairs Law, which was fully enforced in April 2005, enhancement of measures to ensure the safety of pharmaceuticals is an important pillar. The right to create a new business as a manufacturing / sales business, which was previously approved as a manufacturing business or an import / sales business, and a licensed manufacturer / distributor to provide the marketed products to the market At the same time, the system has been changed to have an obligation to perform post-marketing safety management for the product.

  Furthermore, by separating the manufacturing and sales activities in this revision, it was necessary to have a factory that conducts manufacturing activities in order to market pharmaceuticals, but future manufacturers and distributors do not have a factory. It became possible to outsource the entire production. On the other hand, I became responsible for the overall quality of products on the market.

  For this reason, post-marketing safety management standards (GVP) and manufacturing / sales quality standards (GQP) and the installation of functions to fulfill them are stipulated and required to comply with the licensing requirements for pharmaceutical manufacturing and sales. The post-marketing safety management standard (GVP) stipulates the establishment of a safety management department, the establishment of a safety manager, and the creation of post-sales safety management procedures. Is allowed to outsource to other appropriate vendors.

  For post-marketing safety measures, manufacturers or importers have traditionally been required, but this amendment is intended to make this more substantial and clarify the responsibility of manufacturers and distributors after marketing. . If post-marketing safety management and quality control are not sufficient, permission to market the product may not be granted, or renewal of the license may not be granted, or the permission may be revoked.

  There have been reports of side effects, etc. that have been required by manufacturers, importers and distributors in the past, but since April 1997, this has been done in accordance with the Pharmaceutical Affairs Law to collect information necessary for the proper use of pharmaceuticals. In 2001, 22,451 cases, in 2002, 24,221 cases, and in 2003, 28,004 cases.

    In the future, it will be necessary to proactively obtain information on side effects, etc., to consider safety management information including side effect information and to formulate safety measures based on the results, and to implement them appropriately. . Failure to do so will result in inadequate compliance with GVP and will lead to revocation of permission.

2. Problems from the viewpoints of prescribing generic names and out-of-hospital prescriptions Pharmaceutical manufacturers own MRs and visit medical institutions to obtain information on side effects. This is because most medicines are prescribed by brand name, so that the names of medicines that have been administered immediately can be identified at medical institutions that have obtained information such as side effects from patients.

  On the other hand, in recent years, a policy to promote the use of generic drugs that leads to a reduction in medical costs has been put in place, and prescriptions for generic names have already been made in some medical institutions (over 400 nationwide). Some medical institutions prescribe it under a brand name, but an increasing number of medical institutions can replace generic drugs. In the near future, it is expected that the brand name prescription will be switched to the generic name prescription.

    In addition, the proportion of out-of-hospital prescriptions (the ratio of the number of “prescription fee” calculation to the total number of “prescription fee” and “prescription fee”) has been increasing year by year due to the promotion of pharmaceutical division of labor. It has become.

  As the number of pre-hospital prescriptions increases in this way and prescriptions by general names progress, the name of the drug administered to the patient cannot be specified by the medical institution, and the information acquisition route from the medical institution via the conventional MR It becomes difficult to capture information such as side effects. In such a state, a pharmaceutical manufacturer cannot access complete side effect information simply by visiting a medical institution as in the prior art, so the acquisition method is forced to be improved.

The above problems are summarized as follows.
(1) Under the revised Pharmaceutical Affairs Law, pharmaceutical manufacturers are proactively obtaining side effect information, planning safety assurance measures based on the examination of safety management information including such side effect information, and the results, If not implemented properly, it will be incompatible with GVP and will lead to revocation of permission.
(2) As generic name prescriptions and out-of-hospital prescriptions become more widespread, it is difficult for pharmaceutical manufacturers to obtain accurate information on side effects only from medical institutions, so a visit to a dispensing pharmacy is required. Although it is difficult for pharmaceutical manufacturers to visit both medical institutions and pharmacies frequently with current MR personnel, it is considered impractical to increase the number of MRs solely for this purpose.

  As a conventional system for managing drug information, for example, the configuration disclosed in Patent Document 1 or 2 is known, but none of them solves the above problem.

In the medication instruction support system disclosed in Patent Document 1, when a side effect of a drug newly occurs, a user such as a doctor or a pharmacist reads out the side effect information from the drug database and inputs new side effect information. The side effect information can be updated, but if the prescription drug name is written in a generic name, the doctor who consulted with the patient about the side effect of the drug may identify the suspected drug by the product name. It was difficult to enter new adverse event information. On the other hand, if a pharmacist consults about side effects, even if the product name of the drug can be identified, comments on adverse events and judgment of severity cannot be made, so accurate adverse event information cannot be entered. There was a problem.
JP 2004-295414 A JP 2002-15061 A

  Therefore, an object of the present invention is to provide a pharmaceutical information collection management system, server, and method capable of efficiently collecting and providing accurate adverse event information.

