Study on Problems and Countermeasures in the Management of Spot Check of Chinese Herbal Pieces

Cui Yihang,Chen Binbin,Sun Lihua

(1.School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;2.Beijing Medical and Health Economic Research Association,Beijing 100020,China)

Abstract Objective To provide suggestions for optimizing the sampling management of Chinese herbal pieces and improving the quality Chinese herbal pieces.Methods Logical reasoning method was used to analyze the problems in the drug spot check of Chinese herbal pieces based on the data of drug quality published by the National Medical Products Administration from 2013 to 2021,combined with the current provisions and implementation of drug spot check management in China.Results and Conclusion At present,there are some problems in the drug spot check of Chinese herbal pieces,such as fewer varieties of Chinese herbal pieces in the national drug spot check,the unreasonable sampling links,the insufficient territorial management in some areas,and error-prone sample extraction.It is suggested that the actual quantity and overall quality of Chinese herbal pieces should be fully considered in the formulation of sampling plan.Besides,the variety coverage of drug spot check of traditional Chinese medicine should be strengthened.In the planning,the sampling links shall be made as a whole,and the credit rating and distribution of drug production,operation and use units within the jurisdiction shall be fully combined.While strengthening the sampling management at the production end in areas with concentrated industries,regional special drug spot check should be carried out or the administrative forces at the provincial,municipal and county levels should be fully mobilized to avoid local protection.In the assigned tasks,the name of Chinese herbal pieces should be accurately expressed to avoid the sampling errors of Chinese herbal pieces with the same original medicinal materials and different processing methods.

Keywords: Chinese herbal pieces;drug spot check;evaluation spot check;supervision spot check

1 Introduction

On October 20,2019,the “Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance,Innovation and Development of Chinese herbal pieces” was officially released,which clearly put forward the goal of promoting the quality improvement of Chinese herbal pieces and strengthening the safety supervision of Chinese herbal pieces.Chinese herbal pieces refer to prescription drugs that can be directly used in TCM clinical or preparation production after processing[1].In the process of promoting the development of Chinese herbal pieces,the quality control of Chinese herbal pieces is vital.

The industry of Chinese herbal pieces has the characteristics of agricultural production of original medicinal materials,non-uniform processing standards,and incomplete management of approval number.As a technical means of post marketing supervision,spot check plays an important role in the quality management of Chinese herbal pieces.From 2013 to 2020,the qualif ied rate of drug spot check of Chinese herbal medicines and herbal pieces increased from 64% to 96%[2],but there was still a certain gap with the overall qualif ied rate of national sampling of 99.42% in 2020[3].This paper used the drug quality announcement issued by the State Drug Administration to summarize the detection links,institutions,regions and other information of unqualif ied prepared pieces of Chinese herbal pieces.Combined with the “Annual Report of National Drug Spot Check” from 2016 to 2020[3-7]（Hereinafter referred to as the “Annual Report”）and the administrative measures for drug spot check of drug quality[8],the drug spot check management modes and measures were analyzed.In addition,the method of logical reasoning was used to explore the problems and countermeasures in the drug spot check of Chinese herbal pieces,so as to better ensure the safety of public medication.

2 Management mode of drug spot check in China

Spot check of drug quality refers to the inspection of the quality of drugs produced,sold and used by the drug regulatory departments at the State Council,provincial,municipal and county levels according to law[8].Under the current management mode,drug spot check in China can be divided into supervision sampling and evaluation sampling according to the purpose of supervision.Supervision sampling refers to the spot check of drugs with suspicious quality by the drug supervision and administration department according to the needs.Evaluation sampling which is also called national drug spot check,refers to the spot check carried out by the drug supervision and administration department to evaluate the quality of drugs in a certain category or region.The two have different purposes and emphases.The workf iow of drug spot check is shown in Fig.1.

