Drug utilization evaluation of medications used in the management of neurological disorders

Background and object:The burden of neurological disorders in India is expected to increase due to the rapid demographic and epidemiological transition,with irrational drug use,which is also a global concern.Thus,drug utilization evaluation is designed to ensure appropriate medicine use within the healthcare settings.The aim of the study was to assess the rate and pattern of drug utilization in the management of neurological disorders.Materials and methods:A hospital-based cross-sectional drug utilization evaluation study on neurological drugs was carried out at the Department of Neurology over a span of six months.All legible prescriptions consisting neurological medications irrespective of patient's gender,aged≥18 years were included for the study.The World Health Organization(WHO)core drug use indicators were used to assess the drug prescribing and utilization patterns.Results:A total of 310 prescriptions were reviewed,where male predominance was found to be 56.45%.Out of 310 prescriptions,drugs belonging to 26 neurological classes were prescribed for the management of various neurological disorders.The majority of patients were diagnosed with epilepsy and the most prescribed drugs per patient were phenytoin(14.8%)and valproic acid(6.45%).By following the WHO core drug prescribing indicators,65.47%of drugs prescribed from the India National List of Essential Medicines,2022,followed by 29.83%of drugs prescribed in generic name and 10.86%of prescriptions including injections.Conclusion:The study findings showed that the prescribing pattern in the Department of Neurology was in accordance with the WHO core prescribing indicators.But,the extent of polypharmacy prescriptions was very high.Therefore,interventions are very necessary to promote rational drug prescribing patterns and thus clinical pharmacists can contribute to assess and review the drug utilization pattern to optimize the drug therapy and improvement in patient safety.

The role of drug utilization evaluation in medical sciences

Background:Drug utilization evaluation(DUE)is defined by the World Health Organization(WHO)and focuses on the medical,social,and economic consequences of pharmaceutical marketing,distribution,prescribing,and usage in society.The WHO recommends a physician to every 1000 people.According to the recent data from the Health Ministry in 2019,in which 1.16 million doctors are of active population with just 80%,or 0.9 million,practicing.As a result,a ratio of 0.68 doctors for every 1000 people,which is much below as per the WHO reports.This article describes history,types,WHO guidelines,need and purpose of DUE.Objective:The main aim of this paper is to provide information about the rational use of medication in outpa­tient and inpatient department with special emphasis of DUEs.It also provides awareness directly to healthcare professionals,researchers,academicians,pharmacist and nurses to reduce the irrationality of medicines.Methods:The method used to compile this review information gathered from websites,Google scholar,PubMed,Research gate,and studies published on DUE from July 20 to Oct 22 were included as source of information.Results:We studied more than 35 published study on DUE,that reveals most of the physicians prescribed branded drugs not generic drugs,but WHO prescribing indicator allows to prescribe generic drugs in the hospital pharmacy to maintain better inventory control.It may also help to prevent pharmacist misunderstanding during dispensing.Conclusion:The use of generic prescription names avoids the possibility of medication product duplication and lowers patient costs.It is important to remember that incorrect medication prescriptions have impact on both patients and their family members.WHO indicators identify irrational prescribing behaviours to make therapy more rational and cost-effective.

DRUGDEX DRUG EVALUATIONS数据库介绍

DRUGDEX DRUG EVALUATIONS数据库主要收录基于实时证据,针对药品临床使用信息编撰而成的独立专论。本文简要介绍DRUGDEX数据库的数据开发流程、专论内容及组织结构、检索方法和获取途径等,目的是为医药专业人员提供一个药品评价信息的参考资源。

Clinical Observation and Safety Evaluation of Zhuang Medicine Xiaoyan Zhiyang Formula for Dermatosis

[Objectives]To observe the clinical efficacy and safety of Zhuang Medicine Xiaoyan Zhiyang Formula by retrospective analysis of clinical use.[Methods]A total of 225 cases were collected,including 117 males and 108 females,115 cases of contact dermatitis and 110 cases of acute eczema.Zhuang Medicine Xiaoyan Zhiyang Formula was administered to 225 patients with contact dermatitis and acute eczema and the clinical efficacy was evaluated.[Results]After one week of treatment,among 225 patients with contact dermatitis and acute eczema,76 cases were cured(33.78%),133 cases showed marked response(59.11%),16 cases(7.11%)were improved,0 case was ineffective,and the overall response rate was 92.89%.After one week of Zhuang Medicine Xiaoyan Zhiyang Formula treatment,the symptoms of itching,pain and swelling were significantly improved in all patients,and the rash was partially crusted without new symptom,and there were no complications and adverse reactions.[Conclusions]Zhuang Medicine Xiaoyan Zhiyang Formula therapy has a remarkable effect in the treatment of contact dermatitis and acute eczema.

