曲马多复方制剂监管现状研究

doi:10.19803/j.1672-8629.2019.09.03

摘要/Abstract

摘要： 目的介绍国际曲马多复方制剂滥用情况,总结各国对曲马多复方制剂的监管经验,以期为中国曲马多复方制剂的监管提供思路。方法通过文献阅读法、对比分析法就各国滥用现状、监管现状、监管手段等方面进行归纳比较。结果对比国际经验,我国曲马多单复方制剂存在管制级别差异;缺乏全面的处方监测;曲马多复方制剂说明书成瘾性表述不完善;医护人员滥用知识培训有限。结论建议调整我国曲马多复方制剂管制级别;完善药物滥用监测系统,建立药品信息化追溯体系;修改药品说明书,增加成瘾性的风险提示;加强药物滥用风险知识的宣传与培训。

关键词: 曲马多复方制剂, 成瘾性, 药物滥用, 管制级别, 国际监管

Abstract: Objective To summarize supervision experiences in various countries with an eye to providing ideas for China on basis of introducing current status of compound tramadol abuse worldwide. Methods To Summarize and compare the abuse status, supervision situations and measures, etc. in various countries through literature review. Results In comparison with foreign experiences, China was confronted with the following problems: differentiation of control level for tramadol and its compound preparations, lack of comprehensive surveillance on prescription, inadequate description of addiction in the package insert, limited knowledge of drug abuse of healthcare professionals. Conclusion China should make efforts to uniform control level for all tramadol containing preparations, set up medication tracking system, revise the package insert to emphasis the risk of addiction and strengthen awareness and training on risks of drug abuse.

Key words: compound tramadol, addiction, drug abuse, control hierarchy, international supervision

中图分类号:

R971

孙祯辉, 孙骏, 王佳域, 于丹丹, 王玲, 余正. 曲马多复方制剂监管现状研究[J]. 中国药物警戒, 2019, 16(9): 528-535.

SUN Zhenhui, SUN Jun, WANG Jiayu, YU Dandan, WANG Ling, YU Zheng. Research on the Status Quo of the Regulation of Compound Tramadol[J]. Chinese Journal of Pharmacovigilance, 2019, 16(9): 528-535.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.2019.09.03

