News & Press: Patient Safety

An Important Message from Dr. Ray Baker, ISIS President, on the Meningitis Outbreak

Tuesday, October 16, 2012  
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As I write this, there have been a total of 247 confirmed fungal infections in 15 states, resulting in 19 deaths. This is a horrible tragedy for all involved. At ISIS, we are most concerned with the patients and their families, and we want to offer our sincere condolences during this difficult time to all those who have been affected. We are also concerned about the treating physicians who assumed and expected that they were obtaining safe medications from a reputable, national compounding pharmacy. Patients and physicians alike may have been unwitting victims of poor oversight and under-regulation of compounding pharmacies. This letter is to update you on some information related to the fungal outbreak, and to keep you abreast of what ISIS is doing on your behalf.


After being alerted by the Centers for Disease Control (CDC) of the outbreak, we assisted in contacting stakeholder societies by providing the CDC with names and contact information. We immediately began informational posts on the ISIS website, with daily updates and have issued multiple e-blasts to the membership. These have contained the most up-to-date information available regarding the outbreak, as well as links to the CDC and Food and Drug Administration (FDA).


Having worked with the CDC since last April on safe injection practice policies, including the single dose vial policy, ISIS appointed a Patient Safety Task Force in July, composed of members from the Standards, Education, Research, and Socioeconomic Committees. This task force just published the first in a series of ‘FactFinder’ statements aimed at increasing member awareness of safe injection practices, and dispelling myths around single dose vials and repackaging of medications (ISIS SDV/Repackaging FactFinder).


Predictably, as soon as the outbreak became public, numerous media outlets contacted ISIS for statements and content expertise. Having been alerted by the CDC, ISIS had ‘talking points’ already prepared. We distributed these to other stakeholder societies, and worked collectively with them to assure that accurate information was transmitted to the media, and focus remained on the primary issue associated with this outbreak: the contamination of medication by a compounding pharmacy.


Indeed, ISIS’ emphasis has remained consistent over time: properly performed interventions - interventions performed by skilled physicians who are appropriately trained and are performing the right procedure on the right patient for the right indications - are safe and effective.


Although not quoted often, ISIS representatives have spent countless hours on the phone and on email with reporters over the past two weeks providing content expertise and answering questions. We have provided media representatives with scientific data refuting claims of treatment ineffectiveness and injections abuse, and supporting the efficacy of our interventions. We have facilitated patient interviews with reporters to help balance some of the stories of alleged harm from injections that have been highlighted in the media. Indeed, positive stories are getting out, but not as often as we would like. Unfortunately, as is often the case, some in the media seem most interested in sensational stories and allegations.


We have countered claims of physician ‘profit motive’ as the rationale for using compounding pharmacies, and have made the media aware that the primary reason physicians use compounding pharmacies for methylprednisolone is not a result of the CDC SDV policy or any profit motive; it is to obtain a preservative-free preparation that is commercially unavailable, and may be safer for patients. We also reminded reporters of ISIS’ strong stance on scope of practice, and of the fact that ISIS only teaches specialty boarded physicians who are qualified to undertake the complex practice of medicine required to diagnose and treat these complicated patients.


We continue to stress that the overall number of severe complications with interventional pain procedures is very small, and that sensationalizing these complications might actually lead to greater numbers of patients being harmed as they opt for other, riskier treatments. As issues of increased utilization are raised, while not condoning the abuse of injections, we note that the vast number of Interventional Pain Medicine (IPM) physicians are conscientious and are earnestly trying to provide the best care for their patients.


This weekend, I traveled to Washington, DC and attended the American Society for Anesthesiologists (ASA) Pain Committee Meeting and a meeting of the "Council of Pain Physician Societies” where representatives from ISIS, ASA, American Academy of Pain Medicine, American Society for Interventional Pain Physicians, and North American Neuromodulation Society spent a great deal of time discussing issues related to the outbreak, and developing a common response.


At ISIS, we realize that this is a very difficult time for all of you. We want to assure you that we will continue to work ceaselessly to provide you with timely, accurate information during this crisis; to provide you with the education you need moving forward; to work on solutions to reduce the need for reliance on compounding pharmacies; to advocate for strict and appropriate regulation of compounding pharmacies; and to safeguard the reputation of Interventional Pain Medicine.


I want to especially thank the ISIS staff, who have worked tirelessly keeping the board and committees updated on breaking events, gathering the latest media releases, obtaining background information, and preparing web posts and various responses. Suffice it to say that all of the staff have done a tremendous job during this difficult time.


Please continue to monitor our e-news, website and social media as we continue to bring you breaking news and up-to-date information on this issue.

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