Dilemma and promotion strategy of “dual channel”management policy for China’s medical insurance negotiated drugs / 中国药房

OBJECTIVE To provide reference for the smooth implementation of the “dual channel” management policy for China’s medical insurance negotiated drugs. METHODS Based on Smith policy implementation process model， the dilemmas for the implementation of “dual channel” policy for medical insurance negotiated drugs were analyzed from four aspects： implementation details and regulatory system， drug selection， drug provision and quality control， the situation of medical insurance funds and information technology capabilities. The corresponding promotion strategies were put forward. RESULTS & CONCLUSIONS The “dual channel” policy for medical insurance negotiated drugs in China might face implementation difficulties such as a lack of clear implementation rules and a full process supervision system， the suitability and operability of some medical insurance negotiated drugs need to be considered in the “dual channel” management， difficulties in drug allocation and quality control， differences in the management and operation of medical insurance funds in different regions， and insufficient informatization capability. In this regard， this study suggests that measures， such as improving the implementation rules of the “dual channel” policy， enhancing the rationality of the “dual channel” drug catalog， establishing a dynamic exit mechanism for “dual channel” pharmacies， promoting professional delivery services， and improving the electronic prescription circulation platform， which can be taken to enhance the implementation effect of the “dual channel” policy.

Introduction and enlightenment of foreign remote inspection mode of pharmaceutical production / 中国药房

OBJECTIVE To provide reference for the construction of remote inspection mode of pharmaceutical production in China. METHODS By combing the guidance documents of remote inspection and related pilots issued abroad， the experience of constructing remote inspection mode of pharmaceutical production was summarized. RESULTS & CONCLUSIONS Typical foreign countries and regions have carried out remote inspection pilots all over the world， and clearly defined the application situation， implementation process， inspection techniques and related points for attention of remote inspection of pharmaceutical production. In terms of application， the European Union pointed out four specific applicable situations， including travel restrictions， while the United States stipulated that remote inspection was applicable to pre-approved inspection and so on. In terms of the implementation process， the United States developed a four-step method of remote inspection， while the European Union has defined the specific implementation process of remote inspection in more detail. In comparison， Japan paid more attention to the remote inspection process of production documents. In terms of inspection techniques， the European Union used 360° cameras， Matterport 3D technology and document review software to realize the remote inspection of production sites and production documents. In terms of attention points for remote inspection， the United States required that access rights should be set for information sharing to avoid information disclosure. Both the European Union and the United States required inspectors to be trained and equipment inspected before remote inspection. It is suggested that China should formulate unified guidelines for remote inspection of pharmaceutical production， clarify the applicable situations， and formulate the implementation process of remote inspection of pharmaceutical production with reference to the opinions of drug manufacturers. In addition， intelligent remote inspection technology can be used in combination with the information construction level of drug manufacturers， and remote inspection training program can be formulated to cultivate professional remote inspection team.

Discussion of the process of conducting an investigator-initiated research / 中国胸心血管外科临床杂志

@#The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.

Cross-cultural adaptation of the NoMAD questionnaire to Brazilian Portuguese

SUMMARY BACKGROUND: The Normalization Measure Development (NoMAD) tool is used to determine the contextual determinants in the process of implementing complex health interventions. The aim of this study is to translate and culturally adapt NoMAD to Brazilian Portuguese. METHODS: The cross-cultural adaptation was performed in five steps: 1) translation of the questionnaire into Portuguese; 2) synthesis and creation of the first version; 3) back-translation of the instrument into the source language; 4) review of the instrument by a group of experts and target professionals; and 5) pretesting. A final version of the questionnaire was answered by users of a clinical monitoring system in specialist care services for people living with HIV/AIDS, and the internal consistency of the questionnaire was assessed using Cronbach's alpha. RESULTS: The questionnaire was answered by 188 health professionals, of which 87.7% were female, and the average age was 45.2 years. For the final version of the questionnaire, Cronbach's alpha was over 0.70 for the construct's coherence (0.74), collective action (0.70), cognitive participation (0.71), and reflexive monitoring (0.81). CONCLUSION: The NoMAD questionnaire was cross-culturally adapted and can be used to evaluate the implementation of complex health care interventions.

