Medical institution drug alert system vulnerability evaluation index system construction method

Abstract

The invention discloses a medical institution drug alert system vulnerability evaluation index system construction method, which comprises the following steps: comprehensively establishing an exposure-susceptibility-resistance vulnerability analysis framework, and constructing a medical institution drug alert system vulnerability conceptual model from two aspects of risk impact force and risk resistance; according to an operation mechanism of a medical institution drug alert system, influence factors of the drug alert system are determined, evaluation indexes of key influence factors are selected according to an exposure-susceptibility-resistance model, and an evaluation index system is constructed and comprises a target layer, a criterion layer and an index layer. According to the method, an exposure-susceptibility-resistance three-dimensional analysis framework is introduced, the risk of the medical institution drug alert system is evaluated from multiple dimensions, more systematic risks neglected by a traditional method can be recognized, the risk recognition rate is increased, the medical institution can effectively recognize potential risks, and the medical institution drug alert system risk assessment method is suitable for medical institution drug alert system risk assessment. Vulnerabilities existing in the drug alert management process are deeply known, and the drug alert level of medical institutions is improved.

Description

Technical Field

[0001] This invention belongs to the subfield of pharmacovigilance and risk management system technology in the field of medical quality management technology, and specifically relates to a method for constructing a vulnerability evaluation index system for a pharmacovigilance system in medical institutions. Background Technology

[0002] Currently, there is limited research on evaluation index systems for pharmacovigilance systems in medical institutions both domestically and internationally. Only one scholar has constructed an evaluation index system for pharmacovigilance work in Fujian Province using the Delphi method; however, this research is limited to Fujian Province and lacks universal applicability. The expert structure included in the study is too singular, primarily consisting of pharmacists and monitoring agency experts, failing to involve clinicians, nurses, and information system personnel, thus lacking a multidisciplinary perspective. The relevant indicators in the paper are only qualitative descriptions, without defined quantitative rules or automated data collection methods. The information-based indicators are vague and lack detail; "third-level indicators," such as "report authenticity," are compliance checks or behavioral descriptions, lacking practically quantifiable scoring standards or detailed scoring rules, and heavily relying on the subjectivity of the implementers. Summary of the Invention

[0003] In view of this, the purpose of this invention is to provide a method for constructing a vulnerability evaluation index system for pharmacovigilance systems in medical institutions, so as to overcome the shortcomings of the prior art.

[0004] To achieve the above objectives, the present invention is implemented through the following technical solution:

[0005] A method for constructing a vulnerability assessment index system for pharmacovigilance systems in medical institutions is provided, wherein:

[0006] A comprehensive vulnerability analysis framework of exposure-susceptibility-resistance is established, and a conceptual model of the vulnerability of the pharmacovigilance system in medical institutions is constructed from the two aspects of risk impact and risk resistance.

[0007] Based on the operational mechanism of the pharmacovigilance system in medical institutions, the influencing factors of the pharmacovigilance system are identified, and evaluation indicators of key influencing factors are selected based on the exposure-susceptibility-resistance model to construct an evaluation indicator system.

[0008] The evaluation index system includes a target layer, a criterion layer, and an indicator layer. The target layer is the vulnerability of the pharmacovigilance system in medical institutions. The criterion layer includes exposure, susceptibility, and resilience. Exposure mainly reflects the degree of external risks faced by medical institutions and information transparency, focusing on the institutional construction of pharmacovigilance within medical institutions, the monitoring of adverse drug reactions, reporting channels, and the participation of medical staff. It is directly related to the breadth and depth of exposure to drug use safety risks. Susceptibility emphasizes the internal weaknesses of the organization that may amplify drug use safety risks. Resilience covers the ability to respond to, prevent, and recover from risks.

[0009] As described in the method for constructing a vulnerability assessment index system for pharmacovigilance systems in medical institutions, a vulnerability identification model for the pharmacovigilance system of medical institutions is constructed, and the comprehensive quantitative model weights for vulnerability dimensions are determined:

[0010] The coefficient of variation method is used to calculate the dispersion of indicators within each dimension, and to objectively evaluate the weights of the three dimensions. The implementation steps of this method are as follows:

[0011] Calculate the coefficient of variation (CV) of the metrics within a dimension. j =σ j / μ j

[0012] σ j μ is the standard deviation. j The mean;

[0013] Normalization was used to obtain objective weights for the three dimensions of exposure (E), susceptibility (S), and resistance (R):

[0014]

[0015] The method for constructing a vulnerability assessment index system for pharmacovigilance systems in medical institutions includes constructing a comprehensive quantitative model for vulnerability assessment.

