PRG Dallas ASC, LP Surgery Center & Key-Whitman Have Stopped Use Of Guardian Compounded Medications

Doctors at Key-Whitman Eye Center and the PRG Dallas Surgery Center do not use any Guardian pharmacy medications. This precautionary step was taken because post-operative cataract patients who had surgery here at the PRG Dallas Surgery Center January 30 to February 21, 2017 developed issues with their vision during their recovery period. The issue is isolated to only those patients who received the combined antibiotic and steroid medication compounded by one specific Dallas pharmacy during the January 30 – February 21 timeframe. There is no indication that the issue was due to any surgical technique.

The surgery center and the Key-Whitman doctors using the surgery center no longer use any Guardian products, so there is no chance that patients currently scheduled for surgery will be exposed to any risk of those medications.

Based on Key-Whitman Eye Center’s long history performing successful cataract surgeries, the issues that these specific cataract patients were experiencing was extremely unusual and the team took immediate action.

“Our first priority was the wellness of the patients,” said Jeffrey Whitman, M.D., President and Chief Surgeon at Key-Whitman Eye Center. “We immediately referred patients showing symptoms to retinal specialists for examination and treatment at no cost to the patients. We also notified all patients who had cataract surgery during that time period of January 31 to February 21, 2017, and requested that they come in for an examination at no cost to them. Some patients did not experience any visual acuity issues. For those patients under the care of retinal specialists, some patients have regained normal – or close to normal – visual acuity. Others are apparently still experiencing visual impairment. All surgeons at the PRG Surgery Center who used the locally compounded medication were advised so that they could notify all affected patients.”

Key-Whitman hired an outside laboratory and a pharmacy expert to investigate, and the preliminarily findings have just been released. A pharmacy expert concluded that the compounded medication, which was prepared by an FDA-inspected laboratory in Dallas and provided to the PRG Surgery Center during that exact time-period, may not have been compounded to the specifications represented. The pharmacy expert believes this medication most likely caused the reduction in visual acuity in some patients. Key-Whitman continues to investigate the medication and is following up with patients.

Key-Whitman undertook a comprehensive investigation as soon as the eye center became aware of this matter. Here is what has been learned to date:

1. The visual acuity issue is not caused by any bacteria.
2. The laboratory testing and analysis performed indicate that the medicine that was compounded may be out of specifications and was not as represented to Key-Whitman.
3. The issue is isolated to only those patients who received the combined antibiotic and steroid medication compounded by one specific Dallas pharmacy during the January 31 – February 21 timeframe, and to patients that did develop visual acuity issues.
4. Key-Whitman discontinued its use of the locally compounded medication on February 21, 2017, and experienced no similar issues prior to January 31, 2017 or since February 21, 2017.
5. Key-Whitman has provided a notice letter to the compounding pharmacy requesting they address these issues.
6. Key-Whitman has reported the issues to the FDA and other authorities.
7. The Texas Department of Health Licensing Division inspected and reported no deficiencies with the surgery center.

Surgery centers do not make the medicine. It’s made and delivered pre-packaged by a compounding pharmacy.

“We have never experienced any issues of this nature during our long history of performing successful cataract procedures,” said Dr. Whitman. “We are genuinely concerned and saddened that this has happened and the investigation is ongoing. We are here for our patients and will continue to keep them posted with additional information. We’ve been in touch with all affected patients and continue to monitor their
progress.”

The medication issue is isolated to only one 3-week timeframe: January 31 – February 21, 2017. Key-Whitman no longer uses the medication. There is no risk of getting this medicine at Key-Whitman before or after this three-week time period.