经营企业占28.2% Business enterprise accounted for 28.2%

　　药品生产企业占0.8% Pharmaceutical producing enterprises accounted for 0.8%

　　医疗机构占71.0% Medical institutions accounted for 71.0%

　　2011年，郑州市药监局共接到药品不良反应报告10530份，其中，医疗机构仍是上报主体，上报7471份，占71%，而药品生产企业上报仅仅87份，占0.8%。这是郑州市药监局不良反应中心近期公布的结果。

In 2011,，Zhengzhou city were received, the administration's adverse drug reaction report of 10530，the，A medical institution is still the main report，Report of 7471，71%，And pharmaceutical production enterprise report of 87 only，0.8%。This is the administration's adverse reaction of zhengzhou city center recently published results。

　　药品不良反应信息监测，本该是“主角”的药品生产企业，为何成了“配角”？

Adverse drug reaction monitoring information，Should be“Leading role”The pharmaceutical production enterprise，Why was“Supporting role”？

　

　数字 digital

　　郑州市去年报告药品不良反应10530例 Zhengzhou city last year's report 10530 cases of adverse drug reaction

　　昨天，记者从郑州市药监局不良反应中心了解到，2011年，郑州市共收到药品不良反应报告数量10530份；其中严重不良反应报告数量167份，一般不良反应10363份。

yesterday，Reporters from the administration's adverse reaction of zhengzhou city center to know，In 2011,，Zhengzhou received a total of adverse drug reaction report of 10530 number；The serious adverse reaction report of 167 number，General adverse reactions of 10363。

　　在这些不良反应中，男性要稍微多于女性。数字显示，男性5489例，占52.13%，女性5041例，占47.87%。

In these adverse reaction，Men want a little more than women。Digital display，5489 male patients，Accounted for 52.13%，Women in 5041 cases，Accounted for 47.87%。

　　而不良反应报告比较集中的药品品种则为左氧氟沙星、阿奇霉素、头孢曲松。

And adverse reactions report quite centralized drug varieties is levofloxacin、azithromycin、ceftriaxone。

　

　问题 problems

　　不良反应报告中企业上报比例仅占0.8% Adverse reaction report only accounted for 0.8% of enterprise report

　　根据国家相关法规，不良反应信息上报主体有3个：药品生产企业、各级医疗机构以及药品经营企业。

According to the relevant state regulations，Adverse reaction information report has three main body：Pharmaceutical production enterprise、At all levels of medical institutions and drug operation enterprise。

　　但令人遗憾的是，原本是不良反应上报主角的企业却成了“配角”。

But unfortunately，Originally reported adverse reactions leading enterprises have become“Supporting role”。

　　统计数字显示，郑州市这10530份报告中，来自医疗机构的有7471份，占71.0%，来自经营企业的有2972份，占28.2%，而来自药品生产企业的仅有87份，占0.8%。

Statistics show that，Zhengzhou the 10530 report，From medical institutions have 7471 copies，Accounted for 71.0%，From the business enterprise with 2972 a，Accounted for 28.2%，And from the pharmaceutical production enterprise's only 87 copies，0.8%。

　　无独有偶，根据国家药监局今年5月31日发布的《2011年国家药品不良反应监测年度报告》，报告显示，2011年，我国药品不良反应报告中来自医疗机构的占83.1%，来自药品生产、经营企业的占13.7%，来自个人的报告占3.2%。报告认为“医疗机构作为不良反应报告主体的格局依然不变”，药品生产、经营企业的报告比例“仍显不足”。

similarly，According to the state's drug watchdog on May 31, this year released《The 2011 national adverse drug reaction monitoring the annual report》，The report shows that，In 2011,，Our country adverse drug reaction report from medical institutions accounted for 83.1%，From the pharmaceutical production、Business enterprise's 13.7%，From personal report accounted for 3.2%。The report says“Medical institutions as adverse reactions reporting entity pattern is still the same”，Pharmaceutical production、Business enterprise report proportion“It still shows insufficient”。

