Risk Management

OMIC Encourages Prompt Reporting of Endophthalmitis in Patients given Brilliant Blue G (BBG)

An alert was released this week by the American Academy of Ophthalmology (AAO) and the Food and Drug Administration (FDA) regarding the use of Brilliant Blue G for eye surgery. (See below) OMIC encourages policyholders who report cases to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program to also call OMIC’s Risk Management Hotline to report the incident and for advice on mitigating risks associated with the event.   Hotline: OMIC’s ophthalmic risk management hotline receives thousands of calls each year from policyholders and their employees in every region of the country. Policyholders and their staffs should know that any time they encounter a difficult situation, they can call an OMIC Risk Manager for help. OMIC’s risk management hotline is confidential from other OMIC Departments and Risk Management staff does not discuss any issues raised through the hotline with anyone else..Records are kept within a secure document imaging system and access to files are limited to Risk Management/Legal staff only.

Policyholders should encourage staff members to use this policyholder benefit whenever needed.

Call (800) 562-6642 then press 4.

UPDATE: FDA Clarifies Its Recall of Brilliant Blue G for Eye Surgery
 

The U.S. Food and Drug Administration issued additional clarifications this week regarding a March 19 recall of Brilliant Blue G (BBG). The FDA recommends that ophthalmologists immediately quarantine and return only any remaining Brilliant Blue G product that was received from Franck’s Compounding Lab in Ocala, Fla.

Prior quarantine recommendations had not been specific to that compounding laboratory.

Academy members are asked to report any cases of post-procedural fungal or bacterial endophthalmitis that occurred in the last six months that are associated with eye surgery in which BBG was used. Reports should be made to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online at www.fda.gov/MedWatch/report.htm; or

Call 800.332.1088 to request a reporting form and return to the address on the pre-addressed form, or submit by fax to 800.332.0178.

AAO/FDA Alert:

The Academy is assisting the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention and state and local health agencies with an ongoing public health investigation. The FDA has received reports of fungal endophthalmitis in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians in several states have reported adverse events. The BBG was supplied by Franck’s Compounding Lab in Ocala, Fla. The pharmacy issued a recall of all lots of BBG on March 9.

Brilliant Blue G is not an approved drug in the United States. The FDA recommends that all Brilliant Blue G be immediately quarantined and returned. This includes all lots of BBG received from Franck’s Pharmacy. To assist with this investigation, Academy members are asked to report any cases of post-procedural fungal or bacterial endophthalmitis that occurred in the last six months that are associated with eye surgery in which BBG was used. Reports should be made to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Online at www.fda.gov/MedWatch/report.htm; or
• Call 800.332.1088 to request a reporting form and return to the address on the pre-addressed form, or submit by fax to 800.332.0178.

For more information, contact the Academy’s Governmental Affairs Office at 202.737.6662.