February 6, 2014
Two recent outbreaks of fungal endophthalmitis caused by environmental mold contamination were traced to compounded medications labeled as sterile from the same compounding pharmacy, according to results of a multistate investigation by the CDC.
The first reports of this outbreak surfaced in Los Angeles County in nine patients of the same ambulatory surgery center. All patients had undergone pars plana vitrectomy, and all had been exposed to the same lot of brilliant blue G (BBG) dye, which is used to stain the epiretinal membrane during the vitrectomy procedure. The BBG utilized in these cases was produced by Franck’s Compounding Lab, a compounding pharmacy based in Ocala, Florida.
A subsequent case-control study was initiated at the surgical center and evaluated 42 patients who underwent vitrectomies during the same time period (October 2011 to January 2012). The only variable associated with the onset of fungal endophthalmitis was Franck’s Compounding Lab (P<.001). After microbiological testing was conducted on an unopened vial of BBG from the same lot, the environmental mold Fusarium was detected. After it was determined that Franck’s had distributed BBG from this contaminated lot to 22 centers in 15 states, Franck’s recalled all lots of BBG. The CDC then launched its multistate investigation of fungal endophthalmitis.
On March 26, 2012, the CDC learned of a case in New York related to an intravitreal injection of the corticosteroid triamcinolone. Three subsequent cases surfaced at the same ophthalmic practice, and it was revealed that all four patients had been injected with triamcinolone from a single lot compounded at Franck’s Compounding Lab in November 2011. CDC laboratory testing detected Bipolaris hawaiiensis, a rare environmental mold, in this lot.
Franck’s subsequently recalled this lot of triamcinolone. Further case-control studies were conducted to confirm that the two separate outbreaks were associated with Franck’s. The studies confirmed that all Fusarium-confirmed patients had been exposed to BBG, with female sex also associated with infection status (P=.05). The CDC studies also confirmed a significant association between Bipolaris infection and Franck’s triamcinolone (P=.001). In May 2012, Franck’s suspended all sterile compounding services. As of March 22, 2013, a total of 47 cases had been identified in nine states.
The study researchers emphasized the need for greater transparency regarding the FDA approval status of compounded products.
“Clinicians should be aware that the availability of a compounded medication in the United States is not a guarantee of its quality or of FDA approval,” the researchers wrote. “Maintenance of the safety and integrity of sterile compounded drugs in the United States demands a thorough review and improvement of compounding pharmacy regulatory practices.
Disclosure: The researchers report no relevant financial disclosures
quoted from here
The first reports of this outbreak surfaced in Los Angeles County in nine patients of the same ambulatory surgery center. All patients had undergone pars plana vitrectomy, and all had been exposed to the same lot of brilliant blue G (BBG) dye, which is used to stain the epiretinal membrane during the vitrectomy procedure. The BBG utilized in these cases was produced by Franck’s Compounding Lab, a compounding pharmacy based in Ocala, Florida.
A subsequent case-control study was initiated at the surgical center and evaluated 42 patients who underwent vitrectomies during the same time period (October 2011 to January 2012). The only variable associated with the onset of fungal endophthalmitis was Franck’s Compounding Lab (P<.001). After microbiological testing was conducted on an unopened vial of BBG from the same lot, the environmental mold Fusarium was detected. After it was determined that Franck’s had distributed BBG from this contaminated lot to 22 centers in 15 states, Franck’s recalled all lots of BBG. The CDC then launched its multistate investigation of fungal endophthalmitis.
On March 26, 2012, the CDC learned of a case in New York related to an intravitreal injection of the corticosteroid triamcinolone. Three subsequent cases surfaced at the same ophthalmic practice, and it was revealed that all four patients had been injected with triamcinolone from a single lot compounded at Franck’s Compounding Lab in November 2011. CDC laboratory testing detected Bipolaris hawaiiensis, a rare environmental mold, in this lot.
Franck’s subsequently recalled this lot of triamcinolone. Further case-control studies were conducted to confirm that the two separate outbreaks were associated with Franck’s. The studies confirmed that all Fusarium-confirmed patients had been exposed to BBG, with female sex also associated with infection status (P=.05). The CDC studies also confirmed a significant association between Bipolaris infection and Franck’s triamcinolone (P=.001). In May 2012, Franck’s suspended all sterile compounding services. As of March 22, 2013, a total of 47 cases had been identified in nine states.
The study researchers emphasized the need for greater transparency regarding the FDA approval status of compounded products.
“Clinicians should be aware that the availability of a compounded medication in the United States is not a guarantee of its quality or of FDA approval,” the researchers wrote. “Maintenance of the safety and integrity of sterile compounded drugs in the United States demands a thorough review and improvement of compounding pharmacy regulatory practices.
Disclosure: The researchers report no relevant financial disclosures
quoted from here