來源：RAPS

4月8日，美國食品藥品監(jiān)督管理局（FDA）警告患者不要使用二手或未批準上市的診斷試紙來監(jiān)測血糖或華法林水平。

通常，糖尿病患者每天需要使用血糖監(jiān)測儀和試紙多次測試血糖水平，以控制病情。服用血液稀釋劑華法林的患者通過試紙測量其國際標準化比值（INR），該比值用于確定華法林用藥劑量。

“數(shù)百萬美國人會在家里使用試紙來監(jiān)測嚴重的疾病或病癥。我們認識到，有些人可能會選擇購買二手或未經(jīng)批準的試紙，因為他們認為這樣可以節(jié)約成本。然而，這樣做可能會使他們處于嚴重受傷甚至死亡的危險境地，”FDA器械和放射健康中心（CDRH）體外診斷和放射健康辦公室主任Tim Stenzel說。

FDA表示，他們已經(jīng)發(fā)現(xiàn)有人在Amazon、eBay和Craigslist等網(wǎng)站上購買二手和未經(jīng)批準的試紙，也有人直接從其他賣家處購買。

雖然美國FDA表示，目前尚未收到與此類試紙相關(guān)的嚴重傷害或死亡報告，但其警告說，試紙所顯示的結(jié)果可能并不準確，進而可能導(dǎo)致患者服藥過多或服藥過少。

FDA還表示，二手試紙可能存在過期、儲存不當(dāng)或被上任使用者的血液污染等問題，這些因素都可能導(dǎo)致讀數(shù)不準確或引發(fā)感染。

因此，F(xiàn)DA建議檢查包裝是否已打開或更改，并檢查其試紙包裝上顯示的有效期，并警惕任何表明試紙未經(jīng)批準的指示信息，如非英文說明。FDA警告說，不核實患者試紙?zhí)幏降馁u家可能出售的就是二手或未經(jīng)批準的產(chǎn)品，因為如果用戶能夠在不提供處方的情況下購買**處方的試紙，則表明其試紙在美國不被授權(quán)銷售。

FDA還要求患者向其MedWatch數(shù)據(jù)庫上報使用試紙所造成的傷害或問題，并舉報任何涉嫌在網(wǎng)上銷售的非法醫(yī)療產(chǎn)品。

對于那些買不起試紙的患者，F(xiàn)DA鼓勵他們與醫(yī)生或藥劑師交談，看看是否有任何患者援助計劃或優(yōu)惠券，幫助他們降低成本。

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 prescr1ption 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.