From the perspective of the user: it is used by people to prevent, treat, and diagnose human diseases. Purposeful adjustment of human physiological functions, with prescribed symptoms, usage and dosage requirements; from the point of use: In addition to the appearance, the patient cannot recognize its intrinsic quality, and many drugs need to be used under the guidance of a doctor, rather than being selected by the patient Decided. At the same time, a variety of factors such as the method, quantity, and time of the use of drugs determine the effects of their use to a large extent. Misuse not only cannot "cure" diseases, but may also "disease" and even endanger life. Therefore, medicine is a special commodity.
1. Variety complexity: There are more than 20,000 specific types in the world. There are about 5,000 kinds of traditional Chinese medicine preparations in my country and more than 4,000 kinds of western medicine preparations. It can be seen that the types of medicines are complex and diverse.
2. Medical specificity of medicine: medicine is not an independent commodity, it is closely integrated with medicine and complements each other. Patients can only achieve the purpose of preventing diseases and protecting their health through the examination and diagnosis of doctors and the rational use of medicines under the guidance of doctors and licensed pharmacists.
3. Strict quality of medicines: medicines are directly related to people's health and even survival. Therefore, their quality must not be sloppy. We must ensure that medicines are safe, effective, uniform and stable.
In addition, the quality of medicines has significant characteristics: unlike other products, there are quality grades: high-quality, first-class, second-class, qualified, etc., all can be sold , And medicines can only be divided into compliance and non-compliance, and only products that comply with the regulations can be allowed to be sold, otherwise they are not allowed to be sold.
Classification of drug properties
Enteric-coated tablets, coated tablets, film-coated tablets, sugar-coated tablets, extract tablets, dispersible tablets, scratches Tablets, sustained-release tablets, sustained-release coated tablets, controlled-release tablets
Hard capsules, soft capsules (capsules), enteric-coated capsules, sustained-release capsules, controlled-release capsules Release capsules
Oral tincture ointment
Oral solutions, oral suspensions, oral emulsions, mucilages, oral liquids, emulsions, emulsions, colloidal solutions, mixtures, tinctures, drops Pills, suspension drops
big pills, drip pills, honey pills
oral granules, powders, powders
Granules, enteric-coated granules, dry suspensions, inhalable powders, dry powders, dry powder inhalants, powder inhalants, dry powder inhalants, powders, powders, powders
topical tinctures, ointments, patches , Powder
Ointment, cream, cream, paste, ointment, plaster, hydrophilic plaster, emulsion, gel, patch, patch, film, transdermal Patches, eye drops, eye drops, ear drops, ear drops, nose drops, nasal drops, powders, powders, spreads, powders
topical paints, suppositories
Suppositories, anal suppositories, vaginal suppositories, paints, coatings, coatings
injections, injections, solutions for injections, intravenous drops Injection, suspension for injection, sterile powder for injection, intravenous injection, water injection, emulsion for injection, powder injection, injection, sterile powder injection, freeze-dried powder injection
Containing poppy, musk, ephedra drugs and hormone drugs, state-issued stimulant drugs, anabolic drugs
Drugs containing compound ephedrine preparations
Medicine quality compliance not only means that the product quality meets the registered quality standards, but also the whole process should comply with the "Pharmaceutical Manufacturing Quality Management Practice" (Referred to as GMP).
Good Manufacture Practice (GMP) is the basic guideline for pharmaceutical production and quality management, applicable to the entire process of pharmaceutical preparations and the production of raw materials The key process that affects the quality of the finished product. Vigorously promoting pharmaceutical GMP is to avoid pollution and cross-contamination in the production process of pharmaceuticals to the greatest extent, and to reduce the occurrence of various errors. It is an important measure to improve the quality of pharmaceuticals.
In early January 2013, the National Development and Reform Commission issued a notice, deciding to adjust respiration, antipyretic and analgesic, and specialty medications from February 1, 2013 The highest retail price limit of the company involves 20 types of drugs, more than 400 varieties, and more than 700 representative dosage forms. The average price reduction is 15%, and the average price reduction of high-priced drugs is 20%.
