Drug Supervision Research Articles

Intelligent supervision of PIVAS drug dispensing based on image recognition technology.

Pharmacy Intravenous Admixture Services (PIVAS) are places dedicated to the centralized dispensing of intravenous drugs, usually managed and operated by professional pharmacists and pharmacy technicians, and are an integral part of modern healthcare. However, the workflow of PIVAS has some problems, such as low efficiency and error-prone. This study aims to improve the efficiency of drug dispensing, reduce the rate of manual misjudgment, and minimize drug errors by conducting an in-depth study of the entire workflow of PIVAS and applying image recognition technology to the drug checking and dispensing process. Firstly, through experimental comparison, a target detection model suitable for drug category recognition is selected in the drug-checking process of PIVAS, and it is improved to improve the recognition accuracy and speed of intravenous drug categories. Secondly, a corner detection model for drug dosage recognition was studied in the drug dispensing stage to further increase drug dispensing accuracy. Then the PIVAS drug category recognition system and PIVAS drug dosage recognition system were designed and implemented.

Time series analysis of using the PDCA method combined with the Teach-back method to improve spontaneous reports of adverse drug reactions in a grade IIIA hospital in China.

Spontaneous reporting of adverse drug reactions (ADRs) is essential for the post-marketing safety evaluation of drugs. Therefore, good monitoring of ADRs is vital for strengthening drug supervision, management, and guiding rational drug use. Chinese medical institutions are the primary source of ADR case reports, but the proportion of the reports in grade IIIA hospitals is still low due to serious under-reporting. The 3rd Affiliated Hospital of Chengdu Medical College, Chengdu Pidu District People's Hospital, also has such a problem. To improve the quantity and quality of ADR reports and enhance the level of pharmacovigilance in hospitals, the Third Affiliated Hospital of Chengdu Medical College, People's Hospital of Chengdu Pidu District experienced 10years to gradually establish a management model to improve the medical staff's reporting rate of spontaneous reporting of ADRs. The management model is led by clinical pharmacists and combines the PDCA with Teach-back methods. The purpose of this paper is to introduce the management model and discuss its advantages and shortcomings of this model. This study was conducted at the Third Affiliated Hospital of Chengdu Medical College-Chengdu Pidu District People's Hospital. From 2016, the daily management of reporting, auditing, and data improvement of adverse drug reactions in the hospital was carried out by clinical pharmacists, who used the PDCA method combined with the Teach-back method to continuously improve the reporting program of ADRs in the hospital during 2016-2021. Then, the proportion of spontaneous reports of total, new, and serious ADRs was compared before and after the intervention. Also, we performed a time series analysis using an autoregressive moving average model to assess changes in the total number of spontaneous ADR reports before the intervention (2013-2015), the first intervention (2016-2018), and the second intervention (2019-2021). After the combined PDCA and Teach-back method intervention, the median number of reported ADRs per year increased from 50 (range 37-55) in the pre-intervention period to 88 (range 83-162) in the first intervention period and to 374 in the second (range 312-566). Breakpoint regression analysis of the spontaneous reporting rate of ADRs showed that the instantaneous increase after the first intervention was not statistically significant (P = 0.526). However, the reporting rate of ADRs increased at a month-by-month growth rate during the second intervention compared to the first intervention. Its spontaneous reporting rate improved 1.034 times (P = 0.002). After the second intervention, the spontaneous reporting rate of ADRs transiently increased 6.111-fold (P < 0.001), and the month-to-month growth rate increased 1.024-fold (P < 0.001) again. The management model that combines the PDCA and the Teach-back method significantly improves the reporting rate of adverse drug reactions.

