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20 18 refined examination questions for licensed pharmacists (3)
Chapter VI Administration of Traditional Chinese Medicine

1, the contents that need not be indicated on the label of Chinese herbal pieces are

A. Date of production

B. country of origin

C. Product batch number

D. Effective time

Reference answer: D.

Reference analysis: the label of Chinese herbal pieces must indicate the name, specification, origin, manufacturer, product batch number and production date. Chinese herbal pieces subject to the approval number management must also indicate the drug approval number. So choose D.

2, drug dispensing personnel in the deployment of "eighteen evils" and "nineteen fears" of Chinese herbal medicine prescription, the measures should be taken are

A. As an illegal prescription, refuse to prepare it and report it as required.

B notify the prescriber and ask him to confirm and sign before dispensing.

C deployment can only be carried out after being examined and signed by the professional and technical personnel above the Chinese pharmacist in charge.

D. give medication guidance to patients. Only after the patient is fully informed and asked to sign for confirmation can he be prepared.

Reference answer: b

Reference analysis: there are prescriptions of Chinese herbal pieces with "eighteen evils" and "nineteen fears" It should be confirmed or reissued by the prescriber before deployment. So choose B.

It is wrong to say that medical institutions process Chinese herbal pieces.

A. For Chinese herbal pieces not available in the market, medical institutions can process and use them in their own medical institutions according to the needs of doctors' prescriptions.

B. When processing Chinese herbal pieces, a medical institution shall file with the local provincial drug supervision and administration department.

C medical institutions shall abide by the relevant regulations on the processing of Chinese herbal pieces, be responsible for the quality of processed Chinese herbal pieces, and ensure the safety of drug use.

The processing of Chinese herbal pieces by medical institutions should be carried out in strict accordance with the national drug standards and the processing norms formulated by the provincial drug supervision and administration departments.

Reference answer: b

Reference analysis: (1) For Chinese herbal pieces not available in the market, medical institutions can process and use them in their own medical institutions according to the needs of doctors' prescriptions. Therefore, A is correct. (two) medical institutions shall file with the municipal drug supervision and administration department where the Chinese herbal pieces are processed. So, B is wrong. (three) medical institutions shall abide by the relevant provisions of the processing of Chinese herbal pieces, and be responsible for the quality of the processed Chinese herbal pieces to ensure the safety of medication. So, C is correct. (four) medical institutions should have suitable processing conditions and facilities for Chinese herbal pieces, and strictly follow the national drug standards and the processing norms formulated by the provincial drug supervision and administration departments. Therefore, d is correct.

4, about Chinese herbal pieces, the correct are

A. The production of Chinese herbal pieces must hold the Pharmaceutical Production License and the good manufacturing practice Certification Certificate.

B. Medical institutions can purchase Chinese herbal pieces from the Chinese herbal medicine market for adjustment and use.

The wholesale and retail of Chinese herbal pieces must hold a Pharmaceutical Trading License and a Certificate of Quality Management Standards for Pharmaceutical Trading.

D Chinese herbal pieces production enterprises can outsource semi-finished Chinese herbal pieces for sub-packaging and label replacement.

Reference answer: a, c

Reference analysis: (1) The production of Chinese herbal pieces must hold the Pharmaceutical Production License and the Pharmaceutical GMP Certificate. (2) Wholesale and retail of Chinese herbal pieces must hold the Drug Business License and GSP certificate. (3) It is forbidden for production enterprises to outsource and repackage semi-finished or finished Chinese herbal pieces or change the packaging label. (four) it is forbidden for medical institutions to illegally purchase Chinese herbal pieces from the Chinese herbal medicine market or other unqualified units and individuals. Therefore, A and C are correct and B and D are wrong.

5, about the preparation of traditional Chinese medicine in medical institutions, the mistakes are

A. A medical institution shall obtain a Pharmaceutical Preparation Permit for Medical Institutions when preparing Chinese medicinal preparations.

B. medical institutions shall not entrust the preparation of traditional Chinese medicine preparations.

C the varieties of traditional Chinese medicine preparations prepared by medical institutions shall be filed with the provincial drug supervision and administration department where the medical institutions are located.

D medical institutions should obtain the approval number of traditional Chinese medicine preparations prepared by traditional techniques.

Reference answer: b, c, d

Reference analysis: (1) Traditional Chinese medicine preparations in medical institutions. It shall obtain a Pharmaceutical Preparation License from a medical institution, or entrust a pharmaceutical production enterprise that has obtained a Pharmaceutical Production License or other medical institutions that have obtained a Pharmaceutical Preparation License to prepare traditional Chinese medicine preparations. So, A is right and B is wrong. (two) the varieties of traditional Chinese medicine preparations prepared by medical institutions shall obtain the preparation approval number according to law; Only the varieties of traditional Chinese medicine preparations prepared by traditional technology can be prepared after being filed by the provincial drug supervision and administration department where the medical institution is located, and it is not necessary to obtain the preparation approval number. So both c and d are wrong.

6. There is an error in the statement that medical institutions entrust traditional Chinese medicine preparations.

A medical institution may entrust a pharmaceutical production enterprise that has obtained a pharmaceutical production license to prepare traditional Chinese medicine preparations.

B A medical institution may entrust other medical institutions that have obtained the Pharmaceutical Preparation License for Medical Institutions to prepare traditional Chinese medicine preparations.

The preparation of traditional Chinese medicine preparations by medical institutions shall be approved by the provincial drug supervision and administration department where the entrusting party is located.

D when a medical institution entrusts the preparation of traditional Chinese medicine preparations, it shall file with the municipal drug supervision and administration department where the entrusting party is located.

Reference answer: c, d

Reference analysis: (1) A medical institution shall obtain the Pharmaceutical Preparation License for Medical Institutions, or entrust a pharmaceutical production enterprise that has obtained the Pharmaceutical Production License or other medical institutions that have obtained the Pharmaceutical Preparation License for Medical Institutions to prepare traditional Chinese medicine preparations. Therefore, A and B are correct. (2) Where a medical institution entrusts the preparation of traditional Chinese medicine preparations, it shall file with the provincial drug supervision and administration department where the entrusting party is located. So both c and d are wrong.

7. The important wild medicinal materials with reduced distribution area and exhausted resources are

A. ginseng

rhizome of Chinese goldthread

C. licorice

D. scutellaria baicalensis Georgi

Reference answers: a, b, c

Reference analysis: Ginseng, Coptis chinensis and Glycyrrhiza uralensis are important wild medicinal materials, with reduced distribution area and exhausted resources, belonging to second-class protected wild medicinal materials, so A, B and C are selected.

8, the national second-class protection of wild Chinese herbal medicine medicinal species include

A. bear bile

B. toad venom

C. snake gall

D. Eucommia ulmoides

Reference answer: a, b, d

Reference analysis: Bear bile, toad venom and Eucommia ulmoides belong to the second-class protected wild medicinal species. So choose a, b and d.

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