美国国家公共电台 NPR--The FDA has approved an over-the-counter spray to treat opioid overdose

The FDA has approved an over-the-counter spray to treat opioid overdose

Transcript¹

In a long anticipated decision, the Food and Drug Administration approved an over-the-counter version of naloxone spray, a generic² form of the opioid overdose treatment called Narcan.

A MART?NEZ, HOST:

People will no longer need a prescription³ to buy Narcan. That's a nasal spray that reverses opioid overdoses. The Food and Drug Administration announced this morning that it has been approved as an over-the-counter product. NPR pharmaceuticals⁴ correspondent Sydney Lupkin is here to tell us all about it. Sydney, it sounds like a pretty big step.

SYDNEY LUPKIN, BYLINE⁵: Yes. Opioid overdoses are a huge public health problem. The deaths keep climbing. According to the National Institutes of Health, there were more than 80,000 opioid deaths in 2021, and that's up from 21,000 in 2010. So they've basically quadrupled. Opioids are deadlier now because of fentanyl, which is highly potent⁶ and it's, you know, readily available and flooding the market. Narcan is an effective opioid overdose reversal nasal spray that can be used by health care providers, first responders, family members, you name it.

MART?NEZ: And why now?

LUPKIN: The drug maker⁷, Emergent BioSolutions, applied⁸ for Narcan to be available without a prescription for any over-the-counter use back in December. And last month, the FDA held a meeting of its advisers⁹ - these doctors and other outside experts that aren't in the agency, but they advise it - and they wanted them to weigh the risks and benefits of making this change from prescription to over-the-counter. And those advisers voted unanimously to approve Narcan, which is the brand name for naloxone, for use without a prescription.

They said it can be used safely and effectively without the supervision¹⁰ of a doctor or another health care provider. And the advisers emphasized the need to make sure Narcan is really accessible. With a prescription, that obviously takes time, and there's also stigma¹¹. So now it can be sold in gas stations, convenience stores, you know, just about anywhere. And this should hopefully save a lot of people.

MART?NEZ: Why did it take so long to weigh those risks?

LUPKIN: So mainly the reason it took so long in general is because a company needed to step forward and give it a try. The FDA can't force a company to make an application. It's this big time-consuming step where the company needs to gather data, show that people can use it safely, and then the FDA has to do its review.

MART?NEZ: All right. So how soon then can someone get Narcan at any pharmacy¹² without that prescription?

LUPKIN: It's a great question. So not right away nationally. The FDA says the timeline is really up to the manufacturer and it could take months to make the switch from prescription to over-the-counter. And then the other thing that's up in the air is actually price. It's unclear how much this is going to cost over the counter.

MART?NEZ: In the meantime, though, Sydney, what can people do?

LUPKIN: Well, in the meantime, Narcan is available with a prescription, and it's already available in some places for free without a prescription. Public health officials have done what's called a standing¹³ order, which is basically a prescription that covers an entire jurisdiction¹⁴, and that's made the drug widely available in a lot of places. So Baltimore did that, for example. For instance, here in D.C., there's a program for free Narcan pickup¹⁵ or, you know, getting it by mail with discreet¹⁶ packaging.

And there are Good Samaritan laws to protect people seeking and giving help during an opioid overdose. According to GoodRx, there are also three states that provide free Narcan in general. And then cities like Philadelphia and Chicago offer it for free in public libraries. But this new FDA over-the-counter approval would really make it more available everywhere.

MART?NEZ: All right. Thanks for the update. That's NPR pharmaceuticals correspondent Sydney Lupkin. Thanks.

LUPKIN: Thank you.

