PUKYONG

약화사고에 있어서 약사의 주의의무

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Abstract
Abstract

As an expert in pharmacy who deals with patients' life, physical status, health, a pharmacist is obliged to do his/her best in order to prevent drug accidents in terms of prescription and sales of medicine and medical supplies. Such obligations as obligations in the management of medicines, obligations in terms of prescription, obligation in terms of sales, obligations in guidance and explanation of taking medicine are summarized as follows:
First, a pharmacist should check medicines to be used in terms of prescription and sales in order to see if foreign matters and alien substances are included in the current year's medicines or they are decay or deteriorated. And it is stipulated that a pharmacist is required not to display, keep, and store medicines contrary to the Provisions of the Pharmaceutical Affairs Law in terms of handling of medicines, and the Pharmaceutical Affairs Law prescribes things-to-be-written on the medications and things-not-to-be-written in the medications. The obligations in the management of such medications have the intention to prevent drug accidents in advance by ensuring the safety of medicines.
Second, a pharmacist cannot deny a patient's request of prescription without a justifiable reason if requested, and a pharmacist is obliged to prepare enough not to disrupt the prescription of special medicines in preparation for a doctor's prescription in advance. In addition, a pharmacist should prescribe according to a doctor's prescription except direct preparation which is stipulated exceptionally in Pharmaceutical Affairs Law, and must not misread a prescription when filing a prescription, and especially, strictly observe the prescribed concentration and dose in a prescription. If there occurs drug accidents due to the errors in concentration and dose, it may cause fatal consequences, more careful attention is required. When issuing drugs, a pharmacist must be careful not to change medicines to be administered to patients or not to be wrongly delivered. This plays an important role in preventing the drug accidents caused by a slight negligence. a pharmacist cannot change, modify, and prepare a prescription without the consent of the doctor who issued the prescription, and should receive the consent of the doctor who issued the prescription in advance even if he/she plans to prepare by replacing prescribed medicines to other ones with the same components, contents, and dosage forms. If he/she prepared by replacement without a doctor's consent in advance, the doctor is not responsible for the occurrence of the drug accidents caused by the replacement of medicines. And a pharmacist is not allowed to prepare medications without the consent of the doctor who issued the prescription in case he/she doubts of the name, quantity, usage, and dose indicated in the prescription. This aims to correct errors in prescription and get the drugs to be safely administered to the patient. If. looking from the pharmaceutical level at the time of prescription, he/she did not find any doubts from the prescription that might be found by a pharmacist in the average level and then prepared and sold according to a doctor's prescription, the consequences are the pharmacist's violation of his/her obligations. This plays a pivotal role in the pharmacist's administration as well as the guidance of taking medicine. pharmacist must prepare medicines at a pharmacy or at a prescription laboratory in medical institutions for the pharmaceutical preparations, and a pharmacist must specify certain matters on the container of the prescribed medicine and package and prescription, and preserve the prescriptions prepared by a pharmacy in store for two years after the date of prescription. And a pharmacist must keep the prescription records for five years, and respond to the patients who request to read or copy the prescription. This is the evidence of a pharmacist's preparation and administration and also to patients an important evidence to divide responsibilities in case of drug accidents. And a pharmacist must not reveal the secrets that are casually known to him/her when he/she prepared and sold medicines.
Third, Pharmaceutical Affairs Law classifies prescription drugs from OTC drugs and promotes temporal and economic convenience so that a pharmacist is able to sell OTC drugs that are less concerned with the misuses and overuses among the medicines and are expected to achieve safety and efficacy without a doctor's prescription. However, the place of sales of medicines is restricted to a pharmacy, and the limitations that medicine containers and package cannot be opened before they are sold are imposed. In addition to this, no medicines are allowed to be sold except a pharmacist, and such an intention is to prevent drug accidents by making those drugs be treated or dealt with by a qualified person according to the original intention of the Pharmaceutical Affairs Law since the medication dealings have a big and direct impact on the public health.
Fourth, a pharmacist must explain in detail about the precautions and adverse effects of the medicines to be administered to the patients in order to prevent drug accidents in terms of prescription and sales of the medicines, and should provide information such as medicine's name, usage and dose, efficacy and effectiveness as well as the explanatory obligations. But, when it comes to the sales of OTC drugs, guidance of taking medicine is stipulated as a voluntary one. So although a pharmacist is not given the obligations of taking medicine, even so, obligations of taking medicine as a explanatory obligation is not considered to be exempted.



