题名

台灣毒劇藥品相關法令及管理改進芻議

并列篇名

An Initiative to Amend the Regulation and Management of Poisons and Dangerous Drugs in Taiwan

DOI

10.6288/TJPH201534104020

作者

廖怡清(Yi-Ching Liao)；游雯淨(Wen-Jing Yu)；李志恒(Jih-Heng Li)

关键词

毒劇藥品 ； Kappa係數檢定 ； 管理規範 ； poisons and dangerous drugs ； Kappa coefficient ； regulations

期刊名称

台灣公共衛生雜誌

卷期/出版年月

34卷5期（2015 / 10 / 01）

页次

534 - 547

内容语文

繁體中文
中文摘要

目標：確保用藥安全為公共衛生的優先議題，本研究探討台灣毒劇藥品項及管理規範是否符合時代需求。方法：先檢視美國、澳大利亞、英國、歐盟、台灣、日本、中國大陸、香港及新加坡相關法規，進一步以中華藥典102項毒劇西藥品為基準，比較台、日、中、港、星毒劇性藥品定義、品項及管理措施，並利用百分比一致性及Kappa係數檢定品項相似性。結果：台灣與日本百分比一致性最高（64.7），其次依序為新加坡、香港及中國大陸（47.1、40.2及4.9）。日本毒劇藥品有明確定義及審定基準，台灣的毒劇藥品項與日本之一致高（Kappa=0.63, p＜0.05），品項收載及分類亦符合日本毒劇藥審定基準。日本之毒劇藥品包括近期抗癌藥、免疫製劑及抗病毒藥，其品項數（148、39及39）較台灣多（3、0及0），而台灣的毒劇藥品近20年未增修，有些臨床少用的列載藥品在日本並未收載。有關毒劇性藥品管理規範，台灣缺少明確毒劇字樣標籤及貯存之規定，但相關紀錄留存時間較其他國家久。結論：台灣毒劇藥品之管理有改善空間，日本毒劇藥品管理相關規範可作為台灣之參考。
英文摘要

