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本文引用的文献

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Accessibility and quality of drug company disclosures of payments to healthcare professionals and organisations in 37 countries: a European policy review.37 个国家/地区的制药公司向医疗保健专业人员和组织披露支付款项的可及性和质量:一项欧洲政策审查。
BMJ Open. 2021 Dec 16;11(12):e053138. doi: 10.1136/bmjopen-2021-053138.
2
Quality of advertisements for prescription drugs in family practice medical journals published in Australia, Canada and the USA with different regulatory controls: a cross-sectional study.不同监管控制下的澳大利亚、加拿大和美国家庭医学期刊中处方药广告的质量:一项横断面研究。
BMJ Open. 2020 Jul 19;10(7):e034993. doi: 10.1136/bmjopen-2019-034993.
3
The "Nuts and Bolts" of Opioid Marketing: Promotional Messages to Family Doctors in Sacramento, Vancouver, Montreal, and Toulouse.阿片类药物营销的“基本要素”:面向萨克拉门托、温哥华、蒙特利尔和图卢兹家庭医生的促销信息
J Gen Intern Med. 2020 Dec;35(12):3730-3732. doi: 10.1007/s11606-019-05584-5. Epub 2020 Feb 10.
4
Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.制药行业的药品未按批准说明书用药推广与自我监管:对英国药品使用规范管理局2003 - 2012年未按批准说明书用药推广裁决的文件分析
PLoS Med. 2016 Jan 26;13(1):e1001945. doi: 10.1371/journal.pmed.1001945. eCollection 2016 Jan.
5
Randomised controlled trials cited in pharmaceutical advertisements targeting New Zealand health professionals: do they support the advertising claims and what is the risk of bias?针对新西兰医疗专业人员的药品广告中引用的随机对照试验:它们是否支持广告宣传内容,以及存在何种偏倚风险?
N Z Med J. 2015 Sep 4;128(1421):22-9.
6
Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry self-regulation.2004年至2012年英国和瑞典关于药品促销的投诉、投诉者及裁决:制药行业自我监管的定量与定性研究
PLoS Med. 2015 Feb 17;12(2):e1001785. doi: 10.1371/journal.pmed.1001785. eCollection 2015 Feb.
7
Misleading advertising for antidepressants in Sweden: a failure of pharmaceutical industry self-regulation.在瑞典,抗抑郁药的误导性广告:制药行业自我监管的失败。
PLoS One. 2013 May 1;8(5):e62609. doi: 10.1371/journal.pone.0062609. Print 2013.
8
Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.医药代表与患者安全:加拿大、法国和美国的医药代表信息质量比较前瞻性研究。
J Gen Intern Med. 2013 Oct;28(10):1368-75. doi: 10.1007/s11606-013-2411-7. Epub 2013 Apr 5.
9
UK regulator is to take lighter approach to drug advertisements.英国监管机构将对药品广告采取更宽松的方式。
BMJ. 2013 Mar 1;346:f1396. doi: 10.1136/bmj.f1396.
10
Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.来自制药公司的信息以及医生处方的质量、数量和成本:系统评价。
PLoS Med. 2010 Oct 19;7(10):e1000352. doi: 10.1371/journal.pmed.1000352.

对加拿大违反自愿和制药行业主导的药品促销法规的投诉。

Complaints about Violations of Voluntary and Pharmaceutical Industry-Run Medicine Promotion Codes in Canada.

机构信息

School of Health Policy and Management, York University, Toronto, Canada.

Faculty of Medicine, University of Toronto, Toronto, Canada.

出版信息

Int J Soc Determinants Health Health Serv. 2023 Oct;53(4):518-527. doi: 10.1177/27551938231165158. Epub 2023 Mar 20.

DOI:10.1177/27551938231165158
PMID:36938584
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10631264/
Abstract

Although regulation of pharmaceutical promotion in Canada is covered under the Food & Drugs Act and Regulations, in practice it is regulated by two codes, one a code administered by the Pharmaceutical Advertising Advisory Board and a second one controlled by Innovative Medicines Canada, the lobby organization for the large majority of the Canadian and foreign-owned pharmaceutical companies operating in Canada. This study examines complaints about code violations between 2012 and 2021 and puts those complaints and their outcomes into the context of the stringency of the codes, their governance, monitoring, penalties for violations, and compliance by companies. It combines the findings from this analysis with international experience with industry-run codes and concludes that overall, the Canadian codes are ineffective in controlling promotion. Finally, it offers recommendations for how regulation can be improved and how doctors' reliance on information from pharmaceutical companies can be reduced.

摘要

虽然加拿大的药品促销监管涵盖在《食品和药品法》及其法规之下,但实际上,它由两个规范来管理,一个是由药品广告咨询委员会管理的规范,另一个是由加拿大创新药品协会(代表在加拿大运营的绝大多数加拿大和外资制药公司的游说组织)控制的规范。本研究调查了 2012 年至 2021 年期间对违反规范的投诉,并将这些投诉及其结果置于规范的严格性、治理、监测、违规处罚以及公司合规性的背景下。它将分析结果与国际上行业管理规范的经验相结合,并得出结论,总的来说,加拿大的规范在控制药品促销方面是无效的。最后,它提出了如何改进监管以及如何减少医生对制药公司信息的依赖的建议。