20 17 licensed pharmacist "pharmaceutical affairs management and regulations" questions and answers 2
1. The following statement is wrong.
A. The licensed pharmacist qualification system belongs to the licensed pharmacist qualification system, which controls the professional access of pharmaceutical personnel.
B. Licensed pharmacists refer to pharmaceutical technicians who have passed the national unified examination, obtained the qualification certificate of licensed pharmacists and registered, and practiced in pharmaceutical production, marketing and use units.
C. China's licensed pharmacists implement registration system and continuing education registration system.
D "Licensed Pharmacist Registration Certificate" is valid nationwide.
"correct answer" d
2. The following statement is wrong.
A. Ministry of Human Resources and Social Security and China Food and Drug Administration are jointly responsible for the qualification examination of licensed pharmacists, and the examination is conducted with a unified national outline, proposition and organization.
B China citizens and people of other nationalities who are allowed to work in China, who have technical secondary school education or above in pharmacy, traditional Chinese medicine or related majors and have certain professional work experience, can apply for licensed pharmacists.
C. Persons who have been rated as senior professional and technical positions, have apprenticeships in traditional Chinese medicine, pharmacy or technical secondary school education, and have been engaged in pharmacy or traditional Chinese medicine for 15 years, and may be exempted from some examination subjects.
D. The conditions for the registration of licensed pharmacists are: obtaining the qualification certificate of licensed pharmacists; Abide by discipline and law, and abide by professional ethics; Being in good health and able to persist in the work of licensed pharmacists; With the consent of the practicing unit
"correct answer" c
The following statement is wrong.
A the provincial food and drug supervision and administration department is the registered institution of licensed pharmacists in this area.
B A licensed pharmacist shall register with the provincial licensed pharmacist registration agency where the practicing unit is located according to the category, scope and area of practice.
C licensed pharmacists can only be registered in the licensed pharmacist registration institution and practice in a practicing unit according to the registered practice category and scope.
D There is an urgent need for licensed pharmacists in China. Licensed pharmacists working in government agencies, universities, scientific research institutions and drug inspection institutions can register.
"correct answer" d
The following statement is wrong.
Licensed pharmacists are registered for three years. A licensed pharmacist who changes the practice area, practice unit and practice scope shall go through the registration formalities in time.
B those who have not been on the job for more than half a year without justifiable reasons will not be registered.
C licensed pharmacists take drug quality responsibility and ensure the safety and effectiveness of public medication as the basic criteria.
D licensed pharmacists are responsible for reviewing and supervising prescriptions, providing medication consultation and information, guiding rational drug use, and carrying out clinical pharmacy work such as therapeutic drug monitoring and drug efficacy evaluation.
"correct answer" b (quality and safety; In accordance with the law, quality management, rational use)
5. The following statement is wrong.
Personnel who have obtained the Qualification Certificate of Licensed Pharmacists must receive continuing education of licensed pharmacists every year.
Continuing education is the obligation and right of licensed pharmacists.
C The continuing education of licensed pharmacists shall be subject to the credit registration system, and they shall participate in the national or provincial pharmacists association 15 credits of continuing education every year, and the credits obtained shall be valid within their respective scope.
D. Credit certificate is one of the necessary conditions for licensed pharmacists to register again.
"correct answer" c
6. The Twelfth Five-Year Plan for National Drug Safety was put forward.
A. It is necessary to increase the use of licensed pharmacists and give full play to the role of licensed pharmacists in guiding rational drug use and drug quality management.
B new retail pharmacies must be equipped with licensed pharmacists.
C all legal persons or main managers of retail pharmacies must be qualified as licensed pharmacists.
D all retail pharmacies and hospital pharmacies have licensed pharmacists to guide rational drug use when they are fully operational.
"correct answer" a
7. The following are not within the scope of practice of licensed pharmacists.
A. retail pharmacies
B. Pharmaceutical wholesale enterprises
C. medicine pharmacy
D. Drug inspection agencies
"correct answer" d
The teacher didn't explain the problem.
8. The following statement is wrong.
A drugs refer to substances used to prevent, treat and diagnose human diseases, purposefully regulate human physiological functions, and specify indications or functional indications, usage and dosage.
B drugs not only refer to finished drugs or pharmaceutical preparations, but also include raw materials, Chinese herbal medicines and diagnostic drugs. Biochemical drugs belong to biological products.
C Except for in vitro diagnostic reagents used for blood source screening and those labeled with radionuclides, other in vitro diagnostic reagents are managed according to medical devices in China.
The quality characteristics of drugs include effectiveness, safety, stability and consistency; The particularity of drugs includes specificity, duality, quality importance and time limit.
"correct answer" b
9. The following statement is wrong.
A. Drug safety is a major basic livelihood, economic and political issue; The characteristics of drug safety risk include complexity, unpredictability and inevitability.
