Non-steroidal anti-inflammatory drugs in postoperative hand fracture management:Do they positively or negatively impact recovery?

This editorial explores the impact of non-steroidal anti-inflammatory drugs(NSAIDs)on postoperative recovery in hand fracture patients,amidst shifting pain management strategies away from opioids due to their adverse effects.With hand fractures being significantly common and postoperative pain management crucial for recovery,the potential of NSAIDs offers a non-addictive pain control alternative.However,the controversy over NSAIDs'effects on bone healing—stemming from their Cyclooxygenase-2 inhibition and associated risks of fracture non-union or delayed union—necessitates further investigation.Despite a comprehensive literature search,the study finds a lack of specific research on NSAIDs in postoperative hand fracture management,highlighting an urgent need for future studies to balance their benefits against possible risks.

Research Progress and Suggestions on China’s Drug Registration Management Based on CiteSpace Knowledge Maps

Objective To analyze the research status and hot spots in the field of drug registration in China,and to provide some suggestions for the follow-up research.Methods CiteSpace was used to conduct literature quantitative analysis on 684 related articles from 2012 to 2022,and the knowledge map was drawn.Based on this,the main characteristics and development trends of the related studies were summarized.Results and Conclusion The number of articles published was closely related to the regulatory policy of drug registration reform.The authors of these articles did not have good continuity.Besides,research hot spots were closely related to the actual work,which was mainly around the improvement of the review and approval policy,encouraging innovative drug research and development,improving the level of new drug development and other directions.The follow-up studies should further strengthen the continuity of research and inter-agency collaboration.In addition,biomedical registration may become a new research focus in the future.

Identifying and Managing Technical Risks in the Process of Innovative Drugs Development in China

Objective To identify technical risks in the process of innovative drug development,and to provide reference for technical risk management so as to reduce the uncertainties and improve the efficiency of research and development.Methods The initial risk index was investigated by literature research.Then,the Likert scale was used to design a questionnaire,and the experts’opinion was used to analyze the risk factors affecting the different stages of the development of innovative drugs in China.Results and Conclusion Based on the analysis of questionnaire,31 risk indicators of five key stages in the development of innovative drugs from drug discovery to marketing authorization were established.The key risk indicators constructed in this study can provide reference for technology-related risk management in the process of innovative drug development.

Application and Effect Evaluation of the Integrated“5A and 3+3”Management Model in the Safe Medication Use for Chemotherapy Patients

Objective:To explore the application and effect evaluation of the integrated“5A and 3+3”management model in ensuring safe medication use for chemotherapy patients.Methods:A total of 100 intravenous chemotherapy patients admitted to the oncology department of Shaanxi Provincial People’s Hospital were randomly divided into two groups using a random number list method.Both groups received conventional nursing management during chemotherapy,while the study group additionally received the integrated“5A and 3+3”safety management model.The nursing intervention effects between the two groups were compared.Results:After the intervention,the study group showed higher levels of self-management ability,compliance,and nursing satisfaction compared to the control group.The overall incidence of adverse events during hospitalization was lower in the study group,with statistically significant differences(P<0.05).The knowledge scores of medical staff in the study group,related to the prevention and treatment of chemotherapy drug side effects,daily symptom management,and daily life management,were higher than those in the control group,with statistically significant differences(P<0.05).Conclusion:Implementing the integrated“5A and 3+3”model in the safe medication management of intravenous chemotherapy patients can effectively enhance patients’self-management abilities and compliance,improve medical staff’s ability to safely administer chemotherapy drugs,reduce adverse events caused by chemotherapy,and increase patient satisfaction.

Present Situation and Enlightenment of Post-Approval Change Management of Drugs in China,USA and EU

Objective To provide suggestions for further improvement of China’s drug post-approval change management system.Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA,EU and China were compared and analyzed.Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs.However,there are still some problems in China’s current post-approval change management systems.According to the model and requirements of the post-approval change management systems of the USA and EU,this paper proposes the following suggestions for the improvement of China’s post-approval change management system.Firstly,electronic files for licensed products should be created.Then,regulatory standards at the national level must be unified.Lastly,the concept of product life cycle management should be implemented.

