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Error-prone Test Set of Pharmaceutical Affairs Management and Licensed Pharmacist Examination Rules (2)
1. According to the planning outline of Healthy China 2030, the strategic goal of a healthy China by 2050 is

A. Main health indicators are in the forefront of low-income countries

B main health indicators are in the forefront of middle and high income countries.

C. Major health indicators are among the best in high-income countries.

D. Building a healthy country that is compatible with the socialist modernized country

Reference answer: D.

Analysis: Investigate the objectives and tasks of the healthy China strategy. The strategic goal of healthy China defined in the outline of Healthy China 2030: By 2020, a basic medical and health system with China characteristics covering urban and rural residents will be basically established, the level of health literacy will continue to improve, the health service system will be perfect and efficient, and everyone will enjoy basic medical and health services and basic sports and fitness services, basically forming a healthy industrial system with rich connotations and reasonable structure, and the main health indicators will be in the forefront of middle-and high-income countries. By 2030, the institutional system for promoting the health of the whole people will be more perfect, the development of the health field will be more coordinated, healthy lifestyles will be popularized, the quality of health services and the level of health protection will be continuously improved, the health industry will prosper and basically achieve health equity, and the main health indicators will enter the ranks of high-income countries. By 2050, we will build a healthy country that is compatible with the socialist modern country.

2. The National Medical Insurance Bureau and Ministry of Human Resources and Social Security issued the Catalogue of Drugs for National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance. What's wrong with this directory is that

A. The catalogue * * * is divided into five parts: generic drugs, western medicines, Chinese patent medicines, drugs negotiated during the agreement period, and Chinese herbal pieces.

B. Western medicine includes chemicals and biological products; Chinese patent medicines include Chinese patent medicines and ethnic medicines; Drugs negotiated during the agreement period include drugs that are still within the validity period of the negotiation agreement.

C. During the agreement period, the negotiated drugs are only managed according to Class B and paid according to Class B..

D industrial injury insurance and maternity insurance do not distinguish between Class A and Class B when paying for drugs.

Reference answer: C.

Analysis: Investigate the classification, formulation and adjustment of medical insurance drug list. Western medicine, Chinese patent medicine and drugs negotiated during the agreement period are managed according to Class A and Class B, and drugs negotiated during the agreement period are paid according to Class B. It is wrong to say that drugs negotiated during option C are only managed according to Class B, so the answer is C.

3, the following drugs can be included in the national basic medical insurance coverage is?

A. Various wine preparations brewed with Chinese herbal medicines and Chinese herbal pieces.

B. National immunization program vaccine

C. Chinese herbal pieces processed according to provincial processing standards

D bring the winning drugs into the national centralized procurement scope.

Reference answer: D.

Analysis: Review the Regulations on the Administration of Drug List of Basic Medical Insurance. Liquor preparation shall not be included in the basic medical insurance coverage. Option a does not meet the problem. Preventive vaccine shall not be included in the basic medical insurance coverage. Option b does not meet the problem. Drugs included in the national basic medical insurance drug list should be chemicals, biological products and Chinese patent medicines (ethnic medicines) approved by the State Administration of Pharmaceutical Products and processed according to national standards, which meet the basic conditions of clinical necessity, safety, effectiveness and reasonable price. Option c is a provincial standard, which does not meet the meaning of the question.

4, the characteristics of drug safety risks do not include

A. Complexity

B. Unpredictability

C. inevitability

Out of control

Reference answer: D.

Analysis: Investigate the risk management requirements of drug safety. Drug risk management does not pursue "zero risk", but pursues control within an acceptable range. So the answer is d.

5. The statement about the provisions of the professional qualification examination for licensed pharmacists is wrong.

A. Bachelor degree in pharmacy or traditional Chinese medicine, who has worked in pharmacy or traditional Chinese medicine for 2 years, can apply for the professional qualification examination for licensed pharmacists.

B college degree in pharmacy or Chinese pharmacy, who has been engaged in pharmacy or Chinese pharmacy for 6 years, can apply for the professional qualification examination of licensed pharmacists.

C. The management of test scores takes four years as a cycle, and some test-free subjects must pass the test subjects within two consecutive test years.

D. Persons who have obtained senior titles in pharmacy or medicine in accordance with the relevant provisions of the state and work in pharmaceutical posts may take the professional qualification examination for licensed pharmacists who are exempt from some pharmaceutical subjects.