RESUMO INTRODUÇÃO: O questionário Normalisation Measure Development (NoMAD) tool busca identificar os fatores contextuais determinantes no processo de implementação de intervenções complexas em saúde. Este artigo tem por objetivo traduzir e adaptar culturalmente o NoMAD para o português do Brasil. MÉTODOS: A adaptação transcultural foi realizada em cinco etapas: 1-Tradução do questionário para o português; 2-Síntese e criação da primeira versão; 3-Retro-tradução do instrumento para a língua de origem; 4-Revisão por grupo de especialista e profissionais-alvo do instrumento; e 5-Pré-teste. A versão final do questionário foi respondida por usuários do sistema de monitoramento clínico em serviços de assistência especializada às pessoas vivendo com HIV/AIDS e sua consistência interna foi avaliada por meio de alpha de Cronbach. RESULTADOS: O questionário foi respondido por 188 profissionais, 87,7% eram do sexo feminino e média de idade de 45,2 anos. A versão final do questionário apresentou α de Cronbach superiores a 0.70 nos construtos coerência (0.74), ação coletiva (0.70), participação cognitiva (0,71) e monitoramento reflexivo (0.81). CONCLUSÃO: O questionário NoMAD foi adaptado transculturalmente e pode ser utilizado para avaliar a implementação de intervenções complexas no cuidado em saúde.

Implementation of the hierarchical medical system :an analysis based on the Smith policy implementation process model / 中华医院管理杂志

Objective To analyze the problems existing in the implementation of the hierarchical medical system in China under the new situation .Methods The Smith policy implementation process model was used as an analytic framework.By means of literature analysis ,stakeholder analysis and PEST analysis ,the analysis was conducted in terms of such elements as the Smith policy implementation process model ,namely ,the idealized policy ,the implementing organization ,the target group and the environmental factors ,as well as its mechanism of action .Results The literature review found that the main obstacle that hinders the smooth implementation of the hierarchical medical system was the lagging of relevant supporting measures ,which accounted for 16.6％ (161)of the problems.In addition ,defects in policy design(the lack of division and cooperation mechanism etc .)and constraints in existing institutional mechanism (separation of revenue and expenditure ,unclear orientation ,etc .) were suggested to accelerate the introduction of supporting policies ,respectively accounting for 6.0％(58) and 9.3％ (90 ) of the results .Conclusions In the process of policy implementation ,the relationship between the four elements of the ideal policy outcomes ,the implementing organization ,the target group and the environmental factors needs to be coordinated to ensure the effective implementation of the hierarchical medical system .

Implementation,Existing Problems and Reform Strategy for Licensed Pharmacist System in China / 中国药房

OBJECTIVE:To provide reference for breaking the“dual-track”system of the pharmacist and perfecting pharmacist system in China. METHODS:By reviewing laws and regulations relating to the pharmacist in recent 21 years,the implementation and problems of pharmacist system was investigated. RESULTS & CONCLUSIONS:The imperfection and dissonance of pharma-cist management regulations and laws system result in long-term“dual-track”system of pharmacist authentication. There still are other problems such as low rate of pharmacist registration and unbalanced regional distribution;unbalance between national li-censed pharmacist examination and examination condition of health systems pharmacist;divergence and mismatching between phar-macy education pharmacist training;social value of pharmacists cannot be reflected adequately. It is suggested to formulate Regula-tions on the Licensed Pharmacists as soon as possible,establish uniform and standard qualification and title appraisal system for na-tional pharmaceutical professional and technical personnel,promote licensed pharmacist classification registration and examination system reform,strengthen pharmacy education and licensed pharmacist training system reform,guide licensed pharmacist allocation rationally and orderly by various measures and enhance the propaganda of licensed pharmacist and their work,so as to promote the mergence of national licensed pharmacists qualification system and health professional technical pharmacist competence system.

Analysis of Implementation and Effect of Accounting Simulation Experiment / 中华医学教育探索杂志

The content of accounting is so abstract that the teaching result is poor in many universities.The author tried to make the simulation experiment in the after-activities to raise teaching result,and then analyzed its effect by questionnaire.