Quality Management Model for Phase I Clinical Drug Trials:A Structural Equation Model

This study aimed to construct a quality management model for phase I clinical drug trials.A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials.Exploratory and confirmatory factor analyses were used to develop the survey tool.Structural equation modeling was used to construct a quality management model for phase I clinical drug trials.The results showed that the final survey tool had good reliability and validity(Cronbach’sα=0.938,root mean square error of approximation=0.074,comparative fit index=0.962,and Tucker—Lewis index=0.955).The model included five dimensions:government regulation,industry management,medical institution management,research team management,and contract research organization(CRO)management.In total,22 measurement items were obtained.The structural equation model indicated government regulation,industry management,medical institution management,and CRO management significantly affected the quality of phase I clinical drug trials(β=0.195,β=0.331,β=0.279,andβ=−0.267,respectively;P<0.05).Research team management had no effect on the quality of trials(β=0.041,P=0.610).In conclusion,the model is valuable for identifying factors influencing phase I clinical drug trials and guiding quality management practices.

Analysis of Compliance Management Practice of American Drug Registration Applicants and Its Enlightenment to China

In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management for U.S. pharmaceutical manufacturers as described in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug registration stages. Finally, some suggestions and implications are proposed to strengthen the construction of compliance management for Chinese drug registration applicants based on the former practical experience.

Practice of Perioperative Rational Use of Antibacterial Drugs Based on Drug Pathway

[Objectives]To establish a new management model for rational use of perioperative antibacterial drugs in surgical departments.[Methods]Based on evidence-based medicine,the department s drug pathway was formulated,and the new mode of rational drug use control was established by using fine pharmaceutical technology intervention,and the intervention effect was evaluated by the intensity of antibacterial drug use,per capita drug costs and the proportion of drugs.[Results]After adopting drug pathway in departments,the intensity of antibacterial drug use,per capita drug costs and the proportion of drugs decreased significantly,and the effect of rational drug use control was remarkable.[Conclusions]The drug pathway provides a new management and control mode for the rational use of perioperative antibacterial drugs in surgical departments of hospitals.Thus,it is worthy of popularization and application.

Factors Affecting the Knowledge and Practice of Drug Management among Healthcare Workers in Primary Health Centers in South-East, Nigeria

The knowledge of health workers regarding their management of drugs is very important in ensuring good health. One of the major indices of the performance of primary health care (PHC) remains improved access to essential drugs as they are the link between patients and health services. Consequently, their availability or absence will contribute to a positive or negative impact on health. This was a quasi-experimental study, carried out in Anambra state, which compared the intervention and control groups following the training and provision of drug management tools to PHC workers in the intervention group. A multi-stage sampling technique was used to select 264 health workers from 132 health centers from two senatorial zones in the State, one acting as a control group and the other as an intervention group. Data was collected using a pre-tested in-depth interview guide and semi-structured interviewer administered questionnaire. Statistical analysis was conducted using SPSS at a statistical significance level of p value less than 0.05, while qualitative data was analyzed using N-Vivo. Several factors such as age, sex, educational qualification, cadre of staff, years of practice and PHC workers’ previous training were identified as affecting the knowledge and practice of drug management. The majority (72.0% and 71.2%) in intervention and control groups respectively said inadequate information or lack of knowledge was the main reason for poor practices while the proportion with low interest of health workers for drug management was (38.5%) for intervention and (59.8%) for the control group and the difference between the groups was statistically significant (p = 0.034). In conclusion, this study has shown that age, sex, educational qualification, cadre of staff, years of practice and PHC workers’ previous training were factors associated with health workers’ knowledge and practice of drug management. The study recommends the development of Aide Memoire and conduct of training and retraining on drug management to improve both knowledge and practice of drug management in PHCs in Nigeria.