B. Drug safety management is the risk management of drug safety, and the core requirement is to organically combine prevention in advance, control in the process and disposal afterwards to form the whole chain management.
C. Strengthen the management of drug research and development, production, marketing and use, and drug production enterprises shall undertake the safety monitoring and risk management of drugs throughout their life cycle.
D. Drug safety risks can be divided into man-made risks and natural risks. The former is the inherent property of drugs, which belongs to the risk of drug design and exists objectively; The latter belongs to "accidental risk", which refers to the drug safety risk caused by intentional or unintentional violation of laws and regulations. It exists in all aspects of drug research and development, production, management and use, and is the key factor of drug safety risk in China.
"correct answer" d
10. The planning index of drug safety management in China is wrong.
A the standards of all chemicals, biological products, traditional Chinese medicines, medical devices, national essential drugs and commonly used drugs in clinic meet or approach international standards.
B 100% of pharmaceutical production meets the requirements of the revised good manufacturing practice.
C 100% sterile and implantable medical devices meet the requirements of "Quality Management Standard for Medical Device Production".
D. 100% of the pharmaceutical business meets the requirements of the "Quality Management Standards for Pharmaceutical Business".
"correct answer" a
1 1. The following statement is wrong.
A. Essential drugs refer to drugs that meet the basic medical and health needs, have appropriate dosage forms, are reasonably priced, can guarantee supply, and can be fairly obtained by the public (meet the demand, have reasonable dosage and price, and can be supplied).
B the national essential drug system is the core of the national drug policy and the basis of the drug supply guarantee system. The national essential drug system was first implemented in the primary medical and health institutions organized by the government. Its main contents include the selection and adjustment of the national essential drug list, production and supply guarantee, centralized bidding and procurement and unified distribution, zero-difference sales *, all equipment and use, medical insurance reimbursement, financial compensation, quality and safety supervision, performance evaluation and other related policies and measures (standardizing production and circulation, improving accessibility rights, and implementing zero-difference rate).
C. The National Health and Family Planning Commission is responsible for the relevant policy issues in all aspects of the national essential drug system, and all relevant departments do a good job in the selection and adjustment of national essential drugs within the scope of their duties.
D The Office of the National Essential Drugs Working Committee is located in the National Health and Family Planning Commission and undertakes the daily work of the National Essential Drugs Working Committee.
"correct answer" c
What's wrong with the 12.20 12 version of the National Essential Drugs List?
A continue to pay equal attention to both Chinese and western medicine, pay attention to the connection with common diseases, chronic diseases, especially major diseases, and be suitable for the elderly, women and children in medical and health institutions at all levels.
B listed drugs are divided into three parts: chemical drugs and biological products, Chinese patent medicines and Chinese herbal pieces. Chemicals and biological products are mainly classified according to their functions; Chinese patent medicines are mainly classified according to clinical pharmacology; Chinese herbal pieces stipulate that "Chinese herbal pieces that have issued national drug standards are national basic drugs"
The "△" in the remarks column indicates that drugs should be used by doctors with corresponding prescription qualifications or under the guidance of specialists.
D. the State Council Food and Drug Administration is responsible for the evaluation and sampling of essential drugs, and organizes the re-evaluation of essential drug varieties; The provincial food and drug supervision department is responsible for the supervision and sampling of essential drugs.
"correct answer" b
13. The following statement is wrong.
A. Adhere to the direction of centralized online purchasing of essential drugs by provinces (autonomous regions and municipalities).
B All essential drugs are included in the reimbursement list of basic medical insurance drugs, with 65,438+0,000% reimbursement, and the reimbursement ratio is significantly higher than that of non-essential drugs.
C. Basic medical and health institutions should all be equipped with essential drugs to achieve zero-difference sales. Other medical institutions must also use essential drugs according to regulations, and all retail pharmacies must be equipped with and sell essential drugs.
D. The administrative department of health shall formulate guidelines for clinical application of essential drugs and prescription sets of essential drugs, and strengthen the guidance and supervision of drug use.
"correct answer" c
14. Regarding the origin of legal validity, the mistake lies in
A. The legal system of drug supervision includes: laws, administrative regulations, departmental rules, and normative documents according to the level of legal effect (the superior law has special new provisions).
Law B refers to the normative documents formulated by the National People's Congress and its Standing Committee, such as the Drug Administration Law.
C. Administrative regulations are promulgated by the the State Council Order signed by the Prime Minister, such as the Regulations for the Implementation of the Drug Administration Law.
Local regulations shall be formulated by the people's governments of provinces, autonomous regions, municipalities directly under the Central Government, cities divided into districts and autonomous prefectures.
"correct answer" d
15. The following statement is wrong.
Legal liability includes civil liability, administrative liability and criminal liability.
B The three main bodies of the legal relationship of drug supervision in China are: state organs, institutions and organizations, and individual citizens, including administrative legal relationship, service relationship and management relationship; The three targets are drugs, people and spiritual products (new drugs, new technologies and new standards).