  The object of the present invention is pharmaceutical information collection management in which a management server and a plurality of user terminals are connected via a network, and the management server collects and provides pharmaceutical information based on access from the user terminals. The management server includes an input person information file including input person information for specifying an input person and job type of adverse event information related to a pharmaceutical product, and an adverse event information file including the input adverse event information. The job type of the input person is specified by access from the user terminal based on the input person information, and an input screen on which input items corresponding to the job type can be input is displayed on the user terminal. The drug information collection management system is characterized in that the adverse event information is created based on the inputted information.

    In addition, the object of the present invention is a drug information collection and management server that is connected to a user terminal via a network and collects and provides drug information based on access from the user terminal. An input person information file containing input person information specifying an input person and job type of event information, and an adverse event information file containing the inputted adverse event information, from the user terminal based on the input person information The job type of the input person is specified by access, an input screen on which input items corresponding to the job type can be input is displayed on the user terminal, and the adverse event information is created based on the information input via the input screen This is achieved by a pharmaceutical information collection and management server characterized by:

    Further, the object of the present invention is a method for collecting drug information based on access from the user terminal in a management server to which a user terminal is connected via a network, the management server comprising: An input person information file including input person information for specifying an input person and job type of adverse event information related to a medicine, and an adverse event information file including the input adverse event information, and based on the input person information The step of specifying the job type of the input person by accessing from the user terminal, the step of displaying an input screen on which the input item corresponding to the job type can be entered on the user terminal, and the information input via the input screen And creating the adverse event information on the basis of the drug information collection and management method.

  In order to obtain drug information including information on future adverse events, the involvement of dispensing pharmacies was the key, including medical institutions and dispensing pharmacies, as well as patients who were the final consumers of drugs and the primary source of side effect information. Network construction is a powerful tool. According to the present invention, it is possible to efficiently collect and provide accurate adverse event information through a network connecting such parties. As a result, compliance with GVP by proactively obtaining information on adverse events can be promoted, and measures for ensuring the safety of pharmaceutical products under the revised Pharmaceutical Affairs Law can be facilitated.

  Moreover, it is becoming difficult for medical institutions, particularly doctors, to specify which products are used for prescriptions written by themselves when a generic name is prescribed. Identification can be performed easily.

  In addition, according to the present invention, since the voice of the patient who is the final consumer of the medicine can be reflected in the medicine information not only by the doctor but also by the pharmacist, it is possible to convey the patient's request or complaint to the manufacturer. It becomes easier and increases the chances that the pharmacist is in direct contact with the patient, so that the pharmacist can actively contribute to the promotion of community medicine.

  Hereinafter, actual forms of the present invention will be described with reference to the accompanying drawings. FIG. 1 is a block diagram showing a schematic configuration of an entire system including a drug information collection management server according to an embodiment of the present invention. As shown in FIG. 1, a drug information collection management server (hereinafter simply referred to as “management server”) 1 is connected to a plurality of user terminals 4 via an in-house LAN 2 and the Internet 3. In this embodiment, the user terminal 4 includes a pharmacy terminal 4a arranged in a pharmacy, a medical institution terminal 4b arranged in a medical institution, and a manufacturer terminal 4c arranged in a pharmaceutical manufacturer. By making it accessible from medical institutions and pharmacies at any location, it is possible to collect a wide range of information including remote areas.

  The management server 1 is a WWW (web) server, to which databases 10 and 20 are connected. Although the number of databases is two in this embodiment, it may be one or three or more.

  The database 10 stores an input person information file 11, an adverse event information file 12, a first report information file 13, an improvement request / complaint file 14, and the like. The database 20 includes a report information file 21 for the Ministry of Health, Labor and Welfare, statistics An analysis data file 22 is stored. As described later, reports to the Ministry of Health, Labor and Welfare include “Individual Case Safety Report”, “Safety Periodic Report”, “Pharmaceutical Unknown / Non-Severe Side Effects Periodic Report”, etc. , Safety odds ratio, patient background analysis, dose analysis, etc. In addition, the management server 1 can also be comprised from single hardware, or can also be set as the structure provided with the web server and the database server.

  The input person information file 11 includes information for specifying the input person who created the drug information such as the input person ID, password, address, mail address, telephone / fax. The input user ID is classified according to the job type (doctor, pharmacist, etc.) of the input person, and is given so that the classification of the input person can be specified, for example, by using the first digit as the classification code. The classification of the input person is not necessarily performed based on the input person ID, and a classification code may be separately provided, and the input person information file 11 may be generated by associating the classification code with each input person ID.