The average price of the earliest medical insurance products is reduced by 40%
According to the relevant person in charge of the Price Department of the National Development and Reform Commission, Drugs in the catalogue), the National Development and Reform Commission implements a dynamic price adjustment mechanism based on factors such as drug costs and market price changes, and usually adjusts once every 2-3 years. Since 2001, the National Development and Reform Commission has issued three rounds of drug price adjustment plans, involving nearly 2,000 drugs. The products that are the first to enter the medical insurance catalog have a cumulative price reduction rate of 40% on average, and the highest rate reaches 80%; for the newest varieties to enter the medical insurance catalog, the price reduction has just begun, with an average of about 15%.
The first round of adjustments from 2001 to 2003 was the first comprehensive adjustment of government-controlled drugs.
The second round of adjustments from 2006 to 2007, combined with the categories of the medical insurance catalog, once again made a comprehensive adjustment to the government-controlled prices of drugs.
From 2011 to 2012, the National Development and Reform Commission carried out a comprehensive adjustment of the price-controlled chemicals of the government.
Since 2011, the eight types of drugs that have been adjusted in four batches, including antibiotics, circulation, nerves, hormones, digestion, anti-tumor, immunity and blood, belong to the same round of price adjustment products, and most of them are clinically commonly used drugs. . At this point, the National Development and Reform Commission has basically completed the price adjustment of chemical drugs. Starting in 2013, the price adjustment of Chinese patent medicines will be initiated.
Appropriate price increases for low-cost drugs in clinical shortages
According to the tracking and investigation of the previous drug price adjustments by the National Development and Reform Commission, the The patient's burden reduction effect is obvious. The latest round of drug price cuts can reduce the burden on patients by more than 60 billion yuan each year. This round of price adjustments for high-priced drugs has dropped by an average of 20%. For example, for the treatment of Alzheimer's disease (senile dementia), Rivastigmine capsules 1.5 mg×28 tablets (produced by Novartis, trade name "Esner"), the price was 32.6 yuan before the price reduction, and the day after the price reduction was 19.8 yuan, a decrease of 39% .
At the same time, the price adjustment of medicines has also played a positive role in the adjustment of the production structure of enterprises. The relevant person in charge of the National Development and Reform Commission said that in response to the problem of "decreasing prices" of some drugs reported by the media, the investigation found that, in addition to short-term removals, a very small number of drugs were withdrawn from the market due to poor business operations and low product market utilization. But there is no case that disappeared just because of lowering prices. While lowering the price of high-priced drugs and reducing the burden on the masses, the state also paid attention to strengthening price support for low-priced drugs. Especially for low-priced drugs that are clinically in short supply, the National Development and Reform Commission has appropriately increased prices based on cost price surveys, expert reviews, and extensive listening to the opinions of relevant parties to encourage the production and supply of low-priced drugs to meet clinical needs.
The mission of the pharmaceutical man: to ensure the safety, effectiveness, uniformity and stability of drugs.
First, social publicity. The biological endowment of human beings has been urging human beings to improve their health and extend their lives as much as possible to ensure the reproduction of human beings. Drugs are highly valued because of their special effects. In modern society, the right to health and the right to life have become basic human rights protected by law. Therefore, medicine is related to the reproduction and development of the entire human society. The social publicity of medicines is the basis for establishing a universal medical care and medical insurance system.
Second, the duality of action. Medicines can prevent and cure diseases, and recover health care. However, "the medicine is three-part poison", and any medicine has different degrees of toxic and side effects. Therefore, with proper management and proper use, drugs can cure diseases and save people and protect health. Otherwise, it will degenerate into a terrible poison, endangering human health and life safety.
Third, the unity of quality. The physical, chemical, biopharmaceutical, safety, effectiveness, stability, uniformity and other quality indicators of drugs must meet the standards set by the state. Only drugs that meet national standards can guarantee the efficacy. Lower or higher quality standards may reduce or even lose the efficacy of drugs or aggravate the toxicity and side effects of drugs. Therefore, only qualified products are allowed for medicines entering the circulation channels, and no defective products or other foreign products are absolutely not allowed.
Fourth, the professionalism of the appraisal. The quality and authenticity of medicines are difficult for ordinary consumers to identify. There must be professional technicians and specialized institutions, according to statutory standards, using scientific methods and qualified equipment to make the appraisal.
Fifth, the limitations of application. Due to the lack of professional medical and pharmacy knowledge required for disease treatment and prevention, people can only use medicine rationally and achieve disease prevention and treatment under the guidance of licensed physicians and licensed pharmacists, or even under the supervision of medical staff. , The purpose of protecting health. If drugs are abused, it is easy to cause poisoning or drug-induced diseases. In addition, people sometimes need a little more medicine when they are sick.