Advances on biological evaluation methods of programmed cell death protein-1/ligand-1 inhibitors

Immuno-oncology represents a groundbreaking and well-established field within cancer treatment.Among the various immuno-oncology targets,the exploration of programmed cell death-1/ligand-1 for drug discovery has proven to be one of the most successful endeavors.Remarkably,it took nearly 30 years from the initial target identification to the clinical approval of monoclonal antibodies.Providing suitable and reliable bioassays for drug candidate evaluation is of paramount importance throughout the early stages of drug discovery,from lead compound identification to in vivo efficacy testing.This assay review aims to shed light on diverse assays reported in the literature for testing antagonism activity and efficacy of programmed cell death-1/ligand-1 inhibitors.Each of these assays possesses inherent advantages and can be applied in different research scenarios.The insights presented in this summary can serve as a valuable resource for scientists in this field,aiding in the selection of appropriate assays for their specific investigations.

<i>In Vitro</i>Evaluation of Anticancer Drugs with Kinetic and Static Alternating Cell Culture System

Variable bioreactors have been developed for the evaluation of anti-cancer drug efficacy. The Kinetic and Static Alternating Cell Culture System (KSACCS) combines the advantages of kinetic bioreactors and static cultures to improve cell growth by providing adequate metabolic support while minimizing shear-stress. In the current studies, the KSACCS in the ZYX Bioreactor could significantly increase the sensitivity of lung cancer cells (PLS008) and leukemia cells (HL60) to anticancer drugs Cisplatin and 5-FU by accelerating the apoptosis of cancer cells. It was also shown that excessive agitation of the cells could lead to severe cell damage, which resulted in a diminished sensitivity of anticancer drug evaluation, and co-culture systems tend to reduce the sensitivity of anticancer drug evaluation although it might better mimic in vivo conditions.

An Evaluation Synthesis of US AIDS Drug Assistance Program Policy

US Congress passed the CARE Act in 1990 in response to a dramatically growing need for resources to combat the AIDS epidemic. One of the programs contained in the Act was the AIDS Drug Assistance Program (ADAP), a federally-funded but state-maintained and managed program primarily concerned with providing medication for low-income HIV/AIDS patients. While ADAP programs across the country reached one-third of all patients in 2007, these programs are now in budgetary danger due to the economic recession, state budgetary constraints, the rising cost of healthcare generally, and longer life expectancies associated with current highly active antiretroviral therapy (HAART). This paper first evaluates the current state of ADAP, its strengths and weaknesses, and examines its sustainability in the short term if short-term measures are taken. Concluding that such measures would not lead to long-term sustainability, this paper then argues for a long-term solution to ADAP’s current problems, namely a national, centralized ADAP standard for budgetary and administrative matters. Such a program would increase the long-term sustainability and effectiveness of current ADAP programs by employing more efficient, standard policies and allowing larger, wholesale purchases of costly HAART medications. Moreover, a national policy would address the disparity that currently exists in ADAP programs today with regard to both minorities and those on the waiting lists for treatment. The institution of a national ADAP program would certainly face many political hurdles. Consequently, this paper also looks to a recent political dispute, the enactment of the Affordable Care Act (ACA), for guidance. Using the passage of the ACA as an example could light the path for passage of a national ADAP standard. Ultimately, this would lead to a more effective and sustainable program for HIV/AIDS patients in the United States.