  The adverse event information file 12 includes the input person ID of the person who provided the information, input person information (ID of medical institution, pharmacy, name, address, telephone / fax, etc.), patient information (patient ID, patient abbreviation, Gender, age, height, weight, related treatment history and associated conditions (original disease / complications / history), past drug use history, etc., side effects / treatment information (side effects / events (MedDRA-PT) , MedDRA-LLT), onset date, end date, serious / non-serious, outcome, side effect / infection status, symptoms and course of treatment, etc.), test and treatment result information (date, test, unit) , Normal range (low value / high value), test value, determination, results of tests and procedures related to diagnosis, etc., drug use information (pharmaceutical ID, name of drug, position of involvement (suspected drug, concomitant drug, Interaction), generic name, dosage form, approval number, dose / dose, Given count / day, period of administration, adverse events information batch / etc. lot number), etc., are associated with adverse events identification ID.

  The first report information file 13 is a file that is generated to enable reporting even if there is an unfilled item regarding the above-mentioned adverse event information that is highly urgent such as serious.

  The improvement request / complaint file 14 includes the input person ID of the person who provided the information, input person information (ID of medical institution, pharmacy, name, address, telephone / fax, etc.), pharmaceutical information (pharmaceutical ID, sales of pharmaceuticals) Name, general name, dosage form, approval number, batch / lot number, etc.), improvement request / complaint information (improvement request, complaint classification, complaint content), etc. It has been.

  Further, a management terminal 6 is connected to the management server 1 via the in-house LAN 2, and the data manager accesses the management server 1 from the management terminal 6, thereby checking the consistency of adverse event information and data. Work such as fixing can be performed.

  In the management server 1 having the above configuration, registration of information in the adverse event information file 12 is performed by an input operation from the user terminal 4 (pharmacy terminal 4a and medical institution terminal 4b). When the web page of the management server 1 is accessed from the user terminal 4, the management server 1 first displays a user ID and password input screen on the user terminal 4, and performs user authentication based on these inputs.

  The user ID and password are issued in advance based on information such as the user's job title, name, address, e-mail address, and address acquired by user registration using the web page or mail of the management server 1. The acquired information is included in the input user information file 11 together with the user ID and password. As described above, the user ID is assigned so that the job type of the user can be identified. For example, in the case of a doctor, the user ID starts with “1”, and in the case of a pharmacist, the user ID is “2”. The management server 1 can determine the job type of the user who has accessed.

  After performing user authentication, the pharmaceutical information collection management server 1 identifies the user's job type based on the user ID, and displays an input screen in which input items are set according to the user's job type. 4 is displayed. For example, when the user is a doctor, an input screen on which input information, patient information, side effect / treatment information, examination and treatment result information can be sequentially input is displayed, while when the user is a pharmacist, An input screen is displayed on which input information, patient information, side effect / treatment information, and drug use information can be sequentially input.

  Management server 1 when adverse events related to drugs such as patient complaints, abnormal findings of patients at medical institutions and abnormal laboratory test values occur, or when there are requests for improvement or complaints regarding drugs by patients, doctors, or pharmacists On the other hand, a doctor and a pharmacist at a medical institution and a pharmacist at a dispensing pharmacy can collect the information by inputting the information from the user terminal 4.

  In the case of prescription by generic name, for drugs related to adverse events due to patient complaints, the pharmacist who can specify the prescription drug product sells the medical institution name and doctor name as prescription information and the drug as drug usage information Information such as name, generic name, dosage form, approval number, dose / dose, number of doses / day, duration of administration, batch / lot number will be collected. Moreover, patient ID, patient abbreviation, sex, age, etc. are collected as patient information for identifying a patient.

  The flow of adverse event information processing based on a specific example will be described with reference to the sequence diagram shown in FIG. First, when a patient X who feels stomach discomfort due to the medicine M issued at the pharmacy A consults with the pharmacist Y of the pharmacy Y, the pharmacist Y receives drug information from the pharmacy terminal 4a installed at the pharmacy A. The collection management server 1 is accessed and the user ID and password of the pharmacist Y are input.

  When the user authentication is completed, a first input screen for inputting patient information is displayed on the pharmacy terminal 4a as shown in FIG. 3, and the pharmacist Y uses the input user information and Enter patient information according to each item. For the input on the first input screen, it is not always necessary to input all the items, and only items that can be input according to the job type may be input. For example, in FIG. 3, each item of (patient) weight, height, related treatment history and associated state, and past history (including allergy history) cannot be input by the pharmacist. When accessed based on the above, the character background color is displayed in color to clarify that these items do not require input.

  As input information for each item, a term file such as “Medical Dictionary for Regulatory Activities (MeDDRA)” is stored in the database 10 in advance, and a list of terms starting with those characters is displayed by inputting the first few characters. By making it possible to select an appropriate term from these, it is possible to reduce the labor of inputting.