Objectives: Ensuring that drugs are used safely is a major priority in public health. The aim of the study was to investigate whether the listed items and related regulations for poisons and dangerous drugs (PDDs) in Taiwan were appropriate and timely. Methods: We initially evaluated the drug toxicity-related regulations in the United States, Australia, United Kingdom, European Union, Taiwan, Japan, China, Hong Kong and Singapore. The definitions, items and regulations related to PDDs were further compared among those in Taiwan, Japan, China, Hong Kong and Singapore. Based on the 102 items of western medicine considered to be PDDs in Taiwan, the item differences among countries were determined as percent agreements and kappa coefficients. Results: Taiwan and Japan showed the highest percent agreement, followed by Singapore, Hong Kong and China (64.7, 47.1, 40.2 and 4.9, respectively). Taiwan and Japan had substantial agreement (Kappa=0.63, P ＜ 0.05) about PDD items. The regulations of Japan have criteria for judging whether a drug is poisonous or dangerous, and seem to be generally in line with the PDD items in Taiwan. The numbers of antineoplastic drugs, immunologic agents and antiviral agents listed as PDDs in Japan (148, 39 and 39, respectively) were much higher than those in Taiwan (3, 0 and 0, respectively). The list of PDD items in Taiwan has not been amended for almost 20 years, and some without current clinical use were not included in the Japanese regulations. Compared to other countries, the regulations in Taiwan lacked definite label and storage requirements for PDDs, but the period of record-keeping was longer than that in other countries. Conclusions: The Japanese PDD-related regulations could serve as a reference for Taiwan in improving the management of PDDs.
主题分类 醫藥衛生 > 預防保健與衛生學
醫藥衛生 > 社會醫學
参考文献
  1. 徐佳青、黃文鴻(2006)。RU486合法化過程意識形態論述分析。台灣衛誌，25，11-25。
    連結：
  2. Department of Health, Australian Government. Poisons Standard. Available at: http://www.comlaw.gov.au/Details/F2015L00749. Accessed June 3, 2015
  3. Agency for Toxic Substances and Disease Registry. Toxicological profile for carbon tetrachloride. Available at: http://www.atsdr.cdc.gov/ToxProfiles/tp30.pdf. Accessed June 3, 2015
  4. 中華人民共和國香港特別行政區政府律政司：藥劑業及毒藥規例。http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/3F42C500A2E12EAA482575EE00439460?OpenDocument&bt=0。引用2015/06/03。Department of Justice, The Government of the Hong Kong Special Administrative Region. Pharmacy and Poisons Regulations. Available at: http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/3F42C500A2E12EAA482575EE00439460?OpenDocument&bt=0. Accessed June 3, 2015
  5. Singapore Statutes Online. Poisons Act. Available at: http://statutes.agc.gov.sg/aol/search/display/view.w3p;page=0;query=DocId%3A%22463fb76c-3fdc-432eb1f9-d9c8cfa607b9%22%20Status%3Ainforce%20Depth%3A0;rec=0. Accessed June 3, 2015
  6. Institute for Safe Medication Practices. Pharmaceutical industry and medical device companies: part of the solution. Available at: https://www.ismp.org/newsletters/acutecare/articles/20061116.asp. Accessed June 3, 2015
  7. 衛生福利部醫事司：103年醫院評鑑基準及評量項目。http://www.mohw.gov.tw/cht/DOMA/DM1_P.aspx?f_list_no=608&fod_list_no=4907&doc_no=44705。引用2015/06/03。Department of Medical Affairs, Ministry of Health and Welfare, R.O.C. (Taiwan). Hospital accreditation criteria and evaluation items, 2013. Available at: http://www.mohw.gov.tw/cht/DOMA/DM1_P.aspx?f_list_no=608&fod_list_no=4907&doc_no=44705. Accessed June 3, 2015
  8. 衛生福利部：藥物藥商管理法及施行細則。台北：衛生福利部，1988。Ministry of Health and Welfare, R.O.C. (Taiwan). Drugs and Pharmacists Management Act and the Rules for Enforcement. Taipei: Ministry of Health and Welfare, R.O.C. (Taiwan), 1988
