撰写
Comic: The Ministry of Health "blocked" Wandashan Acanthopanax Injection. Zhongxin News Agency Song Xuehai photo
"This is the best time, this is the worst time", and the coming year of 2008 is doomed to be extraordinary. With the freezing snow disaster at the beginning of the year, the earthquake in May, the successful convening of the Olympic Games in August, and the global financial turmoil, the domestic pharmaceutical industry can be described as surging. Undoubtedly, 2008 is one of the most intensive years for the formulation and revision of China’s drug and medical policies recently, and it is also another year for the pharmaceutical industry to rebound after several downturns. From the epidemic of influenza and EV71 virus to the brisk sales of Chinese medicine materials in the earthquake; From the incorporation of the Food and Drug Administration into the Ministry of Health, to the draft of the medical reform plan with a half-appearance; From the pilot work of medical service and drug price reform in Guangdong, to the information about the contrarian growth of the industry from time to time …
This year, there are too many events that have far-reaching effects and are worth remembering. We can only intercept fragments and peek at the leopard in the tube, expecting a series of policy programs to stimulate domestic demand and stimulate development to light up the aviation lights for the confused pharmaceutical industry.
Public health events
1. Death of children with influenza in Hong Kong leads to panic.
Since March 10th, the Hong Kong Centre for Health Protection has received nine new reports of influenza outbreaks in schools. By the 13th, four children in Hong Kong had died of influenza, and schools with influenza outbreaks spread all over Hong Kong, causing social panic. On the evening of March 12th, the Education Bureau of the Hong Kong SAR Government announced that kindergartens, child care centers, primary schools and special schools would have Easter holidays two days earlier from the 13th until March 28th. Affected by this, all parts of China have strengthened their prevention. On the 12th, Guangzhou Municipal Health Bureau held a special meeting on influenza. On the 13th, the education administrative department of Guangdong Province issued an early warning notice.
2. Hand, foot and mouth disease
In March, Fuyang City Hospital in Anhui Province admitted many children with fever, and five children died in succession. In April, experts from the Ministry of Health went to the local area for investigation and were diagnosed as enterovirus EV71 infection, which is often called hand, foot and mouth disease. Subsequently, hand, foot and mouth disease spread from Beijing, Shanghai, Guangdong and other provinces and regions all over the country, and children died from time to time. As of May 12, Guangdong reported a total of 14,793 cases of hand, foot and mouth disease, with a total of 7 deaths.
Reporter’s comments:
It is never possible to say hello to human beings in advance when the virus spreads. Influenza in Hong Kong and hand, foot and mouth disease in mainland China are all sudden outbreaks, but with the lessons of SARS, government departments can release information in a timely and public manner to avoid public panic caused by poor information at the beginning of SARS.
Different from SARS, this year’s influenza and hand, foot and mouth disease are routine diseases, which occur every year, but the prevention seems simple but few people really do it. Therefore, in summary, when public health emergencies occur, we must make a mountain out of a molehill, otherwise there will be diseases as common as hand, foot and mouth disease.
Wenchuan earthquake
On May 12th, when the Wenchuan earthquake occurred, the Ministry of Health and National Medical Products Administration launched the first-level response. In order to ensure the supply of urgently needed drugs for earthquake relief, on May 22, the State Food and Drug Administration implemented special approval for urgently needed drugs for earthquake relief. The earthquake tested the emergency production capacity and emergency allocation capacity of domestic pharmaceutical enterprises. Due to the serious disaster, medical supplies are not only larger in quantity, but also more urgent in allocation and more in categories.
1. The hospital actively manpower.
At 18 o’clock on the evening of May 12, upon receiving an urgent notice from the Guangdong Provincial Health Department, the Guangzhou Municipal Health Bureau organized 8 municipal hospitals overnight, sent 18 medical personnel to form an earthquake relief medical rescue team, and rushed to the disaster area with materials and medicines worth more than 2 million yuan. From the first batch of medical rescue teams, up to now, medical workers all over the country, including Guangdong Province, continue to provide various rescue services for earthquake-stricken areas.
2. Enterprises generously donate materials.
From the day of the earthquake, donations from pharmaceutical companies began to flow continuously. Only three days after the earthquake, more than 50 pharmaceutical companies donated medicines, with a total amount of more than 250 million yuan. Subsequently, enterprises made more donations, especially in Guangdong. Zhang Jun Xiu, president of Guangdong Food and Drug Industry Association, said that Guangdong food and drug industry donated 334 million yuan to the earthquake-stricken areas. Guangdong has created "the number of donations from a single enterprise is the highest in the country", and the total amount of money and materials donated to the people in the disaster areas is "the highest in the country", making it the vanguard of earthquake relief in the same industry in the country.
Reporter’s comments:
At the time of the disaster, medical rescue in all parts of the country was launched, which can be said that there was great love in the face of the catastrophe. For a time, the "Great White Wolf" in the tense doctor-patient relationship returned to "angels in white" and rushed to the disaster area one after another, and the tall image of medical workers was once again established. The "profiteers" in the eyes of consumers also suddenly gave generously, and many pharmaceutical companies organized donations, materials and medicines in the first time, especially Guangdong pharmaceutical companies. ?
