의료과실의 판단기준으로서 의약품 첨부문서에 반하는 허가외 사용
Off-label use contrary to instructions on drug label as standards of medical care
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Many types of new drugs have been developed in accordance with numerous advances in medicine. New drugs may be more effective than old ones, but they may sometimes provoke serious adverse reactions. Medical professionals should make efforts to acquire current knowledge via medical articles, conferences and by other means. Instructions on drug label are also important materials for doctors to prescribe drugs, and play significant roles in finding medical faults. They contain the highest level of information provided by pharmaceutical companies. When doctors prescribe medicine or pharmacists fill the prescription, the instructions must be noted first. Therefore, prescriptions of drugs contrary to the instructions on the drug label may lead to doubts about whether the doctor is at fault. In actual medical practice, doctors commonly prescribe drugs for off-label use. Off-label use can be defined as the practice of prescribing drugs for an unapproved indication or in an unapproved age group, at an unapproved dose or in an unapproved form of administration. Although the off-label use of prescription drugs involves unpredictable risks, it may be necessary to treat some cases of diseases. In these cases, a higher duty of care is required compared to cases of the approved use of drugs. Especially where there are alterative approved medications, all of the information about off-label drug prescriptions has to be provided so that patients can decide upon their treatment. Doctors must let patients compare the benefits and risks of off-label use and must advise them to choose their own therapy. Patients have the right of self-determination, whereas doctors have the obligation to provide information to patients. This information has the role of not only in raising patients' autonomy but also helping patients appropriately manage the adverse effects of off-label drug use. As drug information alerts patients to possible adverse effects, they can detect even subtle changes in their own body early after taking the drugs. Doctors have to instruct patients to cope with the adverse effects of drugs should they arise. Health care problems, such as outbreaks of antimicrobial resistant organisms and the rapid increase in health care expenditures, must be taken into account when doctors prescribe medicine. Therefore, legal policies for health care can be considered with the presumption of medical errors.
Abstract
Many types of new drugs have been developed in accordance with numerous advances in medicine. New drugs may be more effective than old ones, but they may sometimes provoke serious adverse reactions. Medical professionals should make efforts to acquire current knowledge via medical articles, conferences and by other means. Instructions on drug label are also important materials for doctors to prescribe drugs, and play significant roles in finding medical faults. They contain the highest level of information provided by pharmaceutical companies. When doctors prescribe medicine or pharmacists fill the prescription, the instructions must be noted first. Therefore, prescriptions of drugs contrary to the instructions on the drug label may lead to doubts about whether the doctor is at fault. In actual medical practice, doctors commonly prescribe drugs for off-label use. Off-label use can be defined as the practice of prescribing drugs for an unapproved indication or in an unapproved age group, at an unapproved dose or in an unapproved form of administration. Although the off-label use of prescription drugs involves unpredictable risks, it may be necessary to treat some cases of diseases. In these cases, a higher duty of care is required compared to cases of the approved use of drugs. Especially where there are alterative approved medications, all of the information about off-label drug prescriptions has to be provided so that patients can decide upon their treatment. Doctors must let patients compare the benefits and risks of off-label use and must advise them to choose their own therapy. Patients have the right of self-determination, whereas doctors have the obligation to provide information to patients. This information has the role of not only in raising patients' autonomy but also helping patients appropriately manage the adverse effects of off-label drug use. As drug information alerts patients to possible adverse effects, they can detect even subtle changes in their own body early after taking the drugs. Doctors have to instruct patients to cope with the adverse effects of drugs should they arise. Health care problems, such as outbreaks of antimicrobial resistant organisms and the rapid increase in health care expenditures, must be taken into account when doctors prescribe medicine. Therefore, legal policies for health care can be considered with the presumption of medical errors.
참고문헌 (27)
- 郭潤直, "民法注解(XVIII)" (2005), 博英社
- 김기영, "새로운 약제의 사용과 의사의 민사책임의 근거", 법조, 59(5), pp.77~118 (2010), 법조협회
- 김기영, "의약품의 사용설명서와 부작용에 대한 의사의 설명의무- 대법원 2005. 4. 29. 선고 2004다64067 판결을 중심으로 -", 법조, 58(8), pp.242~280 (2009), 법조협회
- 김민중, "의사의 설명의무에 관한 몇 가지 특수문제", 의료법학, 4(2), pp.249~ (2003)
- 김충원, "약사의 설명의무위반과 손해배상책임", JURIST, 388, pp.50~ (2003)
- 문유림, "의약품 임상시험에 관하여", 의료법학, 5(2), pp.181~ (2004)
- 박주현, "의료과오소송에 있어서 과실과 인과관계의 인정에 관한 연구", 박사, pp.2008
- 서광민, "의료과오책임의 법적 구성", 민사법학, 8, pp.324~ (1990)
- 이수경, "의사의 설명의무의 내용", 판례연구, 19(2), pp.287~ (2005)
- 최상회, "의약품의 허가사항 외 사용으로 발생한 사고에 대한 의사와 제약회사의 책임", 인권과 정의, 400(400), pp.6~18 (2009), 대한변호사협회
- 최재천, "의료과실과 의료소송" (2001), 육법사
- 浅井登美彦, "医療過誤:現代裁判法大系7" (1998), 新日本法規
- 藤山雅行, "判例にみる医師の説明義務" (2006), 新日本法規出版
- 三輪亮寿, "法的側面からみた臨床試驗とPL法", Jpn.J.Pharmacol, 27, pp.519~ (1977)
- R.C. Alvarez, "Mislabeling the phramacyst who does more than just mislabel the prescription: pharmaceutical liability under Florida Law", Fla.B.J, 81, pp.53~ (2007)
- M. Angell, "The Truth About Drug Companies" (2006), Random House
- R.M. Arnold, "Dealing with dangerous mix-ups: descriptive labels on prescription drugs", McGeorge L. Rev, 35, pp.379~ (2004)
- T.M. Grace, "Rite Aid Corp. v. Levy-Gray: Unjustly holding pharmacies liability for breach of express warranty by providing drug information after filling prescriptions", Md. L. Rev, 66, pp.956~ (2007)
- V. Henry, "Off-label prescribing legal implications", J. Legal Med, 20, pp.365~ (1999)
- R-M Jansen, "Bad handwriting and medication errors", S. African L. J, 124, pp.867~ (2007)
- M.Z. Johns, "Informed consent: requiring doctors to disclosure off-label prescriptions and conflicts of interest", 58, pp.967~ (2007)
- C.A. Moyer, "Off-label use and the medical negligence standard under Minnesota law", Wm. Mitchell L. Rev, 31, pp.927~ (2005)
- C. Quinn, "The right to refuse medical treatment or direct the course of medical treatment: where should inmate autonomy begin and end?", New Eng. J. on Crim. & Civ. Confinement, 35, pp.453~ (2009)
- P.M. Rosoff, "The case for legal regulation of physician's off-label prescribing", Notre Dame L. Rev, 86, pp.649~ (2011)
- S.S. Salbu, "Off-label use, prescription, and marketing of FDA-approved drugs: an assessment of legislative and regulatory policy", Fla. L. Rev, 51, pp.181~ (1999)
- K.J. Stoffelmayr, "Products liability and "Off-Label" uses of presciption drugs", U. Chi. L. Rev, 63, pp.275~ (1996)
- P.P. Tak, "Advances in rheumatology: new targeted therapeutics", Arthritis Res, 13(Suppl. 1), pp.S5~ (2011)