  9. 衛生福利部食品藥物管理署：102年度新藥查驗登記審查成果創新績。http://www.fda.gov.tw/pda/page02Content.aspx?id=10815&chk=f51ee80f-0f06-4e12-a978-1f22a90c9f35¶m=pn%3D1。引用2015/06/03。Food and Drug Administration, Ministry of Health and Welfare, R.O.C. (Taiwan). New drug inspection and registration review results pass a new milestone in 2013. Available at: http://www.fda.gov.tw/pda/page02Content.aspx?id=10815&chk=f51ee80f-0f06-4e12-a978-1f22a90c9f35¶m=pn%3D1. Accessed June 3, 2015
  10. 厚生労働省：毒薬・劇薬指定基準について。http://www.mhlw.go.jp/file/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka/0000014658.pdf。引用2015/06/03。Ministry of Health, Labour and Welfare (Japan).Standards for Designating Poisons and Toxic Medications. Available at: http://www.mhlw.go.jp/file/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka/0000014658.pdf. Accessed June 3, 2015
  11. 立法院：立法院內政司法兩委員會第六十六次聯席會議紀錄(第四十三會期)。立法院公報 1969；58：29-37。The Legislative Yuan, R.O.C. (Taiwan). Record of the 66th Joint Conference of the Legislative Yuan Internal Affairs and Judicial Committees (43nd session). The Legislative Yuan Gazette 1969;58:29-37
  12. 衛生福利部：管制藥品管理條例。http://law.moj.gov.tw/Law/LawSearchResult.aspx?p=A&t=A1A2E1F1&k1=%E7%AE%A1%E5%88%B6%E8%97%A5%E5%93%81%E7%AE%A1%E7%90%86%E6%A2%9D%E4%BE%8B。引用2015/06/03。Ministry of Health and Welfare, R.O.C. (Taiwan).Controlled Drugs Act. Available at: http://law.moj.gov.tw/Law/LawSearchResult.aspx?p=A&t=A1A2E1F1&k1=%E7%AE%A1%E5%88%B6%E8%97%A5%E5%93%81%E7%AE%A1%E7%90%86%E6%A2%9D%E4%BE%8B. Accessed June 3, 2015
  13. 衛生福利部：藥事法。http://law.moj.gov.tw/Law/LawSearchResult.aspx?p=A&t=A1A2E1F1&k1=%E8%97%A5%E4%BA%8B%E6%B3%95。引用2015/06/03。Ministry of Health and Welfare, R.O.C. (Taiwan).Pharmaceutical Affairs Act. Available at: ttp://law.moj.gov.tw/Law/LawSearchResult.aspx?p=A&t=A1A2E1F1&k1=%E8%97%A5%E4%BA%8B%E6%B3%95. Accessed June 3, 2015
  14. Institute for Safe Medication Practices. ISMP list of high-alert medications in acute care settings. Available at: http://www.ismp.org/Tools/institutionalhighAlert.asp. Accessed June 3, 2015
  15. Legislation.gov.uk. Poisons Act. Available at: http://www.legislation.gov.uk/ukpga/1972/66. Accessed June 3, 2015
  16. 立法院：藥事法法條沿革。http://lis.ly.gov.tw/lgcgi/lglaw?@172:1804289383:f:NO%3DE02510*%20OR%20NO%3DB02510$$10$$$NO-PD。引用2015/06/03。The Legislative Yuan, R.O.C. (Taiwan) .Legislative history of Pharmaceutical Affairs Act. Available at: http://lis.ly.gov.tw/lgcgi/lglaw?@172:1804289383:f:NO%3DE02510*%20OR%20NO%3DB02510$$10$$$NO-PD. Accessed June 3, 2015
  17. 厚生労働省：薬事法。http://law.e-gov.go.jp/htmldata/S35/S35HO145.htm。引用2015/06/03。Ministry of Health, Labour and Welfare (Japan). Pharmaceutical Affairs Act. Available at: http://law.e-gov.go.jp/htmldata/S35/S35HO145.html. Accessed June 3, 2015
  18. 立法院：立法院內政、司法兩委員會第十次聯席會議紀錄(第八十九會期)。立法院公報 1992；81：232-54。The Legislative Yuan, R.O.C. (Taiwan). Record of the 10th Joint Conference of the Legislative Yuan Internal Affairs and Judicial Committees (89nd session).The Legislative Yuan Gazette 1992;81:232-54
  19. 立法院：立法院內政、司法兩委員會第四十二次聯席會議紀錄(第四十二會期)。立法院公報 1968；58：12-7。The Legislative Yuan, R.O.C. (Taiwan). Record of the 42th Joint Conference of the Legislative Yuan Internal Affairs and Judicial Committees (42nd session). The Legislative Yuan Gazette 1968;58:12-7.
  20. 国家食品药品监督管理总局： 中华人民共和国品管理法。http://www.sda.gov.cn/WS01/CL1030/23396.html。引用2015/06/03。China Food and Drug Administration. Drug Administration Laws of the People's Republic of China. Available at: http://www.sda.gov.cn/WS01/CL1030/23396.html. Accessed June 3, 2015
  21. U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm. Accessed June 3, 2015
  22. 国家食品品督管理局： 医疗用毒性品管理办法。http://www.sda.gov.cn/WS01/CL0784/10770.html。引用2015/06/03。China Food and Drug Administration. Management Regulations for Toxic Medicinal Drug Use. Available at: http://www.sda.gov.cn/WS01/CL0784/10770.html. Accessed June 3, 2015
  23. European Union. EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:en:PDF. Accessed June 3, 2015
