【奥译言】美国FDA警告患者不要使用二手和未经批准的诊断试纸

2019-04-11 09:14 阅读数：3249 标签：

4月8日，美国食品药品监督管理局（FDA）警告患者不要使用二手或未批准上市的诊断试纸来监测血糖或华法林水平。

通常，糖尿病患者每天需要使用血糖监测仪和试纸多次测试血糖水平，以控制病情。服用血液稀释剂华法林的患者通过试纸测量其国际标准化比值（INR），该比值用于确定华法林用药剂量。

“数百万美国人会在家里使用试纸来监测严重的疾病或病症。我们认识到，有些人可能会选择购买二手或未经批准的试纸，因为他们认为这样可以节约成本。然而，这样做可能会使他们处于严重受伤甚至死亡的危险境地，”FDA器械和放射健康中心（CDRH）体外诊断和放射健康办公室主任Tim Stenzel说。

FDA表示，他们已经发现有人在Amazon、eBay和Craigslist等网站上购买二手和未经批准的试纸，也有人直接从其他卖家处购买。

虽然美国FDA表示，目前尚未收到与此类试纸相关的严重伤害或死亡报告，但其警告说，试纸所显示的结果可能并不准确，进而可能导致患者服药过多或服药过少。

FDA还表示，二手试纸可能存在过期、储存不当或被上任使用者的血液污染等问题，这些因素都可能导致读数不准确或引发感染。

因此，FDA建议检查包装是否已打开或更改，并检查其试纸包装上显示的有效期，并警惕任何表明试纸未经批准的指示信息，如非英文说明。FDA警告说，不核实患者试纸处方的卖家可能出售的就是二手或未经批准的产品，因为如果用户能够在不提供处方的情况下购买仅限处方的试纸，则表明其试纸在美国不被授权销售。

FDA还要求患者向其MedWatch数据库上报使用试纸所造成的伤害或问题，并举报任何涉嫌在网上销售的非法医疗产品。

对于那些买不起试纸的患者，FDA鼓励他们与医生或药剂师交谈，看看是否有任何患者援助计划或优惠券，帮助他们降低成本。

英文原文

FDA Warns Patients Against Using Pre-Owned and Unauthorized Diagnostic Test Strips

The US Food and Drug Administration (FDA) on Monday warned patients against using pre-owned or unauthorized diagnostic test strips used to monitor glucose or warfarin levels.

Patients with diabetes are typically required to test their blood sugar using a glucose monitor and test strips multiple times per day to manage their condition. For patients taking the blood thinner warfarin, test strips are used to measure their international normalized ratio (INR), which is used to determine dosing.

“Millions of Americans use test strips at home to monitor serios diseases or conditions. We recognize that some people may be choosing to purchase pre-owned or unauthorized test strips because they believe there is a cost savings. However, by doing so they may be putting themselves at risk for serious injury or even death,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the Center for Devices and Radiological Health (CDRH).

FDA says it has found preowned and unauthorized test strips for sale on online marketplaces including Amazon, eBay and Craigslist, as well as directly from other sellers.

While the agency says it has not received reports of serious injuries or deaths associated with such test strips, it warns that inaccurate results could lead patients to take too much or too little medicine.

FDA says that pre-owned test strips could potentially be expired, improperly stored or contaminated with the previous owner’s blood, which could result in inaccurate readings or cause infection.

As such, FDA is advising patients to check the expiration dates on the packaging of their test strips and to be wary of signs that the test strips are unauthorized, such as instructions that are not in English. FDA warns that sellers who do not verify a patient’s prescription for test strips may be selling pre-owned or unauthorized products.

FDA is also asking patients to report an injury or problem they have with test strips to its MedWatch database and to report any suspected unlawful medical products being sold online.

For patients who may be having difficulty affording their test strips, FDA encourages them to speak with their physician or pharmacist to see whether there are any patient assistance programs or coupons that could reduce their costs.

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/4/fda-warns-patients-against-using-pre-owned-and-una

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