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Rhophylac vs. Rhogam


melvolny

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Pricing was slightly better and shipping receipt time is 24 hours from order on weekdays for our facility. We did have a surprise within the last year or so on a weekend (of course). Mom delivered fine with no suspected bleeding. We wound up giving her 6 units of Rhophylac! She was very appreciative of the IV administration!

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:confused:An Ortho rep once said that if the doctor ordered Rhogam, you would have to have his/her permission to "substitute" another brand.

I wonder if there was a policy stating that the substitute was routinely used in the hospital, if that would be acceptable.

When the Dr. orders something that is not currently stocked, e.g. FFP but you stock FP24 or 7 random platelets but you have pheresis only, you probably have a policy that states that equivalent components will be substituted, correct? There is no difference if he orders RhoGam and you stock Rhophylac. We switched to Rhophylac about 7 years ago due to price and the flexibility of the administration route. The nurses (and patients) really like the ability to give it IV.

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One word of caution with the IV administration of Rhophylac. I think I read on this site that there have been some problems with the multiple doses of Rhophylac given too quickly and too close together by the IV route causing some "transfusion reaction like" problems and that the product insert had to be modified to address the problem and slow the administration rates down. Any one else remember that? I know we have a policy for the number of shots of RhoGam and how close together thay can be given - same problem, just faster through the IV route.

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  • 2 months later...

Our policy states that we will only stock 300cmg (1500 IU) units of Phophylac. Our Blood Bank serves a trauma center and critical care OB units at two different hospitals. The one situation that still sticks with me is a mother came to one of the critical care areas after a car crash and delivered. She ended up needing something like 19 vials. I am sure that she appreciated not having all of those IM.

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We use Rhophylac (patients and nurses love the IV capability) and pharmacy profiles each order electronically just like any other drug for possibility of interactions or contraindications. Our orders are linked in the HIS in that Pharmacy and lab see their orders separately but they are a part of the same order set.

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  • 4 weeks later...

We have been using Rhophylac for >10 years. Our Pharmacy orders it and gets the revenue, but the entire supply is stocked and issued by the Blood Bank.

This is about to change. Our hospital corporation (TENET) is requiring that Pharmacy issue it. The change will occur with a massive number of hospitals switching to Cerner Millenium software. We have no idea what the process will be, and we 'Go Live' in October.

Anyone using Cerner and have a process for RhIG they would like to share?

Currently we use Sunquest and have 3 different orders for RhIG, but TENET is no longer allowing test bundling.

I'm afraid that there will only be an order for RhIG product, and the Blood Bank will have to order the appropriate tests.

RHIG-OP (for all antepartum reasons) includes:

ABO/Rh

Antibody Screen

RhIG Interpretation (RhiG indicated or not indicated)

Allocate and issue product

RHIG-AB (fetal demise - abortion or miscarriage) includes:

ABO/Rh

Antibody Screen

Fetal Screen - if needed

RhIG Interpretation (RhiG indicated or not indicated)

Allocate and issue product

Women in Labor are Typed and Screened upon admission

RHIG (post partum) includes:

Mother's ABO/Rh (we perform a weak D as a check for FMH - backup for FS)

Baby's ABO/Rh

Fetal Screen

RhIG Interpretation (RhiG indicated or not indicated)

Allocate and issue product

How does everyone else handle requests? Thanks

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It's still debatable whether the Joint Commission specifically requires oversight by Pharmacy. Some inspectors are citing for it, but we have yet to find a regulation stating RhIg specifically. Comes down to semantics: is it a "drug" or a "derivative"?

Just to cover ourselves, our order for RhIg in our HIS is two-fold: one order goes to Pharmacy to go on the MAR in the electronic medical record, the other comes to us so that we can issue it from the Blood Bank after all necessary tests are complete. Until the JC comes up with clear guidance on this, you might want to try something like this to get the inspectors to leave you alone.

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We have been told recently that JCAHO requires pharmacy oversight and that RIG is to be treated as a drug, so we are currently redefining our process.

Interesting - I had just been communicating with the FDA about RhIG and requirements of CLIA testing. It appears that they consider RhIG the same as a blood product based on the CLIA testing requirements. If the testing must meet CLIA requirements and is not considered waived, I'm not sure how RhIG can be treated solely as a drug. :confused: Of course, dealing with JCAHO is a horese of a different color but I think it at least needs to be considered.

Jeanne

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My statement was based on a communication from our Quality/Performance Improvement Department which was based on the following post by the Joint Commission:

Thank you for submitting your standards question to the Joint Commission!

Below you will find the response to your original submitted question(s).

Original Question:

During our recent triennial survey, discussion centered on the

administration of RhoGam for the RH Negative mother. Does Joint Commission

consider RhoGam to be a medication or a blood product? Does Joint

Commission require 2 RNs to sign off for the administration of RhoGam as

either a medication or a blood product?

Thank you.

SIG Response:

Thank you for your inquiry. We use the FDA's list to determine whether

substances are medications and Rhogam is listed as a medication,

therefore, the medication management standards would be applicable. The

organization would determine which department - blood bank or pharmacy -

would be responsible for dispensing, however, the pharmacy should be

involved in the process and consider reviewing the process for managing

Rhogam under MM.08.01.01. Regarding two RNs to sign off, the organization

would determine this based on law and regulation or by organizational

policy.

I hope you will find this information helpful. If you have additional

questions please submit them online or call 630-792-5900 option 6.

Please understand that full compliance with the intent of the standards

can only be assessed during an onsite survey.

The information transmitted is intended only for the person or entity to

which it is addressed and may contain confidential and/or privileged

material. Any review, retransmission, dissemination or other use of this

information by persons or entities other than the intended recipient is

prohibited. If you receive this in error, please immediately contact the

sender and delete the material from any computer.

John Wallin

Joint Commission

www.jointcommission.org

Standards Interpretation Group

Phone: 630-792-5900, Option 6

It would seem that we are getting conflicting information from the FDA and Joint Commission.

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