Drugs are classified by nature, including Chinese medicinal materials, Chinese herbal medicines, Chinese patent medicines, Chinese and Western patent medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serums, vaccines , Blood products and diagnostic drugs.
In 2010, China will surpass India as the most popular international drug purchase destination.
China’s exports of APIs and active ingredients are expected to grow from US$5.63 billion in 2007 to US$9.9 billion in 2010, while India’s exports from US$1.7 billion in 2007 to 2010’s 2.76 billion US dollars.
These products exported by China mainly include antibiotics, vitamins, amino acids and organic acids. The main markets include the European Union, the United States, India and Japan. In terms of finished drug exports, India will continue to lead, with exports expected to grow from US$4.8 billion in 2007 to US$6.4 billion in 2010; China will grow from US$700 million in 2007 to US$1.88 billion in 2010.
In the international procurement market, China ranks first, India second, and South Korea third in terms of comprehensive cost, market opportunities, and risk factors. Although India's drug exports exceed China's, China has achieved a leading position in the export of raw materials and active ingredients of drugs.
"The domestic new drug research and development enthusiasm is high, the staff is large, the demand is urgent, the market is vast, and the government attaches great importance to it. It can be said that opportunities are frequent, but the current situation is not optimistic. "At the 4th China International Biomedicine Development Summit, this view was very representative.
1. New drugs are hard to find, and generic drugs are hard to imitate
"The existing R&D model and process are becoming increasingly difficult to discover new drugs. On the basis of life science technology, after rounds of screenings, almost all known biochemical molecular reactions and biochemical enzyme reactions have been developed by the pharmaceutical industry." said John Duan, senior US FDA examiner and clinical pharmacologist .
The output rate of new drugs is decreasing, the cost of research and development is rising, the clinical time is too long, and the marketing process is too slow... These old clichés about drug innovation still exist, and due to their weak foundation and lack of accumulation, domestic biology The sustainability of drug development is difficult.
The biopharmaceutical industry has been growing at a higher rate than the overall pharmaceutical industry, but domestic biopharmaceutical technology still has a considerable gap with developed countries, and the scale of biopharmaceutical companies is also much smaller than that of chemical pharmaceutical companies . The “me to (imitation)-me better (better imitation)-me new (innovation)” route that domestic chemical drugs have been following is not easy for biological drugs. The reason is that the bioequivalence of biosimilars is difficult to determine.
In fact, the production process between chemical medicine and biological medicine is very different. Chemical drugs are simple small molecule compounds. By controlling the chemical formula, products with similar structures can be easily produced. At the same time, it can be confirmed through laboratory tests whether generic drugs have the same efficacy as the original patented products. But the situation of biological drugs is completely different, and the difference in a small group will lead to very different effects. Therefore, whether in the United States or China, it is very difficult for biosimilars to obtain regulatory approval. However, if large-scale clinical trials are used to prove its bioequivalence, the cost and time spent are considerable.
Senior Vice President of Shanghai Biochip Company Jin Gang analyzed that biopharmaceuticals themselves are already a high-investment and high-risk industry. Generic drugs do not have patent protection, and great efforts have been made to conduct clinical trials. As a result, the market is not protected, and it is easy to be copied by other competitors, and profits are rapidly reduced. Therefore, in the United States, no VCs are willing to accept drugs without patents. Even with complete patent protection, there is still a long way between patented technology and products that can be marketed. Even many patents themselves do not have the possibility of listing or the target market is too small to make it meaningful. In other words, the products developed must not only have biopharmaceutical properties, but also have complete patent protection.
2. Funds and technology are not fully connected
After returning to China for more than a year, Zhang Lei, Ph.D. in Immunology and Medicine, discovered some phenomena that puzzled him: domestic R&D institutions and some biological companies are too poor, and it is difficult for R&D and results to be transformed; at the same time, investment companies dare not easily inject capital due to long investment cycles, no clear prospects, and no next home. .
In fact, due to the high growth of the pharmaceutical industry, a lot of funds are circulating around medicine, but it is understood that the funds attracted by domestic biomedicine only account for about 5% of the entire pharmaceutical financing. In addition, the general financial investment mostly hopes to see benefits in a short time, and it takes a long time for a drug to be on the market to see results. Even if it is on the market, subsequent risks still exist. Relatively speaking, strategic investment pays more attention to long-term benefits, which can spend several years on financing and help companies make strategic planning and management optimization.
