On the morning of December 17, the Huizhou Press Conference Hall held a press conference on drug safety in Huizhou with the theme of "My 'Drug' Safety huizhou in action". Huang Zhixiong, deputy director of the Huizhou Municipal Market Supervision Bureau, Zhang Liqin, member of the party group of the Huizhou Municipal Market Supervision Bureau, Zhong Xiyuan, director of drug safety of the Huizhou Municipal Market Supervision Bureau, and Zeng Jinhong, a third-level researcher of the Huizhou Municipal Market Supervision Bureau, attended the press conference. At the meeting, the relevant situation of drug safety work in Huizhou City was briefed, and the relevant staff answered reporters' questions on hot issues of public concern.
The scene of the press conference
At the meeting, Huang Zhixiong, deputy director of the Huizhou Municipal Market Supervision Bureau, introduced the drug safety supervision work in Huizhou. Huang Zhixiong said that as of December 13, 2021, Huizhou city has carried out a total of 17,544 supervision and inspection of retail pharmacies to implement epidemic prevention and control measures, ordered 293 rectification within a time limit, suspended 157 businesses for rectification, and filed 4 cases for investigation. On the other hand, the quality of the new crown vaccine circulation is good. Strengthen the quality supervision of vaccine storage and transportation, the city has a total of 125 new crown vaccination units, 6 CDC, 1 distribution enterprise, and has completed two rounds of full coverage inspections of the city's vaccination-related units in the first half of the year, with 8 rectifications within a time limit and 1 interview.
With risk prevention and control as the core, strengthen daily supervision and inspection
It is reported that as of December 13, Huizhou City inspected 52 pharmaceutical production enterprises and interviewed 1 enterprise; inspected 3589 pharmaceutical trading enterprises, rectified 385 within a time limit, and filed 228 cases; inspected 1136 medical institutions, rectified 47 within a time limit, and filed 2 cases. Inspected 142 medical device manufacturers, 2995 operating enterprises, and 156 users; 74 cosmetics production enterprises and 2010 operating enterprises, covering key areas and varieties such as beauty salons, children's and special cosmetics.
In order to ensure the safety and effectiveness of drug use, increase the intensity of sampling work
Huizhou Municipal Market Supervision Bureau to the municipal drug production and operation and use units to carry out drug sampling work, this year Huizhou City drug sampling task 698 batches, from January to November, has completed the drug sampling 698 batches, completed the inspection of 679 batches, found unqualified batches of 2 batches, the pass rate of 99.7%. Among them, the implementation of 100% full coverage of the national essential drug preparation varieties produced by the city's pharmaceutical production enterprises, the matter was listed as a key people's livelihood project in Huizhou City to carry out the "I do practical things for the masses" practical activities, and the sampling task has been completed, with a pass rate of 100%; 60 batches of medical device sampling have been completed, and 3 batches of unqualified batches have been found, with a pass rate of 95%; 100 batches of cosmetics have been completed, with a pass rate of 99%.
Focus on monitoring, effective prevention and control of drug safety risks
Strengthen the monitoring and evaluation of adverse drug reactions, adverse events of medical devices, adverse reactions of cosmetics, and drug abuse, hereinafter collectively referred to as "monitoring and evaluation of adverse drug reactions". As of December 13, a total of 5292 ADR reports were reported by 140 medical institutions in the city, 874 per million population; a total of 2123 MDR report forms were reported by 127 units, with a total of 351 reports per million population; a total of 460 ACR report forms (municipally evaluated) were reported by 10 provincial and municipal sentinel hospitals in Huizhou City, with 76 reports per million population; and 267 drug abuse monitoring questionnaires were received from 5 drug rehabilitation institutions. The quality of adverse drug reaction monitoring data has been steadily improved, the data and information on drug safety risks have been effectively collected, the early warning signals of drug quality and safety hazards in the jurisdiction have been grasped in a timely manner, and the ability to actively monitor and judge has been improved year by year.
At present, two hospitals in Huizhou (Huizhou Central People's Hospital and Huizhou First People's Hospital) have been licensed as national adverse drug reaction monitoring posts.
Strict investigation and punishment, drug safety violations effectively cracked down
In response to the special rectification actions of various drugs, medical devices and cosmetics, the Huizhou Municipal Market Supervision Bureau focused on the hot issues, new trends and new situations that the masses strongly responded to, and increased the crackdown on various illegal acts. As of December 13, Huizhou had concluded 429 administrative punishment cases of "two products and one weapon" (311 drug cases, 46 medical device cases, and 72 cosmetics cases), with a fine of 2.5447 million yuan. Investigated and handled 2 major cases with a value of more than 500,000 yuan (Guangdong Fengsheng Energy Health Care Technology Co., Ltd. produced counterfeit cosmetics with a value of 575,300 yuan; Huizhou Shuoguo Garment Co., Ltd. produced a second-class medical equipment "disposable protective clothing" without a license, involving a value of 1.116 million yuan). In the transfer of 1 suspected criminal case (Huizhou Shuoguo Garment Co., Ltd. producing the second type of medical equipment without a license "disposable protective clothing"), the public security organ will investigate and deal with the criminal acts of the parties, and effectively achieve "execution linkage".