Fig.1 Workflow of drug spot check

3 Problems and causes of drug spot check of Chinese herbal pieces in China

At this stage,the disclosure of drug spot check information mainly involves “Drug Quality Announcement” “Annual Report of National drug spot check”,and news release of major drugs.In this study,a total of 14 940 unqualified Chinese herbal pieces were collected from the announcement of drug spot check issued by the National Medical Products Administration from 2013 to 2021.The information was up to the announcement issued on January 10,2022[9].Based on the data and the comparative analysis of the sampling management of Chinese herbal pieces in the literature and annual report,the following problems in the drug spot check of Chinese herbal pieces were found.

3.1 Few varieties of Chinese herbal pieces sampled by the government

According to the data in the “Annual Report”[3-7],a total of 7 varieties of Chinese herbal pieces were selected through national drug spot check in 2019 and 8 varieties were selected in 2020.However,there were a total of 616 varieties of Chinese herbal pieces in the market according to the“Chinese Pharmacopoeia (2020 edition)”.In terms of national standards,the coverage rate of national drug spot check of prepared Chinese herbal pieces was lower than that of other kinds of drugs,as shown in Table 1.Meanwhile,as the prepared Chinese herbal pieces were Chinese traditional drugs,there were local standards before the establishment of national standards.By 2020,there were about 3 500 local varieties of prepared Chinese herbal pieces[10],which far exceeded the number recorded in the“Chinese Pharmacopoeia (2020 edition)”.Therefore,the variety coverage of drug spot check of prepared Chinese herbal pieces was very small.

Table 1 Number of different varieties of national drug spot check

Sorting out the data of “Annual Report”,we can get the national sampling results in recent three years.Although the unqualified rate of Chinese herbal pieces has decreased year by year,as shown in Table 2,Chinese herbal pieces have the highest unqualified rate in the drug spot check in recent five years.Therefore,Chinese herbal pieces have more quality problems than other drugs.If we want to comprehensively evaluate the quality of Chinese herbal pieces,we should expand the coverage of sampling varieties of Chinese herbal pieces.

Table 2 Unqualified rate of different varieties of national drug spot check

3.2 Unreasonable allocation of national sampling links of Chinese herbal pieces

From the perspective of the flow direction of drugs after listing,retail pharmacies and medical institutions are the last link from the manufacturer to the consumers through the circulation link,which gather all the risks affecting the quality in the production process and circulation process.In terms of the distribution links of unqualified Chinese herbal pieces,they were in production,operation and use.Except 2018 and 2020,the unqualified Chinese herbal pieces in different links were production link

Table 3 Number of batches detected in different links of unqualified Chinese herbal pieces

According to the annual report of national drug spot check,the national drug spot check focused more on the production link from 2018 to 2020.The number of inspection batches in the use link in 2020 only accounted for 12.43% of the total number,as shown in Table 4.The purpose of national drug spot check was to comprehensively evaluate the quality of drugs.If the drug spot check of more business links and use links of unqualified Chinese herbal pieces is weak,it is unable to achieve the goal of promoting the overall quality of Chinese herbal pieces.

Table 4 Number of batches in different links of national spot check of Chinese herbal pieces

The statistical results show that a large number of unqualified pieces exist in the use end and retail end in China.However,in the process of drug spot check,the general inventory of medical institutions is small,and even some varieties are in shortage,the actual sampling amount is small[11].

In terms of system,the current “Administrative Measures for Drug Spot Check” do not involve the provisions on sampling links and specific sampled units.In the “Principles and Procedures for Drug Spot Check”[12],it is proposed that the sampling personnel should carefully study the background information,make a basic judgment on the sampling requirements,and negotiate with the inspection agency on the sampling link,sampling quantity and other specific issues when necessary.It means that the distribution of sampling phase and sampling batch in each company is regarded as the work of sampling personnel.Therefore,the main reason for the unreasonable distribution of sampling links is that the system does not stipulate a good plan for the sampled units at the planning level.