Uterotonic drugs use for post partum hemorrhage: An audit of the third stage of labor management

Objectives: Worldwide the use of uterotonic drugs has significantly reduced maternal mortality from postpartum hemorrhage. The objective is to audit the use of uterotonics in the active management of the third and fourth stages of labor. Methods: Personal data, diagnostic clinical information, blood loss and uterotonics administered were extracted from a cohort of 634 consecutive parturient. Trend in Shock Index (Pulse Rate/Systolic Blood Pressure) and 48 hours hematocrit changes were computed and analyzed. Results: There were 422 vagina deliveries and 212 caesarean sections. Primiparous mothers were 141 (34.2%), while grand multiparous mothers were 14 (3.4%). The mean visually estimated postpartum blood loss 165.9 ± 80 ml. There was no significant difference in the mean blood loss between the three parity groups of parturient [P = 0.09]. Fourteen parturient (3.44%) had blood loss ≥500 ml. The value of Shock Index (Pulse Rate/Systolic Blood Pressure) in the study ranged between 0.43 and 1.38. Logistic regression analysis of the variables associated with the switch between the three regimens of uterotonic drugs, showed a significant positive correlation between VEBL and uterotonic drugs administered [Pearson correlation = 0.130, P-value = 0.008]. In addition, there was a significant negative correlation between uterotonic drugs administered and Shock Index at 30 minutes and 2 hours postpartum. The correlation coefficient between VEBL and regimens of uterotonic drugs used was positive and significant (P = 0.019). Conclusion: Visually estimated blood loss, with shock are the main Triggers involved in switching between uterotonic drugs regimens used in active management of PPH. Shock index calculation is vital in management decision. We advocate training of all birth attendants on VEBL.

Exploration and Discussion on Drug Management in the Operating Room

Operating room drug management work directly related to the safety of medication and the scientific nature of medication,the most important content of operating room drug management is to ensure the rational and safe use of drugs,to avoid drug abuse and misuse.This paper mainly explores the problems existing in the current operating room drug management process,points out the specific drug management model,and hopes to give full play to the role of drug management to ensure that drugs can be applied scientifically.

Analytic Hierarchy Process for Technological Risks in the Process of Innovative Drug Development in China

Objective To identify the critical risks in the process of innovative drug research and development,and to provide reference for improving the efficiency of innovative drug development and risk control in China.Methods Expert investigation and analytic hierarchy process were used to determine the weights of different risks.Results and Conclusion The research and analysis results showed that the risks at different stages of development had different effects on the success rate of drug development,among which the risk at the drug discovery stage influenced the most.In the drug discovery stage,inappropriate target selection had the greatest impact on the success rate of drug development.The lack of appropriate cell tissue or animal models had the greatest impact on the success rate of drug development from the discovery of a compound to the application for clinical trials.The difference in changes between nonclinical and clinical studies had the greatest impact on the success rate of drug development from early clinical studies to pivotal clinical studies.Incorrect dose selection had the greatest impact on the success rate of drug development from pivotal clinical studies to marketing authorization applications.The biggest impact from the marketing authorization application to the approval stage was inadequate communication with regulators.After investigating the weight of risk factors in the process of innovative drug development based on scientific methods,a new perspective for the risk control of new drug development and improving the research and development efficiency is provided.

Problems and Measures in Internal Control and Risk Management of Drug Research and Development Enterprises

The internal control and risk managementof drug research and development enterprises directlyaffects the survival and development of enterprises.With the development of information technologyand the integration with the global economy,pharmaceutical companies are able to achieve moreachievements in development while facing increasingcompetitive pressures. Finance is a pivotal spine of acompany’s development. If the internal control andrisk management of a company are not complete andcomprehensive, the enterprise will inevitably turn intoa crisis. Therefore, it is necessary to strengthen theanalysis of the problems in the internal control andrisk management of drug research and developmententerprises, and propose corresponding solutions.

Management of Orphan Drug Reimbursement Abroad and Its Enlightenment to China

Objective To analyze relevant policies and measures on the management of orphan drug reimbursement in foreign countries to provide a reference for future reimbursement management in China.Methods According to the percentage of health care expenditure in GDP,the completeness of rare disease policies,and the total population,Russia,Australia,and India were selected as the reference.Based on the existing literature,the main content and characteristics of the reimbursement of rare disease drugs were analyzed.Results and Conclusion Russia manages rare diseases in the form of lists.Special rare diseases are reimbursed by federal or regional finances,and ordinary rare diseases are reimbursed by statutory medical insurance funds.Orphan drugs in Australia are included in the pharmaceutical benefits scheme(PBS)and the lifesaving drugs program(LSDP),LSDP provides fully reimbursed drugs for eligible rare disease patients.India’s proposal takes health system sustainability into consideration.China should carry out epidemiological research to legally determine the rare diseases,establish reasonable reimbursement standards,and improve the multi-level reimbursement system.