Legal and Ethical Protection in Drug Distribution: Examining Health Efforts and Drug Supervision in Indonesia

The National Agency of Drug and Food Control (BPOM) has regulations regarding the Good Drug Distribution Method (CDOB), which is a guideline for distributing drugs properly. Community Health Centres (Puskesmas) are one of the legitimate institutions in distributing antibiotics. However, there is misuse of antibiotic distribution from community health centres to unofficial channels. This research uses normative juridical method by using secondary data from literature study and interviews with resource persons at the community health centre. The purpose of this study is to analyse the legal protection for drug users and consumers as well as the effectiveness of the legal responsibility of pharmaceutical facilities in overcoming pharmacist malpractice. The results show that legal protection for drug users is inadequate and the legal responsibility of pharmaceutical facilities is not yet effective in overcoming pharmacist malpractice, due to the lack of regulations governing pharmacist practices and firm handling of malpractice.

AI-driven smart pharmacology

With the progress of digital technology and innovative drug R&D, machine learning and data-driven algorithms have been increasingly used to support the core work of pharmaceutical areas such as new drug discovery, drug reuse and drug supervision, etc.1 A new concept of "Smart Pharmacology" has gradually grown into a system with rich connotations and comprehensive coverage, and the related applications and industrial chain have high prospects for development. The so-called "Smart Pharmacology " mainly uses big data, cloud computing, AI, IoT, 5G, Blockchain and other forefront digital technologies to provide whole-process, information-based, intelligence-driven solutions for various scenarios in the pharmacy sectors, including new drug development, drug molecular design, hospital drug management, clinical drug decision support, modernization of traditional medicine, pharmacy informatization, drug regulation and other broad areas, with a wide range covering drug discovery, production, supply, circulation, procurement, allocation and monitoring. In fact, the emergency of smart pharmacology provides a comprehensive and optimized path for modernizing the whole life cycle management of drugs and instills new vitality into the development of modern pharmacy.

Neither an offender nor a ‘free’ person: Drug supervision and desistance in Singapore

AbstractIn 2019, the Misuse of Dugs Act, the main legislative instrument in combatting drug offences in Singapore, underwent a landmark amendment where it strove to strike a balance between subjecting persistent drug offenders to long‐term imprisonment and enhancing the reintegration potential of those offenders whom the state considered as ‘pure abusers’ without a penal charge. While this risk‐differentiated approach could be seen as progressive and moving away from the harsh response that has had traditionally characterised the Singapore state's treatment of persistent drug abusers, this article contends that extending the maximum period of drug supervision from two to 5 years, which the amendments called for, of even pure abusers upon their completion of the detention order, hinder efforts at desistance. This article focuses specifically on the contradictions of the urine testing regime post‐release and seeks to contextualise its counter effects on the various dimensions of desistance among recovering drug abusers.

Three oral Chinese patent medicines for children with tic disorder: a rapid health technology assessment

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as &quot;some concerns&quot; and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(&lt;7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.

Predicting the structure of unexplored novel fentanyl analogues by deep learning model.

Fentanyl and its analogues are psychoactive substances and the concern of fentanyl abuse has been existed in decades. Because the structure of fentanyl is easy to be modified, criminals may synthesize new fentanyl analogues to avoid supervision. The drug supervision is based on the structure matching to the database and too few kinds of fentanyl analogues are included in the database, so it is necessary to find out more potential fentanyl analogues and expand the sample space of fentanyl analogues. In this study, we introduced two deep generative models (SeqGAN and MolGPT) to generate potential fentanyl analogues, and a total of 11041 valid molecules were obtained. The results showed that not only can we generate molecules with similar property distribution of original data, but the generated molecules also contain potential fentanyl analogues that are not pretty similar to any of original data. Ten molecules based on the rules of fentanyl analogues were selected for NMR, MS and IR validation. The results indicated that these molecules are all unreported fentanyl analogues. Furthermore, this study is the first to apply the deep learning to the generation of fentanyl analogues, greatly expands the exploring space of fentanyl analogues and provides help for the supervision of fentanyl.