1 transcript   

n.抄本，誊本，副本，肄业证书

参考例句：

• A transcript of the tapes was presented as evidence in court.一份录音带的文字本作为证据被呈交法庭。
• They wouldn't let me have a transcript of the interview.他们拒绝给我一份采访的文字整理稿。

2 generic   

adj.一般的，普通的，共有的

参考例句：

• I usually buy generic clothes instead of name brands.我通常买普通的衣服，不买名牌。
• The generic woman appears to have an extraordinary faculty for swallowing the individual.一般妇女在婚后似乎有特别突出的抑制个性的能力。

3 prescription   

n.处方，开药；指示，规定

参考例句：

• The physician made a prescription against sea- sickness for him.医生给他开了个治晕船的药方。
• The drug is available on prescription only.这种药只能凭处方购买。

4 pharmaceuticals   

n.医药品；药物( pharmaceutical的名词复数 )

参考例句：

• the development of new pharmaceuticals 新药的开发
• The companies are pouring trillions of yen into biotechnology research,especially for pharmaceuticals and new seeds. 这些公司将大量资金投入生物工艺学研究，尤其是药品和新种子方面。 来自《简明英汉词典》

5 byline   

n.署名；v.署名

参考例句：

• His byline was absent as well.他的署名也不见了。
• We wish to thank the author of this article which carries no byline.我们要感谢这篇文章的那位没有署名的作者。

6 potent   

adj.强有力的，有权势的；有效力的

参考例句：

• The medicine had a potent effect on your disease.这药物对你的病疗效很大。
• We must account of his potent influence.我们必须考虑他的强有力的影响。

7 maker   

n.制造者，制造商

参考例句：

• He is a trouble maker，You must be distant with him.他是个捣蛋鬼，你不要跟他在一起。
• A cabinet maker must be a master craftsman.家具木工必须是技艺高超的手艺人。

8 applied   

adj.应用的；v.应用，适用

参考例句：

• She plans to take a course in applied linguistics.她打算学习应用语言学课程。
• This cream is best applied to the face at night.这种乳霜最好晚上擦脸用。

9 advisers   

顾问，劝告者( adviser的名词复数 )； （指导大学新生学科问题等的）指导教授

参考例句：

• a member of the President's favoured circle of advisers 总统宠爱的顾问班子中的一员
• She withdrew to confer with her advisers before announcing a decision. 她先去请教顾问然后再宣布决定。

10 supervision   

n.监督，管理

参考例句：

• The work was done under my supervision.这项工作是在我的监督之下完成的。
• The old man's will was executed under the personal supervision of the lawyer.老人的遗嘱是在律师的亲自监督下执行的。

11 stigma   

n.耻辱，污名；(花的)柱头

参考例句：

• Being an unmarried mother used to carry a social stigma.做未婚母亲在社会上曾是不光彩的事。
• The stigma of losing weighed heavily on the team.失败的耻辱让整个队伍压力沉重。

12 pharmacy   

n.药房，药剂学，制药业，配药业，一批备用药品

参考例句：

• She works at the pharmacy.她在药房工作。
• Modern pharmacy has solved the problem of sleeplessness.现代制药学已经解决了失眠问题。

13 standing   

n.持续，地位；adj.永久的，不动的，直立的，不流动的

参考例句：

• After the earthquake only a few houses were left standing.地震过后只有几幢房屋还立着。
• They're standing out against any change in the law.他们坚决反对对法律做任何修改。

14 jurisdiction   

n.司法权，审判权，管辖权，控制权

参考例句：

• It doesn't lie within my jurisdiction to set you free.我无权将你释放。
• Changzhou is under the jurisdiction of Jiangsu Province.常州隶属江苏省。

15 pickup   

n.拾起，获得

参考例句：

• I would love to trade this car for a pickup truck.我愿意用这辆汽车换一辆小型轻便卡车。||The luck guy is a choice pickup for the girls.那位幸运的男孩是女孩子们想勾搭上的人。

16 discreet   

adj.(言行)谨慎的；慎重的；有判断力的

参考例句：

• He is very discreet in giving his opinions.发表意见他十分慎重。
• It wasn't discreet of you to ring me up at the office.你打电话到我办公室真是太鲁莽了。