cytotec, do you plaor do the docs do it?

Specialties Ob/Gyn

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we are having a little debate at one of the hospitals i work at , the nurses are refusing to place it lady partslly they insist it is not in our scope of practice. i say it is and am the only one doing it. We have a consent form we use and a nursing policy written for us to place it.

let me here how you all do it.

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Specializes in Specializes in L/D, newborn, GYN, LTC, Dialysis.

We nurses place it, if given intralady partslly. None of us has a problem w/it. why would we? it IS in scope of practice the same way starting IV pitocin or putting internal monitors in would be. As long as there are clear protocols in place, and very concise informed consent forms are signed, I am not quite clear why the nurses you work with have a problem. What does your State's nurse practice act say?

I will say this; more and more doctors/midwives are considering changing to the oral route, an idea that seems to work well at the one hospital where i work! Sure would be a LOT more pleasant for the patient, I would think, also.

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according to the board of nursing it is in our scope of practice. but you know some nurses just refuse to change,:). i also think the oral route is a lot nicer for the patient nothing like tring to get that little piece of a pill in the fornix of patient with a very posterior cervix.

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Nurses do it at my hospital. Hmmmmm, that sounded funny, huh? LOL The oral route sure would be nice, we still using only lady partsl.

Anita

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Uuuuuuuuuuuugggggggggghhhhhh.........cytotec gives me the willies.

Yeees, our hosp. has the same deal as yours, Mark, and our nurses place it. I try to get out of placing it if I can. I just don't feel comfortable since that nastygram from the pharm. co. that manufactures it came out a couple of years ago.

I hate using it. It works, but I'd rather use it if I knew the co. that manufactured it backed us up. Potential lawsuit city.

The only time I place it and feel TOTALLY comfortable is with an IUFD.

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i feel the same way SHAY my old hospital i worked at it was used only for IUFD. we never used it with viable babies.

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we also only use it for iufd and drs. place it.

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I have heard Cytotec is only FDA approved for preventing ulcers, and that the insert in the package says it is not to be used on pregnant women. This isn't to start a debate or anything, just wondering how in the world did someone realize this drug is good for induction, and what makes it legal to be used in another way than it was approved for?

The info below is not by me, just stuff I found on the net.

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Here is the label insert from cytotec:

Cytotec®

(misoprostol)

WARNINGS

CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE

BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN

PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see

also PRECAUTIONS, and LABOR AND DELIVERY). CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO

REDUCE THE RISK OF ULCERS INDUCED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See

CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).

PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO

GIVE THE DRUG TO OTHERS.

Cytotec should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing

potential unless the patient is at high risk of complications from gastric ulcers associated with use of the

NSAID, or is at high risk of developing gastric ulceration. In such patients, Cytotec may be prescribed if

the patient

has had a negative serum pregnancy test within 2 weeks* prior to beginning therapy.

is capable of complying with effective* contraceptive measures.

has received both oral and written warnings of the* hazards of misoprostol, the risk of possible

contraception failure, and the danger to other women of childbearing potential should the drug be

taken by mistake.

will begin Cytotec only on the second or third day of the next* normal menstrual period.

DESCRIPTION

Cytotec oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E 1

analog.

This is the revised label. The following is a letter from the company that makes cytotec, this letter was sent out to OB's

Letter from Searle Warning Doctors Against Cytotec Birth Inductions

Cytotec's manufacturer, Searle, pleaded for doctors to stop using Cytotec on pregnant women. Here is a reprint of the letter, also found on this FDA web page.

August 23, 2000

Important drug warning concerning unapproved use of intralady partsl or oral misoprostal in pregnant women for induction of labor or abortion

Dear Health Care Provider:

The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.

Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.

The uterotonic effect of Cytotec is an inherent property of prostaglandin E1(PGE1), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.

Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe lady partsl bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established

Searle promotes the use of Cytotec only for its approved indication.

Further information may be obtained by calling 1-800-323-4204.

Michael Cullen, MD

Medical Director, U.S.

Searle

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Specializes in Specializes in L/D, newborn, GYN, LTC, Dialysis.

and BRETHINE was approved for use in ASTHMATICS and had similar warnings, also Magnesium was not put into IV form for preterm labor treatment, either, if memory serves. You bring up good points, Natalie. Many many drugs are being used and/or tested for different purposes than originally designed. And boy, do I agree, the issues w/liability are scary. And cytotec is no different. But you can get into similar hyperstim. situations with prostin gel and cervidil. I only like cervidil and other products like laminara because you can remove them! Once a pill is inserted or swallowed, you cannot take it back.

I agree with ANYone who says it can be risky. I keep the brethine very, very handy (e.g. in my pocket, drawn up) and it behooves any nurse to keep these things in mind when administering ANY medication. One cannot ever predict with 100% accuracy all the potential side-effects and adverse reactions that might occur with meds and various patients/medical conditions!

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Specializes in ER.

The docs put it in at our hospital, the nurses were going to but refused after an episode of hyperstim during which the doc accused the RN of putting it IN the cervix.

Perhaps the drug company is not willing/wants to make sure that potential suits r/t use with pregnant women are directed away from their company. The main deterrent was that it can cause abortions, but that is also the reason we use it- the side effect is the desired effect. Many hospitals-including ours- review all miso charts to get statistics re adverse events and it's safety relative to all out other options including section. So far miso comes out as extremely safe and effective. Apparently all the published studies back up our findings.

Lots of times we give our doses q4h x3 and the woman has no effect, but will wake in the middle of the night in a "natural" labor and come back to the hospital. I think it is a very gentle induction- would have an easier time justifying myself in using miso than in some cases of pit inductions.

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We had a policy in which physicians were to place it BUT we many times did it. Then, the committee decided, with legal counsel that the hospital should not have a policy for cytotec and took it away. Now, the understanding is that we DON'T HAVE a cyctotec protocol and the doc has to write his own orders for it. Some of the nurse insert it and others do not. I don't. At least they no longer insert it and send the patients home....That was lawsuit just waiting to happen. My feeling is that this is experimental and we have no policy....so it is their place to insert it. That is how I stand on cytotec.

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Tiffany, you make excellent points that it looks like ALL OF US have made re: cytotec.

It's a scary drug. The whole potential for hyperstim is just too great.

Blue eyes, I did NOT know that about brethine or mag!!! Huh...educational!!

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