Analysis and Discussion on the Ethical Pre-review Model of Clinical Trials under the Pharmaceutical Innovation Strategy / 中国医学伦理学

With the implementation of the national biomedical innovation strategy, new requirements for ethical review of clinical trials have been put forward, and more attention has been paid to the ethical pre-review. Based on the current situation of clinical trials and ethical review of new drugs in China, this paper discussed the concept, advantages and necessity of ethical pre-review, sorted out the problems and challenges in the implementation of ethical pre-review at this stage, and put forward the following suggestions on how to better implement ethical pre-review in clinical trials under the pharmaceutical innovation strategy: the complete definition of "ethical pre-review" should be made clearly; ethical review should be carried out on the basis of necessary reference; the scope of application of ethical pre-review should be clarified; after the ethical pre-review, the statement of the approval document should be standardized and accurate.

Optimization and practice in pre-review rules of traditional Chinese medicine prescription in medical institutions / 中国药房

OBJECTIVE To improve the a pplicability of the prescription pre-review system to traditional Chinese medicine （TCM），and improve the quality of prescription review and rational drug use. METHODS The inappropriate pre-review rules of TCM prescription in prescription automatic screening system of our hospital were summarizd ，review rules were revised and the review process was standardized purposefully. The data of prescription review of Chinese patent medicine and TCM decoction pieces were collected from outpatient and emergency department of our hospital in the second quarter of 2020 （before the optimization of review rules ）and the fourth quarter of 2021（after the optimization of review rules ）. The reasonable rate of prescription and effective rate of intervention before and after the optimization of review rules were compared，and unreasonable problems were counted. RESULTS In our hospital ，the pre-review system had poor applicability in reviewing TCM prescriptions. There were some problems ，such as inconsistent or nonstandard names of TCM decoction pieces ，unreasonable dosage range settings，mechanical review of repeated drug use ，excessively strict review of “eighteen incompatible medicaments ”and“nineteen medicaments of mutual restraint ”and lack of safety warnings for special populations. In view of the above problems ，our hospital standardized the name of TCM decoction pieces ，and optimized the review rules such as dose range of TCM decoction pieces ， usage and dosage of Chinese patent medicine ，repeated medication ，drug interaction ，drug taboos for special people ，etc. After the revision of the rules ，the qualification rate of Chinese patent medicine prescriptions increased from 97.38％ to 98.17％（P＞0.05）， and the rate of effective intervention increased from 42.86％ to 79.71％（P＜0.05）；the qualification rate of TCM decoction pieces prescriptions increased from 47.98％ to 79.29％（P＜0.05），and the rate of effective intervention increased from 11.17％ to 29.13％（P＜0.05）. The number of unreasonable problems such as excessive daily dosage of TCM ，excessive dosage range ，drug interaction and drug contraindications for special groups decreased significantly in our hospital （P＜0.05）. There was no statistical significance in the number of unreasonable problems of repeated medication between 2 groups （P＞0.05），but there was a downward trend. T he total number of unreasonable problems had also decreased significantly （P＜0.05）. CONCLUSIONS The optimization measures of review rules in our hospital canimprove the applicability of the review system for TCM prescriptions，and improve the quality of prescription review and the level of rational drug use. However ，review rules of indications and the effectiveness of prescription intervention still needs to be further improved.

Discussion on the Optimization of Pre-review Rules for PASS System in Our Hospital ：Taking Cal cineurin Inhibitor as an Example / 中国药房

OBJECTIVE：To provide r eference for optimizing the review rules of PASS system and improving rational drug use in our hospital. METHODS ：The prescription review of Calcineurin inhibitor （CNI）was taken as an example. The pharmacists of our hospital collected the inappropriate rules in PASS system in their daily work ，and modified and improved them. Three thousands outpatient prescriptions and inpatient orders containing CNI in the fourth quarter of 2019（before the rule modification ） and the fourth quarter of 2020（after the rule modification ）were randomly selected for our hospital. The warnings ，false positives and false negatives of PASS system review were compared before and after rule modification. RESULTS ：There were some problems in the PASS system of our hospital ，such as too strict judgement on off-label use ，lax review rules ，false positive in the audit of contraindications ，failure to grade warnings according to the severity of drug interactions ，inaccurate judgment of patients ’ liver and kidney function ，lengthy problem description ，incomplete or wrong information in the system database ，lack of effects information of food and traditional Chinese medicine on CNI ，etc. In view of these inappropriate rules ，the pharmacy department of our hospital improved the quality of PASS system review rules through formulating the standardized management process of off-label use ， reasonably enabling the interception function of PASS system ， modifying the false-positive rules of drug contraindications，warning drug interaction by grade ，reviewing in combination with laboratory test reports ，and real-time maintenance of system database information and adding patient education content. The number of warning had decreased from 182 to 105，and the proportion of false-negative and false-positive review results from 25.03％ to 0.43％ after a year of optimization. CONCLUSIONS：The optimization of CNI review rules can enhance the applicability of the PASS system ，facilitate the advance of the prescription pre-review ，and promote clinical rational drug use.