Application Research of Earned Value Management in New Drug Research and Development Projects

Objective To help investors assess and control the costs of new drug development and reduce the risks of new drug development projects.Methods Cost analysis and financial forecasting were carried out with the integrated approach of earned value management.According to the principle of earned value management deviation analysis,the basic process of the new drug research and development project was combined with the hypothesis method from the research of Tufts Drug Development Research Center.Results and Conclusion If the project progress check was carried out in the clinical trial,the project costs were found overspent,the efficiency was low,the project progress was faster,and the resource investment was ahead.It is recommended that the adjustment should be made to reduce the input of resources,and increase the efficient key personnel to take the place of some less efficient staff.

State-of-the-Art management of knee osteoarthritis

Osteoarthritis(OA) is the most common type of arthritis found in the United States' population and is also the most common disease of joints in adults throughout the world with the knee being the most frequently affected of all joints. As the United States' population ages along with the increasing trends in obesity prevalence in other parts of the world, it is expected that the burden of OA on the population, healthcare system, and overall economy will continue to increase in the future without making major improvements in managing knee OA. Numerous therapies aim to reduce symptoms of knee OA and continued research has helped to further understand the complex pathophysiology of its disease mechanism attempting to uncover new potential targets for the treatment of OA. This review article seeks to evaluate the current practices for managing knee OA and discusses emerging therapies on the horizon. These practices include non-pharmacological treatments such as providing patient education and self-management strategies, advising weight loss, strengthening programs, and addressing biomechanical issues with bracing or foot orthoses. Oral analgesics and anti-inflammatories are pharmacologicals that are commonly used and the literature overall supports that some of these medications can be helpful for managing knee OA in the short-term but are less effective for long-term management. Additionally, more prolonged use significantly increases the risk of serious associated side effects that are not too uncommon. Diseasemodifying osteoarthritis drugs are being researched as a treatment modality to potentially halt or slow disease progression but data at this time is limited and continued studies are being conducted to further investigate their effectiveness. Intra-articular injectables are also implemented to manage knee OA ranging from corticosteroids to hyaluronans to more recently plateletrich plasma and even stem cells while several other injection therapies are presently being studied. The goal of developing new treatment strategies for knee OA is to prolong the need for total knee arthroplasty which should be utilized only if other strategies have failed. High tibial osteotomy and unicompartmental knee arthroplasty are potential alternatives if only a single compartment is involved with more data supporting unicompartmental knee arthroplasty as a good treatment option in this scenario. Arthroscopy has been commonly used for many years to treat knee OA to address degenerative articular cartilage and menisci, however, several high-quality studies have shown that it is not a very effective treatment for the majority of cases and should generally not be considered when managing knee OA. Improving the management of knee OA requires a multi-faceted treatment approach along with continuing to broaden our understanding of this complex disease so that therapeutic advancements can continue to be developed with the goal of preventing further disease progression and even potentially reversing the degenerative process.

Failure mode and effect analysis of the risk management of non-integral-dosage drug dispensing in PIVAS

To mitigate risks associated with the prescription examination,marking,dispensing,checking,and review of non-integral-dosage drugs in Pharmacy Intravenous Admixture Service(PIVAS),we formed a project team.Employing the failure mode and effect analysis(FMEA)management method,we identified potential risks in four critical steps of the non-integral-dosage drug dispensing process within PIVAS drug management:prescription verification,mixed allocation,and verification.For each step,we assigned scores for severity,incidence,and detectability,subsequently calculating the Risk Priority Number(RPN)to prioritize identified risks.Targeted measures for improvement were developed for steps with the highest RPN values.A total of 31 risk factors were documented in the management of non-integral-dosage drugs,with the dispensing process being particularly vulnerable.Specific measures were devised for eight high RPN risks.Following a 3-month optimization and improvement period,RPN values and incidences of internal differences were significantly reduced.The implemented measures demonstrated effective risk control.Notably,we established a comprehensive conversion system for partial-dose drug dispensing,directly translating into a volume of suction fluid for dispensing personnel based on doctor orders.This eliminated the need for manual secondary calculations,thereby standardizing and automating the dispensing of non-integral-dosage drugs in PIVAS.Simultaneously,our project team conducted a dissolution test on 23 types of drugs with non-integral dosage,revealing that the solvent volume increased for 11 types after dissolution.The dosage conversion for partial dosage was recalibrated based on the volume of the final solution to ensure dosage accuracy.Through the application of failure mode and effect analysis,we systematically managed the risks associated with non-integral-dosage drugs in PIVAS.This approach addressed safety concerns in the dispensing process,reduced errors,and ensured the safe and precise administration of medication to patients.