  Thus, after the input operation on the first input screen is completed, by clicking an input completion button (not shown) on the screen, a second input screen for inputting side effect information as shown in FIGS. And the 3rd input screen which inputs pharmaceutical sales name information is sequentially displayed on the pharmacy terminal 4a. The pharmacist Y inputs only the items that can be input in accordance with the job type on each input screen in the same manner as described above.

  Enter all the items that can be entered in this way, and finally click the send button (not shown), and the adverse event information including the entered patient information, side effect information, drug name information, etc. will be entered. At the same time, it is transmitted to the management server 1 (step S101 in FIG. 2). In response to this, the management server 1 associates the input adverse event information with the adverse event identification ID, generates an adverse event information file 12 and stores it in the database 10, and as shown in FIG. The user terminal 4 displays an input completion confirmation screen indicating completion of input. After determining whether the first report described later is necessary, the management server 1 generates an adverse event information file 12 based on the adverse event information input by the pharmacist and stores it in the database 10 (step S102).

  The completion of the input of the above-mentioned adverse event information is notified by email to the user terminal 4 (pharmacy terminal 4a) of the pharmacist Y, and when the adverse event information includes information on a medical institution or doctor in charge. The medical institution and doctor are also notified by e-mail.

  Thereafter, when the patient X receives the medical examination of the doctor Z who prescribed the medicine M, the doctor Z accesses the management server 1 from the medical institution terminal 4b installed in the medical institution, and the user ID of the doctor Z And enter the password.

  After performing the user authentication, the management server 1 first searches the adverse event information file 12 and extracts the adverse event information related to the doctor Z based on the medical institution ID and the input person ID, as shown in FIG. The list is displayed on the user terminal 4 (medical institution terminal 4b) of the doctor Z. In this list display screen, record number (adverse event identification ID), status (data fixed / not fixed), input date / time, drug name, patient ID, patient abbreviation, sex, age, etc. are displayed based on the adverse event information. When the doctor Z specifies a record number related to the patient X from among them and clicks on this part, the first input screen (see FIG. 3) is displayed as shown in FIG.

  In the first input screen for inputting patient information, the adverse event information that has already been input by the pharmacist Y and is read from the adverse event information file 12 is displayed as it is. Doctor Z is a blank item that can be entered from the standpoint of Doctor Z (height, weight, related treatment history and associated condition (original disease / complication / history), related past drug use history Etc.) will be entered sequentially. Items that need to be input by the doctor Z may be clarified by changing the character color of the items.

  When the input on the first input screen is completed, the second input screen for inputting the adverse event information is displayed (see FIG. 4). When the second input screen is completed, the result information of the examination / treatment shown in FIG. 9 is input. A fourth input screen is displayed. On the fourth input screen, after the doctor Z examines the patient X, comments regarding the examination and treatment are input. These pieces of input information related to the adverse event information are transmitted to the management server 1 (step S103 in FIG. 2).

  Thus, after items that are difficult to be input by pharmacist Y in the adverse event information are supplemented by a doctor who has recognition based on the patient's prescription, the patient performs a doctor's examination and treatment on the occurrence of the adverse event. As a side effect / treatment information, side effect / event name (MedDRA-PT, MedDRA-LLT), onset date, end date, serious / non-serious, occurrence of side effect / infection, symptoms, treatment, etc. Information on the results of examination and treatment, such as date, examination, unit, normal range (low value / high value), test value, judgment, and results of examination and treatment related to diagnosis, etc. For information, information is collected as to whether the medicinal product used as the position of involvement is a suspected drug, a concomitant drug, or due to its interaction. Thus, the input for all items of the adverse event information is completed.

  The completion of the input of the adverse event information is notified by email to the user terminal 4 (medical institution terminal 4b) of the doctor Z, and if the adverse event information includes pharmacy or pharmacist information, the pharmacy And pharmacists are also notified by email.

  In the e-mail notified to the doctor or pharmacist, the access destination (URL) to the adverse event information file 12 is displayed. By entering the user ID and password after the access, a list screen similar to FIG. Is displayed. By clicking any record number (adverse event identification ID) on this list screen, an input screen is displayed, and appropriate corrections can be made on this screen.

  For example, regarding the patient's subsequent condition such as recovery from an adverse event, the medication status is collected from the pharmacist, the findings and clinical laboratory values are collected from the physician, and the outcome and date of the outcome are collected as side effect information. Collected information on adverse events will be revised and added as appropriate.

  The breakdown and order of the adverse event information collection process is not limited to the above in the generic name prescription, but various cases are assumed, but management that enables mutual feedback between doctors and pharmacists at medical institutions and dispensing pharmacies, etc. It is possible to clarify the state of information collection as quickly as possible on the network of servers.