The Problems of the Safety Evaluation of Biotechnology Derived Drugs

Recent years have witnessed rapid advances in the toxicologic assessment of biotechproducts.Safety assessment of a biotech product is a complex and multiple process.This includes a knowledge of its pharmaco-biological characteristics,and identifyingthe target patient population and the proposed clinical application. To make a decision on the safe human application(the products are administering tohumans for therapeutic purposes),besides the identity and purity of the final product,

A Few Specialized Issues That Should Be Focused on Anti-HIV Drug Evaluation In Vitro

Since the introduction of antiretroviral therapy (ART), the lifespan and quality of life of patients infected with HIV have been significantly improved. But treatment efficacy was compromised eventually by the development of resistance to antiretroviral drugs, and more new anti-HIV drugs with lower toxicity and higher activity were needed. Based on the experience and lessons learned from the treatment in the developed countries, US FDA suggested that more pharmacodynamical researches should be considered ahead of the clinical trials. To facilitate the anti-HIV drug research and development, we reviewed a few specialized issues that should be focused on drug evaluations in vitro, including: 1) Mechanism of action studies, demonstrating the candidate drug's efficacy to specifically inhibit viral replication or a virus-specific function and confirm the drug target. 2) Drug resistance studies, selecting the drug-resistant variants in vitro and determining the activities inhibiting HIV isolates resistant to approved antiretroviral drugs of the same class. 3) Antiviral activity in vitro in the presence of serum proteins, ascertaining whether an investigational product is significantly bound by serum proteins. 4) Combination activity analysis, evaluating in vitro antiviral activity of an investigational product in two-drug combinations with other drugs approved.

Evaluation and Risk Prevention and Control of Hepatic Injury by Traditional Drugs

My topic is the risk assessment of safety of Chinese materia medica.Next I will take drug-induced hepatic injury as an example.First of all,let us look back at what Chinese materia medica is.What are the real meanings of these 3 words? These 3 words Zi Hua Zi have been said more than BC 500."TCM practitioners are for treatment and medicines," what do you mean? Treatment means to find the cause of the disease and to find the law,while medicine is to find ways and means to cure diseases.

The Impact of Generic Drug Consistency Evaluation Policy on Pharmaceutical Enterprises

Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.

Requirements for Evaluation on Drug-medical Device

The administration of combination products in U.S.Food and Drug Administration(FDA)are analyzed and summarized in this paper.Furthermore,the technical evaluation on drug-medical device in the State Food and Drug Administration of China(SFDA)is also illustrated.Meanwhile,this paper discusses how to promote the development of drug-medical device in the administration and technical evaluation.

Evaluation of directly observed treatment short courses at a secondary health institution in Ibadan,Oyo State,Southwestern Nigeria

Objective:To evaluate the success rate of tuberculosis intervention programme at a specialist hospital in(?)badan,Nigeria through a retrospective study as well as carry out physicochemical evaluation of anti-tuberculous agents as a way of eliminating drug-related failure.Methods:The retrospective study involved the use of quarterly tuberculosis central register at the Government Chest Hospital,(?)badan between 1st quarter(2003)to 4th quarter(2009).Relevant data were extracted from these register with the aid of data collection forms.The basic physicochemical analyses of the drugs given to the patients were also carried out using the International Pharmacopoeia methods.Results:All the drugs examined for their physicochemical properties passed the International Pharmacopeia recommended tests.A total number of 1 260 patients enrolled at the hospital were assessed through case notes.This comprises of 59.4%males of which69.23%new cases were also males.There was a significant(P<0.05)patient enrollment across the quarters for the seven years.An overall 80.24%cure rate over the 7-period was obtained which is less than the WHO target of 85%.Cure rates were better in females than males.Failure treatment outcomes such as positive(1.51%),deaths(8.73%),defaulted(3.33%)and transferred out(5.95%)were recorded though not statistically significant(P>0.05).Failure rates in all categories were higher in males than females(P>0.05).Conclusions:More enlightenment and counseling is still required to meet up with the target for TB control.