  24. Singapore Statutes Online. Poisons Rules. Available at: http://statutes.agc.gov.sg/aol/search/display/view.w3p;page=0;query=DocId%3A%22a896cf2a-cd5e-42d4-be46-9442e5943020%22%20Status%3Ainforce%20Depth%3A0;rec=0. Accessed June 3, 2015
  25. 厚生労働省：薬事法施行規則。http://law.e-gov.go.jp/htmldata/S36/S36F03601000001.html。引用2015/06/03。Ministry of Health, Labour and Welfare (Japan). Ordinance for Enforcement of the Pharmaceutical Affairs Act. Available at: http://law.e-gov.go.jp/htmldata/S36/S36F03601000001.html. Accessed June 3, 2015.
  26. 衛生福利部：藥品優良調劑作業準則。http://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0030052。引用2015/06/03。Ministry of Health and Welfare, R.O.C. (Taiwan). Good Drug Dispensing Practices. Available at: http://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0030052. Accessed June 3, 2015
  27. 立法院：立法院內政司法兩委員會第四十七次聯席會議紀錄(第四十二會期)。立法院公報 1969；58：11-7。The Legislative Yuan, R.O.C. (Taiwan). Record of the 47th Joint Conference of the Legislative Yuan Internal Affairs and Judicial Committees (42nd session). The Legislative Yuan Gazette 1969;58:11-7
  28. 中華人民共和國香港特別行政區政府律政司：藥劑業及毒藥條例。http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/4B641A439A9863A9482575EE004385FE?OpenDocument&bt=0。引用2015/06/03。Department of Justice, The Government of the Hong Kong Special Administrative Region. Pharmacy and Poisons Ordinance. Available at: http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E532/4B641A439A9863A9482575EE004385FE?OpenDocument&bt=0. Accessed June 3, 2015.
  29. Barle, EL,Looser, R,Cerne, M,Bechter, R.(2012).The value of acute toxicity testing of pharmaceuticals for estimation of human response.Regul Toxicol Pharmacol,62,412-8.
  30. Bovill, JG(2008).Inhalation anaesthesia: from diethyl ether to xenon.Handb Exp Pharmacol,182,121-42.
  31. Gibaud, S, ,Jaouen, G(2010).Arsenic-based drugs: from Fowler's solution to modern anticancer chemotherapy.Top Organomet Chem,32,1-20.
  32. Grissinger, M(2012).Reducing the risk of deadly mixups with epidural and intravenous drugs.Pharm Therapeut,37,432-4.
  33. IARC Working Group(2010).Ethyl carbamate.IARC Monogr Eval Carcinog Risks Hum,96,1281-378.
  34. IARC, Working, Group(2012).Phenacetin.IARC Monogr Eval Carcinog Risks Hum,100A,377-98.
  35. Kaitin, KI、DiMasi, JA(2011)。Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009。Clin Pharmacol Ther，89，183-8。
  36. Kenna, JG,Jones, RM(1995).The organ toxicity of inhaled anesthetics.Anesth Analg,81(Suppl 6),S51-66.
  37. Landis, JR,Koch, GG(1977).The measurement of observer agreement for categorical data.Biometrics,33,159-74.
  38. Li, JH(2012).Evolution of the legislative and administrative system of controlled drugs in Taiwan.J Food Drug Anal,20,778-85.
  39. Olson, KR(2012).Poisoning and Drug Overdose.San Francisco:McGraw Hill Professional.
  40. Paci, A,Veal, G,Bardin, C(2014).Review of therapeutic drug monitoring of anticancer drugs part 1 - cytotoxics.Eur J Cancer,50,2010-9.
  41. Platt, R,Madre, L,Reynolds, R,Tilson, H(2008).Active drug safety surveillance: a tool to improve public health.Pharmacoepidemiol Drug Saf,17,1175-82.
  42. Rajkumar, SV(2004).Thalidomide: tragic past and promising future.Mayo Clin Proc,79,899-903.
  43. Ram, VJ,Nath, M(1996).Progress in chemotherapy of Leishmaniasis.Curr Med Chem,3,303-16.
  44. Spiller, HA,Winter, ML,Weber, JA,Krenzelok, EP,Anderson, DL,Ryan, ML(2003).Skin breakdown and blisters from senna-containing laxatives in young children.Ann Pharmacother,37,636-9.
  45. U.S. Food and Drug Administration(1981).Taste of raspberries, taste of death. The 1937 Elixir Sulfanilamide incident.FDA Consumer magazine,1981
  46. Whalen, FX,Bacon, DR,Smith, HM(2005).Inhaled anesthetics: an historical overview.Best Pract Res Clin Anaesthesiol,19,323-30.
  47. 監察院。,未出版
  48. 劉仲冬、陳惠馨、陳惟華(2003)。衛生福利部國民健康署九十一年度科技研究發展計畫研究報告衛生福利部國民健康署九十一年度科技研究發展計畫研究報告,台北=Taipei:衛生福利部國民健康署=Health Promotion Administration, Ministry of Health and Welfare, R.O.C. (Taiwan)。
  49. 潘香櫻、王兆儀、鄒玫君(2013)。我國新藥審查機制之改革與展望。食品藥物研究年報，4，458-68。
print cancel