[0016] For the raw measured values ​​of each secondary indicator in the evaluation scale of pharmacovigilance system in medical institutions, a differentiated standardization processing mechanism was used to convert the scores into percentages.

[0017] For positive evaluation metrics (the higher the value, the more fragile the system):

[0018] Y ij =[X ij -X min (j)] / [X max (j)-X min (j)]

[0019] For negative evaluation indicators (the larger the value, the more robust the system):

[0020] Y ij =[X max (j)-X ij ] / [X max (j)-X min (j)]

[0021] Where X ij Let X be the original score of the i-th medical institution on the j-th indicator. max (j) and X min(j) represent the theoretical maximum and minimum values ​​of the indicator across all evaluation units, respectively; when using an m-point Likert scale, the default value is X. max (j)=m,X min (j) = 1; when using a percentage scale, the default value is X. max (j)=100,X min (j) = 0, and the result of this transformation process can be output as the standardized score rate Y. ij Y ij ∈[0,1], the larger the value, the higher the vulnerability of the system to that index;

[0022] A weighted composite score is calculated across three dimensions. Based on the indicator fusion weighting system derived from Delphi expert consultation results, the weighted composite value for each vulnerability dimension is calculated:

[0023]

[0024] Among them, II d Y represents the set of secondary indicators belonging to dimension d (exposure, susceptibility, resistance); ij Standardized score rate; w j The weights of the secondary indicators generated using the Delphi expert method, and which satisfy the normalization constraints:

[0025]

[0026] Finally, the objective weights (W) of the three dimensions of exposure (E), sensitivity (S), and resistance (R) obtained based on the coefficient of variation method are determined. E W S and W R ), calculate the vulnerability (V) of the pharmacovigilance system in a healthcare facility: V = (W E ×Score E +W S ×Score S ) / W R ×Score R .

[0027] The method for constructing a vulnerability assessment index system for pharmacovigilance systems in medical institutions, as described above, involves constructing a vulnerability assessment scale for pharmacovigilance systems in medical institutions. Based on the determined assessment indicators and combined with the actual processes of the operation of pharmacovigilance systems in medical institutions, such as system construction, organizational structure, signal monitoring and reporting, quality improvement, and information technology support, an assessment scale and scoring rules are generated to provide a structured evaluation tool for empirical research on the vulnerability assessment of pharmacovigilance systems in medical institutions.

[0028] The beneficial effects of the technical solution of this invention are:

[0029] This invention follows a research approach of defining the connotation, identifying vulnerability factors, constructing a vulnerability evaluation index system, and applying it empirically. It comprehensively uses a combination model of the coefficient of variation method and the weighted method to conduct qualitative and quantitative analysis of the evaluation index system, analyzes the formation mechanism of vulnerability in the pharmacovigilance system of medical institutions, and helps medical institutions to effectively identify potential risks, gain a deeper understanding of the loopholes in the pharmacovigilance management process, improve internal management, optimize resource allocation, and enhance the pharmacovigilance level of medical institutions.

[0030] This invention introduces a three-dimensional analysis framework of "exposure-susceptibility-resistance" to assess the risks of pharmacovigilance systems in medical institutions from multiple dimensions. Through the analysis framework and refined indicator system proposed in this invention, more systemic risks that are ignored by traditional methods can be identified, more risk points can be covered, and thus the risk identification rate can be improved.

[0031] This invention employs a method combining expert and objective weighting, integrating subjective experience with objective data to achieve a more stable and scientific weight allocation. It innovatively establishes a quantifiable index scoring model that combines vulnerability calculation and grading. This model can quantify the pharmacovigilance risk level of each hospital or institution into a specific score and classify institutions into different risk levels based on the score. According to empirical data, the vulnerability scores of 95 sample hospitals can differ by up to 6-7 times, demonstrating the effectiveness and operability of the quantitative scoring model. Attached Figure Description

[0032] To further illustrate the above-mentioned objectives, structural features, and effects of the present invention, the present invention will be described in detail below with reference to the accompanying drawings.

[0033] Figure 1 A schematic diagram illustrating the mechanism of action of vulnerability factors in the pharmacovigilance system of medical institutions;

[0034] Figure 2 This is a brief technical roadmap including the system construction method of this invention. Detailed Implementation

[0035] The terms “invention” and “the present invention” used in this specification are intended to broadly refer to all subject matter of this specification and any of the following patent claims. Statements containing these terms should not be construed as limiting the subject matter described herein or limiting the meaning or scope of any of the following patent claims. Furthermore, this specification does not attempt to describe or limit the subject matter covered by any claim of any particular component, paragraph, statement, or drawing of this application. The subject matter should be understood with reference to the entire specification, all drawings, and any of the following claims. The invention may have other embodiments and be practiced or implemented in other ways. Moreover, it should be understood that the wording and terminology used herein are for illustrative purposes and should not be considered limiting.