Reference answer: b

Analysis: This question examines the professional qualification examination for licensed pharmacists. The working experience of related majors is higher than that of pharmacy and traditional Chinese medicine seniors 1 year. Option B should have worked in pharmacy or Chinese pharmacy for five years before entering the exam, which is wrong. So the answer is B.

6. The administrative punishment stipulated in the Drug Administration Law of People's Republic of China (PRC) shall be decided by the drug supervision and administration department of the people's government at or above the county level in accordance with the division of responsibilities; If the license is revoked or revoked, it shall be decided by the department that originally approved the issuance of the license. "This reflects.

A unless otherwise provided by laws and administrative regulations, administrative punishment shall be under the jurisdiction of the administrative organ of the local people's government at or above the county level where the illegal act occurred.

B. Two or more administrative organs with the power of administrative punishment according to law have jurisdiction over the same case of administrative violation. If the administrative organs have disputes over the jurisdiction of the case and the two sides fail to reach an agreement through consultation, they shall report to the administrative organ at the next higher level with the same name for designation of jurisdiction.

If the illegal act constitutes a crime, the administrative organ with jurisdiction must transfer the case to the judicial organ.

D if an illegal act is not discovered within two years, no administrative penalty shall be imposed unless otherwise provided by law.

Reference answer: a

Analysis: Investigate the jurisdiction of administrative punishment. The administrative punishment of the Drug Administration Law is basically the responsibility of the drug supervision and administration department at or above the county level where the illegal act occurred, but the license issuing agency is responsible for issuing licenses and registration certificates. So the answer is a.

7, the following items belong to the national drug supervision and administration department's main responsibilities are

A. Organize and guide the investigation of food and drug crime cases

B responsible for the safety supervision and management, registration management, quality management and post-marketing risk management of drugs, medical devices and cosmetics.

Organize and deepen the comprehensive reform of public hospitals and improve the modern hospital management system.

D to be responsible for the examination and approval of the purchase and use of signature cards for narcotic drugs and psychotropic drugs of category I in medical institutions.

Reference answer: b

Analysis: It is the public security department that organizes and guides the investigation of food and drug crimes. It is the health authorities that organize and deepen the comprehensive reform of public hospitals and improve the modern hospital management system. The examination and approval authority for the purchase and use of narcotic drugs and psychotropic drugs of category I by medical institutions is the municipal health department with districts. The State Administration of Medical Devices is responsible for the safety supervision and management, registration management, quality management and post-marketing risk management of drugs, medical devices and cosmetics. So the correct answer is B.

8. The statement about the revision of drug standards is correct.

China Pharmacopoeia is revised and promulgated every five years from 1985.

B The national drug standards of the State Food and Drug Administration ("local drug standards" or "local drug standards") are revised every five years.

C. Drug registration standards are revised every five years.

D. The processing standard of Chinese herbal pieces is revised every five years.

Reference answer: a

Analysis: Investigate the categories of national drug standards. China Pharmacopoeia is revised every five years, but there is no such provision in other national drug standards. So the answer is a.

9. The management of drugs used in drug clinical trials shall conform to the relevant requirements of the Quality Management Standard for Drug Clinical Trials. It is wrong to say that clinical trials of drugs are needed.

First, clinical trials of drugs should be implemented within three years after approval.

B. If the subject fails to sign the informed consent within 3 years from the date of approval of the drug clinical trial application, the drug clinical trial license will automatically become invalid.

C. If the clinical trials of drugs that have not been implemented still need to be implemented after 3 years of approval, they may apply for extension.

Clinical trials of drugs should be reviewed and approved by the ethics committee.

Reference answer: C.

Analysis: To investigate the regulations and quality management requirements of drug clinical trials. After three years of approval, the clinical trials of drugs that have not been implemented will automatically become invalid and need to be reapplied, not renewed. So the answer is C.

10, drug marketing license holders can pass the exam if they want to declare more question banks in the annual report 100.

A. Minor changes in the pharmaceutical production process

B. Moderate changes in the pharmaceutical production process

C. moderate changes in the pharmaceutical production process

D. Sub-packaging of drugs

Reference answer: a

Analysis: The holder of drug marketing license should report the following changes in the annual report: ① minor changes in drug production process; (2) Other changes required to be reported by the State Administration of Pharmaceutical Products. So the correct answer is a.