Adverse event
1. An incident of "lethal injection of immune protein" occurred in Jiangxi.
On June 1, Jiangxi Food and Drug Administration reported that it received a report on May 28, and from May 22 to 28, six patients in the Second Affiliated Hospital of Nanchang University died after using intravenous immunoglobulin (PH4) (liquid) with batch number of 20070514 and specification of 5%2.5g produced by Jiangxi Boya Biopharmaceutical Company.
On May 29th, the State Food and Drug Administration and the Ministry of Health jointly issued a document, demanding immediate emergency measures to suspend the sale and use of all batches of intravenous immunoglobulin labeled as Jiangxi Boya Bio-pharmaceutical Co., Ltd., and instructing enterprises to recall the products with batch number of 20070514 quickly.
2. Acanthopanax Senticosus incident
On October 11, the State Food and Drug Administration informed that on October 6 this year, the State Food and Drug Administration received a report from Yunnan Food and Drug Administration that six patients in Honghe Prefecture of Yunnan Province had serious adverse reactions after using two batches of acanthopanax senticosus injection labeled as Wandashan Pharmaceutical Factory in Heilongjiang Province, of which three died and the other three patients with serious adverse reactions were in stable condition.
According to the investigation, there are 47,930 bottles labeled as "Acanthopanax Senticosus Injection" produced by Wandashan Pharmaceutical Factory in Heilongjiang Province with two batch numbers (batch numbers: 200712272 and 200712151, specification: 100ml/ bottle), which are sold to 53 pharmaceutical enterprises and 92 medical institutions in 16 provinces, autonomous regions and municipalities directly under the central government. Except for 43383 bottles that have been used, others have been controlled. Other batches of acanthopanax senticosus injection produced by Wandashan Pharmaceutical Factory in Heilongjiang Province (now renamed as Wandashan Pharmaceutical Co., Ltd. in Heilongjiang Province) have also been temporarily detained. Subsequently, the Food and Drug Administration strengthened the management of traditional Chinese medicine injections.
Reporter’s comments:
This year’s adverse drug events are all from "Chinese medicine preparations". Combined with the Houttuynia cordata incident that happened earlier and SFDA’s subsequent suspension of Houttuynia cordata injection, compound dandelion injection, Yujin injection and Yanduqing injection, the safety of Chinese medicine injection has been worrying.
Aside from the quality of drug production, there are essential differences between traditional Chinese medicine and western medicine. Western medicine focuses on single medicine, while western medicine thinks that injection is faster than oral medicine, while traditional Chinese medicine usually follows the principle of "can be used externally without oral administration, but can be taken orally without injection". It seems that the development technology of modernization of traditional Chinese medicine needs to be continuously strengthened.
laws and regulations
1. The Food and Drug Administration was merged into the Ministry of Health.
Chen Zhu, Minister of Health, revealed on March 4th that the reform plan of the "multi-ministry system" in the health system has been completed, and the National People’s Congress will consider specific plans including the merger of National Medical Products Administration into the Ministry of Health during the "two sessions".
On March 11th, according to the institutional reform plan of the State Council submitted by the State Council to the National People’s Congress for deliberation, the State Food and Drug Administration was transferred to the Ministry of Health. The "Ministry of Health" system was formed. Expect to straighten out China’s food and drug supervision system. Among them, National Medical Products Administration’s original food and drug standards, as well as the establishment of relevant systems and comprehensive management and coordination functions were stripped, and specific licensing and supervision functions were undertaken instead.
2. Public consultation on "medical reform"
On October 14th, the National Development and Reform Commission publicly issued the Opinions on Deepening the Reform of the Medical and Health System (Draft for Comment). Since then, it has triggered a big discussion in society.
3. Guangdong has become a pilot of medical service and drug price reform.
Just in December, Guangdong Province officially launched the pilot reform of medical services and drug prices. The Guangdong provincial government held a video conference on the pilot reform of medical services and drug prices in the whole province. As the first pilot province of "national medical services and drug price reform", the relevant pilot scheme in Guangdong attracted attention. According to the published plan, Guangdong will put the prescription drugs for common diseases into government supervision and implement the maximum price, and will also try to reduce the drug prices of public hospitals in Shenzhen, Zhanjiang and Shaoguan, and explore measures such as charging for single diseases in community hospitals, township hospitals and other medical institutions.
Reporter’s comments:
With the integration of departments, the incorporation of the Food and Drug Administration, the functions of the Ministry of Health have been sorted out, and the draft for the new medical reform has also appeared in a long-awaited manner. China’s medical reform for more than 20 years has been "crossing the river by feeling the stones" from the central government to the local government. In the past, the medical reform was "unclear in purpose and unclear in goal" and failed to make an accurate positioning of medical institutions. Many hospitals aimed at maximizing profits and grasping income and investment, which led to chaos in medical reform.
The proposal of the draft of the new medical reform for comments makes people see two points: promoting the reform of the management system of public hospitals; Vigorously develop rural medical service system and urban community medical service system; Multi-level medical security system covers urban and rural residents; Establish a basic drug system to reduce the burden of people’s drug expenses. Although the road to universal health insurance is full of difficulties, it is full of hope.
Editor: Wang Jiaolong