[0036] The details of the invention will now be discussed with reference to the accompanying drawings, which are illustrated by way of example only. In the drawings, similar features or components may be labeled using the same reference numerals.

[0037] The use of the terms "comprising," "having," and "including," and variations thereof, herein means to include the items listed herein and their equivalents and additional items. While reference may be made in the description of the drawings to directions such as above, below, upward, downward, backward, bottom, top, front, rear, etc., for convenience, reference is made relative to the drawings. These directions are not intended to literally accept or limit the invention in any form. Furthermore, terms such as "first," "second," "third," etc., are used herein for illustrative purposes and are not intended to indicate or imply importance or significance.

[0038] This invention comprehensively establishes a vulnerability analysis framework of "exposure-susceptibility-resistance," constructing a conceptual model of the vulnerability of pharmacovigilance systems in medical institutions from two aspects: risk impact and risk resistance. The mechanism of action of vulnerability factors is as follows: Figure 1 As shown.

[0039] Specifically, pharmacovigilance systems are susceptible to both external environmental factors (such as new drug launches, changes in healthcare policies, increased patient demand, or technological updates) and internal environmental factors (such as design flaws, human error, operational errors, or equipment malfunctions). They also lack the capacity to cope with both external and internal risks (such as untimely early warning mechanisms, insufficient emergency response, and inadequate personnel training). Risk resilience refers to the pharmacovigilance system's ability to withstand, respond to, and adapt to external and internal risk shocks. It depends on the system's design and management measures, including the effectiveness of early warning mechanisms, the timeliness of emergency response, personnel training, and awareness enhancement.

[0040] Construct a vulnerability assessment index system for pharmacovigilance systems in medical institutions: Based on the operational mechanism of pharmacovigilance systems in medical institutions, identify the influencing factors of pharmacovigilance systems, select evaluation indicators for key influencing factors based on the "exposure-susceptibility-resistance" model, and construct an evaluation index system.

[0041] In this invention, exposure primarily reflects the degree of external risks faced by medical institutions and information transparency, focusing on the institutional establishment of pharmacovigilance within medical institutions, the monitoring and reporting channels for adverse drug reactions, and the participation of medical staff. It directly relates to the breadth and depth of exposure to drug use safety risks; an unreasonable design can easily trigger drug use safety risks. Susceptibility emphasizes internal organizational weaknesses that may amplify drug use safety risks, such as organizational structure, personnel qualifications, and reward / punishment mechanisms. Resilience encompasses the ability to respond to, prevent, and recover from risks, including pharmacovigilance training, information systems, and quality improvement. A total of 34 indicators are listed in Table 1.

[0042] Table 1. Vulnerability Assessment Index System for Pharmacovigilance Systems in Medical Institutions

[0043]

[0044]

[0045] Constructing a vulnerability identification model for pharmacovigilance systems in medical institutions: Comprehensive quantitative model weighting of vulnerability dimensions

[0046] To eliminate dimensional differences and integrate multidimensional data, the coefficient of variation method is used to calculate the dispersion of indicators within each dimension, objectively evaluating the weights of the three dimensions. The implementation steps of this method are as follows:

[0047] Calculate the coefficient of variation (CV) of the metrics within a dimension. j =σ j / μ j

[0048] σ j μ is the standard deviation. j The mean;

[0049] Normalization was used to obtain objective weights for the three dimensions of exposure (E), susceptibility (S), and resistance (R):

[0050]

[0051] The weights of the three dimensions of vulnerability assessment for pharmacovigilance systems in medical institutions are shown in Table 2.

[0052] Table 2 Weights of Vulnerability Dimensions of Pharmacovigilance Systems in Medical Institutions

[0053] Vulnerability Dimension coefficient of variation Weight Exposure 8.271 0.199 Susceptibility 16.160 0.390 resistance 17.037 0.411

[0054] Constructing a comprehensive quantitative model for vulnerability assessment:

[0055] For the raw measured values ​​of each secondary indicator in the evaluation scale of pharmacovigilance system in medical institutions, a differentiated standardization processing mechanism was used to convert the scores into percentages.

