It is widely discussed about the meningitis outbreak that has happened in several states of America. Contaminated Methylprednisolone Acetate injections led to fungal meningitis in over 500 patients. The contamination turned out to be fatal for 39 persons: they died. The majority of deaths occurred in Tennessee.
It was said that contaminated steroid injections had been produced by the New England Compounding Center (NECC) that is based in Massachusetts. The FDA tested the company in order to determine what caused contamination and see the situation at the NECC. It was affirmed by the FDA that the contaminated steroid injections were really produced by this compounding pharmacy.
The FDA told the Associated Press that it was evident that preparing of products was unsterile at the NECC. The FDA noticed that leaking water and uncontrolled temperature were only certain problems at the pharmacy. The equipment used for manufacture of solution for injections was unsterile.
Furthermore, the FDA stated that there were certain other contaminants. Several bacterial contaminants were discovered at the compounding center. However these contaminants were not real pathogens, they were capable to lead to infection as well. These bacterial contaminants were found in such medicines, as Betamethasone and Triamcinolone. There were not any situations reported about contamination resulted from usage of these preparations. But it was noted that these medicines were also able to cause contamination. Although the bacterial contaminants were anywhere in the environment, they had not to be in drugs. This fact pointed at unsterile conditions at the compounding center and confirmed that the Methylprednisolone Acetate injections turned out to be contaminated with fungal meningitis because they were produced in inappropriate conditions.
The situation made it clear that new rules on compounding pharmacies should be implemented. Contamination should be prevented. Otherwise, public health is in danger in the USA.
Комментариев нет:
Отправить комментарий