Keywords: drug accident, medicines, pharmacist, precautionary obligations, preparation, prepared medicine, contract for work and labor, guidance of taking medicine, duty of description(or explanation), prescription, self-care, prescription review, diagnostic determination
Author(s)
신동환
Issued Date
2012
Awarded Date
2012. 2
Type
Dissertation
Keyword
약화사고 의약품 약사 주의의무 조제 조제약 조제계약 자가치료 처방검토 진단적 판단 제조물책임
Publisher
부경대학교 대학원
URI
https://repository.pknu.ac.kr:8443/handle/2021.oak/9064
http://pknu.dcollection.net/jsp/common/DcLoOrgPer.jsp?sItemId=000001965564
Department
대학원 법학과
Advisor
고명식
Table Of Contents
제1장 서론 1
제1절 연구의 목적 1
제2절 연구의 범위와 방법 3
Ⅰ. 연구의 범위 3
Ⅱ. 연구의 방법 4
제2장 약화사고와 의약품 6
제1절 약화사고 6
Ⅰ. 약화사고의 개념 6
Ⅱ. 구별개념 7
1. 의료사고, 의료과오(과실) 7
2. 의약품사고 8
3. 의료분쟁, 의료소송 9
Ⅲ. 약화사고의 특징 9
1. 피해의 심각성 10
2. 피해의 광범위성 10
3. 피해회피의 곤란성 10
4. 피해구제의 곤란성 11
5. 피해발생의 구조 12
Ⅳ. 약화사고의 현황 12
1. 약화사고사망 발생규모 예측 13
2. 의약품 부작용 실태조사 15
3. 약화사고 발생유형 및 사례 15
제2절 의약품 20
Ⅰ. 의약품의 개념 20
Ⅱ. 약사법상의 의약품 21
Ⅲ. 의약품에 대한 대법원의 판단 24
1. 의약품 판단의 일반적인 기준 25
2. 의약품으로 인정한 사례 28
3. 의약품으로 인정하지 아니한 사례 33
Ⅳ. 소결 34
제3장 약사의 주의의무 36
제1절 서설 36
제2절 과실 37
Ⅰ. 서언 37
Ⅱ. 과실의 연원 37
Ⅲ. 과실의 구조와 본질 38
Ⅳ. 과실의 판단기준 39
Ⅴ. 과실의 기능 41
제3절 주의의무의 일반적 기준 42
Ⅰ. 서언 42
Ⅱ. 주의의무의 판단기준 44
1. 약학수준 44
2. 약사관행 48
3. 재량성 50
4. 지역성 52
5. 환자의 특이체질 53
Ⅲ. 주의의무위반의 제한원리 54
1. 허용된 위험의 법리 54
2. 신뢰의 원칙 55
제4절 주의의무의 구체적 유형 56
Ⅰ. 서언 56
Ⅱ. 의약품 관리상의 주의의무 57
1. 의약품의 결함여부 확인 57
2. 의약품의 진열․보관․저장 58
3. 의약품의 기재 및 기재금지사항 60
Ⅲ. 조제상의 주의의무 61
1. 조제거부금지 61
2. 처방의약품의 구비 62
3. 처방전에 따른 조제 63
4. 처방전의 수정․변경 67
5. 처방전내용의 확인(처방검토) 69
6. 대체조제 77
7. 조제장소의 제한 81
8. 의료기관 조제실의 조제제한 81
9. 조제내용의 기록․보존 84
10. 비밀누설 금지 86
Ⅳ. 판매상의 주의의무 87
1. 판매장소 88
2. 판매방법 98
Ⅴ. 설명의무 및 복약지도의무 100
1. 약사의 설명의무 101
2. 복약지도의무 104
3. 복약지도에 있어서의 진단적 판단 105
Ⅵ. 소결 108
제4장 주의의무 위반의 효과 112
제1절 서설 112
제2절 법적책임의 주체 113
Ⅰ. 의약품 제조상 제조업자의 책임 114
Ⅱ. 의약품 안전성확보상 국가의 책임 117
Ⅲ. 의약품 처방상 의사의 책임 119
Ⅳ. 의약품 조제․판매상 약사의 책임 120
Ⅴ. 의약품 사용상 환자의 책임 121
Ⅵ. 책임의 경합 122
제3절 계약책임의 법리구성 123
Ⅰ. 서언 123
Ⅱ. 조제계약 126
1. 조제계약의 의의 126
2. 조제계약의 내용 128
3. 조제계약의 법적성질 131
Ⅲ. 불완전이행(적극적 채권침해) 139
1. 불완전이행으로서의 부수의무 139
2. 부수의무의 내용 140
3. 조제계약에서 부수의무의 태양 141
4. 부수의무의 위반 142
Ⅳ. 소결 143
제4절 입증책임 145
Ⅰ. 입증책임의 의의 146
Ⅱ. 과실 및 인과관계의 입증 147
Ⅲ. 약화사고의 입증책임 완화 149
1. 입증책임 완화의 필요성 149
2. 개연성설 151
3. 사실상의 추정 153
4. 입증책임의 전환 154
제5장 무과실책임의 적용가능성 161
제1절 조제약의 제조물책임 적용 161
제2절 제조물책임법의 적용요건 163
Ⅰ. 서언 163
Ⅱ. 제조물로서의 조제약 164
1. 제조물책임법상의 제조개념 164
2. 약사법상의 제조 및 조제 165
3. 약사법상 조제와 제조물책임법상 제조의 관계 166
4. 조제약의 제조물성 167
Ⅲ. 제조업자로서의 약사 169
1. 처방조제 169
2. 직접조제 170
3. 약국제제 171
Ⅳ. 조제약의 결함 171
1. 제조상의 결함 173
2. 설계상의 결함 175
3. 표시상의 결함 177
Ⅴ. 소결 179
제3절 무과실보상제도 181
제6장 결론 185
참 고 문 헌 190
Degree
Doctor
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