首页 > 资讯 > 仿制药标签变更投票结果耐人寻味

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2014-06-21 Lachman CONSULTANTS

仿制药协会（GPhA）委托了一家调研机构（PublicMind）来针对医生、医师助理、药剂师们对于仿制药拟议标签变更规定的了解程度、它将如何影响他们的行医实践、以及他们对于FDA现行的仿制药标签批准体系的看法。 这一调查得出了一些耐人寻味的结果，概括如下：

再次强调：“调查旨在明确医生、药剂师和医师助理对于该拟议规定的态度、以及它将如何影响他们和/或他们的患者。”该研究调查了450位上述三类医疗保健专业人士，每一类有150人，以下是一些研究得出的结论：

• 有86%的调查者认为在仿制药标签中呈现的有关安全性的信息是足够的。
• 大部分的医生、医师助理及药剂师都没有听过这项拟议规定的新闻，事实上76%的被调查者根本不知道这一拟议规定。
• 处方者和配药师均表达了他们的担忧，认为这项拟议规定将会在市场中造成困惑。大部分（76%）认为患者或多或少都会感到困惑，一半以上（53%）认为，作为从业人员，这种多标签的现象将会使他们“非常”困扰。
• 大多数人认为这个新规定将带来时间上的负面的影响。
  • 71%的参与者认为新规定将会增加他们和他们的患者和回顾个人病例及新标签的时间。
  • 74%的被调查者认为，新规定至少占用了他们的时间来研究标签的不同之处。
  • 同等重要地，大多数（68%）表示，他们没有时间来关注标签的变更情况。
  • 大部分（81%）认为FDA的批准应在在仿制药的安全性标签变更之前， 几乎所有（91%）的被调查者认为在变更仿制药安全标签之前应该可以得到安全性数据。
  • 有关责任的担忧也是另外一个问题，77%的被调查者认为拟议规定多少会影响到他们的法律责任。这一担忧在药剂师（85%）当中更加强烈。
  • 60%的被调查者表示拟议规定将至少“一定程度上”影响他们将来开具仿制药处方的决定。

让人有点心寒的结果是，许多利益攸关方并没有在签发拟议规定时候很恰当地被考虑进来，甚至许多人都对此一无所知。这个例子也证实了对于FDA拟议规定的评论中提到过的问题。其中一个特别令人担忧的问题就是，如果按照现在这份拟议规定来实施的话，许多开具处方者将会在开具仿制药处方的时候思索再三。与此同时，患者和政府都在尝试减少相关的医疗开始，但这项规定事实上会使得治疗药品的开支增高，并且使高质量低价格的仿制药对原研产品的替代性降低了。

除了说FDA这项拟议仿制药标签规定是一剂劣药，我们无需多言！详细的调研结果和方法论证可以在GPhA网站中找到。

Lachman CONSULTANTS - Bob Pollock先生 2014-06-18
校译：识林-柯 2014-06-21

Poll Produces Interesting Results on Generic Drug Labeling Rule
Written by Bob Pollock • June 18, 2014

The Generic Pharmaceutical Association (GPhA) commissioned a survey organization (PublicMind) to poll physicians, physician assistants and pharmacists about how much they knew about the proposed generic drug labeling rule, how it would impact their practice (if at all), and how they felt about the current system of how generic drug labeling is approved by the FDA. The survey had some interesting results, which are summarized below.

Again, “The intention of this study was to ascertain the awareness of physicians, pharmacists and physician's assistants of this proposed rule, and their perceptions of how it may impact them and/or their patients.” The survey polled 450 healthcare professionals in the groups identified above and included 150 participants from each group. Here are some of the conclusions reached from the study:

• Among those surveyed, there is a strong belief (86%) that information presented in generic drug labeling relative to safety was adequate.
• News of the proposed rule had not reached most physicians, physician assistants or pharmacists; as a matter of fact, 76% said they had heard nothing about the proposed rule.
• Prescribers and dispensers both expressed concern that the proposed rule would lead to confusion in the marketplace. Most (76%) said that their patients would be at least somewhat confused, while more than half (53%) say that having multiple safety labels would be “very” confusing for themselves as practitioners.
• Most believe the new rule would have a negative impact on their time.
  • 71% anticipate the new rule would increase the amount they need to spend with their patients reviewing individual patient histories and the new labels;
  • 74% percent believe it would have at least some impact on the time they will need to spend researching labeling differences;
  • Equally as important, most (68%) believe they would NOT have the time required to keep current with the labeling changes.
  • The majority (81%) believe FDA approval should be required prior to changing generic safety labels; while almost all (90%) believe access to safety data should be required prior to changing generic product safety labels.
  • Concerns regarding liabilities are also an issue, as 77% are at least somewhat concerned the proposed rule could impact their legal liabilities. This concern is even more pronounced among pharmacists (85%).
  • 60% say that the proposed rule will have at least “some” influence on their decision to prescribe generic drugs in the future.

These somewhat chilling conclusions are an indication that many of the stakeholders were not properly included in the decision to issue the proposed rule, nor were many even aware of it. The results of this sample also validate many of the issues that have been raised in comments to the FDA's proposed rule. One issue that is of particular concern is that many prescribers indicate that they may think twice about prescribing a generic drug in the future if the rule is implemented in its current proposed form. In a time when patients and the government are all trying to reduce associated healthcare costs, such a result could actually work to increase the costs of drug therapy and reduce the substitution of high quality lower cost generics.

There is no need for us to repeat ourselves, other than to say that the FDA's proposed generic drug labeling rule is bad medicine! The detailed findings and methodology can be found on the GPhA web page, which can be found here.

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