Advances and controversies in the management of acute cholecystitis in high-risk, critically ill, and unfit-for-surgery patients: the Italian Society of Emergency Surgery and Trauma guidelines

There is an ongoing debate about the therapeutic strategies for acute cholecystitis in high-risk,critically ill patients,and finding the optimal management option is a work in progress.In the recent study“Acute cholecystitis management in high-risk,critically ill,and unfit-for-surgery patients:the Italian Society of Emergency Surgery and Trauma(SICUT)guidelines”,Prof.Coccolini et al.summarize current knowledge on treating acute cholecystitis in high risk,critically ill,and unfit for surgery patients(1).The article encompasses topics such as patient stratification,risk factors,and outcomes of non-operative gallbladder drainage and advances the knowledge of the field by proposing specific management recommendations for these patient groups.

Perioperative management of the patient with rheumatoid arthritis

A multidisciplinary approach is required to care for patients with rheumatoid arthritis(RA)in the perioperative period.In preparation for surgery,patients must have a cardiovascular risk assessment performed due to the high risk of heart disease in patients with RA.Treatment of RA is with immunomodulatory medications,which present unique challenges for the perioperative period.Currently,there is no consensus on how to manage disease modifying antirheumatic drug(DMARD)therapy in the perioperative setting.Much of the data to guide therapy is based on retrospective cohort data.Choices regarding DMARDs require an individualized approach with collaboration between surgeons and rheumatologists.Consensus regarding biologic therapy is to hold the therapy in the perioperative period with the length of time dictated by the half-life of the medication.Special attention is required at the time of surgery for potential need for stress dose steroids.Further,there must be close communication with anesthesiologists in terms of airway management particularly in light of the risk for cervical spine disease.There are no consensus guidelines regarding the requirement for cervical spine radiographs prior to surgery.However,history and exam alone cannot be relied upon toidentify cervical spine disease.Patients with RA who undergo joint replacement arthroplasty are at higher risk for infection and dislocation compared to patients with osteoarthritis,necessitating particular vigilance in postoperative follow up.This review summarizes available evidence regarding perioperative management of patients with RA.

Acute pain management in symptomatic cholelithiasis

AIM To review the evidence for the use of different nonsteroidal anti-inflammatory drugs(NSAIDs) in the treatment of biliary colic.METHODS The strategies employed included an extensive literature review for articles and studies related to biliary colic from electronic databases including Pub Med,Science Direct,Wiley Inter Science,Medline and Cochrane from last 15 years.Keywords: "Biliary colic","management of biliary colic","non-steroidal anti-inflammatory drugs","cholelithiasis" and "biliary colic management".Six randomized control trials,1 non-randomized trial and 1 meta-analysis were included in this review.The outcomes of these studies and their significance have been reviewed in this paper.RESULTS Current evidence suggests there are no set protocols for biliary colic pain management.NSAIDs are potent in the management of biliary colic,not only in terms of symptom control but in disease progression as well.Apart from the studies on diclofenac and ketorolac,there are studies which have shown that intravenous tenoxicam and injectable flurbiprofen are equally effective in managing biliary colic.The efficacy of NSAIDs is superior in terms of lower number of doses and longer duration of action in comparison to other analgesic agents.CONCLUSION This literature review has found that NSAIDs are safe and effective for pain control in biliary colic,and reduce the likelihood of further complications.