Ugh! Is this happening, again?
Image of Fungi Growing in Culture. Credit: istockphoto.com
The last several months have been rough for the compounding pharmaceutical industry. This past week, the Food and Drug Administration (FDA) website posted a press release from MedPrep Consulting regarding possible fungal contamination in pharmaceuticals processed at the MedPrep New Jersey compounding facility. The press release quickly followed a recall advisory posted on the FDA website on Monday on the same issue. (1, 2)
Ironically, a “60 Minutes” expose about the now-bankrupt New England Compounding Center (NECC) was aired just a couple of weeks ago. Hundreds of patients were sickened and 50 patients died after mold-contaminated injectible steroid medications processed at NECC were shipped to medical facilities in several states. (3, 4)
The MedPrep problem has the potential to be much worse, as the contaminated product, magnesium sulfate intravenous (IV) solution, could be administered to many more patients. (1, 2)
The battle over profit versus patient welfare continues as compounding facilities try to balance profit vs. patient welfare. The patients don’t always win in the end. I don’t know if that was the situation in the MedPrep case, but I do believe there should be some kind of financial incentive (other than possible bankruptcy from potential lawsuits if something goes wrong) for ensuring sterile laboratories. Right now, the most the FDA can do is post recall advisories after the fact. (5)
So far, there have been no reported incidents of patients who have become ill in this latest contamination scare. All we can do now is watch and wait.
Update: Yes, again. A Georgia compounding pharmacy, Clinical Specialties Compounding Pharmacy, has issued a recall for all of its sterile pharmaceuticals, including Avastin, after several patient complaints of eye infections. The “Sterile ophthalmic” section of their website is now “under construction.” (6, 7) The saga continues…..
1. “MedPrep Consulting Inc. Announces Voluntary Nationwide Recall of All Lots of All Compounded Products Due to Potential Mold Contamination.” MedPrep Press Release. Food and Drug Administration (FDA) Website. March 20, 2013. http://www.fda.gov/Safety/Recalls/ucm344787.htm. Retrieved March 21,2013.
2. “FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey” Food and Drug Administration (FDA) Website. March 18, 2013. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm344314.htm. Retrieved March 21,2013.
3. “Lethal Medicine Linked to Meningitis Outbreak.” 60 Minutes. Website. http://www.cbsnews.com/video/watch/?id=50142537n. Retrieved March 21,2013.
4. AP Wire. “FDA warns of possible mold contamination as New Jersey pharmacy recalls all compounded drugs.” The Washington Post. March 18, 2013. Website. http://www.washingtonpost.com/business/fda-warns-of-possible-mold-contamination-as-new-jersey-pharmacy-recalls-all-compounded-drugs/2013/03/18/6b36f572-9009-11e2-9173-7f87cda73b49_story.html. Retrieved March 21,2013.
5. Tavernise, Sabrina. “F.D.A. Chief Seeks Expanded Authority to Improve Safety of Drug Compounders.” New York Times. Website. http://www.nytimes.com/2012/11/15/health/fda-asking-for-more-control-over-drug-compounding.html?_r=0. Retrieved March 22, 2013.
6. “Georgia Compounding Pharmacy Recalls Sterile Products: FDA.” Reuters. March 21, 2013. Website. http://www.reuters.com/article/2013/03/21/us-fda-recall-idUSBRE92K1DF20130321. Retrieved March 21, 2013.
7. “Sterile Ophthalmics.” Clinical Specialties Compounding Website. http://www.clinicalrx.net/sterile_ophthalmic.html. Retrieved March 27, 2013.
Post Updated March 27, 2013.