An Analysis of Pharmacy Policy Implementation in Bantul Regency, Indonesia

The Bantul Regency Government has arranged the implementation of pharmacy services so that a good business environment is established. This study was conducted to conduct a conceptual analysis of the establishment of pharmacies between high ratio and low ratio areas based on applicable regulations. The purpose of this study is to develop a policy of improving the effectiveness of drug supervision in pharmaceutical service facilities, and the formulation of patterns of strengthening and empowerment pharmacies. The method used is literature review on related articles from various countries. With certain filtering techniques, there are six articles meet the criteria. The results of the analysis of the article can be used to explain various patterns in the management of pharmacies implementation policies. The government needs to coordinate with associations, pharmacies provider on making policy that protect consumers. This policy is important because drug services have a broad impact on public health.

Application of Laser-Induced Breakdown Spectroscopy Combined with Chemometrics for Identification of Penicillin Manufacturers

Due to the differences in raw materials and production processes, the quality of the same type of drug produced by different manufacturers is different. In drug supervision, determining the manufacturer can help to trace drug quality issues. In this study, a method for the quick identification of drug manufacturers based on laser-induced breakdown spectroscopy (LIBS) was proposed for the first time. We obtained the LIBS spectra from 12 samples of three types of penicillin (phenoxymethylpenicillin potassium tablets, amoxicillin capsules, and amoxicillin and clavulanate potassium tablets) produced by 10 manufacturers. The LIBS characteristic lines of the three types of penicillin were ranked by importance based on the decrease in the Gini index of random forest (RF). Three classifiers—the linear discriminant analysis (LDA), support vector machine (SVM) and artificial neural network (ANN)—were used to identify the different manufacturers of the three types of penicillin. RF-ANN provided the best classification result and an accuracy of 100% in penicillin manufacturer identification. The results show that LIBS combined with chemometrics could be used in the identification of penicillin manufacturers, and this method has application potential in drug quality supervision.

SpectraTr: A novel deep learning model for qualitative analysis of drug spectroscopy based on transformer structure

The drug supervision methods based on near-infrared spectroscopy analysis are heavily dependent on the chemometrics model which characterizes the relationship between spectral data and drug categories. The preliminary application of convolution neural network in spectral analysis demonstrates excellent end-to-end prediction ability, but it is sensitive to the hyper-parameters of the network. The transformer is a deep-learning model based on self-attention mechanism that compares convolutional neural networks (CNNs) in predictive performance and has an easy-to-design model structure. Hence, a novel calibration model named SpectraTr, based on the transformer structure, is proposed and used for the qualitative analysis of drug spectrum. The experimental results of seven classes of drug and 18 classes of drug show that the proposed SpectraTr model can automatically extract features from a huge number of spectra, is not dependent on pre-processing algorithms, and is insensitive to model hyperparameters. When the ratio of the training set to test set is 8:2, the prediction accuracy of the SpectraTr model reaches 100% and 99.52%, respectively, which outperforms PLS_DA, SVM, SAE, and CNN. The model is also tested on a public drug data set, and achieved classification accuracy of 96.97% without pre-processing algorithm, which is 34.85%, 28.28%, 5.05%, and 2.73% higher than PLS_DA, SVM, SAE, and CNN, respectively. The research shows that the SpectraTr model performs exceptionally well in spectral analysis and is expected to be a novel deep calibration model after Autoencoder networks (AEs) and CNN.

