For patients and doctors alike, this should be a nightmare. A drug that a doctor orders and injects into a patient that isn’t sterile. It is supposed to be sterile but it is not. This simply can’t happen. Ever. As a matter of fact, not only isn’t the drug sterile, the drug has a fungus growing in it. This is a disaster.
In the US, there is no excuse. This is what happens when there is no oversight of business. Profits. Profits are the bottom line. Good people lose sight of what they are doing. I don’t know whether the folks that ran New England Compounding Center were good folks or not. What I do know is that New England Compounding Center took advantage of a loophole in our laws. As a compounding company they didn’t fall under the FDA. Compounding companies are not manufacturers. Unfortunately, New England Compounding Center acted as the manufacturer for many, many patients.
| Laboratory-Confirmed Organisms from Product Samples Associated with NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions |
||
|---|---|---|
| Medication | Lot Number | Microbial Contamination |
| Betamethasone6 mg/mL injectable – 5 mL per vial | [email protected] | Paenibacillus pabuli/amolyticus; Bacillus idriensis; Bacillus flexus; Bacillus simplex; Lysinibacillus sp., Bacillus niacini, Kocuria rosea, Bacillus lentus |
| Betamethasone6 mg/mL injectable – 5 mL per vial | [email protected] | Bacillus niabensis; Bacillus circulans |
| Betamethasone12 mg/mL injectable – 5 mL per vial | [email protected] | Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis |
| Betamethasone6mg/mL injectable – 5 mL per vial | [email protected] | Bacillus lentus, Bacillus firmus, Bacillus pumilus |
| Betamethasone6 mg/mL injectable – 5 mL per vial | [email protected] | Penicillium sp., Cladosporium sp. |
| Triamcinolone40mg/mL injectable – 1 mL per vial | [email protected] | Bacillus lentus, Bacillus circulans, Bacillus niabensis, Bacillus nealsonii, Bacillus subtilis group, Bacillus firmus |
| Triamcinolone40 mg/mL injectable – 2 mL per vial | [email protected] | Aspergillus tubingensis, Penicillium sp. |
| Triamcinolone40mg/mL injectable – 10 mL per vial | [email protected] | Aspergillus fumigatus |
| Cardioplegia solution 265.5 mL per bag |
[email protected] | Bacillus halmapalus/horikoshii, Brevibacillus choshinensis |
This is a partial list of the medications that were contaminated at the New England Compounding Center. This wasn’t just one batch. Instead, multiple medications were found to be contaminated. Again, let me reiterate, there is no excuse. In the United States, if are going to get serious about healthcare, we have to begin taking care of patients. This means that everything that doctors order are prepared to the highest standards. It is that simple.
To date, there have been 63 deaths associated with contamination of medications compounded at the New England Compounding Company. There are 749 patients who are infected and who are receiving anti-fungal treatment.
Somebody needs to go to jail. (You can find more information here.)