　　

原因 reason

　　生产企业“家丑不外扬”，法律处罚额度低 Production enterprise“There is a skeleton in the cupboard are”，Legal penalty line low

　　药品企业为何不愿意主动上报不良反应信息？

Pharmaceutical enterprise why not willing to report adverse reaction information？

　　“有些企业认为报告药品不良反应会影响药品销售，因此抱着‘家丑不可外扬’的心理进行瞒报。”郑州大学法学院教师潘永建认为，由于药品的特殊性以及制药企业和普通消费者之间极大的信息不对称，企业在决策时往往会倾向有利于经济利益的决定。

“Some enterprise think report adverse drug reaction will affect drug sales，Therefore hold‘Skeleton in the closet’Psychological to conceal。”Zhengzhou university law school teachers PanYongJian think，Due to the particularity of drugs and pharmaceutical enterprises and average consumer information asymmetry between greatly，Enterprises in the decisions often have a tendency to economic interests decision。

　　除此以外，潘永建认为，我国法律、法规不太健全，处罚力度不够也是一个重要原因。

In addition，PanYongJian think，Our country law、Rules and regulations don't too perfect，Punishment is not enough is also an important reason。

　　据了解，2004年颁布实施的《药品不良反应报告和监测管理办法》是我国首部药品不良反应报告和监测管理的行政法规，根据该办法，我国对企业未按要求及时上报不良反应信息的，给予1000元以上3万元以下罚款。

It is understood，Issued and implemented in 2004《Adverse drug reaction monitoring reports and management measures》Is China's first adverse drug reaction report and monitoring management of administrative rules and regulations，According to the way，To our country enterprise fails to timely according to the requirements of information reported adverse reaction，Give more than 1000 yuan to 30000 yuan。

　　2011年7月开始，这个《办法》进行了修订，新修订的《办法》对生产企业主动开展监测工作提出更明确和更高的要求，处罚额度提高，但也只有5000元以上3万元以下。

Beginning in July 2011，this《way》Were revised，The newly revised《way》On production enterprise actively carry out monitoring work more clear and put forward higher requirements，Punishment line to improve，But only 5000 yuan of above 30000 yuan of the following。

　　而英国规定可处以罚金和最高2年监禁，其中罚金无数额限制。日本规定对违规企业可处以罚金30万日元并从NHI药品目录中删除直至撤销产品许可证。美国采取警告信、禁令、传讯、起诉等多种方式。

The British regulations may be fined and maximum 2 years in prison，The amount of the fine without limit。Japan rules for illegal enterprise can be fined 300000 yen and from NHI drug directory delete or even revoke the product license。The United States take warning letters、ban、cited、Prosecution and so on many kinds of ways。

　

　建议 Suggestions

　　营造企业主动上报积极性 Build enterprise initiative enthusiasm report

　　加大处罚力度 Increase punishment

　　药品不良反应，是指合格药品在正常用法用量下出现的与用药目的无关的有害反应。

Adverse drug reaction，Refers to the qualified pharmaceutical in normal usage and dosage of the drug appear with unrelated to adverse reaction。

　　潘永建认为，由于缺乏相关的专业知识，一些公众常将药品不良反应误认为是由药品的质量问题引起的。这种认识就导致公众排斥药品不良反应通报品种，于是不敢使用该品种，甚至不敢使用同类产品。而这在一定程度上也会影响制药企业药品不良反应上报的积极性，因此，他建议公众也应科学认识药品不良反应。

PanYongJian think，Due to the lack of related professional knowledge，Some of the adverse drug reaction will often mistaken for the pharmaceutical quality problems cause。This kind of understanding will lead the public to reject adverse drug reaction bulletin varieties，So can't use this variety，Don't even use similar products。And this, to a certain extent, also can affect pharmaceutical enterprise adverse drug reaction the enthusiasm of the report，therefore，He suggested that the public should also scientific understanding of the adverse drug reaction。

