Usage of informed consent form for Bee-venom pharmacopuncture Therapy at korean medicine hospitals and Proposal for development of a standard informed consent form

Article information

J Korean Med. 2020;41(3):66-80
Publication date (electronic) : 2020 September 01
doi : https://doi.org/10.13048/jkm.20026
Department of Acupuncture & Moxibustion, College of Korean Medicine, Sangji University
Correspondence to: Minjeong Kim, Department of Acupuncture & Moxibustion, College of Korean Medicine, Sangji University 83 Sangjidae-ro, Wonju, Gangwon-do, 26338, Republic of Korea, Tel: +82-33-741-9289, Fax: +82-33-741-9141, E-mail: goodykmj@hanmail.net
Received 2020 July 27; Revised 2020 August 12; Accepted 2020 August 13.

Abstract

Objectives

We investigated the current status of the consent form for bee-venom pharmacopuncture therapy, which is using in Korean medicine hospitals. We suggest the development of a standard informed consent form.

Method

Through the questionnaire survey, status of using informed consent form was identified at 24 Korean medicine hospitals. We analyze different types of informed consent form, which was developed by each hospitals. We investigated the types of informed consent forms for various medical procedures through electronic searches. A standard informed consent form for bee-venom pharmacopuncture therapy was developed based on the medical law and the standard informed consent form for medical procedures developed by Korea Fair Trade Mediation Agency.

Result

In our survey, 65% of the hospitals do not use consent well, only 35% of the hospitals use informed consent form, and the most hospitals use self-developed informed consent form. As a result of analyzing the contents of informed consent form used in each hospitals, the explanation of diagnosis, treatment precautions, suggestions for other treatments, consequences of not performing the scheduled procedure, possibility of treatment change was insufficient. 48% of hospitals manage consent in recording on a chart, 39% in scanned documents, and 13% in digital electronic consent form.

Conclusion

A standard informed consent form for Bee-venom pharmacopuncture therapy include diagnosis, effectivness, necessity, indications, method, skin reaction test, hypersensitivity questionnaire, treatment precautions, possible hypersensitivity reactions and countermeasures, suggestions for other treatments, consequences of not performing the scheduled procedure, possibility of treatment change and the name of doctor.