Li Yi, a partner of BioVida China Fund, said that there are still many investment opportunities in the pharmaceutical industry. As a professional investment company, they may choose some early-stage companies with breakthrough platform technologies or huge markets. Even if these companies are very small or require a relatively long return on investment time, as long as the company has the characteristics of an efficient and cooperative management team, independent products, significant competitive advantages, clear market opportunities and sustainable business models, the investment company is willing to accept Of.
There are not too many domestic companies that can meet the above standards. In addition, because the upstream and downstream dependency chains have not been established, many domestic companies simply focus on research and development and then transfer projects, lacking long-term strategic positioning and market considerations.
"In fact, China does not lack biological R&D talents, but it has not formed an innovation system with enterprises as the main body, nor has it formed a venture capital market. China's biomedical industry has great potential, but the model is unclear." The industry insiders commented like this.
3.Looking for biological fire seeds
Zhang Fa, president of Sino-American Crown Biotechnology (Beijing) Co., Ltd. believes that our R&D model used to be Using a magnifying glass to find a needle in a pile of firewood, we need to set a fire to burn the unnecessary firewood, so that the needle is left. In the development of new drugs, the biomarker is the match that can burn straw.
The so-called biomarker is to research through the knowledge of genomics and oncology to find a certain characteristic biochemical index in a common physiology or pathology or treatment process that can be objectively measured and evaluated. , Through which we can know the progress of the organism’s current biological process.
In fact, this is a change in R&D thinking. John Duan said that the conventional new drug research method is to conduct basic research first, and then discover pharmacologically active compounds from a large number of compound sample libraries, and then proceed to chemical structure optimization and design, preclinical research, clinical trials and other steps. Usually less than one compound with pharmacological activity is screened out of 10,000 compounds, and even fewer can reach clinical trials. It can be transformed into starting from disease research, studying the principles of the disease itself, figuring out the most influential areas, and conducting targeted research and screening for them. "Better targeted identification capabilities can not only improve the screening efficiency of lead compounds, but also make more accurate judgments about the effectiveness of drugs in the early clinical research phase.
"Be careful when choosing projects. It is necessary to know whether the R&D product has a large enough market, and how long the elimination cycle of such drugs is. "Participants described it.
Some institutions predict that by 2010, China will become the seventh largest pharmaceutical market in the world, and the demand for Chinese people in the health sector will have tremendous growth. Biomedicine is specific because of its specificity. The characteristics of strong, high accuracy, etc., can be researched in many fields. It is just that China’s biomedicine is still in the primary stage of the industry and requires a long time to cultivate.
Drug Control and Marketing
The so-called "sales control": in order to improve sales performance, production enterprises strictly control prices and goods flow in the process of channel distribution and terminal sales, that is, control channels, control prices, and control terminals. This is the most popular now. General drug control sales model.
Since 2005, the vicious price competition brought about by the distribution model has disrupted the terminal market. Controlled marketing—that is, the trinity marketing innovation model of controlling the number of channels and terminals, controlling sales, and controlling varieties and services—is favored by more and more pharmaceutical companies (such as Sunflower Pharmaceutical) and downstream pharmacies. At the same time, it can also Provide variety and price guarantee for the sales of downstream retail pharmacies.
The national sales control model launched by the drug terminal network saves the labor and material costs of traditional marketing of pharmaceutical companies through functions such as drug product invitation and release, region, quantity and price restrictions, and reduces drug prices from the source , Reduce the wholesale price of controlled products to terminal stores, thereby improving the pharmaceutical circulation market and benefiting more people.
Introduction to counterfeit drugs
Bogus Drugs are prohibited from production (including preparation, the same below) and sales of fake drugs in accordance with Article 48 of the Drug Administration Law of the People’s Republic of China Medicine.
A counterfeit drug is one of the following:
(1) The ingredients contained in the drug do not conform to the ingredients prescribed by the national drug standards;
( 2) Using non-drugs to pass off as medicines or other kinds of medicines as such medicines.
Drugs under one of the following circumstances shall be treated as counterfeit drugs:
(1) The use of drugs is prohibited by the State Council’s drug regulatory department;
(2) Produce or import without approval under this law, or sell without inspection under this law;
(5) Produced using APIs that must obtain an approval document number in accordance with this law but have not obtained an approval document number;
(6) The indicated indications Or the functions and indications are beyond the prescribed scope.