Practice of Promoting Rational Use of Antibiotics in Outpatient Department by Special Prescription Pre-review / 中国药房

OBJECTIVE：To provide reference for the participation of clinical pharm acists in outpatient antibiotics management so as to promote the rational use of antibiotics in outpatient department. METHODS ：The pharmacist reset medication rules ， classified irrational medication levels ，formulated warning contents ，and established a diagnosis database of mild to moderate non- complex infections ，according to the problems found in the post review of outpatient antibiotics prescription through sorting out the previous rules of antibiotics use in the Yiyao Rational Drug Use Management Software （called“review software ”for short ）in our hospital. The special pre-review was performed by using combination of system review and manual review. Pharmacists used the review saftware to count the data of outpatient antibiotics prescriptions before （the first quarter of 2020）and after （the second ， third and fourth quarters of 2020）the implementation of special pre-review. The post review for antibiotics prescriptions in Dec. 2019（before the implementation of special pre-review ）and Dec. 2020（after implementation of special pre-review ）were performed by pharmacists to evaluate the impact of the implementation of special pre-review on promoting rational use of outpatient antibitics. RESULTS：Comared with before the implementation of special pre-review in the first quarter of 2020，the prompt rate of the review software for antibiotics prescriptions was decreased ，and the interception rate was increased after the implementation of special pre-review in the second quarter of 2020（P＜0.05）. Compared with before the implementation of special pre-review in Dec. 2019，the proportion of outpatient antibiotics prescriptions in all outpatient prescriptions ，the ratio of bi-antibiotics prescriptions in all antibiotics prescriptions in the same month ，the ratio of prescriptions with unsuitable indications in all antibiotics prescriptions in the same month were all decreased E-mail：phdloveyou@163.com significantly （P＜0.01）， while the ratio of prescriptions with rational antibiotics use in all antibiotics prescriptions in the same month was increased significantly （P＜0.01）. CONCLUSIONS：Pharmacists establishing a rule for rational use of antibiotics in outpatient department b ased o n the hospital ’s situation，implementing a special pre-review for antibiotics prescriptions with the help of review software ，can promote the rational use of antibiotics in outpatient department.

Ethics preparedness: facilitating ethics review during outbreaks - recommendations from an expert panel.

BACKGROUND: Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research "ethics preparedness" constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. MAIN TEXT: A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. CONCLUSION: It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks.

Fine Setting of the Use Rules for Proton Pump Inhibitors in Outpatient Prescription Pre-review of Our Hospital / 中国药房

OBJECTIVE： To improve the proper use of proton pump inhibitors （PPIs） and develop prescription pre-review. METHODS： Among “Hospital Self-Maintenance Rule Base” of “Rational use of drug” in our hospital， according to the application of PPIs in our hospital， the dosage of PPIs under different indications， drug combination， age range and taboo level for children were refined to promote the prescription pre-review. After refinement， the qualified rate of PPIs prescription post-evaluation among outpatient prescriptions， successful rate of pharmacist intervention during pre-prescription review and unqualified prescription rate of each item for 8 PPIs （including “interaction” “clinical diagnosis does not conform to medication” “repeated administration” “inappropriate usage”） were analyzed statistically from Jan. to Aug. 2018. The effects of fined setting were evaluated. RESULTS： From Jan. 2018 to Aug. 2018， the qualified rate of PPIs prescription post-evaluation gradually increased from 81.94％ to 95.10％； successful rate of pharmacist intervention during pre-prescription review increased from 32.75％ to 91.01％； the rate of unqualified prescriptions for 4 items decreased significantly month by month. CONCLUSIONS： The fine setting of the rules for the use of proton pump inhibitors in our hospital has effectively carried out the pre-examination of outpatient prescriptions and promoted the rational use of PPIs.