• The Korean Society of Law and Medicine
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• v.24 no.3
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• pp.3-26
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• 2023

This paper reviewed the Pharmaceutical Affairs Act issues in case of self-administration of medicines by medical personnel without going through the general process (prescription, dispensing, distribution, administration). If a medical personnel self-medicates, the medicine supplier or medical personnel may be subject to criminal punishment under the Pharmaceutical Affairs Act. The core reprehensibility of the punishment lies in undermining the order in distribution of medicines stipulated in the Pharmaceutical Affairs Act. First, the sale of medicines by a medicine supplier to medical personnel may be the violation of Article 47 of the Pharmaceutical Affairs Act. However, if it was distributed for the case where medical personnels can dispense it directly under the Pharmaceutical Affairs Act, it can be justified under the general provision of the Criminal Act (justifiable act, the exclusion of illegality). If medicine suppliers distribute medicines knowing that the medical personnel acquires medicines for selfadministration, they can be punished as the violation of Article 47 of Pharmaceutical Act. Second, when a medical personnel acquires a medicine for the purpose of self-administration, the medicine supplier distributes the medicine under the false pretense that the medical personnel acquires the medicine for the case in which the medical personnel can directly dispense the medicine according to the Pharmaceutical Affairs Act. At this time, even if the medicine supplier has received all the payment for the medicines, the distribution of the medicines by deceit can constitute the fraud under the Criminal Act. Third, self-administration by medical personnel is a the violation of Article 23 of the Pharmaceutical Affairs Act. It is not a justifiable act under the general provision of the Criminal Act. This is because it is the abuse of the special status granted to medical personnel in the Pharmaceutical Affairs Act, which undermines the order in distribution of medicines.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1994.11a
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• pp.5-8
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• 1994

임상시험 guideline은 신약개발을 촉진하기 위하여 약사법 제 26조 제 6항 및 제 24조 제 8호의 규정에 의거하여 신약 임상시험의 안내서로 활용하게 하는데 있다. 임상시험은 특정약의 특정 질환에 대한 임상효과를 판정하기 위하여 시험약의 효과 및 부작용을 윤리적으로 타당한 과학적 시험을 통하여 시행하는 것이다. 특히 임상시험은 사람을 대상으로 하기 때문에 윤리적이고 과학적인 방법을 통하여 시행착오를 최소화하고, 피험자가 위험에 처할 가능성을 최소화하여야 한다.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.119-145
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• 2023

The Pharmaceutical Affairs Act stipulates medication counseling as an obligatory requirement in the case of preparation of medicine. In fact, there are many cases where pharmacists only tell patients the dose and time and do not properly guide them on taking medications. However, in light of the current situation where non-face-to-face treatment is being attempted, there is a high possibility of drug-taking accidents due to insufficient medication guidance. In addition, as an aging society progresses, the need for explanations on pharmaceuticals is increasing. If a pharmacist causes damage to a patient by failing to give appropriate medication guidance, the patient can claim compensation for damages. In addition, if a drug accident occurs due to a conflict between the pharmacist's duty to guide medication and the doctor's duty to explain, a joint tort is established between the pharmacist and the doctor. Nevertheless, there are cases in which only doctors are judged to bear the tort liability. However, the Pharmaceutical Affairs Act includes providing information for the selection of over-the-counter drugs in the medication guidance as part of the medication guidance obligation. Therefore, in order to reconsider the importance of the medication-taking guidance duty, it is necessary to define the medicationaking information provision method and the medication-taking guidance duty as separate concepts. In addition, it is necessary to amend related regulations centered on patients so that medication guidance, such as side effects of medicines and interactions with concomitant medications, can be made in detail.