[0056] For positive evaluation metrics (the higher the value, the more fragile the system):

[0057] Y ij =[X ij -X min (j)] / [X max (j)-X min (j)]

[0058] For negative evaluation indicators (the larger the value, the more robust the system):

[0059] Y ij =[Xmax (j)-X ij ] / [X max (j)-X min (j)]

[0060] Where X ij Let X be the original score of the i-th medical institution on the j-th indicator. max (j) and X min (j) represent the theoretical maximum and minimum values ​​of the indicator across all evaluation units, respectively; when using an m-point Likert scale, the default value is X. max (j)=m,X min (j) = 1; when using a percentage scale, the default value is X. max (j)=100,X min (j) = 0, and the result of this transformation process can be output as the standardized score rate Y. ij Y ij The larger the standardized value is, the higher the vulnerability of the system to that index.

[0061] Then, a weighted composite score is calculated across the three dimensions. Based on the indicator fusion weighting system derived from Delphi expert consultation results, the weighted composite value for each vulnerability dimension is calculated:

[0062]

[0063] Among them, II d Let represent the set of secondary indicators belonging to dimension d (exposure, susceptibility, resistance); Yij is the standardized score rate; wj is the weight of the secondary indicators generated by the Delphi expert method, and satisfies the normalization constraint.

[0064]

[0065] Finally, the objective weights (W) of the three dimensions of exposure (E), sensitivity (S), and resistance (R) obtained based on the coefficient of variation method are determined. E W S and W R ), calculate the vulnerability (V) of the pharmacovigilance system in a healthcare facility: V = (W E ×Score E +W S ×Score S ) / W R ×Score R .

[0066] The weights of each indicator are determined based on the coefficient of variation method and the weighted model. The weights of the indicators for evaluating the vulnerability of the pharmacovigilance system in medical institutions in this invention are shown in Table 3.

[0067] Table 3 Weights of Vulnerability Indicators for Pharmacovigilance Systems in Medical Institutions

[0068]

[0069]

[0070] Vulnerability Assessment Scale for Medical Institution Pharmacovigilance Systems:

[0071] Based on the established evaluation indicators and considering the actual processes of pharmacovigilance system operation in medical institutions, including system construction, organizational structure, signal monitoring and reporting, quality improvement, and information technology support, an evaluation scale and scoring rules are generated to provide a structured assessment tool for empirical research on the vulnerability assessment of pharmacovigilance systems in medical institutions. The evaluation scale and scoring rules are shown in Table 4.

[0072] Table 4 Vulnerability Assessment Scale for Pharmacovigilance Systems in Medical Institutions

[0073]

[0074]

[0075]

[0076]

[0077]

[0078] Vulnerability assessment of pharmacovigilance systems in healthcare facilities:

[0079] Based on the comprehensive quantitative model for vulnerability assessment of pharmacovigilance systems developed in this invention, a systematic empirical survey was conducted on 95 medical institutions in a certain city. The calculated vulnerability index results for each medical institution are shown in Table 5.

[0080] Table 5. Results of the vulnerability of pharmacovigilance systems in 95 medical institutions in a certain city.

[0081]

[0082]

[0083]

[0084] Based on the vulnerability index of the pharmacovigilance system of medical institutions, the vulnerability is classified into four levels according to the quartile method: high, medium-high, medium-low, and low. [0, 0.6) is low vulnerability, [0.6, 0.75) is medium-low vulnerability, [0.75, 1.0) is medium-high vulnerability, and [1.0, ~) is high vulnerability.

[0085] Figure 2 This is a brief technical roadmap including the system construction method of this invention.

[0086] This application introduces a three-dimensional analytical framework of "exposure-susceptibility-resistance" to assess the risks of pharmacovigilance systems in healthcare institutions from multiple dimensions. Existing pharmacovigilance evaluations typically rely on subjective indicators and lack systematic and multi-dimensional measurement models. The analytical framework and refined indicator system proposed in this application can identify more systemic risks overlooked by traditional methods, covering more risk points and thus improving the risk identification rate. In this application, the vulnerability-resistance dimension has the highest weight score (0.411), indicating that the healthcare institution's capabilities in risk prevention, rapid response, and continuous optimization and improvement are most critical for assessing pharmacovigilance vulnerability.

[0087] This application employs a combination of expert and objective weighting methods, integrating subjective experience with objective data to achieve a more stable and scientific weight allocation. It innovatively establishes an indicator scoring model that combines vulnerability calculation and grading. This model can quantify the pharmacovigilance risk level of each hospital or institution into a specific score and classify institutions into different risk levels based on the score. Empirical data shows that the vulnerability scores of 95 sample hospitals can differ by as much as 6-7 times, demonstrating the effectiveness and operability of the quantitative scoring model.