  In addition, when the management server 1 receives adverse event information from the pharmacy terminal 4a or the medical institution terminal 4b (mainly the medical institution terminal 4b), the management server 1 determines whether the adverse event information is serious or not. It is determined whether or not a report is necessary (step S104 in FIG. 2). This determination can be made automatically based on information on the severity in the side effect information. When the management server 1 determines that the first report is necessary, the adverse event information file 12 is generated and stored in the database 10 (step S105). The first report form is created in a state where there is no data (step S106), and the generated first report information file 13 is stored in the database 10 (step S107). On the other hand, if it is determined in step S104 that the first report is not required, the first report information file 13 is not generated, and only the generation and storage of the adverse event information file 12 (step S105) is performed.

  The data manager accesses the management server 1 from the management terminal 6 based on its own user ID and password, and performs consistency check on each item of the adverse event information file 12 stored in the database 10 (step of FIG. 2). S108). Consistency check is performed in advance for clear discrepancy patterns between each item in adverse event information (for example, relationship with primary disease that cannot occur for gender), disease name, drug name, and adverse event terminology. By storing it as a dictionary master and collating the adverse event information input by the doctor or pharmacist with the dictionary master, it is possible to automatically discriminate an erroneous entry or omission of an input item. The data manager checks the adverse event information itself in addition to the automatic check described above, and finally determines the necessity of re-input by the input person such as correction or addition of input information. If it is determined that re-input is necessary, the pharmacist or doctor who is the input person is specified based on the input person information, and that effect is notified to the pharmacy terminal 4a or the medical institution terminal 4b by e-mail or the like (step S109). ). The pharmacist or doctor who has received the re-input request by e-mail or the like accesses the management server 1 to read out the corresponding adverse event information file 12 and corrects or adds the input content. When it is necessary to collect further information in this work, it is possible to make inquiries to other user terminals 4 and the like using this network, so that information collection can be accelerated. The consistency check and notification to the user terminal 4 can be performed in the management server 1 by strengthening the function of the dictionary master described above.

  Regarding the adverse event information file 12 stored in the database 10, the history of the input and correction of the doctor or pharmacist who is the input person, the check by the data manager and the data fixing is the user terminal 4 (pharmacy terminal 4 a or medical institution terminal) 4b) or by accessing the web page of the management server 1 from the management terminal 6 can be viewed at any time. An example of this history display screen is shown in FIG.

  The history display screen can also be viewed by the manufacturer of the drug by accessing it from the manufacturer terminal 4c or the like. As a result, pharmaceutical manufacturers can grasp the status of information collection at any time.For example, by grasping the situation from the initial input stage to completion, such as addition of information and re-investigation, the `` Individual cases for MHLW '' Response to “Safety Report” becomes possible. Whether or not the pharmaceutical manufacturer has the browsing authority can be determined based on the input ID and the pharmaceutical ID together with the password inquiry, and only the information related to the company's product can be browsed.

  If the consistency check result of the adverse event information file 12 has no particular problem, the data manager fixes the data of the adverse event information file 12 (step S110). In response to this, the management server 1 converts the adverse event information file 12 into a file format (for example, a PDF file) that cannot be modified or altered. Adverse event information with fixed data is aggregated and statistically analyzed in real time by the management server 1 having a function of creating and updating a document corresponding to a preset format and a function of statistical analysis. It can be provided as an output that can be used by pharmaceutical manufacturers.

  That is, the management server 1 determines the format of “individual case safety report”, “safety periodic report”, and “pharmaceutical unknown / nonserious side effect periodicity” based on the adverse event information file 12 with fixed data. "Reports" are created and stored in the database 20 as the report information file 21 for the Ministry of Health, Labor and Welfare. Further, the statistical analysis data 22 of the fixed adverse event information file 12 is generated on the basis of a predetermined statistical analysis method such as calculation of safety odds ratio, analysis by patient background, analysis by dose (step) S111, S112). However, the output format is not limited to these, and output functions such as an output format that can be used for medication instruction, an output format that corresponds to patient needs, and an output format that corresponds to genetic information are useful information for pharmacies and medical institutions. By adding, the effectiveness can be enhanced.

  The pharmaceutical manufacturer can appropriately use the generated report information file 21 and statistical analysis data 22 for the Ministry of Health, Labor and Welfare for the pharmaceutical related to the company. If there is an access to the management server 1 from the manufacturer terminal 4c based on the user ID of the pharmaceutical manufacturer, the management server 1 performs authentication based on the user ID and password, and then sets the medicine ID corresponding to the user ID. Based on the information, the adverse event information of the drug related to the manufacturer is extracted, and the drug is listed as shown in FIG.

  When you click on any drug name on this screen, as shown in FIG. 12, the adverse event information related to the selected drug is listed with record number (adverse event identification ID) etc. By clicking the number, a form based on the report information file 21 for the Ministry of Health, Labor and Welfare can be output on the screen (step S113). Then, by printing this, you can prepare documents to be reported to the Ministry of Health, Labor and Welfare (“Individual Case Safety Report”, “Safety Periodic Report”, “Pharmaceutical Unknown / Non-Severe Side Effects Periodic Report”, etc.) This can be done easily and quickly (step S114).