3.3 Insufficient local drug spot check in some areas

At present,more unqualified Chinese herbal pieces appear in the management and use end in China.However,according to the remarks in the announcement of unqualified drugs,in the data of 2020 and 2021,11.31% and 17.37% of unqualified Chinese herbal pieces were caused by non-production end respectively.It means that most of the unqualified herbal pieces were caused by production end.From the perspective of preventing the unqualified pieces into the market,the drug spot check at the production end should be strengthened in the areas with more unqualified pieces.Article 11 of the “Measures for the Administration of Drug Spot Check of Drug Quality”[9]proposes that the drug supervision and administration department may take the drugs produced within its administrative region as the focus when formulating the plan for drug spot check of drug quality.This regulation aims to detect and control unqualified products from the near production end and reduce the cross provincial circulation of unqualified products.For areas where production enterprises are concentrated,this provision should be emphasized in the formulation of drug spot check plan and implementation plan.

After removing the entries in the data base of the unqualified Chinese herbal pieces that were not marked with the place of production and nonproduction end,we selected the data of 2020 and 2021 after the implementation of the measures,and took the detection rate of unqualified Chinese herbal pieces in the province as the index to test the drug spot check strength of each province (Detection rate in this province=the number of unqualified herbal pieces produced in this province/ the total amount of unqualified pieces produced in a province).The results were shown in Table 5.It can be seen that the detection rate of unqualified Chinese herbal pieces in Anhui and Hebei is much lower than that in other provinces,and they have more decoction pieces production enterprises.Further analysis of the production cities of unqualified Chinese herbal pieces showed that 92.19%of the unqualified Chinese herbal pieces in Anhui were produced in Bozhou city,87.80% of the unqualified Chinese herbal pieces in Hebei were from Anguo city.While the detection rate of unqualified Chinese herbal pieces produced in Bozhou was only 1.74%,and the detection rate of unqualified herbal pieces produced in Anguo was only 6.5%.According to the statistics of the information of herbal pieces production enterprises in the database of the National Medical Products Administration,86.16% of Anhui Chinese herbal pieces production enterprises are located in Bozhou city,and 73.61% of Hebei Chinese herbal pieces production enterprises are concentrated in Anguo city.It can be seen that in areas with concentrated industries,such as Bozhou in Anhui Province and Anguo in Hebei Province,the sampling strength is insufficient.

Table 5 Unqualified Chinese herbal pieces in various provinces in 2020 and 2021

For the low detection rate of unqualified Chinese herbal pieces in some areas,the reason is related to the regional industrial characteristics.At present,there is no national unified quality standard covering all varieties of Chinese herbal pieces.So different provinces have different quality standards for Chinese herbal pieces produced and circulated within their administrative regions.However,when these Chinese herbal pieces circulate across provinces,they will encounter different quality judgment standards in other provinces.For example,the vast majority of Chinese herbal pieces in Shanghai are supplied to the local market,and only a small amount is supplied to Zhejiang,Jiangsu or exported to other countries[13].Similarly,Chinese herbal pieces manufacturers in Beijing mainly supply products to medical institutions in Beijing[14].The cross provincial mobility of Chinese herbal pieces produced in Anhui,Hebei and other provinces is high.If the quality standard of local decoction pieces is high,the unqualified sampling rate will increase.Therefore,under the current management,there is a lack of control measures for areas with concentrated quality problems.It is easy to breed local protection or the risk of insufficient supervision in these areas.

3.4 Prone to make mistakes in sampling Chinese herbal pieces

In the sampling,there are often mistakes in the selection of Chinese herbal pieces decoction pieces.In the national drug spot check from 2017 to 2019,more than 100 batches of varieties were sampled wrong in each year[15],accounting for more than 20% of the total number of samples returned.For example,in the sampling task,the variety name is Cistanche deserticola,but the actual samples include different varieties such as Cistanche deserticola powder,Cistanche deserticola,and Cistanche deserticola of Zhejiang.In the normative guidance documentimplementation plan of national drug spot checkdrug spot check[16],it is stipulated that the writing method of sampling Chinese herbal pieces is their names (specification of decoction pieces).The sampling name of Chinese herbal pieces does not indicate its processing method,which leads to the limited understanding of sampling tasks by sampling personnel,resulting in sampling errors in actual work.