Fig. 1

동의서 활용 현황

Fig. 2

동의서 보관 형식

Fig. 3

병원별 동의서에 포함된 항목 분석

각 한방병원에서 사용중인 동의서의 포함 항목 분석

References

1. Kim CH. The study of the introduction of bee venom acupuncture, biochemistry and pharmachology have been obtained the following results. Journal of acupuncture research 1994;11(1):159–171.
2. Korean Acupuncture & Moxibustion society text-book compilation committee. Acupuncture Medicine: Hanmibook 2020;:223–8. [in Korean].
3. Jang GC, Chang Y, Choi SH, et al. Overview of anaphylaxis in korea: Diagnosis and management. Allergy asthma & respiratory disease 2013;1(3):181.
4. Youn HM. The clinical observation of anaphylaxis on bee-venom acupuncture. Journal of acupuncture research 2005;22(4):179–188.
5. An CS, Kwon GR, Lee JS. A clinical study on the cases of the pain shock patients after korean bee-venom therapy. Journal of pharmacopuncture 2001;4(3):109–117.
6. Choi YC, Choi SH, Kwon KR. Purification of peptide components including melittin from bee venom using gel filtration chromatography and propionic acid/urea polyacrylamide gel electrophoresis. Journal of pharmacopuncture 2006;9(2):105–111.
7. Kwon KR, Kang KS, Lee KH, et al. Clinical observation of anaphylaxis after treated with sweet BV. Journal of pharmacopuncture 2009;12(2):85–90.
8. Kim CW, Lee YH, Lee KH. The case report of an anaphylaxis occurred when using sweet bee venom and common bee venom at the same time. Journal of pharmacopuncture 2011;14(4):59–61.
9. Jo NY, Roh JD. Systemic immediate hypersensitive reactions after treatment with sweet bee venom: A case report. Journal of pharmacopuncture 2015;18(4):59–62.
10. Jung DJ. The clinical study on 130 cases with sweet bee venom treatment. Journal of acupuncture research 2013;30(5):211–217.
11. Lee CH, Yoon J, Shim SE, et al. A retrospective study on the clinical safety of bee venom pharmacopuncture at craniofacial acupuncture points for the treatment of facial disorders. Journal of acupuncture research 2019;36(4):245–250.
12. ‘봉침 사망 사건’ 한의사 4 억여원 손해배상 이어 형사처벌 Available from: URL: https://www.yna.co.kr/view/AKR20200525056100065.
13. 최근 국내 의료 분쟁 발생 빈도 Available from: URL: https://news.v.daum.net/v/20181129211626049?rcmd=rn.
14. Song PH. The study regarding teh doctor’s duty of explanation and consent form of medical practice: A clinical field perspective. Doctoral Dissertation Law School, Kyungpook National University; 2019.
15. Park JR. Doctor’s civil liability on the treatment of patients in the medical contract. Legal Theory Practice Review 2015;3(2):65–100.
16. 공정거래위원회 동의서 (수술, 시술, 검사, 마취, 의식하진정) 표준약관 https://www.ftc.go.kr/www/cop/bbs/selectBoardArticle.do?key=201&nttId=82483&bbsId=BBSMSTR_000000002320&bbsTyCode=BBST01.
17. 의료행위 설명 동의서에 환자 서명 받고 2년간보존·관리해야 http://www.akomnews.com/bbs/board.php?bo_table=news&wr_id=3859.
18. 봉약침 시술 동의서 사용 현황 설문 조사 http://naver.me/FSKnsLMb.
19. 각 한방병원 봉약침 시술 동의서 서식 모음 https://drive.google.com/drive/folders/10utCPDbMJPpvGmMq6z_pRl_RU2NB8YZ4?usp=sharing.
20. 대한약침학회 Skin Test 및 시술동의서 파일 http://www.pharmacopuncture.co.kr/ext/bbs/board.php?bo_table=notice&wr_id=761.
21. Korean Pharmacopuncture Institute. Pharmaco-puncturology: Hanmibook 2011;:181–207. [in Korean].
22. Lee SJ. The criminal problems of informed consent. The Yonsei law review 2009;19(1):219–243.
23. Park JK, Kim JO. Application of animation mobile electronic informed consent in inpatient of long-term care hospital: Focused on DNR informed consent. Journal of digital convergence 2015;13(11):187–196.
24. Kim Y. Understanding of surgical informed consent terms, recognition and explanation satisfaction. [Master’s thesis] Pusan National University; 2015.
25. Lee JH. A study on the informed consent process service design: Focusing on redesign of informed consent form. [Master’s thesis] The Graduate School of Hongik University; 2016.

Article information Continued

Fig. 1

동의서 활용 현황

Fig. 2

동의서 보관 형식

Fig. 3

병원별 동의서에 포함된 항목 분석

Table 1

각 한방병원에서 사용중인 동의서의 포함 항목 분석

병원별 현황 합계
동의서항목 강동경희 경희의료원 동국분당 동국일산 대전둔산 대전서울 대전천안 대전청주 대구한의 모커리 부산대 원광익산 자생 포함개 (비율 %) 미포함개 (비율 %)
진단명 O O X O X X X X X O O O X 6 (46%) 7 (54%)
시술명 O O O O O O O O O O O O O 13 (100%) 0 (0%)
환자의 현재상태 O O O O O O O O O O O X O 12 (92%) 1 (8%)
시술의 목적 및 효과 O O X O O O O O O O O O O 12 (92%) 1 (8%)
시술 필요성, 과정 및 방법 O O X O O O O O O X O O O 11 (85%) 2 (15%)
발현 가능한 합병증 내용정도 및 대처방법 O O O O O O O O O O O O O 13 (100%) 0 (0%)
시술 관련 주의사항(시술후관리에 필요한사항) O X X X O O O O X O O O X 8 (62%) 5 (38%)
예정된 시술이외의 시행가능한다른 치료 방법 X X X O O O O O O X O X O 8 (62%) 5 (38%)
예정된 시술을 시행하지않았을 때의 결과 X X X O O O O O X X O X X 7 (54%) 6 (46%)
시술 방법의 변경 또는시술 범위의 추가 가능성 O X X O X X X X X X X X X 2 (15%) 11 (85%)
설명 및 시술에 참여하는주된 한의사의 성명 O O X O O O O O O O O O O 12 (92%) 1 (8%)

O 표시는 포함, X 표시는 미포함을 의미함.