    An example of the format of the created “Individual Case Safety Report” (Pharmaceutical Side Effects / Infectious Diseases Case Report) is shown in FIG. 13 to FIG. FIGS. 19 to 20 show examples of the format of the “safety periodic report” (side effect / infection case report) in FIGS. 21 to 22, respectively. All the information necessary for the entry is acquired from the adverse event information input from the user terminal 4 (pharmacy terminal 4a and medical institution terminal 4b), and a report information file 21 for the Ministry of Health, Labor and Welfare is generated. Since the report information file 21 for the Ministry of Health, Labor and Welfare is stored as electronic data in the database 20, even if the submission to the Ministry of Health, Labor and Welfare is digitized in the future, it can be easily handled.

  The above explanation relates to the output based on the adverse event information fixed by the data manager. As described above, the first information file 13 is generated for serious adverse event information that requires urgency. This information can be output by the pharmaceutical manufacturer even before the data is fixed. The pharmaceutical manufacturer can access the management server 1 and output the first report form on the screen based on the first report information file 13 (step S115). A “case safety report” can be created easily and quickly (step S116).

  Next, the flow of improvement request / complaint information processing based on a specific example will be described with reference to the sequence diagram shown in FIG. First, when a patient X who has noticed that the medicine M issued in the A pharmacy has turned yellow is consulted with the pharmacist Y of the A pharmacy, the pharmacist Y has the pharmacy terminal 4a installed in the A pharmacy. Access to the pharmaceutical information collection management server 1 and input the user ID and password of the pharmacist Y.

  When the user authentication is completed, a first input screen for inputting patient information is displayed on the pharmacy terminal 4a as shown in FIG. When the pharmacist Y selects and clicks “to input improvement request / complaint” on the first input screen, the pharmacy terminal 4a has an input screen for inputting the improvement request / complaint as shown in FIG. Is displayed. The pharmacist Y inputs input person information, drug information, improvement request, and complaint information according to each item on the improvement request / complaint input screen.

    When all the items that can be input are input and a transmission button (not shown) is finally clicked, the input improvement request / complaint information is transmitted to the management server 1 together with the input person information (FIG. 23). Step S201).

    When the patient X consults with the doctor Z of the B medical institution, the doctor Z performs the same operation as the above-described pharmacist Y from the medical institution terminal 4b installed in the B medical institution. The request / complaint information is transmitted to the management server 1 together with the input person information (step S202 in FIG. 23).

    In response to this, the management server 1 generates the improvement request / complaint information file 14 by associating the input improvement request / complaint information with the improvement request / complaint information identification ID and stores it in the database 10 (FIG. 23 step S203).

    The completion of the input of the improvement request / complaint information described above is notified to the user terminal 4 of the pharmacist Y or the doctor Z by e-mail, and the e-mail is also sent to the manufacturer terminal 4c of the drug manufacturer C who is a pharmaceutical manufacturer and distributor. To be notified.

    Pharmaceutical manufacturers can use improvement request / complaint information as appropriate for pharmaceuticals related to the company. If there is an access to the management server 1 from the manufacturer terminal 4c based on the user ID of the pharmaceutical manufacturer, the management server 1 performs authentication based on the user ID and password, and then sets the medicine ID corresponding to the user ID. Based on this information, we will extract and display a list of drug improvement requests and complaints related to the manufacturer. By clicking on any record number, it is possible to inquire about improvement request / complaint information. Since the improvement request / complaint information 14 is stored as electronic data in the database 10, it can be classified and analyzed in accordance with the complaint information system of each manufacturer by downloading at the pharmaceutical manufacturer (FIG. 23). Step S204).

    Conventionally, when the source is a patient, this information is transmitted from the patient to a medical institution or a dispensing pharmacy, and to a pharmaceutical manufacturer's MR through a wholesale MS. If the source is a medical institution or dispensing pharmacy, it is reported directly to the MR of the pharmaceutical manufacturer through a wholesale MS from the medical institution or dispensing pharmacy. In some cases, medical institutions and dispensing pharmacies directly communicate to MRs of pharmaceutical manufacturers. After that, each information is processed from MR according to the internal system of the pharmaceutical manufacturer.

    However, it takes a considerable number of days for these information to reach the department responsible for the original response of the information. Example of delay in response from patients, medical institutions, and pharmacies Has also been seen. In addition, since the transmission route is long, there are cases where information is not transmitted well to the end, or the content of information changes even if it is transmitted, and this point may be a serious problem in practice. If these overlap, the trust to the pharmaceutical manufacturer will be lost and it will be subject to major damage such as suspension of transactions.