TINJAUAN YURIDIS STANDAR MUTU PRODUK DAN PERAN BPOM DALAM MENCIPTAKAN IKLIM PERLINDUNGAN KONSUMEN YANG BAIK DI INDONESIA

Business has become a routine that has the highest percentage of interest to the public at this time. This digitalization era is one of the facilities to facilitate businesses in running their businesses. However, the facility does not rule out the possibility for business actors to cheat in their business, bearing in mind the objective of the business is to seek maximum profits. The purpose of business by obtaining the maximum profit is permitted, but business actors continue to do business in a fair manner and the products produced are prohibited from harming consumers and the most important thing is that businesses can apply product quality standards that are legalized by BPOM. However, business operators are often found intentionally circulating their products, especially drugs, food and beverage products, and cosmetics that do not yet have a BPOM permit. The fraudulent behavior of the business actor must be immediately stopped with discipline and tightening regarding the regulation of product quality standards. The purpose of this research, specifically to find and understand product quality standards that are applied in Indonesia and the role of BPOM as a drug and food control agency to create a climate of good consumer protection in Indonesia. In general, to deepen science, especially in law of consumer protection. The research of method is the normative juridical method. The discussion in this research is related to regulation the standards of product quality that must be applied by businesses and the role of BPOM in efforts to create a good consumer protection climate in the Indonesia. The conclusions of this research include that to affixing of SNI to products and supervision in the Department of Industry and Trade in category of export commodities must not be lower than SNI while for imported commodities the SNI and the role of BPOM as regulators and filters in the supervision of drug and food products in Indonesia are applied.&#x0D; Keywords: SNI Quality Standards, Products, BPOM and Consumer Protection Law

Analysis of Application Value of Reasonable Drug Classification and Drug Supervision System in Hospital Western Pharmacy Management

Analysis of Application Value of Reasonable Drug Classification and Drug Supervision System in Hospital Western Pharmacy Management

Intelligent SERS Navigation System Guiding Brain Tumor Surgery by Intraoperatively Delineating the Metabolic Acidosis

Surgeons face challenges in intraoperatively defining margin of brain tumors due to its infiltrative nature. Extracellular acidosis caused by metabolic reprogramming of cancer cells is a reliable marker for tumor infiltrative regions. Although the acidic margin‐guided surgery shows promise in improving surgical prognosis, its clinical transition is delayed by having the exogenous probes approved by the drug supervision authority. Here, an intelligent surface‐enhanced Raman scattering (SERS) navigation system delineating glioma acidic margins without administration of exogenous probes is reported. With assistance of this system, the metabolites at the tumor cutting edges can be nondestructively transferred within a water droplet to a SERS chip with pH sensitivity. Homemade deep learning model automatically processes the Raman spectra collected from the SERS chip and delineates the pH map of tumor resection bed with increased speed. Acidity correlated cancer cell density and proliferation level are demonstrated in tumor cutting edges of animal models and excised tissues from glioma patients. The overall survival of animal models post the SERS system guided surgery is significantly increased in comparison to the conventional strategy used in clinical practice. This SERS system holds the promise in accelerating clinical transition of acidic margin‐guided surgery for solid tumors with infiltrative nature.

Research on Drug Supervision System Based on Fisco Bcos Blockchain

Drug safety is related to people's livelihood and public safety. Therefore, we must improve drug supervision and curb the circulation of counterfeit and substandard drugs.At present, most of the centralized drug supervision systems have some problems, such as few participants, easy data tampering, lack of credibility and so on.This paper analyzes the application feasibility of blockchain technology in the field of drug supervision, and designs a decentralized drug supervision system based on Fisco Bcos blockchain, which can solve the problems of data forgery, data tampering, centralization and lack of trust in the current drug supervision system, and provide support and reference for all links of drug circulation.

Study on Special Drug Supervision Countermeasures of Anesthesiologists Under The Background of Multi-Point Practice

Study on Special Drug Supervision Countermeasures of Anesthesiologists Under The Background of Multi-Point Practice

Coregulation Supervision Strategy of Drug Enterprises under the Government Reward and Punishment Mechanism