The celebrity endorsed drugs will be held criminally if they know they are fake drugs. The Vice President of the Supreme People’s Court Xiong Xuanguo pointed out at a press conference held by the State Council Information Office that celebrity endorsement drugs If you know that it is a fake medicine, you will be held criminally liable.
When Xiong Xuanguo mentioned the celebrity endorsement behavior, he said that from the perspective of judicial interpretation, the first thing to do is to provide advertising to promote the positioning of this behavior. According to the "Criminal Law", the crime of producing and selling counterfeit or inferior drugs is an intentional crime. The accomplice is based on the premise of knowing or should know that others are producing or selling counterfeit or inferior drugs. Therefore, for the celebrity's endorsement behavior, if he knows that others produce and sell fake or inferior drugs, it is in line with the "Criminal Law" and it can be dealt with as an accomplice, but this premise is very important.
It is understood that on May 13, 2009, the Supreme People’s Court and the Supreme People’s Procuratorate signed the "Interpretation on Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases Concerning the Production and Sale of Counterfeit Drugs and Substandard Drugs." It will come into effect on May 27th. The "Interpretation" clarified some difficult issues in the application of law in handling criminal cases involving the production and sale of counterfeit drugs and inferior drugs.
Avoid counterfeit medicines
The first step: choose a regular pharmacy website
Consumers must distinguish between true and false information, first Go to a legal and formal pharmacy network to buy. Statistics show that as of November 15, 2010, there were 2,588 legal websites providing drug service information across the country, of which 54 websites were involved in drug transactions. Among the 54 websites that provide drug transaction services, only 33 have legal qualifications to sell drugs to individuals. Choosing a regular pharmacy network is an important step to avoid buying fake drugs.
The second step: How to distinguish the authenticity of the drug
The appearance described in the drug appearance identification technique has two meanings. One is the drug packaging office The appearance involved includes items such as packaging boxes, packaging boxes, medicine bottles, labels, instructions, etc. The second refers to the appearance and shape of the medicine itself.
When judging whether the tested product is a counterfeit or inferior drug by the method of visual inspection and identification, the following issues should be paid attention to:
1. The most basic technical basis for identification is the comparison method.
This is a method based on the comparison between genuine and fake products. Therefore, drug inspectors should understand and be familiar with the appearance of products from various regular manufacturers This requires us to accumulate experience in the usual inspection work and continuously improve the level of identification.
2. Check the source channels of drugs
In the process of drug inspection, the source documents of various drugs should be reviewed, and the authenticity of the shipping bills should be carefully identified, and the inspection of relevant conditions should be strengthened. The production of counterfeit and inferior drugs , There is obviously a difference between sales channels and regular products.
3. Check the price of medicines
The selling price of counterfeit and inferior medicines is generally significantly lower than the price of genuine products, and some are even lower than the cost price of the product. In the supervision and inspection of medicines, if the price of a certain medicine is found to be significantly lower Attention should be paid to the price that is lower than or deviated from the cost price, and random inspection should be carried out in time.
4. Drug counterfeiting is generally also regular
Best-selling products, popular products, well-known brands, and valuable drugs are mostly counterfeit objects, and the phenomenon of adulteration in counterfeiting has also occurred. Counterfeiting methods are constantly changing. Drug inspectors should Respond flexibly to actual situations.
5. The identification of the appearance of drugs is very field-based
Therefore, the methods and basic environment are also subject to certain restrictions. When conditions permit, the rapid test identification method should be used to carry out experiments and draw further conclusions. Such as thin layer chromatography and chemical reaction identification method.
Distinguish true from false
Simple identification method:
1. Look at the approval number on the package.
1. The approval number of the drug must be seen on the packaging: "National Medicine Standard H (or ZSJBF) + 8 digits", which means that the State Food and Drug Administration has approved the production and marketing For medicines, the letter H represents chemical medicines, Z Chinese patent medicines, S biological products, J imported medicines in domestic sub-packages, B medicines with auxiliary therapeutic effects, and F medicinal excipients.
2. If there is no "National Medicine Zhunzi" on the package, it is definitely not a drug. If there is a "National Medicine Zhunzi", log in the data query of the State Drug Administration, and enter the name of the drug or the letters and With 8 numbers, what is found is a genuine medicine, but what is not found is a counterfeit medicine.
