[1] The requirements to legally evaluate “act of preparing nurses, etc. according to a doctor’s instructions” as “act of preparing medicines directly by a doctor,” where a doctor directly prepares medicines under the former Pharmaceutical Affairs Act

[2] The case holding that where a doctor prescribed the types and dosage of drugs in the medical record book of an in-patient, and a assistant nurse performed the act of mixing and packing drugs in accordance with the contents of the medical record book without any special direction or supervision of the above doctor, the above doctor cannot be deemed as having directly prepared the drugs pursuant to Article 21 (5) of the former Pharmaceutical Affairs Act

[1] Where a doctor directly prepares medicines pursuant to Article 21(5) of the former Pharmaceutical Affairs Act (amended by Act No. 8365 of Apr. 11, 2007), where a doctor is permitted to directly prepare medicines without preparing medicines at his/her own expense, even if a doctor allows a nurse or an assistant nurse to manufacture medicines by mixing the medicines at his/her own expense, if it is merely a mechanical use of a nurse, etc., he/she may be deemed to have directly prepared medicines. However, in light of the purpose and purport of the medicine business system, the purpose and purpose of the medicine business system, relevant provisions of the Pharmaceutical Affairs Act to achieve such system, concerns about infringement on national health, possibility of weakening accidents, etc., a doctor may be deemed to have practically directed and supervised the preparation of medicines, such as nurses, etc. at least the number of inpatients of the relevant medical institution, location of an in-depth patient, type and efficacy of the medicines, etc., and the doctor should also be deemed to have properly instructed and supervised the patient.

[2] The case holding that where a doctor prescribed the types and dosage of drugs in the medical record book of an in-patient and the assistant nurse performed an act of mixing, packing, etc. the drugs contained in a container by type in accordance with the contents of the medical record book without any special direction or supervision from the above doctor, the above doctor cannot be deemed as directly preparing the drugs in accordance with Article 21 (5) of the former Pharmaceutical Affairs Act (amended by Act No. 8365 of Apr. 11, 2007)

[1] Articles 2, 21(1) (see current Article 23(1)) and (5) (see current Article 23(4)) of the former Pharmaceutical Affairs Act (amended by Act No. 8365 of Apr. 11, 2007) / [2] Articles 21(1) (see current Article 23(1) and (5) (see current Article 23(4)), 76(1) (see current Article 95(1)3) of the former Pharmaceutical Affairs Act (amended by Act No. 8365 of Apr. 11, 2007)

Defendant

Defendant

Gwangju District Court Decision 2006No357 Decided June 16, 2006

The appeal is dismissed.

The grounds of appeal are examined.

1. As to each fraud

In full view of the evidence in its reasoning, the court below found the defendant guilty of the part of the charge of this case's fraud. The judgment of the court below is naturally included in the judgment of the defendant's rejection of the defendant's assertion that the defendant had no intention to commit fraud, and in light of the records, such judgment is just and acceptable. Therefore, the ground of appeal that this part of the judgment of the court below is erroneous in omission of judgment, violation of the rules of evidence, or misapprehension of legal principles

2. As to the violation of the Pharmaceutical Affairs Act

According to Article 2 of the former Pharmaceutical Affairs Act (amended by Act No. 8365 of Apr. 11, 2007), the term "preparation of medicines" refers to preparing medicines for the purpose of treating or preventing specific diseases of a specific person in accordance with a specific usage by mixing two or more medicines or sharing one medicine into a certain quantity according to a specific prescription. Article 21 (1) and (5) of the same Act provides that, in principle, a doctor is prohibited from preparing medicines unless he/she is a pharmacist or a herb pharmacist, and a doctor is allowed to directly prepare medicines for inpatients, etc.

As can be seen, in cases where a doctor directly prepares medicines, even though a doctor has not prepared medicines at his/her own expense and had a nurse or a assistant nurse manufacture medicines by mixing the medicines, if the nurse, etc. is merely a mechanically used, the doctor himself/herself may be deemed to have prepared the medicines. However, if a doctor or a pharmacist takes part in the role of treating patients and inspects and cooperates with each other in the contents of prescriptions and preparation, thereby preventing unnecessary or erroneous medication and disclosing prescriptions to the patient so that he/she can know the information on the medicines prescribed by the doctor, taking into account various circumstances, such as the purpose and purport of the medicine medicine business system, the relevant provisions of the Pharmaceutical Affairs Act for accomplishing such system, concerns over infringement on the public health, and possibility of weakening the medicines, it is recognized that a doctor actually directs and supervises the preparation of medicines such as nurses, etc. at least when he/she actually takes part in the direction and supervision of the doctor, the scale and location of the patient, the type and effect of the medicines available, etc.

The court below found the defendant's act of mixing and sealing drugs contained in a container with the type and volume of drugs according to the contents of the medical record (at least four kinds, but the name of the drugs is at least 10 and the efficacy is included among them) at the place of display of drugs adjacent to the reception office of the hospital and the hospital without any specific instruction or supervision of the defendant, after considering the evidence of the statement, and found that the defendant determined the kind and volume of the drugs in the medical record of the patient concerned and determined the type and volume of the drugs in the medical record of the patient concerned. According to the above facts, according to the above facts, the court below determined that the defendant's act of preparing the assistant nurse could not be deemed as a mere mere mere mere mere mere mere mere mere assisting the defendant's act of preparing the drugs under the condition that the defendant can command and supervise such acts.

In light of the above legal principles and records, the judgment of the court below on this part is not somewhat insufficient, but it is just to find the defendant guilty of violating the Pharmaceutical Affairs Act on the ground that the defendant did not directly prepare drugs. There is no violation of the rules of evidence or misapprehension of the legal principles of the Pharmaceutical Affairs Act, as alleged in the grounds of appeal.

3. Conclusion

Therefore, the appeal is dismissed. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Kim Hwang-sik (Presiding Justice)