Preparation and evaluation of tamsulosin hydrochloride sustained-release pellets modified by two-layered membrane techniques

The aim of the present study was to develop tamsulosin hydrochloride sustained-release pellets using two-layered membrane techniques.Centrifugal granulator and fluidizedbed coater were employed to prepare drug-loaded pellets and to employ two-layered membrane coating respectively.The prepared pellets were evaluated for physicochemical characterization,subjected to differential scanning calorimetry(DSC)and in vitro release of different pH.Different release models and scanning electron microscopy(SEM)were utilized to analyze the release mechanism of Harnual■ and home-made pellets.By comparing the dissolution profiles,the ratio and coating weight gain of Eudragit■ NE30D and Eudragit■ L30D55 which constitute the inside membrane were identified as 18:1 and 10%-11%.The coating amount of outside membrane containing Eudragit■ L30D55 was determined to be 0.8%.The similarity factors(f_(2))of home-made capsule and commercially available product(Harnual■)were above 50 in different dissolution media.DSC studies confirmed that drug and excipients had good compatibility and SEM photographs showed the similarities and differences of coating surface between Harnual■ and self-made pellets before and after dissolution.According to Ritger-Peppas model,the two dosage form had different release mechanism.

EVALUATION OF EFFICACY AND SAFETY OF DIACEREIN IN KNEE OSTEOARTHRITIS IN CHINESE PATIENTS

Objective To evaluate the efficacy and safety of diacerein in patients with knee osteoarthritis (OA). Methods A total of 223 patients satisfying the American College of Rheumatology criteria for knee OA were chosen for this 17-week, randomized, double-dummy, diclofenac sodium-controlled trial, with diacerein dosage of 100 mg/d and diclofenac sodium of 75mg/d. Efficacy and safety of both drugs were evaluated. Results Totally 106 patients in the diacerein group and 107 patients in the diclofenac group were considered qualified for the evaluation. After 12 weeks of treatment, the total effective rates of patients/physicians’ overall assessment in diacerein and diclofenac groups were 65.4%/61.6% and 61.2%/61.2%, respectively (P>0.05). The primary efficacy parameter [visual analog scale (VAS) assessment of pain on 20 metres walking] and the secondary efficacy parameters [tenderness on palpation, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and 36-item Short-Form (SF-36) Health Survey] significantly improved compared with baseline in both groups (P<0.05). In the follow-up period, there were no obvious changes in above parameters in diacerein group. However, in diclofenac group, pain on 20 metres walking, tenderness on palpation, and WOMAC became aggravated after withdrawing the drug for 4 weeks (P<0.05). Moreover, the consumption of paracetamol was significantly lower in diacerein group than in diclofenac group during follow-up (P<0.001). The incidences of related adverse events were 35.7% in diacerein and 45.1% in diclofenac group, respectively. Mild-to-moderate gastrointestinal disorders were the most frequent adverse events. Conclusions Diacerein is as effective as diclofenac sodium in treating patients with knee OA. Furthermore, it has better extended effect and a good safety profile. It is generally well tolerated and has no severe adverse effect.

Quantitative characterization of cell physiological state based on dynamical cell mechanics for drug efficacy indication

Cell mechanics is essential to cell development and function,and its dynamics evolution reflects the physiological state of cells.Here,we investigate the dynamical mechanical properties of single cells under various drug conditions,and present two mathematical approaches to quantitatively characterizing the cell physiological state.It is demonstrated that the cellular mechanical properties upon the drug action increase over time and tend to saturate,and can be mathematically characterized by a linear timeinvariant dynamical model.It is shown that the transition matrices of dynamical cell systems significantly improve the classification accuracies of the cells under different drug actions.Furthermore,it is revealed that there exists a positive linear correlation between the cytoskeleton density and the cellular mechanical properties,and the physiological state of a cell in terms of its cytoskeleton density can be predicted from its mechanical properties by a linear regression model.This study builds a relationship between the cellular mechanical properties and the cellular physiological state,adding information for evaluating drug efficacy.

Multi-factor combined biomarker screening strategy to rapidly diagnose Alzheimer's disease and evaluate drug effect based on a rat model

