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Ophthalmic Medications Supplied by NECC Recalled; Confirms Previous Statement That Mission Health Never Purchased or Used The Product Linked To The Fungal Meningitis Outbreak
ASHEVILLE, N.C. (Oct. 19, 2012) Today, Mission Health officials released the information below regarding medications produced by the New England Compounding Center (NECC).
On Oct. 15, 2012, the Food and Drug Administration (FDA) released a statement expressing concern about the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, produced by NECC and used after May 21, 2012. According to the FDA, the sterility of any injectable drugs produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection.
Mission Health has confirmed its previous statement on Oct. 4, 2012, that it never purchased or used the specific steroid linked to the fungal meningitis outbreak associated with NECC. Since that time, the FDA issued additional recommendations that all health providers alert patients of potential risk of infection from any injectable drugs produced by NECC, including ophthalmic drugs that are injectable or used in conjunction with eye surgery.
Mission Health officials have confirmed that approximately 500 patients at Mission Hospital and Blue Ridge Regional Hospital were administered ophthalmic medications (used during eye surgery) supplied by NECC. As recommended by the FDA, Mission Health is currently contacting all such patients and advising them to contact their medical provider if they develop certain specified symptoms. Additionally, on Oct. 4, 2012, Mission Health immediately suspended all purchases from NECC.
It is important for our patients to understand this notification is a precaution and, at this time, no cases of eye infections have been reported in connection with any NECC-produced ophthalmic drugs administered through Mission Health, said William Maples, MD, Senior Vice President and Chief Quality Officer for Mission Health. However, Mission Health takes patient safety and transparency very seriously, and will continue monitoring this situation and take all appropriate steps to protect those we serve.
About Mission Health
Mission Health, based in Asheville, N.C., is the states sixth-largest health system and the regions only not-for-profit, independent community hospital system governed and managed exclusively in western North Carolina. In 2012 Mission Health was named one of the nations Top 15 Health Systems by Thomson Reuters the only health system in North Carolina to receive this recognition.
Mission Health, which traces its roots in the region back to 1885, operates five hospitals, numerous outpatient and surgery centers, and the regions only dedicated Level II trauma center. Its medical staff consists of more than 1,000 physicians and is certified in over 50 medical specialties and sub-specialties. Mission Health has seven Centers of Excellence: Cancer, Heart, Mission Childrens Hospital, Neurosciences, Orthopedics, Trauma and Womens Health. Mission Hospital, located in Asheville, is the systems flagship hospital and is licensed for 730 beds. It is the regional referral center for tertiary and quaternary care and is the busiest surgical hospital in North Carolina. It also includes Mission Childrens Hospital the regions only childrens hospital. Other Mission Health member hospitals include Angel Medical Center in Franklin, Blue Ridge Regional Hospital in Spruce Pine, McDowell Hospital in Marion and Transylvania Regional Hospital in Brevard. With approximately 8,800 employees and 700 volunteers, Mission Health is dedicated to improving the health and wellness of the people of western North Carolina.