Eylea risk to fetus

This  is an addendum to the Eylea consent form Eylea.Possible risk for the fetus. Use it for women of child-bearing age. This consent form was revised on 11/5/15.

The main Eylea consent form is at www.omic.com/eylea/.

Eylea

There are two Eylea consent forms

• Use Eylea form for all adult patients receiving Eylea. This form was revised on 3/13/20.
• Ask women of child-bearing age to sign Eylea.Possible risk for the fetus. This consent form was revised on 11/5/15.

Review our risk management recommendations on the use of anti-VEGF drugs in adults.

AntiVEFG drugs for adults addresses on- and off-label use, preventing endophthalmitis, informed consent issues, and documentation. It incorporates key guidelines on intravitreal injection published by a panel of experts. It also addresses the FDA warning about Avastin in more detail.

Perform a time out before each intravitreal injection.

OMIC has received reports of “wrong” events associated with intravitreal injections. These include wrong patient, wrong eye, wrong condition, wrong drug, and wrong dose.

To ensure that the correct drug and dose are injected into the correct eye every time, the ophthalmologist needs to lead a time out. Time out before intravitreal injections provides the opportunity to confirm that the patient, medical record, and ophthalmologist are in agreement.

Lucentis risk to fetus

Lucentis.Possible risk for the fetus is an addendum to the Lucentis consent form. Use it for women of child-bearing age. This consent form was revised on 11/5/15.

The main Lucentis consent form is at www.omic.com/lucentis/.

Lucentis

There are two Lucentis consent forms

• Use the Lucentis form for all adult patients receiving Lucentis. This form was revised on 3/13/20 to add intraocular inflammation to the list of complications.
• Ask women of child-bearing age to sign Lucentis.Possible risk for the fetus. This consent form was revised on 11/5/15.

Review our risk management recommendations on the use of anti-VEGF drugs in adults.

AntiVEFG drugs for adults addresses on- and off-label use, preventing endophthalmitis, informed consent issues, and documentation. It incorporates key guidelines on intravitreal injection published by a panel of experts. It also addresses the FDA warning about Avastin in more detail.

Perform a time out before each intravitreal injection.

OMIC has received reports of “wrong” events associated with intravitreal injections. These include wrong patient, wrong eye, wrong condition, wrong drug, and wrong dose.

To ensure that the correct drug and dose are injected into the correct eye every time, the ophthalmologist needs to lead a time out. Time out before intravitreal injections provides the opportunity to confirm that the patient, medical record, and ophthalmologist are in agreement.

Anti-VEGF Drugs for Adults

Vascular endothelial growth factor, or VEGF, is a protein that stimulates the growth of new blood vessels. Ophthalmologists administer intravitreal anti-VEFG agents to adults for a variety of indications. These include Avastin, BEOVU, Lucentis, and Eylea. Sometimes the indication has been approved by the Food and Drug Administration (FDA), other times it is off-label, or the medication itself may never have been approved for any eye indication.

Time out before intravitreal injections is a sample protocol to verify the patient, drug, dose, etc.

AntiVEGF for adults (updated 2023) presents suggestions to increase patient safety and decrease the likelihood of lawsuits related to these drugs. It also provides information about our revised sample consent documents for anti-VEGF agents:

• Avastin

• BEOVU

• Lucentis

• Eylea