During the past few years, compounding pharmacies have received a lot of press. In 2012, a story involving a compounding pharmacy received national attention when as many as 14,000 people received contaminated injections of a steroid medication. A total of 751 patients contracted meningitis or other infections from the injections, and 64 people in 20 states died.1
A year before this nationwide outbreak, ophthalmologists at Bascom Palmer Eye Institute in Miami were treating patients who had received intraocular injections of tainted Avastin. As early as November 2011, Roger A. Goldberg, MD, MBA, reported a series of 12 patients who developed Streptococcus endophthalmitis after injection with intravitreal bevacizumab.2,3 These 12 patients presented to Bascom Palmer with severe intraocular infections one to six days after receiving an intravitreal injection of bevacizumab. The injections occurred at four different clinics in south Florida, but all doses of bevacizumab were prepared by the same compounding pharmacy in Broward County.
None of the patients received injections at Bascom Palmer, but nine patients presented to its tertiary-care ophthalmic emergency room for treatment, and three others were seen in consultation. Initially, all patients were treated with vitreous tap and injections, and eight patients later received a vitrectomy. Microbiology cultures for 10 patients were positive for Streptococcus mitis/oralis. Seven unused syringes of bevacizumab prepared by the compounding pharmacy at the same time as those prepared for the affected patients were also positive for S. mitis/oralis. After four months of follow-up, all but one patient had count fingers or worse visual acuity, and seven ultimately required evisceration or enucleation.
Dr. Goldberg, who is now in practice at Tufts New England Eye Center and Ophthalmic Consultants of Boston, explains that many of the patients in the Miami outbreak of endophthalmitis were part of the same health insurance group.
“They mandated the use of a specific compounding pharmacy for their patients, and this placed the contracted retinologists in a difficult situation,” says Dr. Goldberg. “They were told that they had to get their Avastin from a particular pharmacy for this subset of their patients. The syringes were labeled for each patient and were shipped to the doctor’s office in advance of the patient visit. One patient expected to only need an injection in one eye, so a syringe was sent for that patient. On exam, the patient had a new submacular hemorrhage in the other eye and required treatment in the fellow eye as well. The fellow eye received Avastin from another source, and this eye did not develop endophthalmitis, despite being treated on the same day. So, we know it wasn’t the doctor’s injection technique that caused the infection.”
In another practice, four patients from this medical group were no-shows for their appointment, and Dr. Goldberg and his colleagues were able to track down the four unused syringes, and they were culture-positive with the same bacteria. “We know that the bacteria came in the syringes. It was not introduced by the physicians,” he adds.
Reports in the media have increased awareness about compounding pharmacies and how they operate. “To be honest, I didn’t know much about the compounding process and the regulations and guidelines associated with it until this happened,” Dr. Goldberg says. “In ophthalmology, since the 12-case outbreak of endophthalmitis, we have seen several more small outbreaks associated not just with Avastin, but with triamcinolone and brilliant blue dye. Awareness of the issue has grown over the past few years, and more than a dozen compounding pharmacies have recalled Avastin syringes and other drugs due to sterility concerns.”
Compounding pharmacies are not all the same in terms of their size, their breadth and how many states they operate in. “The south Florida endophthalmitis outbreak originated from a relatively small pharmacy; the nationwide meningitis outbreak was a much larger pharmacy,” Dr. Goldberg says. “Both had problems with how they were handling drugs, inspecting equipment, maintaining sterility and ensuring sufficient documentation. One of the issues that the investigators in south Florida had was tracking down all of the syringes that were made at the time that these contaminated syringes were made. Because the documentation wasn’t in order, it made the Department of Health inspector’s job more difficult.”
He notes that Bascom Palmer has prepared nearly 100,000 Avastin syringes without any incidence of contamination, so they can be prepared safely. “The CATT trial compared the effectiveness of Avastin with Lucentis, and there were no more episodes of endophthalmitis with Avastin than there were with Lucentis,” he says. “Avastin would be more expensive if it was prepared in the way that the CATT trial prepared it, but still a lot less than $2,000, which is what Lucentis costs.”