Alzheimer's disease(AD)represents the main form of dementia;however,valid diagnosis and treatment measures are lacking.The discovery of valuable biomarkers through omics technologies can help solve this problem.For this reason,metabolomic analysis using ultra-performance liquid chromatography coupled with quadrupole time-of-flight tandem mass spectrometry(UPLC-Q-TOF-MS)was carried out on plasma,hippocampus,and cortex samples of an AD rat model.Based on the metabolomic data,we report a multi-factor combined biomarker screening strategy to rapidly and accurately identify potential biomarkers.Compared with the usual procedure,our strategy can identify fewer biomarkers with higher diagnostic specificity and sensitivity.In addition to diagnosis,the potential biomarkers identified using our strategy were also beneficial for drug evaluation.Multi-factor combined biomarker screening strategy was used to identify differential metabolites from a rat model of amyloid beta peptide 1e40(Aβ_(1-40))plus ibotenic acid-induced AD(compared with the controls)for the first time;lysophosphatidylcholine(LysoPC)and intermediates of sphingolipid metabolism were screened as potential biomarkers.Subsequently,the effects of donepezil and pine nut were successfully reflected by regulating the levels of the abovementioned biomarkers and metabolic profile distribution in partial least squaresdiscriminant analysis(PLS-DA).This novel biomarker screening strategy can be used to analyze other metabolomic data to simultaneously enable disease diagnosis and drug evaluation.

Factor Analytical Examination of the Evidence-Based Practice Beliefs Scale: Indications of a Two-Factor Structure

Background: Promotion of Evidence-Based Practice (EBP) in nursing appears to be developing slowly. Research indicates that nurses’ beliefs in EBP may play an even more significant role than knowledge and resources in making implementation feasible. To address this issue, measurement of nurses’ beliefs regarding EBP is paramount. Aims and objectives: This study explores the internal consistency reliability and the construct factor structure of the Norwegian version of the original Evidence-Based Practice Beliefs Scale (EBP-BS). Methods: The study has a Non-experimental exploratory survey design. A Norwegian translation of the EBP-BS was tested in a convenience sample of 118 healthcare professionals (95% nurses) attending a continuing education program at a University College in Norway. The response rate was 95% (n = 112). The internal consistency of the scale was measured by Cronbach’s alpha, and an explorative Principal Component Analysis (PCA) was used to explore the construct structure. Results: The overall internal consistency of the EBP-BS was acceptable. The PCA indicated a four-factor structure. The psychometric properties of two of the factors were too weak for expanding to a four-factor model. Based on our investigation of the EBP-BS, we suggest a two-factor structure model. The factors were named 1) General knowledge and confidence concerning EBP and 2) Task specific beliefs in EBP. This finding differs from previous results that indicated a unidimensional structure. Conclusion: As a starting point, reliable and valid measurement of nurses’ beliefs about EBP is required in order to identify possible obstacles and to optimize implementation in the individual clinical setting. Our results indicate that the EBP-BS has a two-factor structure. Further exploration of the factor structure is needed. Further empirical research may contribute to the resolving of controversies concerning basic understandings of the concept of EBP.

Effect evaluation of artemisia desertorum spreng on ability of daily life after extraction of impacted tooth

AIM:To investigate the effect of locally used Shahaosan on preventing the complication of extraction of impacted tooth.METHODS:274 cases patients with extraction of impacted teeth were randomly devided into 3 groups named A,B and C.Shahaosan and Yunnan white drug were processed into drug A and B by department of pharmacy with the same color, shape and quality which are blind to doctors and patients.When the impacted teeth were extracted, administed group A(92 cases) with drug A,group B(86 cases) with drug B and group C(96 cases ) was a blank control. After the operation,incidence and severe intensity of dry socket in each group were observed and evaluated by scores.RESULTS:The incidence of dry socket in group A,B and C were 0.09%(1/92),2.32%(2/86),8.33%(8/96).There was no significant difference between group A and B, group B and C, while a significant difference showed between group A and C.The PoSSe score in group A, B and C was 19.36,27.80 and 22.83 respectively.Afer the experiment the department of pharmacy informed that drug A is Shahaosan and drug B is Yunnan white drug.CONCLUSTON:Compiments of dry socket induced by extracting of lower jaw impacted teeth can be prevented by locally administered with Shahaosan, but no significant effect of alleviating the symptom of dental extraction.

基于OBE理念的药物临床试验课程教学改革研究

首都医科大学将成果导向型教学(OBE)理念引入药物临床试验课程教学改革中。教师针对课程教学内容更新速度快、教学方式传统陈旧、考评模式较为单一等普遍存在的问题,以学生为中心组织和引导教学过程,优化教学大纲、改善教学方法、提升自身教学能力、完善学生评价体系,有效提升了教学产出和学生的创新性学习能力,可为相关课程教学改革提供借鉴。