Key-Whitman In The News UPDATE: PRG Dallas ASC, LP Surgery Center and Key-Whitman Eye Center Have Stopped Use of All Guardian Compounded Medications
- Posted on: Apr 24 2017
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:
- The visual acuity issue is not caused by any bacteria.
- The laboratory testing and analysis performed indicate that the medicine
that was compounded may be out of specifications and was not as represented
- 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.
- 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.
- Key-Whitman has provided a notice letter to the compounding pharmacy requesting
they address these issues.
- Key-Whitman has reported the issues to the FDA and other authorities.
- 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
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.
Posted in: Key-Whitman News