According to statistics, 4 cases of drug-related crimes were cracked in the city, 17 people were detained, 17 people were arrested, and the amount involved was 3.15 million yuan. 2 cases of crimes involving medical equipment were cracked, 4 people were criminally detained and 4 people were arrested. 1 case of cosmetics-related crime was cracked, 2 people were criminally detained and 2 people were arrested. Among them, the investigation and handling of 1 major illegal case, in early July this year, the Municipal Public Security Bureau Food and Drug Ring Investigation Detachment led the joint Boluo County Public Security Branch Food and Drug Ring Investigation Brigade and the Municipal Market Supervision Bureau and other units, took the initiative, accurately cracked down, successfully detected a case of manufacturing counterfeit and shoddy cosmetics of a famous brand, arrested 2 criminal suspects on the spot, destroyed the entire production line, seized a counterfeit brand of cosmetics on the spot worth 2.05 million yuan, and the relevant cases are currently under investigation and trial.
Smooth channels, effective handling of drug complaints and reports
In 2021, the Huizhou Municipal Market Supervision and Administration Bureau will further smooth the channels for expressing consumer demands, improve the 12315 administrative law enforcement system, realize the "six unification" working mechanism of unified number, unified platform, unified institution, unified system, unified judgment and unified evaluation, and establish a service mechanism of "Bing Response, Nothing to Disturb" to provide strong support for maintaining a safe and comfortable consumer environment. As of November 30, the city's market supervision and management system has accepted/filed 1265 complaints and reports on "two products and one device" (drugs, cosmetics, medical devices) through the national 12315 platform, of which 1131 complaints and 134 reports, with a handling rate of 100%, recovering 189,600 yuan of economic losses and confiscating 0.5 million yuan for consumers. At present, the Huizhou 12315 complaint and reporting system operates safely and stably.
According to reports, Huizhou City will closely focus on the requirements of the "14th Five-Year Plan for Drug Safety and High-quality Development in Guangdong Province (2021-2025)", strengthen and improve drug supervision, fully implement risk research and judgment meetings, strengthen drug safety risk governance, early detection and disposal of drug quality and safety hazards, and ensure that regional and systematic drug safety incidents do not occur.
At the press conference, media reporters asked questions on the supervision of drug abuse monitoring, drug network sales, medical masks and other epidemic prevention materials.
Reporter: What work has the Huizhou Municipal Market Supervision Bureau done in the monitoring of drug abuse, and what results have been achieved?
Zhong Xiyuan, director of drug safety at Huizhou Municipal Market Supervision Bureau: At present, there are 5 drug abuse monitoring institutions in our city, namely: Huizhou Municipal Public Security Bureau Compulsory Isolation Drug Rehabilitation Center, Huizhou Municipal Public Security Bureau Huiyang District Bureau Compulsory Isolation Drug Rehabilitation Center, Huizhou City Compulsory Isolation Drug Rehabilitation Center, Huidong County Compulsory Isolation Drug Rehabilitation Center, Huizhou Dermatology Hospital Drug Maintenance Treatment Point, mainly responsible for the city's reporting of drug abuse work.
Zhong Xiyuan, safety director of Huizhou Market Supervision Bureau
This year, the city's drug abuse monitoring work and the results achieved are mainly in three aspects. High priority is given to timely drug abuse surveillance. Our bureau promptly joined hands with the Municipal Bureau of Justice, the Municipal Public Security Bureau, and the Municipal Health and Health Bureau to supervise drug rehabilitation institutions and drug maintenance drug rehabilitation institutions to conscientiously do a good job in drug abuse monitoring, and promptly issued a letter of assistance in supervision, supervising and urging all drug abuse monitoring institutions to report drug abuse monitoring reports in strict accordance with requirements.
Strengthen departmental linkage and form an effective monitoring mechanism. In September this year, our bureau actively cooperated with the Municipal Bureau of Justice, the Municipal Public Security Bureau, the Municipal Health Bureau and its subordinate drug abuse monitoring agencies to organize and hold a symposium on drug abuse monitoring in Huizhou City, further promoting the in-depth development of drug abuse monitoring in the city, and jointly formulated the "Coordination Mechanism for Drug Abuse Monitoring in Huizhou City", and established a working mechanism of "efficient command, unified coordination and departmental linkage".
