Synagis and consent

What does you hospital policy and procedure call for? Does AWHONN have a policy regarding consent for Synagis?

Federal low requires that parents be given written information and written consent be obtained for certain childhood vaccines. If Synagis is not one of those, then it is up to your institution to formulate an appropriate policy.

One hospital where I worked required written consent for the Hepatitis B vaccine in the NICU, but not on mother-baby. The NICU policy required written consent for all vaccines, but mother-baby required it only for those covered by the federal law. Confusing? You bet!

I just looked this up and I'm wondering why is there a need for consent? What other types of nicu meds would need a consent? TIA!!

Hey again! Per federal guidelines ALL immunizations require informed consent, including HepB. The CDC or AAP.org has the info sheets regarding the immunizations. Synagis isn't considered an immunization,per se, but does have some side effects altho extremely rare. At the other facilities, anything that had a potential for side effects required informed consent. Geesh, we even require a IC for non-invasive hearing screening! I'm just trying to get a feel for what other units do and perhaps why. Thanks for your input!!:)

Thanks for replying Pooh! When I gave immunizations in the office, we had to get the consent. Of course, I've never dealt with Synagis, lol!

We do get a consent. The reason is that not all insurance companies pay for the shot...at $500 for each dose, giving it unwillingly without the parent's knowledge, they'll win if they file suit against the hospital. We didn't realize this until one of our former NICU parents told us...she had twins and had to pay $1000. So since then, we get consent. We get consent also because we inform the parents of any risks and side effects. One of the formula companies offers a great package they put together for Synagis (I think it's Ross). I'm not sure if it's regulated, but any vaccine, we get consent. Just like the flu shot for adults...we don't just give them to all adults that are in the hospital without their knowledge.

Christine, RNC, BSN

According to the CDC website, the National Childhood Vaccine Injury Act requires that the parent/legal guardian be provided a written copy of a Vaccine Information Statement (VIS) prior to each and every dose of any vaccine containing the following components: DPT, MMR, Polio, and Hib. I couldn't actually find anything on the website that mandated written consent, but perhaps that has become the standard of practice to show proof that the parent/guardian received the required information.

Hey there everyone, I have another question and hope ya'll can help. I am working at a new facility and the first ever that has not required a signed consent form to give Synagis. I'm a little leery about this, what's the protocol in your facilities regarding this? Thanks much!

I should have gotten all the info before I posted... but ... I think the reason for this is that Synagis is not an actual "vaccine".its another class of immunization... the word escapes me right now....

Monoclonal Antibody.

Our Pulmonologist speaks with the parents before starting Synagis but no written consent is obtained. I even gave Synagis to my entire assignment one night and none of the kids had consents. This was due to an RSV exposure scare and the entire unit that was "immunized". I'm sure our unit was covering the cost of the Synagis in that case but I don't really know. And whereas I agree that Synagis has potential side effects; don't all drugs? Do we obtain consent before starting Amp and Gent, Caffeine and Reglan? I agree with consents for vaccines, no problem. Course, all we need is a few more suits and we'll have to get a written consent before we change the TPN formulation and vent settings.

But this is the joy of nursing and different hospitals. When I worked adult cardiac and traveled I was amazed to find that what was considered standard procedure and the right thing to do was considered completely wrong at another facility. Hey, I even remember giving transfusions without written consents (seems hard to believe, it was only about 9 years ago). Amazing really. . .

I like the previous post about how infants on the mom/baby unit don't require consent for Hep B but do in the NICU (or was it the other way around?).

We get consent for synargis and all immunizations...we have to have something documented by the docs, even on the mom-baby floor. One of the reasons being (for consent) is that there are many people very opposed to vaccines for a mulititude of reasons and have the right to refuse them...doesn't seem to be an issue with the "standard" meds we use though. The immunizations are a hot topic, esp with the autism concerns. Better to cover thy butt then have it chewed off in court.

Thanks to all of you for your responses! Synagis is a momoclonal antibody and not an immunization per se, but I agree that I should be CMA. There seems to be a wide variance regarding this issue. I spoke to a gentleman from Med-Immune and he says there are no recomendations about IC and that it's left to each individual facility. I agee that this is a potentially HUGE issue since we don't get an IC for HBIG (or amp and gent,etc). With the lawyers and insurance companies directing health care both pre and post hospitalizations, everything has a 50% chance of being the wrong decision,LOL.