3. If the approval document number is: X medicine manufacture character H (Z) + 4 digit year number + 4 digit serial number, such approval document number is a hospital preparation and can only be used in this hospital. It cannot be sold in other hospitals and pharmacies.
4. If the drug package is not marked or the expiry date is changed, if the production batch number is not marked or changed, the medicines that exceed the expiry date are inferior drugs.
5. The identification method of health food and food.
(1). Health care products must be able to see the approval number of the State Food and Drug Administration on the packaging: the national food health character G(J)+8 is a number, and the letter G refers to domestically produced J refers to imported. Or the approval document number of the Ministry of Health: Weishijian word (health food and health word) + 8 digits. And it is stipulated that the special logo of health care products must be marked on the top of the package or label: "blue hat", a pattern similar to a blue hat, with the words health food underneath, and the approval number below the four words health food. Those without blue hats and health food approval numbers are fake health products.
(2). Foods marked with "food production license number" on the package all start with QS followed by a 12-digit serial number. There is a "hygiene license number" starting with the abbreviation of each province followed by a serial number, such as Yuwei Food Certificate, Yuewei Food Certificate, Huwei Food Certificate, etc. Its logo is a rectangular white background with a deformed blue Q and white S. It is called the QS logo, and there are four words for quality and safety under QS.
6. When identifying a drug, it depends on whether there is an approval number: "National Medicine Zhunzi". If there is a National Medicine Zhunzi, log in the database of the State Food and Drug Administration. If you can't find it, it is a counterfeit drug. When buying health care products, you need to look at it: if you have a blue hat and national approval number, you can also log in to the database of the State Drug Administration, and you can’t find fake health care products. When buying food, look for QS logo and food production license number.
Complicated identification methods: Professional institutions (drug inspection institutes) can judge the authenticity of drugs through chemical and physical testing methods.
Specific drug information can be inquired on the official website of the State Food and Drug Administration.
1. Varieties that affect each other's performance, are prone to odor, and whose names are easy to be mistaken, should also be stored separately.
2. Toxic drugs of narcotic drugs and psychotropic drugs should be stored in special warehouses or special counters, and designated personnel for safekeeping.
3. Dangerous goods should strictly follow the "Interim Measures for the Storage and Management of Chemical Dangerous Goods", "Explosives Management Rules" and "Warehouse Fire Safety Management Rules" issued by the Ministry of Public Security. According to their dangerous nature, Classified and stored in a dedicated warehouse with special facilities.
4. The effective drugs are stacked according to the expiration date, batch number, and special code. And in accordance with the time limit stipulated in the "China Pharmaceutical Company's Pharmaceutical Commodity Transfer Responsibility System", periodic reports are made to the business department for timely sales.
5. For long-term storage of products that are afraid of pressure, they should be stacked and stacked regularly, and necessary spacer measures should be taken between the stacks.
6. The returned goods should be stored and marked separately. It is necessary to find out the reason and deal with it in time. Drugs returned due to quality problems must be re-inspected before they can be returned to inventory after obtaining the approval of the health administration department to rework. The return shall be recorded (including the return unit, date, product name, specification, quantity, reason for return, inspection result, processing date and processing situation, etc.) and kept for two years.
7. The handling and stacking should strictly abide by the requirements of the labeling of the outer packaging of the medicine, and operate safely to prevent barbarous loading and unloading.
(5) Pay attention to the timely rotation of the drugs that are directly drawn from the factory with the same varieties as the inventory, and the national reserve drugs and the drugs stored outside the warehouse should be rotated and updated in a timely manner.
(6) The principle of "first in, first out", "first out in the near future" and "changeable first out" shall be implemented. Register the production batch number or year, month, day, expiration date, and year, month, and day when the drug is shipped out of the warehouse. Good medicines must be checked and issued out of the warehouse, and spoiled and expired medicines are strictly prohibited from being shipped.
(7) For all medical warehouses, where the storage area is more than 3000m, professional maintenance organizations should be established, and full-time maintenance personnel should be set up for warehouses less than 3000m.
(8) Tasks of drug conservation work
1. Instruct the custodians to scientifically store drugs.
2. Check whether the storage conditions of the stock medicines meet the requirements, cooperate with the custodians to manage the temperature and humidity of others, and adjust the stock conditions in time.
3. Carry out periodic quality spot checks on stock drugs. The cycle of spot checks is generally one quarter. For perishable drugs, the spot check cycle should be shortened.