    According to the drug information collection and management system of this embodiment, using a network constructed to efficiently collect and provide accurate adverse event information, requests for improvement and quality not only for side effect information but also for drugs (formulations) Complaint information can also be input directly at medical institutions and dispensing pharmacies, which can be used quickly by pharmaceutical manufacturers.

    By the way, with regard to the use of output information, for pharmaceutical manufacturers, for example, the basic fee is calculated based on sales, the number of items, etc. You can charge a usage fee. On the other hand, pharmacists, doctors, etc. can be paid in a corresponding manner such as the number of record registrations, additional input, and investigation support in response to information cooperation. Also, wholesale distributors can be requested to cooperate with information from pharmacists, doctors, etc., and pay according to the number of contracts reached, the number of information entered by pharmacists / doctors, etc.

  As described above, according to the management server 1 of the present embodiment, the job type of the input person is specified based on the user ID of the input person, and input is performed via the input screen displayed on the user terminal corresponding to the job type. Since adverse event information is created based on the information that has been made, it is possible to efficiently create accurate adverse event information in which all necessary items are entered. In addition, it is possible for pharmaceutical manufacturers and the like that use this information to obtain necessary information easily and quickly, and to reduce the burden of dealing with laws and regulations.

  In the specific example of this embodiment, after the pharmacist first inputs each item of the adverse event information, the doctor inputs the items that the pharmacist could not input. The order of input by the person and the number of input persons can be appropriately changed according to the situation. For example, if the patient consulted with a doctor first, the consulted doctor entered each item of the adverse event information, and then information on the use of the drug, such as the sales name for the drug listed under the generic name in the prescription The pharmacist may input the information, and the doctor who performed the diagnosis may input the comment regarding the examination or treatment to create the adverse event information.

  In this embodiment, it is assumed that the user from the user terminal 4 is a pharmacist, a doctor, a person in charge of a pharmaceutical manufacturer, and the like. It is preferable to obtain cooperation from a sales representative of a wholesale dealer who frequently visits a dispensing pharmacy, and this enables quick collection of more accurate adverse event information.

  FIG. 25 shows the flow of information from the generation of adverse event information to the provision of a pharmaceutical manufacturer for the entire system including the pharmaceutical information collection management server according to the present invention.

  In other words, if a patient complains of an adverse event to a doctor (or pharmacist), the doctor (or pharmacist) who receives the complaint accesses the drug information collection management server and inputs information about the adverse event, and receives this notification. When the pharmacist (or doctor) inputs additional information, adverse event information in which the respective input information is mutually complemented is stored in the drug information collection management server. Then, by evaluating and analyzing this adverse event information, a final product is created and used for a pharmaceutical manufacturer or the like.

  As a result, it is possible to make the network system capable of collecting and evaluating information in a wide range of locations and immediacy of output, and to easily meet the demands of the Ministry of Health, Labor and Welfare and the needs of output for each user. Can be used as a safety measure for pharmaceuticals.

    In addition, according to the drug information collection and management system of this embodiment, if a patient requests improvement or quality complaint (complaint) for a drug (formulation) from a medical institution or pharmacy, the medical institution or pharmacy directly reports the information. Since the information can be input, the information is instantly transmitted to the pharmaceutical manufacturer, and the information is transmitted to a necessary department from there. As a result, the number of days of information transmission in the past can be greatly shortened, and the accuracy of information transmission can be greatly improved. As a result, the trust from customers (patients, medical institutions, pharmacies) can be improved by prompt response. It can also be acquired.

  In the pharmaceutical information collection management system of this embodiment, these collected information is stored as electronic data, and the pharmaceutical manufacturer downloads the collected information to classify it according to each manufacturer's complaint information system. This pharmaceutical information collection and management system is also very valuable for pharmaceutical manufacturers, because it can be used to improve the quality of pharmaceuticals (formulations) and improve the quality.