https://zgywjj.magtechjournal.com/CN/Y2019/V16/I9/528

参考文献

[1] Prabhat Chand,Naveen Jayaram,Pratima Murthy.Iatrogenic tramadol addiction[J].indian journal of medical science,2017,69(1):57-58.
[2] Khan N A,Sullivan M A,Vitale M G,et al.Undetected Ultracet dependence in an adolescent with nonmalignant back pain[J]. J Opioid Manag,2013,9(9):225-230.
[3] 满春霞,邹武捷,杨淑苹,等.麻醉药品和精神药品管制研究Ⅳ—我国麻醉药品和精神药品的管制历程与现状[J].中国药房,2017,28(1):18-22.
[4] 樊莹莹,齐莹莹,穆星佳,等.我国麻醉药品和精神药品行政监管法规完善建议[J].中国药物警戒,2018,15(1):28-31.
[5] 韩秀红. 加强曲马多的临床应用监管[J]. 实用医技杂志,2007,14(5):601-602.
[6] 刘存基,齐力,杨洁. 宁夏戒毒机构收治盐酸曲马多依赖人群滥用现状调查[J]. 宁夏医科大学学报,2011,33(1):67-69.
[7] 逄立艳,马军丽,周立新,等.从曲马多能否列入国际管制透视监测信息作用[J].中国药物警戒,2011,8(11):667-670.
[8] 张浩然,刘志民.曲马多药物滥用现状及其管理[J].中国药物依赖性杂志,2014,23(3):170-175.
[9] Tavassoli N,Lapeyremestre M,Sommet A,et al.Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs:Dextropropoxyphene,tramadol and codeine (in combination with paracetamol)[J]. British Journal of Clinical Pharmacology,2010,68(3):422-426.
[10] UNODC.2018 world drug report[EB/OL].(2018-06)[2019-02-02].https://reliefweb.int/sites/reliefweb.int/files/resources/WDR18_Booklet_1_EXSUM.pdf.
[11] Drug misuse and dependency. Consultation on prescription drug tramadol[EB/OL].(2013-07-22)[2018-12-27].https://www.gov.uk/government/news/consultation-on-prescription-drug-tramadol.
[12] AFSSAP. Commission nationale des stup fiantset des psychotropes [EB/OL].(2010-10-12)[2019-02-02].https://www.ansm.sante.fr/content/download/30393/401173/version/5/file/commission-stup-compte-rendu+-221010.pdf.
[13] The globe and mail. Ottawa adds opioid painkillertramadol to controlled narcotics list[EB/OL]. (2018-06-18)[2018-12-28].https://www.theglobeandmail.com/canada/article-ottawa-adds-opioid-painkiller-tramadol-to-controlled-narcotics-list/.
[14] WHO. Annex 1: Report on WHO Questionnaire forReview of Psychoactive Substances for the 39th ECDD: Evaluation of Tramadol [EB/OL].(2017-11-10)[2018-12-23].https://www.who.int/medicines/access/controlled-substances/5.3_Tramadol_Annex1.pdf?ua=1.
[15] WHO. WHO Expert Committee on Drug Dependence:twenty-eighth report[EB/OL].(1992-10-02)[2018-12-27].http://apps.who.int/iris/bitstream/handle/10665/37029/WHO_TRS_836.pdf?sequence=1.
[16] WHO. WHO Expert Committee on Drug Dependence:thirty-second report[EB/OL].(2001-09-15)[2018-12-27].http://apps.who.int/iris/bitstream/handle/10665/42406/WHO_TRS_903.pdf?sequence=1.
[17] WHO. WHO Expert Committee on Drug Dependence:thirty-third report[EB/OL].(2002-09-20)[2018-12-27].http://apps.who.int/iris/bitstream/handle/10665/42655/WHO_TRS_915.pdf?sequence=1.
[18] WHO. WHO Expert Committee on DrugDependence:thirty-fourth report[EB/OL].(2006-03-31)[2018-12-27].http://apps.who.int/iris/bitstream/handle/10665/43608/9789241209427_eng.pdf?sequence=1.
[19] WHO. WHO Expert Committee on Drug Dependence:thirty-sixth report[EB/OL].(2014-06-20)[2018-12-27].https://www.unodc.org/documents/commissions/CND/Mandate_and_Functions/Report_36th_WHO_ECDD.pdf.
[20] WHO. WHO Expert Committee on Drug Dependence:thirty-ninth report[EB/OL].(2017-11-10)[2018-12-27].https://www.who.int/medicines/access/controlled-substances/ECDD39thReportTR1009-2017.pdf?ua=1.
[21] WHO. Forty-first meeting of the ExpertCommittee on Drug Dependence[EB/OL].(2018-11-16)[2018-12-21].https://www.who.int/medicines/access/controlled-substances/ecdd_41_meeting/en/.
[22] DEA. PART1308 — Schedules ofcontrolled substances[EB/OL].(2013-08-14)[2018-12-23].https://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_14.htm.
[23] DEA.Guidance; Dispensing and Purchasing Controlled Substances over the Internet[EB/OL].(2001-04-27)[2019-01-22].https://www.deadiversion.usdoj.gov/fed_regs/notices/2001/fr0427.htm.
[24] ACMD.ACMD consideration of tramadol[EB/OL].(2013-02-13)[2018-12-23].https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/144116/advice-tramadol.pdf.
