Pharmacy Questions? What are the principles of national drug selection?

Eight Principles for Selling Prescription Drugs.

One. High level of security, the "selection principle" stipulates.

1>.Based on the literature and long-term clinical use, it has been confirmed that it is safe and feasible.

2>.There is no potential toxicity, drug residues are metabolized quickly in the body, do not cause accumulation, and do not mask other disease symptoms.

3>.There are basically no adverse reactions.

4>.It will not cause drug dependence and has no "three-cause" effect.

5>.The formula is reasonable, there is no adverse interaction, and there is no "18 antis, 19 fears" in the traditional Chinese medicine formula.

Two. The efficacy is certain, and the "selection principle" stipulates.

1>.The drug has a highly targeted effect, and the function and indication are clear.

2>.The dosage generally does not need to be adjusted, and the dosage is relatively fixed.

3>.Continuous use will not occur drug resistance, drug resistance, so that the drug loses the best effect;

Three. The quality is stable, and the "selection principle" stipulates that the quality of non-prescription drugs must be controllable, stable in nature, and do not require special storage conditions.

Four. Ease of use, "Selection Principles" stipulates, 1>No special inspection or test is required for use.

2>.Dosage forms, specifications are easy to use and carry, mainly oral, external, inhaled, anal plug and other dosage forms.

Clinically necessary, safe and effective, reasonable, easy to use, both Chinese and Western

Clinically necessary, safe and effective, reasonable, easy to use, both Chinese and Western medicines.

National Essential Medicines Number Cavity.

Article 4 of the "Measures for the Administration of the Catalogue" stipulates that the selection of national essential drugs shall be in accordance with the principles of necessary prevention and control, effective safety guessing and demolition, reasonable and easy to use, equal emphasis on Chinese and Western medicines, basic guarantees, clinical first choice and grassroots can be equipped, combined with the characteristics of China's drug use, with reference to international experience, and reasonably determine the variety (dosage form) and number.

China's national essential medicines system is a system for effective management of the formulation of the list of essential medicines, production, procurement and distribution, rational use, management, payment and reimbursement, quality supervision, monitoring and evaluation. The national basic medicine system can improve the current drug security system and protect the people.

safe use of medications. Ensuring the full amount and rational use of basic drugs is conducive to protecting the rights and interests of the masses in basic drug use, transforming the mechanism of "supplementing medicine with medicine", and is also conducive to promoting the optimization and integration of resources in drug production and circulation enterprises, which is of great significance for realizing that everyone enjoys basic medical and health services, maintaining people's health, reflecting social fairness, reducing the burden of drug use on the masses, and promoting the development of health undertakings. In 2009, each province (autonomous region, municipality) implemented the basic drug system in 30% of the first-class urban community health service institutions and counties (primary medical and health institutions), including the implementation of provincial-level centralized online public bidding procurement and unified distribution, all equipped with the use of basic drugs and achieved zero-margin sales.

All essential drugs are included in the reimbursement list of basic medical security drugs, and the reimbursement ratio is significantly higher than that of non-essential drugs. By 2011, a national essential drug system will be initially established. By 2020, a standardized national essential drug system covering both urban and rural areas will be fully implemented.

Licensed Pharmacist Examination.

The knowledge points of the chapter are summarized, and I wish you easy forensics.

Mobile question bank.

PC Question Bank.

Legal analysis: The national principles for the selection of essential drugs include the principles of necessary for prevention and treatment, safe and effective, reasonable, easy to use, equal emphasis on Chinese and Western medicines, basic guarantees, clinical first choice and grassroots can be equipped.

Legal basis: Article 4 of the Measures for the Administration of the National Essential Medicines List The selection of national essential drugs shall be in accordance with the principles of necessary for prevention and treatment, safe and effective, reasonable, convenient to use, equal emphasis on Chinese and Western medicines, basic guarantees, clinical preference and grassroots can be equipped, combined with the inventory of special drugs in China, and with reference to the international experience before stuffiness, and reasonably determine the variety (dosage form) and quantity. The formulation of the National Essential Medicines List shall be linked to the basic public health service system, the basic medical service system, and the Zhengye basic medical security system.

The selection criteria for national essential drugs should not only conform to international trends and international standards, but also be integrated with China's national conditions. China's selection of the National Essential Medicines List mainly follows the following principles:

1 Clinically necessary.

Essential drugs must be able to meet the needs of the broad masses of the people for key medical and health care, that is, they should be able to meet the clinical prevention and needs of people for common diseases, frequent diseases, infectious diseases (including serious major infectious diseases such as AIDS, etc.), poisoning, and primary health care.

2 Safe and effective.

The safety and efficacy of drugs are the most basic conditions for the marketing of drugs. The "safe and effective" required by the national essential drug selection requirement refers to the fact that there is clear efficacy data and clinical use evidence to prove that the drug has definite efficacy and small adverse reactions.

3 **Reasonable.