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A year before this nationwide outbreak, ophthalmologists at Bascom Palmer Eye Institute in Miami were treating patients who had received intraocular injections of tainted Avastin. As early as November 2011, Roger A. Goldberg, MD, MBA, reported a series of 12 patients who developed Streptococcus endophthalmitis after injection with intravitreal bevacizumab.2,3 These 12 patients presented to Bascom Palmer with severe intraocular infections one to six days after receiving an intravitreal injection of bevacizumab. The injections occurred at four different clinics in south Florida, but all doses of bevacizumab were prepared by the same compounding pharmacy in Broward County.
None of the patients received injections at Bascom Palmer, but nine patients presented to its tertiary-care ophthalmic emergency room for treatment, and three others were seen in consultation. Initially, all patients were treated with vitreous tap and injections, and eight patients later received a vitrectomy. Microbiology cultures for 10 patients were positive for Streptococcus mitis/oralis. Seven unused syringes of bevacizumab prepared by the compounding pharmacy at the same time as those prepared for the affected patients were also positive for S. mitis/oralis. After four months of follow-up, all but one patient had count fingers or worse visual acuity, and seven ultimately required evisceration or enucleation.
Dr. Goldberg, who is now in practice at Tufts New England Eye Center and Ophthalmic Consultants of Boston, explains that many of the patients in the Miami outbreak of endophthalmitis were part of the same health insurance group.
“They mandated the use of a specific compounding pharmacy for their patients, and this placed the contracted retinologists in a difficult situation,” says Dr. Goldberg. “They were told that they had to get their Avastin from a particular pharmacy for this subset of their patients. The syringes were labeled for each patient and were shipped to the doctor’s office in advance of the patient visit. One patient expected to only need an injection in one eye, so a syringe was sent for that patient. On exam, the patient had a new submacular hemorrhage in the other eye and required treatment in the fellow eye as well. The fellow eye received Avastin from another source, and this eye did not develop endophthalmitis, despite being treated on the same day. So, we know it wasn’t the doctor’s injection technique that caused the infection.”
In another practice, four patients from this medical group were no-shows for their appointment, and Dr. Goldberg and his colleagues were able to track down the four unused syringes, and they were culture-positive with the same bacteria. “We know that the bacteria came in the syringes. It was not introduced by the physicians,” he adds.
Reports in the media have increased awareness about compounding pharmacies and how they operate. “To be honest, I didn’t know much about the compounding process and the regulations and guidelines associated with it until this happened,” Dr. Goldberg says. “In ophthalmology, since the 12-case outbreak of endophthalmitis, we have seen several more small outbreaks associated not just with Avastin, but with triamcinolone and brilliant blue dye. Awareness of the issue has grown over the past few years, and more than a dozen compounding pharmacies have recalled Avastin syringes and other drugs due to sterility concerns.”
Compounding pharmacies are not all the same in terms of their size, their breadth and how many states they operate in. “The south Florida endophthalmitis outbreak originated from a relatively small pharmacy; the nationwide meningitis outbreak was a much larger pharmacy,” Dr. Goldberg says. “Both had problems with how they were handling drugs, inspecting equipment, maintaining sterility and ensuring sufficient documentation. One of the issues that the investigators in south Florida had was tracking down all of the syringes that were made at the time that these contaminated syringes were made. Because the documentation wasn’t in order, it made the Department of Health inspector’s job more difficult.”
He notes that Bascom Palmer has prepared nearly 100,000 Avastin syringes without any incidence of contamination, so they can be prepared safely. “The CATT trial compared the effectiveness of Avastin with Lucentis, and there were no more episodes of endophthalmitis with Avastin than there were with Lucentis,” he says. “Avastin would be more expensive if it was prepared in the way that the CATT trial prepared it, but still a lot less than $2,000, which is what Lucentis costs.”
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