Procrit FDA Warning: The Language Barrier

[Tait, MSN, RN]

The scenario:

H&H 10.1/29.5

Elderly female hip fx

Does not speak English

Husband of same age refuses to use translation line. States he will translate for her (to the translation line, when I first got him to use it on admission, then he said "no more phone").

Ordered dose of Procrit. Two calls to the pharmacy and we have no information in this patient's language to give them for the FDA required warning.

I chose not to give the medication, and after talking to pharmacy had it retimed for the am in hopes that their more fluent English speaking son would be in to help translate. (Though for the two minutes I saw him during my shift he was very abrupt in telling me not to talk to his mother as "she doesn't understand you". On a side note I told him flat out that my tone and touch was meant to be reassuring, even if she didn't understand). Anyway, I was afraid that if I gave the Procrit, w/o the warning, and she had a reaction, that it would be a hot mess.

My question is, has anyone else run up against this situation with the FDA required warning on Procrit and has anyone procured a multi-lingual copy of it?

Tait

[UM Review RN, ASN, RN]

I would've done what you did. I believe in informed consent.

[Penguin67]

Just out of curiosity, what is the FDA warning for Procrit? I don't give this drug and am interested to know. Thanks.

[Tait, MSN, RN]

Basically the warning is a two page sheet outlining the possible side effects of the drug that we are required to give the patient prior to administration. The first line clearly outlining "death" as a side effect that pretty nmuch stops all patients in thier tracks.

In fact, the patient family, as outlined in my original post, refused the med the next day after reading the paper (in English to the English speaking/reading son).

If I get some time later I will try and "Cliff Notes" the paper we hand out with our Procrit.

Tait

[CraigB-RN, MSN, RN]

Information for Patients

Patients should be informed of the increased risks of mortality, serious cardiovascular events,

thromboembolic events, and tumor progression when used in off-label dose regimens or populations

(see WARNINGS). In those situations in which the physician determines that a patient or their caregiver

can safely and effectively administer PROCRIT® at home, instruction as to the proper dosage and

administration should be provided. Patients should be referred to the full "Information for Patients"

insert and that it is not a disclosure of all possible effects. Patients should be informed of the possible

side effects of PROCRIT® and of the signs and symptoms of allergic drug reaction and advised of

appropriate actions. If home use is prescribed for a patient, the patient should be thoroughly instructed

in the importance of proper disposal and cautioned against the reuse of needles, syringes, or drug

product. A puncture-resistant container should be available for the disposal of used syringes and

needles, and guidance provided on disposal of the full container.

[RN1982]

I think you were right not to give it. I didn't know that there was an FDA warning regarding Procrit. Thanks for the info.

[lpnflorida]

side note, medicare dose not pay for procrit injections unless they are given in a doctors office. Upseting for me as we live 27 miles away from the doctor, so every two weeks its a drive in, wait an hour have injection then drive home.

[traumaRUs, MSN, APRN]

I work in nephrology and Procrit and its associated med; Epogen are given on a daily basis here. Agree pt needs informed consent. I think you did the right thing.

[mariarn80]

Please guys can you send me a concent form for procrit. I am going to give one starting this week. It scares me a lot. So many S/E and so on. I work in home health. Thanks