4 Countermeasures and suggestions

4.1 Strengthening the coverage of national drug spot check of Chinese herbal pieces

The “Guiding Opinions on Implementing the Reform of Urban Medical And Health System” issued by the State Drug Administration in 2000 stipulates that the drug spot check should focus on drugs,Chinese medicinal materials and Chinese herbal pieces in rural areas,medical units and areas with chaotic circulation[17].According to the current situation,the prepared pieces of Chinese herbal pieces are still the drugs with high unqualified rate in the drug spot check.For the national drug spot check,one of its purposes is to understand the overall quality of drugs through inspection.It is suggested that the national drug spot check expand the variety coverage of Chinese herbal pieces,so as to comprehensively evaluate their qualities.It can also achieve the effect of promoting the overall quality of Chinese herbal pieces.

4.2 Planning the links of spot check reasonably

In view of the unreasonable link distribution of national drug spot check under the existing arrangements,it is suggested the units to be sampled should be included in the scope of plan formulation.For the national drug spot check,in order to evaluate the domestic drug quality,the link allocation of the new annual drug spot check task should be determined according to the quality of each link in the previous drug spot check.For the local drug spot check,based on avoiding duplication with the national drug spot check task,the key inspection shall be carried out for the links with many quality problems in the administrative region and the causes of unqualified problems identified in the previous drug spot check.

At the same time,relevant departments shall,according to the sampling results and in accordance with the requirements of the “Interim Provisions on the Classified Management of Drug Safety Credit”[18],classify the credit level of drug production,operation and use institutions.Then,they can and carry out drug spot check in accordance with the principle of more inspection on units with low credit level,less inspection on units with high credit level.According to the actual situation of the medical institutions equipped with large quantities of Chinese herbal pieces,the drug spot check should be strengthened.

4.3 Strengthening the supervision of problem concentrated areas according to local conditions

For areas where there are more concentrated production enterprises of decoction pieces,it is suggested that relevant departments formulate drug spot check plans and implementation plans in combination with the actual situation of the administrative region.Then,they can actively explore and innovate the management mode of drug spot check.The principle of territoriality can be highlighted when the provincial drug administration department formulates the plan,such as arranging the staff of nonindustry concentrated cities and counties to conduct flight inspection in the industry concentrated areas.In addition,since China has carried out special spot checks for the varieties of generic drug quality and efficacy consistency evaluation and the national pilot varieties of centralized drug procurement[19,20],regional special spot checks at the production end can be carried out in areas with serious quality problems and insufficient spot checks.At the same time,in terms of supervision,manufacturers that have been detected to have many batches of unqualified Chinese herbal pieces in the same sampling cycle should strictly implement the provisions of article 137 of the current “Drug Administration Law”[21].Besides,heavier penalties should be made on enterprises that produce and sell fake and inferior drugs.Lastly,regional protection must be avoided.

4.4 Listing the processing methods of Chinese herbal pieces to reduce sampling errors

The varieties listed in the drug spot check plan are the results of collaborative selection by multiple departments in accordance with the requirements of clear objectives,key points,overall consideration,and effective coverage[12].It is wrong to reduce the goal clarity of the whole sampling work due to the sampling error caused by the unclear name of decoction pieces in the task.Therefore,in the sampling plan and follow-up implementation plan,we should fully consider the particularity of the name of Chinese herbal pieces,specify the processing method of Chinese herbal pieces,urge the sampling personnel to learn relevant information,and reduce the occurrence of sampling errors from the two aspects of task assignment and sampling implementation.