Four principles of establishing and implementing administrative license: legality, fairness, convenience, efficiency and trust protection.
D Drug administrative licensing items include: drug production license, business license, drug marketing license, licensed pharmacist license, and new drug research license.
"correct answer" d
16. The cancelled administrative examination and approval items do not include
A. Qualification examination of designated retail pharmacies and designated medical institutions
B. GAP certification of Chinese herbal medicine production.
C. Preliminary examination and approval of research projects on narcotic drugs and psychotropic substances
D. Administrative license for entrusted production of drugs, and approval for the production of precursor chemicals of Class I drugs.
"correct answer" d
17. The mistake of administrative coercion lies in
A the purpose is to prevent or stop illegal acts, dangerous situations and adverse consequences that are happening or may happen.
The purpose of B is to preserve evidence and ensure the smooth investigation and handling of cases.
C. Take temporary administrative compulsory measures or administrative enforcement compulsory obligations against the person or property of the counterpart according to law.
D. Administrative compulsory measures include adding fines or late fees, transferring deposits, remitting money, performing on behalf of others, etc.
"Correct answer" D (The types of administrative compulsory measures include: ① restricting citizens' personal freedom; (2) sealing up places, facilities or property; 3. Seizure of property; (4) Freezing deposits and remittances; ⑤ Other administrative compulsory measures. The ways of administrative enforcement include: ① additional fines or late fees; ② Transfer deposits and remittances; (three) auction or disposal of places, facilities or property sealed up or detained according to law; (4) remove obstacles and restore to the original state; (5) Power generation performance. )
18. The statement about administrative punishment is wrong.
A. Administrative punishment shall be under the jurisdiction of the county-level administrative organ with the power of administrative punishment in the place where the illegal act occurred; Including administrative detention, ordering production and business suspension, revocation of permits or licenses, fines and confiscation of property, warnings, etc.
B. If the illegal act constitutes a crime, the administrative organ with jurisdiction must transfer the case to the judicial organ: if a person is sentenced to criminal detention or fixed-term imprisonment, the administrative organ has given the party administrative detention, and the corresponding sentence shall be reduced according to law; When imposing a fine, if the administrative organ has already imposed a fine, it shall offset the corresponding fine.
C. Non-penalty includes: a person under the age of 14 commits an illegal act; The illegal act has not been discovered within two years; Mental patients commit illegal acts when they can't recognize or control their own behavior; The illegal act is minor and corrected in time, without causing harmful consequences; Actively eliminating or mitigating the harmful consequences of illegal acts; Being coerced by others to commit illegal acts; Having rendered meritorious service in cooperating with administrative organs in investigating and handling illegal acts.
D. If a small fine is imposed (a fine of less than 50 yuan is imposed on citizens, and a fine of less than 1000 yuan is imposed on legal persons or other organizations) or a warning is given, summary procedure shall be applied and punishment shall be imposed on the spot; Before an administrative organ makes a decision on administrative punishment, such as ordering to suspend production or business, revoking the license and license, or imposing a heavier fine, it shall inform the parties of their right to request a hearing.
"correct answer" c
19. The statement about administrative relief is wrong.
A administrative reconsideration shall be submitted to the statutory administrative reconsideration organ according to law. The scope of reconsideration is that the specific administrative act of the administrative subject infringes on its legitimate rights and interests, and the administrative reconsideration organ shall examine the legality and appropriateness of the specific administrative act applying for reconsideration.
B the time limit for administrative proceedings is 60 days.
C. national defense, foreign affairs and other acts of state; Administrative regulations, rules or universally binding decisions and orders formulated and promulgated by administrative organs; The decision of the administrative organ on the rewards and punishments and the appointment and removal of its staff; An administrative act in which an administrative organ makes a final ruling according to law; Acts explicitly authorized by public security, national security and other organs according to the Criminal Procedure Law; Administrative mediation and arbitration prescribed by law; The people's court shall not accept administrative guidance acts that are not mandatory/have no actual impact on the rights and obligations of citizens, legal persons or other organizations.
D. Administrative reconsideration cannot be filed separately for abstract administrative acts, but only when administrative reconsideration is filed for specific administrative acts.
"correct answer" b
20. China Food and Drug Inspection Institute is responsible for.
Undertake technical supervision work such as food and drug registration inspection, inspection and testing, re-inspection, technical arbitration, supervision and sampling inspection.
B organize the formulation and revision of national drug standards, technical requirements and quality standards for pharmaceutical excipients, packaging materials and containers that are in direct contact with drugs.
Responsible for the technical review of drugs applied for registration, and participate in the formulation and adjustment of the national list of essential drugs and over-the-counter drugs.
D participate in the formulation of technical documents such as quality management norms and guiding principles related to drugs, medical devices and cosmetics.
"correct answer" a