　　同时，他还认为，违法成本低，没有风险，也是制药企业不报告药品不良反应的一大原因，他建议，国家应该像国外一些发达国家那样，加大处罚力度。

At the same time，He also thinks，Illegal low cost，No risk，Is also the pharmaceutical enterprise don't report adverse drug reaction one big reason，He suggested that，Countries should like some developed countries abroad as，Increase punishment。

　　据媒体报道，近年来，国际制药巨头因药品安全问题遭受重罚者不在少数，葛兰素史克曾被罚30亿美元，辉瑞也被罚过23亿美元，而今年6月，强生就因隐瞒药物风险被罚22亿美元。

According to media reports，In recent years，International pharmaceutical giant for drug safety problem suffered heavy person is not a few，Glaxosmithkline has been a $3 billion fine，Pfizer has been fined $2.3 billion，But in June this year，Johnson &johnson is for concealing its risk is a $2.2 billion fine。

　

　借鉴 reference

　　建立“药品不良反应强制保险制度” To establish“Adverse drug reaction compulsory insurance system”

　　药品不良反应监测体系是国际上通用的一种体系，我国于1989年成立国家药品不良反应监测中心，负责收集和管理ADR信息，郑州市的不良反应监测中心成立于2004年。

Adverse drug reaction monitoring system is the international general a system，China was founded in 1989 countries adverse drug reaction monitoring center，Responsible for collection and management information ADR，Zhengzhou adverse reaction monitoring center was founded in 2004。

　　在国际医药界，完善的不良反应监测系统通常被看作预防用药事故、推进新药研发以及提升用药安全的有效措施。

In the international pharmaceutical industry，Perfect adverse reaction monitoring system is generally considered as a preventive medicine accident、Promote new drug research and development and promotion of safe drug use effective measures。

　　那么，国外企业在规避药品不良反应风险这一领域有何值得借鉴的做法？

so，Foreign enterprises in the adverse drug reaction to avoid the risk of this field is the practice of what is for reference？

　　郑州市法律援助中心的徐苏说，建立“药品不良反应强制保险制度”是一个值得探索的办法。

The legal aid center of zhengzhou city XuSu said，To establish“Adverse drug reaction compulsory insurance system”Is a worth exploring way。

　　据《中国医药报》报道，早在2008年，有关药品不良反应的险种已经在一些保险公司低调上市，但一直没有大规模推广。而在美国、瑞典等国家，这种方式早已存在。企业可以通过两种方式购买药品保险：一是单一制药企业购买药品保险，保险费由企业自行承担；二是几大制药企业联合购买集团保险，保费共摊、风险共担。这样，就能在一定程度上卸下企业的“包袱”。

According to《Chinese medicine for》reports，As early as in 2008，The adverse drug reaction has been planted in some insurance companies listed on the low key，But there has been no mass promotion。In the United States、Countries such as Sweden，This way has long existed。An enterprise may, through two ways to buy drug insurance：One is single pharmaceutical enterprise purchase drug insurance，Insurance premium shall be borne by the enterprise；The second is a few big pharmaceutical companies to work together to buy group insurance，Premium common stand、Risk sharing。this，Can to a certain extent the unloaded enterprise“burden”。

　　不过，国内药企对这种保险的接受需要一个过程，要想制度化，更不是一朝一夕能实现的。“如果药品不良反应险能够像车险那样实行强制性购买的话，那将是最理想的结果。”徐苏说。 (大河报记者李晓敏 制图 扈森)

but，Domestic medicine vulnerable to this kind of insurance accept need a process，Want to institutionalization，More not in one day can achieve。“If adverse drug reaction risks can be like auto insurance that implement mandatory purchase words，That will be the most ideal results。”XuSu said。 (The river news reporter LiXiaoMin drawing's tenure)