IOM就全球劣质药品问题发布报告

美国医学研究所(IOM) 2月13日发布的一份报告称，假药劣药已对全球公共健康构成威胁，需要政府、制药商以及其他卫生组织合作加以解决。

报告委员会主席、乔治敦大学的Lawrence Gostin教授指出，假药劣药已经成为重大公共健康问题，因为它们不但无效，而且加快耐药，甚至还导致严重疾病和死亡，特别是在假药劣药不断流入市场的发展中国家。基于现代制造业和贸易的国际化特点，每个国家都不能独善其身，在确保高质量药品生产和销售过程中都担负着重要角色。

IOM委员会呼吁世界卫生组织、其他国际组织、政府以及利益相关方应共同制定国际行为准则，增强国家监管能力以及促进国际合作。

该委员会是IOM应美国食品药品管理局(FDA)要求成立的。FDA局长Margaret A. Hamburg在一份声明中指出，FDA已做好充分准备，工作重心由国内监管向确保国际范围内产品安全与质量职能转变。IOM报告中的许多建议已经着手实施，包括在全球7个地区12个国家设立办事机构。

该报告称，首先要做的是事情是世界卫生大会(WHA)应采纳统一的定义，将不符合药典或制药企业标准的药品定义为“劣药(substandard)”，将“虚假表述”性质和(或)来源的药品定义为“假药(falsified)”。为避免混淆，报告委员会反对使用“伪药(counterfeit)”一词。尽管该词已被广泛用于那些没有达到所声称内容的药品，但在有关违反注册商标的法律界定方面过窄。

从集市、缺乏监管的网站以及其他不可靠来源购买的假药和劣药可导致一系列问题，包括缺乏疗效、抗疟药物和抗结核病药物耐受甚至直接中毒。

虽然这一问题的严重程度难以量化，但报告还是引用了一些数据资料，包括25家主要制药公司发现在2011年至少有124个国家存在销售假药和劣药的问题。虽然发展中国家受影响程度更为严重，但发达国家同样也深受其害。该报告特别举出了最近发生在马萨诸塞州化工公司的案例，该公司生产的被污染的类固醇注射剂已导致多例脑膜炎，包括在5个月内发生的44例致命性病例。该报告指出：“FDA与各州药学委员会对化学制药业监管权限不清导致了这一事件的发生。”

另一项关键建议是，在美国建立强制性药品追踪系统，并增加对药品批发商许可证的要求。后者还应包括要求美国各州许可委员会仅对符合美国药房委员会协会(NABP)资格认证标准的批发商发放许可证，FDA和各州许可委员会应建立批发商公共数据库，包括有关取消或暂时取消许可的信息。该报告将二级批发商视为美国药品销售链中的“最薄弱环节”。

该报告指出，为促进上述措施，国会应授权FDA并拨款建立强制性“药品追踪系统”，通过唯一产品编码实现对药品从工厂到消费者的全程追踪。

IOM委员会还建议优化发展中国家药店职员培训，加强交流和训练计划，以培训医务工作者和消费者识别不合格药品以及正确报告疑似情况。来自国际投资机构的资金应该被用于帮助制药企业提高国际标准，帮助中低收入国家监管机构遵守国际生产和质量控制标准。

该研究得到了美国国家科学院与FDA相关协议的资助。

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By: ELIZABETH MECHCATIE, Cardiology News Digital Network

Falsified and substandard drugs are a global public health threat that needs to be addressed cooperatively by governments, manufacturers, and other health organizations, according to an Institute of Medicine report issued Feb. 13.

This is "a grave public health problem because [falsified and substandard drugs] are ineffective, promote drug resistance, and even cause severe illness and death, particularly in developing countries where they regularly flood the market," chair of the report committee, Lawrence Gostin, O’Neill Professor of Global Health Law, Georgetown University Law Center in Washington, said in a statement.

"Given the international nature of modern manufacturing and trade, every nation has a stake and a role to play in ensuring the production and sale of high-quality medications," he said.

The IOM committee is calling on the World Health Organization, other international organizations, governments, and stakeholders to collaborate on "a global code of practice, build national regulatory capabilities, and promote international cooperation."

The committee was convened by the IOM at the request of the Food and Drug Administration. In a statement, Commissioner Margaret A. Hamburg noted that the FDA is transforming from a "predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world," and that many of the recommendations in the IOM report are already underway, including having a presence in 12 countries in seven regions of the world.

Quite simply, the first thing that needs to be done, according to the report, is for the World Health Assembly to adopt consistent definitions, using "substandard" to describe drugs that do not meet pharmacopeia or manufacturer specifications, and "falsified" for those products with a "false representation" of identity and/or source.

To avoid confusion, the report recommends against using the term counterfeit, which, although widely used to refer to drugs that do not contain what they claim to, has a narrow legal definition related to infringement of registered trademarks.

Available in street markets, unregulated websites, and other unreliable sources, falsified and substandard drugs cause problems ranging from a lack of a therapeutic effect and resistance to antimalarial and tuberculosis treatments to frank poisoning.

While it is difficult to quantify the magnitude of the problem, the report cites some data, including the finding by 25 major pharmaceutical companies that in 2011, falsified or substandard drugs were sold in at least 124 countries. And although poorer countries are disproportionately affected, richer countries are impacted too. The report specifically cites the recent case of the Massachusetts compounding company that produced contaminated injectable steroid products, which caused many cases of meningitis, including 44 cases that were fatal in a 5-month period.

"Lack of clarity about the relative authority of the FDA and state pharmacy councils to regulate compounding pharmacies contributed to the outbreak," the report noted.

Another key recommendation: Establish in the United States a mandatory drug tracking system, and strengthen the requirements for licensing medication wholesalers. The report describes secondary wholesalers as the "weakest point" in the U.S. drug distribution chain. The latter should include the requirement that state licensing boards in the United States only license wholesalers that meet accreditation standards of the National Association of Boards of Pharmacy (NABP), and that the FDA and state licensing boards establish a public database with information on wholesalers with revoked or suspended licenses.

To facilitate the changes, Congress should authorize and fund the FDA to create a mandatory "track and trace system" using unique product serial numbers to track packages of medications from the factory to the consumer, according to the report.

The IOM committee also recommended better training for pharmacy staff in developing countries and improved communication and training programs to educate health care workers and consumers about poor-quality medications and how to report suspected cases.

Funding from international investment agencies should be used to help pharmaceutical manufacturers upgrade to international standards, and for governments in low- and middle-income countries to help their regulatory agencies comply with international manufacturing and quality control standards.

The study was supported by a contract between the National Academy of Sciences and the FDA.