Immune globulins

Informed Consent and Documentation

Informed consent for immune globulin administration must be obtained and documented by the midwife. The following is a suggested statement for prescriber use in obtaining informed consent for plasma protein products (immune globulins). The statement primarily addresses infectious disease risks. It is the responsibility of the prescriber to refer to published Transfusion Medicine resources for current risk factor information.

“The product that you are about to receive is made from human plasma. The plasma is obtained from carefully selected donors and has been screened by sensitive tests capable of detecting a wide range of blood-borne infectious agents, including HIV, hepatitis B and hepatitis C. The plasma has also undergone additional manufacturing steps that effectively render this product extremely safe from risk of infection. There has not been a single case in Canada of transmission of HIV, hepatitis B, or hepatitis C caused by plasma protein products since modern manufacturing practices were introduced decades ago. The estimated risk of infection from various known blood-borne infectious agents ranges from less than one in a million to less than 1 in 10 million or even lower.”

If informed consent is obtained in a facility (i.e. hospital) it should be obtained and documented in accordance with facility policies and procedures. If informed consent is obtained in the community, the midwife should document the process in client’s medical record. The Transfusion Service issuing the product(s) is responsible for reporting final disposition to the BC Provincial Blood Coordinating Office, Central Transfusion Registry. Midwives must provide a record of administration of immune globulin(s) to the client’s primary care provider (i.e. family physician or nurse practitioner) upon discharge from care.

Hepatitis B immune globulin