On Oct. 6, 2012, the New England Compounding Center issued a voluntary recall of all products after it distributed a contaminated steroid injection to several practices, resulting in numerous cases of meningitis. Since then a nationwide outbreak of meningitis has infected and killed several people who received the injection to ease chronic joint pain.
The Food and Drug Administration issued warnings about several of the company's products and is currently investigating the outbreak. In the meantime, pain management physicians and clinics have notified patients who may have been infected. Others are reassuring patients they didn't use NECC products.
Here, Edward Tavel, MD, founder and medical director of Pain Specialists of Charleston (S.C.) discusses how pain physicians can avoid these problems in the future.
Q: How can surgery centers make sure they are safe?
Dr. Edward Tavel: Compared to inpatient acute care settings, ambulatory care settings are largely responsible for creating their own safety infrastructure and policies.
For ASCs, the first step towards safety should be accreditation. My practice, Pain Specialists of Charleston, is accredited by the Accreditation Association for Ambulatory Health Care. AAAHC accreditors critically examine practice policies, processes and techniques; this includes an examination of medications and devices, assessment of internal policies, review of vendors and evaluation of procedure technique. Pursuit of an AAAHC Accreditation helps ASCs develop best practice, safety-first infrastructures that benefit both the ASC and the patient.
Outside of accreditation, internal and external oversight is critically important. Recent problems with compounding pharmacies are magnified because these pharmacies do not fall under FDA regulation. If a vendor or provider does not fall under federal or state oversight, it is the ASC's responsibility to self-protect. My practice only works with organizations and suppliers that have FDA regulation, quality controls and well-established oversight systems.
Last but not least, ASCs need to establish processes to promote safety from the top to bottom of their organization. For example, physicians operate under the basic expectation of safe injection practices but staff and support staff (Lab, UDS, etc.) may not have or function under that same expectation. Leveraging the CDC's "One and Only" campaign — "1 needle, 1 syringe, 1 time = 0 infection" — is a great way to establish a practice-wide policy. In addition, we train and retrain on infection control, clinical best practices, OSHA, AIDET, etc. ASCs can look to organizations like APIC for great educational materials.
Q: How does your center stay updated with the regulations?
ET: We do quality assessments on the clinical side all the time and infection control is an important part of that. We have a thorough evaluation policy and standard safe injection policies. Most importantly, we are always focused on our affiliation with AAAHC. We had our re-accreditation last week, and that sets the bar.
Q: What do you do to tell potential patients about your accreditation and how do you show them your center provides high quality care?
ET: We have the AAAHC accreditation on our business cards. After the news about the compounding pharmacies, we ran a letter in the newspaper to put patients at ease and sent emails out telling them not to worry. We strive for quality with the accreditation. Our patients aren't at risk at all, and we wanted to make sure we educated our community about that. There are a lot of people who do what we do, and accreditation is a distinguishing factor for our center.
Q: What will it take to prevent another outbreak like this in the future?
ET: FDA oversight. The FDA needs to get involved with compounding companies like they are with major pharmaceutical companies. ASCs should only work with licensed and credentialed companies.
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Pressing Issues in Interventional Pain Management Advocacy: Q&A With Dr. Scott Glaser of The American Society of Interventional Pain Physicians