[0088] The above are merely preferred embodiments of the present invention and are not intended to limit the implementation methods and protection scope of the present invention. Those skilled in the art should recognize that any equivalent substitutions and obvious changes made based on the description and illustrations of the present invention should be included within the protection scope of the present invention.

Claims

1. A method for constructing a vulnerability evaluation index system of a medical institution pharmacovigilance system, characterized by the following steps: comprehensively establishing a vulnerability analysis framework of exposure-susceptibility-resistance to construct a conceptual model of the vulnerability of the medical institution pharmacovigilance system from the aspects of risk impact and risk resistance; determining the influencing factors of the pharmacovigilance system according to the operation mechanism of the medical institution pharmacovigilance system, selecting evaluation indexes of key influencing factors according to the exposure-susceptibility-resistance model, and constructing an evaluation index system; the evaluation index system comprises a target layer, a criterion layer and an index layer, the target layer is the vulnerability of the medical institution pharmacovigilance system, the criterion layer comprises exposure, susceptibility and resistance, exposure mainly reflects the degree of external risk faced by the medical institution and information transparency, focuses on the institutional construction of the medical institution pharmacovigilance, monitoring of adverse drug reactions, reporting channels and participation of medical staff, and is directly related to the breadth and depth of the exposure of drug use safety risks, susceptibility emphasizes the internal weaknesses of the organization that may amplify the risk of drug use safety, and resistance covers the response, prevention and recovery ability to the risk; constructing a vulnerability identification model of the medical institution pharmacovigilance system and determining the weight of the comprehensive quantification model of the vulnerability dimension: calculating the dispersion degree of indexes in each dimension by using the coefficient of variation method to objectively evaluate the weight of three dimensions, the implementation steps of the method are as follows: obtaining the objective weight of exposure (E), susceptibility (S) and resistance (R) three dimensions by normalization processing: constructing a comprehensive quantification model for vulnerability evaluation: for the original measurement values of each secondary index in the evaluation scale of the medical institution pharmacovigilance system, using a differentiated standardization processing mechanism to convert the score rate: for positive evaluation indexes (the larger the value, the more vulnerable the system is): for negative evaluation indexes (the larger the value, the more robust the system is): calculating the weighted composite value of each vulnerability dimension based on the index fusion weight system of the Delphi expert consultation result: constructing an evaluation scale of the vulnerability of the medical institution pharmacovigilance system: according to the evaluation indexes determined, combining the actual processes of the operation of the medical institution pharmacovigilance system such as institutional construction, organizational structure, signal monitoring and reporting, quality improvement and information support, generating an evaluation scale and scoring details, and providing a structured evaluation tool for empirical research on the vulnerability evaluation of the medical institution pharmacovigilance system. ​ ​ ​ 2. The medical institution pharmacovigilance system vulnerability evaluation index system construction method of claim 1, wherein, ​ ​ Coefficient of variation for intra-dimension indicators: CV j = σ j / μ j σ j is the standard deviation, μ j is the mean; ​ 3. The medical institution pharmacovigilance system vulnerability evaluation index system construction method of claim 1, wherein, ​ ​ ​ Y ij = [X ij - X min (j)] / [X max (j) - X min (j)] ​ Y ij = [X max (j)-X ij ] / [X max (j)-X min (j)] where X ij is the original score of the ith medical institution on the jth indicator, X max (j) and X min (j) are the theoretical maximum and minimum values of the indicator across all evaluation units, respectively; when an m-point Likert scale is used, by default X max (j) = m, X min (j) = 1; When using a percentage scale, default X max (j) = 100, X min (j) = 0, the conversion process results can output normalized score rate Y ij , Y ij ∈ [0, 1], the larger the value indicates that the system exhibits higher vulnerability in this index; ​ wherein II d represents the set of secondary indicators belonging to dimension d (exposure, susceptibility, resistance); Y ij is the standardized score rate; w j is the weight of the secondary indicators generated by the Delphi expert method and satisfies the normalization constraint condition: Finally, the objective weights (W E , S and W R ) of the three dimensions of exposure (E), sensitivity (S) and resistance (R) based on the coefficient of variation method were used to calculate the vulnerability (V) of the medical institution pharmacovigilance system: V = (W E × Score E + W S × Score S ) / W R × Score R .

4. The medical institution pharmacovigilance system vulnerability evaluation index system construction method of claim 1, wherein, ​

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