Highlight the business training, and the monitoring effect is obvious. In the second half of this year, Huizhou added a new drug abuse monitoring agency - Huidong County Compulsory Isolation Drug Rehabilitation Center, and the Municipal Adverse Reaction Monitoring Center actively applied for the drug abuse monitoring account password for the unit, and gave it on-site guidance and training to ensure that the unit's report form could be reported on time. Up to now, the city has reported a total of 267 drug abuse monitoring reports, which basically achieved the expected monitoring goals.
Reporter: This year, Guangdong issued the "14th Five-Year Plan" for drug safety, paying special attention to the online sale of drugs, how does Huizhou supervise the online sale of drugs?
Huang Zhixiong, deputy director of the Huizhou Municipal Market Supervision Bureau: In recent years, new formats such as drug network sales have developed rapidly, and only 63 pharmaceutical retail enterprises in our city have registered to carry out online sales in 2020, reaching 686 this year.
The safety of online drug sales has also become a hot spot for the public. Since last year, in accordance with the deployment of the Provincial Drug Supervision Bureau, our bureau has carried out special rectification actions for violations of laws and regulations in drug network sales in the city for two consecutive years. Organize each county (district) to carry out online and offline inspections and supervision of drug network sales enterprises in their jurisdictions, focusing on rectifying the problem of drug sales that have not obtained qualifications to engage in online sales, as well as the problem of drug network sellers selling drugs through the Internet in violation of laws and regulations, and promptly handle the monitoring clues transferred by the Provincial Food and Drug Administration to our city in accordance with the law, investigate and deal with drug trading enterprises suspected of violating the provisions on online sales in accordance with laws and regulations, and transfer those suspected of committing crimes to the public security departments for criminal prosecution in accordance with law. Through these regulatory measures, enterprises are urged to implement the main responsibility and effectively maintain the order of drug network sales in our city.
Huang Zhixiong, deputy director of the Huizhou Municipal Market Supervision Bureau
Since the special action, the city has inspected a total of 38 drug network sales and wholesale enterprises, 12 retail chain enterprises, 540 retail pharmacies, and 5 cases. Down, we will take the standardization of drug network sales behavior as a long-term task and always make unremitting efforts, study and innovate the ways and methods of drug network sales supervision, strengthen departmental coordination, case investigation, publicity and guidance, etc., form a long-term regulatory mechanism, and ensure the safety of online drug shopping.
Reporter: What are the highlights of the work of the municipal food and drug inspection, and what role has it played in ensuring the safety of drugs in our city?
Zhong Xiyuan, director of drug safety of Huizhou Market Supervision Bureau: As the technical support agency of the Market Supervision Bureau, in addition to completing the daily sampling inspection tasks of food, drugs and cosmetics in quality and quantity, the highlights of the work in recent years are mainly in two aspects: First, it has presided over the completion of the drafting of local standards for plum vegetables in Huizhou, promoted the promulgation and implementation of local standards for plum vegetables in our city, standardized industry management, and promoted the development of local characteristic industries. The second is to promote the construction and use of Chinese medicine halls.
The role of the Municipal Food and Drug Inspection Institute in drug safety in our city mainly has three aspects, serving administrative supervision and providing technical support for drug safety supervision; serving the industries in the jurisdiction and promoting the high-quality development of enterprises; and leading by science demonstration and serving the public.
Reporter: At present, the situation of epidemic prevention and control is still severe and complicated, and the general public is very concerned about the quality and safety of epidemic prevention materials. How does the market supervision department ensure the quality and safety of medical masks and other epidemic prevention materials?
Zeng Jinhong, a third-level researcher of Huizhou Municipal Market Supervision Bureau: Since the new crown epidemic, the quality and safety of medical masks and epidemic prevention materials in our city are generally safe and controllable. In the past two years, among the new medical masks and other epidemic prevention materials production enterprises, individual enterprises have not had a strong sense of continuous improvement when implementing the "Good Manufacturing Practice for Medical Devices", such as the traceability and integrity of the production link records are lacking, and the quality awareness is not high. Individual product quality sampling in the circulation link is unqualified and illegal sales occur from time to time.
Zeng Jinhong, a third-level researcher of Huizhou Market Supervision Bureau
In view of this situation, our bureau first is to strictly implement the "four strictest" regulatory requirements and implement 100% full coverage inspection of medical epidemic prevention material production enterprises; the second is to normalize and solidly grasp the investigation of medical device risks. Strengthen the supervision and inspection of medical epidemic prevention materials trading enterprises and user units, and supervise the implementation of rectification and reform to eliminate hidden risks at the source; the third is to strengthen the sampling of medical equipment for epidemic prevention and control to ensure that the quality of medical epidemic prevention materials in our city is controllable.
Written by: Nandu reporter Wang Shiyuan Correspondent Fang Yuan Guo Wenjiang