The selection of essential medicines must take into account the pharmacoeconomics of total cost versus benefit. The relative cost-benefit ratio is the main issue that should be considered when selecting a drug in the same category. According to the comparison of the unit price and the cost of the whole course of treatment, select the most reasonable varieties to enter the list of essential drugs.

4 Ease of use.

It is necessary to have a suitable dosage form and an appropriate amount of packaging, which is suitable for use in medical institutions of different sizes and levels. It is convenient for both doctors and patients, and at the same time facilitates transportation and storage.

5. Equal emphasis on Chinese and Western medicines.

In the selection of essential medicines, Chinese medicine and Western medicine should be given equal importance.

Legal basis

Pharmaceutical Administration and Regulations

Principles of drug selection.

1. The principle of non-prescription drug selection: "safe application, exact efficacy, stable quality, and convenient application." ”

2. The selection principle of national essential drugs: "clinically necessary, safe and effective, reasonable, easy to use, and equal emphasis on Chinese and Western medicines." ”

3. The selection principle of basic medical insurance drugs for urban employees: "clinically necessary, safe and effective, reasonable, easy to use, and guaranteed by the market." ”

4. The guiding ideology for the selection of over-the-counter drugs is: "safe and effective, prudent and strict, combined with national conditions, and paying equal attention to Chinese and Western." ”

The principle of the selection of the National Essential Medicines List is that it is necessary for prevention and treatment, safe and effective, reasonable, convenient to use, and attaches equal importance to Chinese and Western medicines, combined with the characteristics of China's medication, and refers to international experience.

Legal basis: Article 3 of the Work Plan for the Adjustment of the National Medical Insurance Drug List in 2019 involves three aspects: Western medicine, Chinese patent medicine, and Chinese medicine decoction pieces, including drug transfer in and drug transfer. Based on the information of drugs approved for marketing by the State Food and Drug Administration, it does not accept enterprise applications or recommendations, and does not charge review fees and other fees.

The western medicines and proprietary Chinese medicines to be transferred should be drugs registered and marketed by the State Food and Drug Administration before December 31, 2018 (inclusive). Priority will be given to national essential drugs, drugs for major diseases such as cancer and rare diseases, drugs for chronic diseases, drugs for children, and drugs for first aid and rescue. According to the first field of drugs, pharmacological effects, functional indications, etc., the classification is carried out, and experts are organized to review by category.

Compare similar drugs in accordance with the principles of pharmacoeconomics, and give priority to the varieties that have sufficient evidence to prove that they are clinically necessary, safe and effective, and reasonable. Under the premise of satisfying the effectiveness and safety, the cost is equivalent to or lower than the existing varieties in the drug catalog, which can be included in the catalog in a conventional way; **Higher or greater impact on medical insurance** patented exclusive drugs shall be admitted through negotiation (the identification time of exclusive drugs is subject to the day before the selection and voting date).

Selection principles: clinically necessary, safe and effective, reasonable, easy to use, equal emphasis on Chinese and Western medicines.

National essential drugs: refers to drugs that can meet people's priority needs for health care, and are drugs that are determined in limited quantities after careful screening in accordance with certain selection principles.

The purpose of formulating the list of essential drugs: The purpose of formulating the national essential drug policy is to strengthen the scientific management and macro-control of the national drug development, production, operation, use and supervision, rationally allocate resources, and ensure that the health requirements of the public are met. To make the essential medicines policy fully effective in the following ways:

to ensure the health of all people; standardize the rational use of drugs; promote the reform of the health insurance system; Properly guide drug research and development.

First, experts are randomly selected from the national essential drug expert database to set up a catalogue advisory expert group and a catalogue review expert group; Second, the advisory expert group conducts technical evaluation of the drugs included in the selection scope according to evidence-based medicine and pharmacoeconomics, puts forward selection opinions, and forms a list of candidates; Third, the review panel will review and vote on the alternative catalogs to form the first draft of the catalog; Fourth, the first draft of the catalog will solicit the opinions of relevant departments, and form a draft for review after revision and improvement; Fifth, the Ministry of Health is authorized to release the draft for review after being reviewed by the National Essential Drugs Working Committee.

Legal analysis: the selection principles of essential drugs: clinically necessary, safe and effective, reasonable, easy to use, both Chinese and Western, merit-based selection, regular adjustment and supplementation.

Legal basis: "Drug Administration Law of the People's Republic of China with Lu Bird".

Article 1 This Law is enacted in order to strengthen drug management, ensure drug quality, protect the safety and legitimate rights and interests of the public, and protect and promote public health.

Article 2 This Law shall apply to those engaged in the development, production, distribution, use, supervision and management of drugs within the territory of the People's Republic of China.

The term "drugs" as used in this Law refers to substances used to prevent, diagnose and diagnose human diseases, purposefully regulate human physiological functions, and stipulate indications or functional indications, usage, and dosage, including traditional Chinese medicine, chemical drugs, and biological products.

Article 3 Drug management should be centered on people's health, adhere to the principles of risk management, whole-process control, and social co-governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, training of drugs early, effective and accessible.