4. Put forward treatment opinions and improve maintenance measures for the problems found in the spot check. Cooperate with the custodians to make necessary sorting out of the problematic varieties.
5. According to seasonal climate changes, formulate a drug inspection plan and a maintenance work plan, list key maintenance products, and implement them.
6. Establish drug conservation files.
7. Carry out retention sample observations on key varieties, investigate the reasons and laws of changes, and provide information for guiding reasonable inventory, improving storage levels and promoting pharmaceutical companies to improve product quality.
8. Carry out maintenance research work, and gradually make warehouse storage and maintenance scientific and modern.
When a drug safety incident occurs suddenly, as the drug supervision and management department, it should deal with it immediately. In the case of group public events, work can be carried out quickly according to the following sequence.
1. Receiving information
When receiving a complaint, report, or information disclosure notification about a drug safety incident, you should ask and quickly determine the time, place, number, history, injury or death of the incident. Form accurate and clear records and report to the supervisor.
2. On-site investigation
The main purpose of the investigation is to investigate the relationship between the incident and the drug. When it is confirmed that the drug has been used before the incident, whether it is caused by the drug or not, the site should be launched immediately Investigate.
(1) Controlled drugs
If injuries or deaths have been caused, drugs of the same manufacturer, variety, and batch number used by the patient shall be seized and seized in accordance with the law. If no harm has been caused, but there are serious adverse reactions, the drugs of the same manufacturer, variety, and batch number used by the patient should be registered and stored in advance according to law. And collect the remaining medicines or packaging as evidence.
Sampling on-site medical devices of the same manufacturer, the same variety, and the same batch number and the same manufacturer, the same model and the same batch number of the drugs used by the patient.
Inquire the medical staff, the patient or the patient’s family members on the spot to understand the name and dosage form of the medicine used, the history of the medicine use, and the number of people involved in the incident. And form the inquiry transcript, please sign and confirm by the inquired person.
The main purpose is to investigate the source, storage environment, and flow of medicines, and collect documents that can prove the source and storage environment of medicines as evidence. At the same time, fill in the "Adverse Drug Reaction Report Form" to investigate the symptoms of serious adverse drug reactions.
3. Preliminary treatment
At the same time or after the on-site investigation, the response and treatment according to the occurrence and development of the incident.
(1) Inform the victim of the incident that the drug supervision and administration department has been involved in the investigation and will have a clear investigation conclusion on whether the injury is caused by the drug, so as to soothe the victim’s emotions.
(2) Inform medical institutions to stop the use of related drugs, take active and effective measures to control the development of the situation, and do a good job of treatment.
(3) Report the time, place and on-site investigation of the incident to the health authority.
(4) If necessary, send personnel to wait for the scene, follow up the development of the incident, and report at any time.
(5) Report the on-site investigation and disposal to the head of the department.
4. Evaluation, Research and Judgment
According to the situation already understood and grasped, the drug supervision and management department will quickly evaluate and study whether the incident is a drug safety emergency public incident and which level of incident in accordance with the relevant provisions of the emergency plan. And judgment. If the injury caused by the sudden incident is particularly serious, there is a serious group adverse reaction, or many people die, the judgment of the public emergency can be made first, the report first, and then the injury consequence and the level of the incident can be studied and judged.
5. Report request
According to the results of the evaluation and judgment, if it is a public drug safety emergency, it should immediately report to the government emergency management agency and the government leader in charge of drug supervision and management, and request the start of the drug safety public emergency Emergency plan. For incidents that are obviously serious in nature and whose harmful consequences continue to develop, the emergency response plan can be directly submitted.
Laws and Regulations
The 1832th meeting of the Judicial Committee of the Supreme People’s Court on February 22, 2021, and the 60th meeting of the 13th Procuratorial Committee of the Supreme People’s Procuratorate on February 26, 2021 The "Supplementary Provisions of the Supreme People’s Court and the Supreme People’s Procuratorate on the Implementation of Determining Crimes (7)" passed at the three meetings stipulated the crime of producing, selling, and providing counterfeit drugs (the crime of abolishing the crime of producing and selling counterfeit drugs). The crime of medicine (the crime of abolishing the crime of producing and selling inferior drugs) and the crime of dereliction of duty in food and drug supervision (the crime of abolishing the crime of dereliction of duty in food supervision) shall come into force on March 1, 2021.