[25] The National Archives. Misuse of Drugs Act1971[EB/OL].(2014-04-28)[2018-12-23].https://www.legislation.gov.uk/uksi/2014/1106/article/5/made.
[26] NHS. Tramadol to be a Schedule 3 Controlled Drug[EB/OL].(2014-05-05)[2019-01-22].http://www.ggcprescribing.org.uk/blog/tramadol-and-changes-controlled-drug-legislation/.
[27] Drugwise.What are the UK drug laws?[EB/OL].(2018-12-10)[2019-01-22].https://www.drugwise.org.uk/what-are-the-uk-drug-laws/.
[28] Health Canada. Consultation on regulatory amendments regarding tramadol[EB/OL].(2018-06-16)[2018-12-23].https://www.canada.ca/en/health-canada/programs/consultation-amendments-tramadol.html.
[29] Health Canada. Regulatory Initiative: Regulations amending Schedule I to the Controlled Drugs and Substances Act and the Schedule to the Narcotic Control Regulations to add tramadol and related substances - Forward Regulatory Plan2018-2020[EB/OL].(2018-10-12)[2018-12-23].https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/2018-2020/tramadol.html.
[30] Commission on Narcotic Drugs.Conference room paper submitted by the Arab Republic of Egypt on strengthening international cooperation in addressing the non-medical use and abuse, the illicit manufacture and the illicit domestic and international distribution of tramadol[EB/OL].(2017-03-17)[2018-12-23].https://www.unodc.org/documents/commissions/CND/CND_Sessions/CND_60/CRPs/ECN72017_CRP4_V1701497.pdf.
[31] Thefreelibrary.Egypt gov't adds Tramadol to list of narcotics.[EB/OL].(2012-02-24)[2019-01-23]. https://www.thefreelibrary.com/Egypt+gov%27t+adds+Tramadol+to+list+of+narcotics.-a0281183767.
[32] WHO. Loi No 182 de1960 (Law 182 of 1960)[EB/OL].(2013-11-20)[2019-01-23].https://www.mindbank.info/item/3 697.
[33] Ministry Of Finance.notification[EB/OL].(2018-04-27)[2018-12-24].http://www.egazette.nic.in/WriteReadData/2018/185016.pdf.
[34] Medicines control council.Medicines and related substances control act[EB/OL].(1990-12-07)[2018-12-23].https://www.nda.agric.za/vetweb/legislation/other%20acts/r_medicines_and_related_substances.htm.
[35] Singpore government.Poision act [EB/OL].(2015-11-13)[2018-12-24].https://sso.agc.gov.sg/Act/PA1938.
[36] Tramadol side effects.Pros and Cons of Tramadol[EB/OL].[2018-12-24].http://www.tramadolfacts.com/pros-and-cons-of-tramadol/.
[37] Healthdirect. Brand name: Tramadol Hydrochloride (Apo)TM[EB/OL].(2018-12-02)[2018-12-24].https://www.healthdirect.gov.au/medicines/brand/amt,53881000168108/tramadol-hydrochloride-apo.
[38] Healthdirect.Brand name: ZaldiarTM[EB/OL].(2018-12-02)[2018-12-24].https://www.healthdirect.gov.au/medicines/brand/amt,1027811000168106/zaldiar.
[39] 陈聘琪. 管制级数改变对Tramadol使用趋势之影响[D].高雄医学大学,2010.
[40] Commission nationale des stup fiantset des psychotropes.resultats de l' enquete officielle d' addictovigilance sur lesspecialites contenant du tramadol [EB/OL].(2010-12-17)[2018-12-23].https://www.ansm.sante.fr/content/download/30393/401173/version/5/file/commission-stup-compte-rendu+-221010.pdf.
[41] DEA.State Prescription Drug Monitoring Programs[EB/OL].(2016-06)[2018-12-23].https://www.deadiversion.usdoj.gov/faq/rx_monitor.htm.
[42] WHO.Curbing prescription opioid dependency[J].Bull World Health Organ.2017,95(5):318-319
[43] MHRA. Public Assessment Report[EB/OL].(2018-04)[2019-01-30]. http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con881403.pdf.
[44] 唐全胜,郝伟.药物滥用流行病学现状与特征[J].中国药物依赖性杂志,2014,23(4):259-263.
[45] 国家药品监督管理局. 食品药品监管总局办公厅关于进一步加强含麻醉药品和曲马多口服复方制剂购销管理的通知[EB/OL].(2014-06-05)[2018-12-23].http://www.nmpa.gov.cn/WS04/CL2196/324062.html,2014-06-05/2018-12-23.
[46] 黑龙江多多药业有限责任公司.盐酸曲马多片说明书[EB/OL].(2007-02-01)[2019-01-24].http://zy.yaozh.com/instruct/hlj/5654779200383b742909345c329a0d6bee58.jpg.