Considering the government reward and punishment mechanism and the collusion behavior between third-party testing agencies and drug enterprises, based on the coregulation information platform, this paper constructs an evolutionary game model of coregulation supervision, which involves the participation of local government, drug enterprises, and third-party testing agencies. The stable equilibrium points of each participant’s strategic choices are solved. The stability of the strategic combination is analyzed by Lyapunov’s first method, and MATLAB 2020b is used for simulation analysis to verify the influence of each decision variable on different players’ strategic choices. The results show that, firstly, the government-increased awards and penalties will promote the integrity of drug enterprises and noncollusion of third-party testing agencies, but it is not conducive to strict performance of regulatory responsibilities by the local government. Secondly, the provision of real drug test reports by third-party testing agencies to the coregulation information platform can supervise drug enterprises and restrict local government to perform its duty. Thirdly, the central government’s punishment to the local government’s dereliction of duty is significant to enhancing the robustness of drug enterprises’ integrity operation. Furthermore, reasonably setting rewards and punishments and perfecting the coregulation information platform will help form a coregulation pattern of government supervision, self-discipline of drug enterprises, and social supervision. Finally, drug quality is highly related to whether drug enterprises operate with integrity. Standardizing coregulation supervision of drug enterprises’ integrity operation is the key to ensuring the safety of the source of drug quality. Therefore, this paper enriches and expands the theoretical basis of the coregulation supervision of drug enterprises’ integrity operation and proposes corresponding countermeasures and suggestions.

Study on the Significance of Rational Drug Classification and Drug Supervision System in Hospital Western Medicine Pharmacy

Study on the Significance of Rational Drug Classification and Drug Supervision System in Hospital Western Medicine Pharmacy

Identification of Multi-Class Drugs Based on Near Infrared Spectroscopy and Bidirectional Generative Adversarial Networks.

Drug detection and identification technology are of great significance in drug supervision and management. To determine the exact source of drugs, it is often necessary to directly identify multiple varieties of drugs produced by multiple manufacturers. Near-infrared spectroscopy (NIR) combined with chemometrics is generally used in these cases. However, existing NIR classification modeling methods have great limitations in dealing with a large number of categories and spectra, especially under the premise of insufficient samples, unbalanced samples, and sensitive identification error cost. Therefore, this paper proposes a NIR multi-classification modeling method based on a modified Bidirectional Generative Adversarial Networks (Bi-GAN). It makes full utilization of the powerful feature extraction ability and good sample generation quality of Bi-GAN and uses the generated samples with obvious features, an equal number between classes, and a sufficient number within classes to replace the unbalanced and insufficient real samples in the courses of spectral classification. 1721 samples of four kinds of drugs produced by 29 manufacturers were used as experimental materials, and the results demonstrate that this method is superior to other comparative methods in drug NIR classification scenarios, and the optimal accuracy rate is even more than 99% under ideal conditions.

3D Tungsten Trioxide Nanosheets as Optoelectronic Materials for On-chip Quantification of Global Antioxidant Capacity

The photoelectrochemical properties of semiconductors mainly depend on the size and shape of the corresponding nanoparticles. Herein, 3D WO3 nanosheets were controllably synthesized with the aid of polyethyleneimine, which presents enhanced photocurrent responses. Based on this excellent photoelectrochemical property, a photoelectrochemical chip was prepared by lithography technology for the smart monitoring of the antioxidant capacity(AC) in red wine and exhibits a series of advantages including rapid response time, high sensitivity, and long-lasting stability. The mechanism of the present photoelectrochemical sensing was explored and shows a single electron transfer reaction. Furthermore, only 200 µL of samples are required for one testing, which demonstrates that the present photoelectrochemical chip can be potentially integrated with a portable commercial device(such as a mobile phone) for further research and development of food and drug supervision.

Application of traditional Chinese medicine(TCM) traceability system based on TCM quality characteristics and HACCP system

It is crucial to establish a complete set of traditional Chinese medicine(TCM) quality traceability management process system, in order to stabilize the pricing order of TCM market and reconstruct the transmission path of TCM quality signals. In this study, we reviewed the mature experience of food and drug supervision at home and abroad, analyzed the quality characteristics of TCM, and put forward that the quality control of TCM products can learn from the hazard analysis and critical control point(HACCP) system in food safety quality control. This study points out that the HACCP system provides not only technical guidance for the traceability management of TCM, but also ideas for improving the quality of TCM products and the safety risk control of TCM. The application of the HACCP system in TCM quality control can help establish an international dialogue platform for TCM and help realize the modernization and internationalization of TCM industry.