The Good Samaritan Hospital is in the process of notifying certain patients to watch for symptoms associated with infections because they may have received medications prepared by the New England Compounding Center (NECC) in Framingham, MA, which are now subject to an investigation by the Food and Drug Administration (FDA). Letters are in the process of being sent to patients who were treated at The Good Samaritan Hospital between May 21, 2012 and October 5, 2012 and who received one of seven medications that may have been produced by NECC. To date, there are no reported cases of infection from anywhere in the nation involving NECC products used at Good Samaritan.
According to the FDA, the NECC produced an injectable steroid medication, methylprednisolone acetate, which has been implicated in the multistate outbreak of fungal meningitis and joint infections. A second NECC product, triamcinolone, is also been identified as a potential infection source by the FDA. The Good Samaritan Hospital did not use either of these NECC products.
For patient safety, the FDA has advised hospitals and physicians to stop using all NECC products. Good Samaritan had previously used seven NECC products.
“Based on the most recent information available from the FDA, there have been no reports of infections in any state that are associated with the NECC products used at The Good Samaritan Hospital,” said Good Samaritan Vice President for Strategic Planning and Marketing William Mulligan. “However, out of an abundance of caution, we are contacting patients as we cannot be sure that other products from the NECC were sterile.”
Signs and symptoms of infection could include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light), altered mental status, swelling, increasing pain, redness, warmth at injection site, or drainage from the surgical site. “If you have any of these symptoms, you should seek medical care so that you can be properly evaluated,” Mulligan said.
Good Samaritan receives medications from a variety of vendors. It is possible that a patient may have received a medication that was produced by a different pharmaceutical supplier. As a precaution, the hospital will notify all patients receiving the seven medications that are used at the hospital and that may have been produced by NECC. Notification letters will be sent to 480 patients.
“When we became aware of the original investigation, The Good Samaritan Hospital pharmacy staff immediately ceased use of all NECC products even though they were not part of the initial outbreak notices. When the FDA updated its advisories to secure and withhold all NECC products, we were already in compliance with the recommendation,” Mulligan said.
If patients want to learn more about the investigation of products from NECC, they may call the FDA’s Division of Drug Information at 855-543-DRUG (3784) and press * to get the most recent information regarding the multistate meningitis outbreak, report an adverse event, or speak directly to a pharmacist. Additional information is available at http://www.cdc.gov/hai/outbreaks/meningitis.html and http://www.fda.gov/drugs.
“Our primary concern at Good Samaritan is to protect our patients,” Mulligan said. “Although it may be scary to receive this information, we want to help patients recognize symptoms so that they can seek treatment if needed.”
For 122 years, the Good Samaritan Health System (www.gshleb.org) has served the health care needs of Lebanon County. The Good Samaritan Hospital is a modern, fully-equipped, fully-accredited 172-bed acute care facility that offers complete inpatient and outpatient care, as well as an inpatient rehabilitation program. The Good Samaritan Health System also provides services at many other sites located throughout Lebanon County.