It is a block diagram which shows schematic structure of the whole system provided with the pharmaceutical information collection management server which concerns on one Embodiment of this invention. It is a sequence diagram for demonstrating the adverse event collection and analysis part of the process flow in the said whole system. It is a figure which shows an example of the 1st input screen displayed on a user terminal. It is a figure which shows an example of the 2nd input screen displayed on a user terminal. It is a figure which shows an example of the 3rd input screen displayed on a user terminal. It is a figure which shows an example of the input completion confirmation screen displayed on a user terminal. It is a figure which shows an example of the list display screen of the adverse event information displayed on a user terminal. It is a figure which shows another example of the 1st input screen displayed on a user terminal. It is a figure which shows another example of the 4th input screen displayed on a user terminal. It is a figure which shows an example of a log | history display screen. It is a figure which shows an example of the pharmaceutical list display screen displayed on a user terminal. It is a figure which shows an example of the list display screen of the adverse event information relevant to the pharmaceutical selected on the screen shown in FIG. It is a figure which shows an example of a format of an individual case safety report (medicine side effect / infection case report, attached sheet form 1). It is a figure which shows an example of a format of an individual case safety report (medicine side effect / infection case report (1)). It is a figure which shows an example of a format of an individual case safety report (medicine side effect / infection case report (2)). It is a figure which shows an example of a format of an individual case safety report (medicine side effect / infection case report (3)). It is a figure which shows an example of a format of an individual case safety report (medicine side effect / infection case report (4)). It is a figure which shows an example of a format of an individual case safety report (medicine side effect / infection case report (5)). It is a figure which shows an example of a format of a pharmaceutical unknown / nonserious side effect periodic report. It is a figure which shows an example of a format of a pharmaceutical unknown / nonserious side effect periodic report. It is a figure which shows an example of a format of a safety regular report (side effect and infectious disease case report). It is a figure which shows an example of a format of a safety regular report (side effect and infectious disease case report). It is a sequence diagram for demonstrating the improvement request and complaint part of the flow of processing in the said whole system. It is a figure which shows an example of the improvement request and complaint input screen displayed on a user terminal. It is a figure which shows typically the flow of the information for producing | generating the adverse event information in the said whole system. It is a figure which shows typically the flow of the information for producing | generating the conventional adverse event information.

Explanation of symbols

1 Pharmaceutical information collection management server 2 Internal LAN
3 Internet 10 Database 11 Input person information file 12 Adverse event information file 13 First report information file 14 Improvement request / complaint file 21 Report information file for Ministry of Health, Labor and Welfare 22 Statistical analysis data file 4 User terminal 4a Pharmacy terminal 4b Medical institution terminal 4c Manufacturer terminal 6 Management terminal

Claims (10)

A management server and a plurality of user terminals are connected via a network, and the management server collects and provides pharmaceutical information based on access from the user terminal,
The management server
An input person information file including input person information for specifying an adverse event information related to pharmaceuticals and a job type;
An adverse event information file including the inputted adverse event information,
The job type of the input person is specified by access from the user terminal based on the input person information, and an input screen capable of inputting input items corresponding to the job type is displayed on the user terminal, and input is performed via the input screen. The pharmaceutical information collection management system, characterized in that the adverse event information is created based on the information obtained. The adverse event information is stored in association with an adverse event identification ID, and is created based on information input from a plurality of input persons with different occupations for the same adverse event identification ID. Drug information collection management system described in 1. The management server reads the adverse event information stored corresponding to the adverse event identification ID from the adverse event information file by access based on the input of the adverse event identification ID in the user terminal, and The pharmaceutical information collection management system according to claim 2, which is displayed as an already input item on the input screen. The management server determines whether the adverse event information is first report information based on information input via the input screen, and generates a first report information file if the information is first report information. The pharmaceutical information collection management system according to any one of claims 1 to 3. A management terminal connected to the management server via a network, wherein the management terminal reads out the adverse event information from the adverse event information file, thereby enabling consistency check and data fixing. Item 5. A pharmaceutical information collection management system according to any one of Items 1 to 4. The management server reports to the Ministry of Health, Labor and Welfare, including “Individual Case Safety Report”, “Safety Periodic Report”, and “Pharmaceutical Unknown / Non-Severe Side Effects Periodic Report” based on the adverse event information file with fixed data. The pharmaceutical information collection management system according to claim 5, wherein the information file is generated. The management server generates statistical analysis data by performing statistical analysis including calculation of safety odds ratio, analysis by patient background, and analysis by dose based on the adverse event information file with fixed data The pharmaceutical information collection management system according to claim 5. 8. The management server generates an improvement request / complaint information file by associating an improvement request / complaint information input at the user terminal with an improvement request / complaint information identification ID. Pharmaceutical information collection management system. A drug information collection management server for collecting and providing drug information based on access from a user terminal connected to a user terminal via a network,
An input person information file including input person information for specifying an adverse event information related to pharmaceuticals and a job type;
An adverse event information file including the inputted adverse event information,
The job type of the input person is specified by access from the user terminal based on the input person information, and an input screen capable of inputting input items corresponding to the job type is displayed on the user terminal, and input is performed via the input screen. The pharmaceutical information collection management server, wherein the adverse event information is created based on the information obtained. In a management server to which a user terminal is connected via a network, a method for collecting drug information based on access from the user terminal,
The management server includes an input person information file including input person information for specifying an input person and job type of adverse event information related to pharmaceuticals, and an adverse event information file including the input adverse event information,
Identifying the job type of the input person by accessing from the user terminal based on the input person information;
Displaying on the user terminal an input screen on which input items corresponding to job types can be entered; and
A pharmaceutical information collection and management method comprising: creating the adverse event information based on information input via the input screen.